|
Pharmed Juno seeks further strategic collaboration with biotechnology company 2SEVENTY BIO
9Pharmaceutical Juno-B announced today that it intends to expand its strategic alliance with 2seventy bio,Inc。
The potential collaboration builds on the company's relationship with 2seventy bio, established in 2022, and builds on the company's translational and clinical cell therapy development platform with 2seventy bio, which was initially aimed at faster development of T cell-based immunotherapy products in Greater China。Specifically, the company and 2seventy bio intend to jointly develop additional drug candidates from 2seventy bio's portfolio for solid tumor indications using T cell receptor-based technologies and autoimmune diseases using CAR T cell technology pathways。
As of the date of this announcement, the potential partnership is still under negotiation, and the Company and 2seventy bio have not reached a definitive agreement regarding the potential partnership。因此，潜在合作未必能进行。
2seventy bioIs a cell and gene therapy company engaged in the research, development and commercialization of innovative cancer therapies with the aim of truly disrupting the field of cancer treatment。Its approach combines its expertise in T cell engineering and lentiviral vector gene delivery methods, its experience in cell therapy research, development and production, and a suite of technologies that can be selectively deployed to develop highly innovative next generation targeted cell therapies for cancer patients。2seventy bio's lead product, ABECMA, is the first CAR T cell therapy approved by the U.S. Food and Drug Administration for the treatment of multiple myeloma。
（信息来源：智通财经）
Corning & Jerry of Suzhou and Broad Life Sciences Group entered into collaboration on TFPI monoclonal antibody KN057
9月20日，Suzhou Kangning Jeri Biotechnology Co., Ltd. and Sichuan Yuanda Shuyang Pharmaceutical Co., LTD., a wholly-owned subsidiary of Broad Life Sciences Group Co., Ltd. announced today，The two parties have signed a cooperation agreement on the rights and interests license of KN057, a monoclonal antibody of tissue factor Pathway Inhibitor (TFPI) independently developed by Corning & Jerry's in Greater China。
根据协议条款，Jerry Corning Suzhou will continue to be responsible for the follow-up clinical studies, marketing registration applications and product supply of KN057 for hemophilia A and Hemophilia B;Broad Shuyang will be exclusively responsible for the marketing and commercial sales of KN057 in Greater China，And to Suzhou Kangning Jereh to pay a cumulative maximum of 500 million yuan of equity payments (including down payment and milestone payment) and graded sales commission。
KN057是苏州康宁杰瑞自主开发，A monoclonal antibody with independent intellectual property rights，通过特异性靶向TFPI，Neutralize the inhibitory effect of TFPI on FXa and TF/FVIIa complexes，维持凝血酶水平，达到预防出血的作用，It is expected to be effective in patients with hemophilia A and B with or without inhibitors。KN057 has a long half-life and can be injected subcutaneously, which is conducive to improving the compliance and effectiveness of long-term preventive treatment for hemophilia patients, so as to improve the quality of life of patients。At present, the Phase II clinical study of KN057 for hemophilia has been basically completed。
Dr. Ting Xu, Founder and Chairman of Suzhou Corning & Jerry, said, "We are delighted to partner with Broad Life Sciences on KN057。KN057 has a unique mechanism of action and molecular design, and there is no drug with the same target on the market in the world。KN057 is expected to overcome the limitations of traditional hemophilia treatment drugs and bring patients an effective and more convenient preventive treatment option。This commercial collaboration further strengthens our confidence in the market potential of KN057.。Next, we will accelerate the registration of KN057 clinical research, and strive to benefit the majority of patients as soon as possible。”
Mr. Feng Zenghui, Chairman of Broad Life Sciences, said, "Diseases of the blood system are one of the therapeutic areas that Broad Life Sciences focuses on。The cooperation between Broad Life Sciences and Suzhou Corning Jerry will better meet clinical needs through innovative research and development, jointly improve the treatment level of hemophilia in China, and benefit the majority of patients。With a strong sense of social responsibility, we look forward to the early approval of KN057。”
Founded in 2008, Suzhou Kangning Jereh is committed to the research and industrialization of antibody and protein macromolecule drugs。The company has a complete macromolecular drug research and development technology platform，It has established a complete R&D functional chain from early screening of macromolecular drugs (antibody screening platform and early efficacy evaluation platform), cell engineering (antibody mixture platform and double specific antibody platform), cell line construction, pilot study, pilot scale up, quality research (macromolecular process development platform), non-clinical and clinical research of drugs to declaration and registration。Up to now, the company has obtained a total of 8 Class 1 biological products and 5 bioanalogues for clinical research approval, of which 3 varieties have been selected for national major new drug development special。The company also transferred more than 30 biotechnology and products to many domestic pharmaceutical companies, which greatly promoted the industrialization process of biomedicine in Suzhou, Jiangsu and even the whole country。
"Honesty, innovation, growth, honor, cooperation" is the core philosophy of Suzhou Corning Jerer, the company hopes to provide patients with more efficient and affordable biological drugs through continuous innovation。
Broad Life Sciences is a comprehensive pharmaceutical enterprise group with profound industrial layout and international vision。The company has R & D centers and production bases in more than 10 cities such as Beijing, Chengdu, Hangzhou, Shenyang, Wuhan, Chongqing, Nanjing, Zhengzhou, Yantai and Anshan，Among them: Yuanda Shuyang based on high-end blood products and to recombinant, gene therapy of blood disease treatment rapidly expanded;Hangzhou Yuanda, Chongqing Yuanda and Qingdao Yihao jointly build a probiotic health industry chain;Broad (Liaoning) deep cultivation perioperative drugs for many years，And has a national class A new drug injection collagenase and domestic exclusive collagenase ointment;Innovation research and development platform with Far Contest prestige as the core，Focusing on the development of therapeutic vaccines, new and improved vaccines and new adjuvants;Broad Medical Nutrition company strategic layout medical nutrition broad market。Relying on rich industry experience and product pipeline, Broad Life Sciences explores unmet clinical needs at home and abroad, and strives to provide professional services from health management, disease prevention to disease treatment for patients around the world。
Yuanda Shuyang is a wholly-owned subsidiary of Yuanda Life Sciences, and is one of the first designated blood products manufacturers in the country。远大蜀阳以工业4.Based on the framework of 0, the digital and intelligent blood products production base designed and built to the international first-class standards has been put into use, and the annual pulp injection volume ranks in the first echelon of domestic blood products monomer production enterprises, with products all over the national market, and is also China's leading blood products export enterprise。The company adheres to the development path of "high quality standards, full product coverage and market internationalization"，Based on albumin, immunoglobulin and coagulation factors and other full range of blood products，And expand to the product field of gene recombinant protein，Six technical platforms of protein separation and purification, aseptic lyophilization preparation, quality standard research, special plasma screening, virus inactivation process and gene recombinant protein are fully deployed，Strive to become a "blood products full product chain international quality service provider"。
（信息来源：医药魔方）
Menarinia Pacific has signed an exclusive licensing agreement with Astellas to commercialize the product in Taiwan and select Southeast Asian markets®
9Menarinipacific has entered into a long-term exclusive licensing partnership with Astellas Pharmaceuticals Group to develop, manufacture and commercialize the oral Janus kinase (JAK) inhibitor Xanax in Taiwan®50mgAnd 100mg tablets (generic name: pyricetinib hydrobromide, peficitinib hydrobromide) for the treatment of rheumatoid arthritis。施寻福®Has been approved in Taiwan, its substance composition patent protection period until 2032。
Under the terms of the agreement, Astellas will receive a total payment of up to €5.5 million, including upfront and milestone payments。In addition, Menarini will also pay Ansteilai the blessing of Zhan Shi®High single-digit percentage of net sales。Menarini also has the option of expanding the rights to select Southeast Asian markets。
施寻福®Developed by Astellas and currently marketed in Japan for the treatment of rheumatoid arthritis that does not respond well to traditional therapies (including prevention of structural joint damage)。
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the joints and can cause inflammation, pain, and potential joint damage。In Taiwan, the incidence of rheumatoid arthritis is estimated at 287 per 100,000 people.0 cases, recognized as a major health problem。Against the backdrop of Taiwan's aging population, the region is working to strengthen diagnosis, treatment and management of the disease。
Maurizio Luongo, Chief Executive Officer of Menarini Asia Pacific, said: "Menarini has long been the partner of choice for many biopharmaceutical companies in the Asia Pacific region, and we are delighted that Astele has trusted Menarini to promote the company®并将其商业化。Patients with rheumatoid arthritis who do not meet treatment goals often need to choose different therapies。施寻福®With the advantages of clear efficacy and flexible dosage, it will play an important role in this regard。”
Menarini is a member of the Menarini Group, the world's largest Italian biopharmaceutical company with more than 130 years of history and more than 17,000 employees in more than 140 countries。In the Asia Pacific region, Menarini's vision is to be a leading supplier of important medical brands that improve the lives of people in the region。Menarinipacific's business spans the entire commercial value chain, from clinical development, regulatory approval, product launch to life cycle management，It has a diverse portfolio of own and partner brands in key treatment areas such as consumer health, Dermatology, allergy/respiratory, Gastroenterology, cardiometabolic, anti-infective, oncology/specialty care and men's health。In fiscal year 2022, the Menarini Group's revenue reached 41.500 million euros, of which the Asia-Pacific region contributes more than 10% of revenue, has become the growth engine of the Group。
（信息来源：美通社）
Fuhong Hanlin expands overseas licensing of Srulizumab to add 12 countries in the Middle East and North Africa
9On October 12, Fuhong Hanlin expanded its partnership with Indonesian pharmaceutical company PT Kalbe Farma Tbk.Exclusive license and commercialization cooperation with its holding subsidiary PT Kalbe Genexine Biologics，Awarded in 12 countries in the Middle East and North Africa region (MENA) to Fuhonghanlin's indigenously developed PD-1 monoclonal antibody Hans-like (Srulizumab)，(commonly known as H drug) has an exclusive interest in the development and commercialization of two indications including extensive stage small cell lung cancer (ES-SCLC)。
In 2019, Fuhong Hanlin has granted KGbio exclusive development and commercialization rights for certain indications and therapies for "H Drug" in 10 ASEAN countries。
根据协议，Fuhong Hanlin will be responsible for the production and supply of Drug H after its launch in 12 Middle East and North Africa (MENA) countries, including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan and Morocco，The company will receive an initial payment of $7 million, a regulatory milestone payment of up to $8 million, and a royalty of 15% to 20% of the net sales of H Drugs in the aforementioned territories。In addition, Fuhong Hanlin will also receive up to 6, 000 based on the cumulative net sales of Srulizumab in the Southeast Asia, Middle East and North Africa cooperation region.$500 million sales milestone payment。
Hans-like is a recombinant humanized PD-1 monoclonal antibody injection independently developed by Fuhong Hanlin, which has been approved for listing in March 2022 and has been approved in China for the treatment of microsatellite highly unstable (MSI-H) solid tumors, squamous non-small cell lung cancer and extensive small cell lung cancer。
In order to promote the synergy of H drug with other products and the combination with innovative therapies, Fuhong Hanlin has carried out more than 10 clinical trials of tumor immunotherapy combination therapy around the world, covering a wide range of indications such as lung cancer, esophageal cancer and gastric cancer, and comprehensively covering the first-line treatment of lung cancer。H drug has a total of more than 3,600 patients enrolled worldwide, and the proportion of whites enrolled in 2 international multi-center clinical trials is more than 30%. Sufficient international clinical trial data are expected to support the declaration of overseas markets and lay the foundation for global clinical application。
（信息来源：新京报）
Nona Biology and Beigene deepen partnership in antibody discovery
9Nona Bio announced the further deepening of its strategic partnership with Beigene in the field of antibody discovery。Under the terms of the partnership, Beigene will have access to Nona Bio's proprietary fully human mouse platform, Harbour Mice®。Beigene has been working with Harbour Mice since 2018®H2L2The cooperation will further expand the applicable platform to Harbour Mice®HCAbTo a more complete Harbour Mice®Technology improves efficiency and flexibility of antibody therapy discovery。
Dr. Jinsong Wang, Chairman of Nona Bio, said, "We are delighted to deepen our cooperation with Beigene as Nona Bio sets sail for the world。Beigene has been one of the best partners for our antibody platform, which continues to enable pharmaceutical, biotechnology companies and academic institutions to develop new antibody drugs worldwide。Our extensive experience and expertise in drug discovery will continue to ensure effective collaboration。”
Nona Bio is an international innovative biotechnology company, as a wholly-owned subsidiary of Hempt Pharma, committed to cutting-edge technology innovation, and provides partners with target validation and diversified forms of drug molecules from discovery to preclinical research and development™(Idea to IND) Full service。Using an integrated and innovative technology platform and a global team of leading scientists, the company offers complete antibody discovery solutions covering antigen preparation, animal immunity, single B cell screening, antibody development and engineering, drug formation evaluation and pharmacological evaluation。
Harbour Mice®Fully human monoclonal antibodies in the form of classical antibody (H2L2) and heavy chain only (HCAb) can be generated, which collaborates with the single B cell clonal screening platform to optimize antibody discovery efficiency。Nona Biology focuses on the global patented technology platform to enable global biomedical source innovation and promote the development of a new generation of antibody drugs worldwide。
Beigene is a global biotechnology company focused on the discovery and development of innovative anti-tumor drugs to improve access and affordability for cancer patients worldwide。Through strong independent research and development capabilities and external strategic cooperation, we continue to accelerate the development of a diverse and innovative drug pipeline。We are committed to improving overall access to medicines for more patients around the world。Beigene has built a team of more than 9,400 people on five continents, with key offices in Beijing, China; Cambridge, Massachusetts, USA; and Basel, Switzerland。
（信息来源：美通社）
Biopharmaceutical company FFirst Wave has announced an exclusive global licensing agreement with Sanofi for Capeserod
9On October 14, First Wave BioPharma(FWBI.US) announced a partnership with French pharmaceutical giant Sanofi (SNY).US) reached an exclusive global licensing agreement for Capeserod, which is expected to be used to treat gastrointestinal disorders (GI).。On the back of this positive news, First Wave BioPharma jumped more than 95% in the U.S. stock market before the press session, up 95 percent.22%，至0.8494美元。
CapeserodIt is a selective 5-HT4 receptor partial agonist that the First Wave will repurpose and develop for gastrointestinal (GI) indications。
Under the terms of the agreement, the Boca Raton, Florida-based biotechnology company will receive an exclusive global license for Capeserod from French drugmaker Sanofi and take over its clinical development in exchange for a "modest" upfront payment。
In addition, there will be additional milestone payments and single-digit net sales royalties, and Sanofi will have the right of first refusal to repurchase Capeserod for future commercialization models。
It is understood that First Wave BioPharma intends to repurpose the drug and develop it for gastrointestinal indications。The company said it is planning to immediately begin discussions with the FDA to chart a development and regulatory path for Capeserod and begin its Phase 2 clinical trial in 2024。
Sanofi's study of Capeserod and subsequent AI analysis suggest that the drug's mechanism of action has potential therapeutic applications for several gastrointestinal disorders。
First WaveJames Sapirstein, President and CEO, said: "Securing Sanofi's exclusive global license for Capeserod could be a transformative event for First Wave，It adds a drug with a documented safety record to our GI-focused development pipeline。”
（信息来源：智通财经）
Samsung Bio works with Squibb to produce cancer drugs
9On October 18, Samsung Biologics and Squibb (BMY).US) has reached an agreement to mass-produce Squibb's commercial antibody cancer drug。
Under the terms of the new agreement, Samsung Bio will provide API production of antibody cancer drugs at its largest biofabration facility, its fourth plant in Songdo, South Korea。
Currently, the two companies have partnered to produce a commercial antibody cancer drug, and over time, they have continued to collaborate not only on the manufacturing side, but also expanded their partnership on a strategic level。
（信息来源：智通财经）
Hanteng Biology completed more than 300 million yuan of C round financing, led by SDIC Venture Capital
9On the 13th, Guangzhou Hanteng Biotechnology Co., Ltd. announced that it has recently completed a C round financing of more than 300 million yuan。This round of financing was led by SDIC Venture Capital, followed by Yueke Financial Group, Taipu Life Science Investment and Dry Silver Investment。The funds obtained in this round of financing will be used to promote the company's new technology research and development, commercial capacity construction, and international business strategic layout。
Founded in Guangzhou in 2016, Hantenbio focuses on the field of macromolecular biologic drug CDMSO, providing one-stop end-to-end services from biologic drug CMC development to commercial production and global clinical supply。At present, the development scale of Hanteng Bio has expanded from several bases in the Greater Bay Area to six global R&D and production bases such as Shanghai and Germany, and the development momentum is strong。Hanteng Bio has achieved success in high-yield cell line construction, high expression capacity of complex proteins, and international production capacity。In particular, major technological breakthroughs have been made in the fields of lgM molecular expression platform, expression of host cells, high-density cell culture, novel preparations and analysis。At the same time, Hanteng Bio has created a new record in service speed from DNA to CMC production in only 7 months, which has played an important role in the rapid promotion of customer products to the clinic。
Dr. Shen Xiao, founder and CEO of Hanteng Bio, said, "I am very grateful to this round of investors for their high recognition of Hanteng's technological capabilities and development potential，Since its establishment, Hanteng Bio has been adhering to the values of "reliable, efficient and innovative" and the mission of "biotechnology to empower the future"，加速新药高质量研发和上市。This round of financing will also accelerate the company's research and development of new technologies and international layout, and continue to empower partners to benefit more patients。”
The lead investor of this round, SDIC Venture Capital, said: "CDMO/CMO, as an important part of the biomedical industry chain, has a key supporting role for innovative drug research and development and post-market production of drugs。We continue to pay attention to and layout in line with the major strategic needs of the country, outstanding technical capabilities, outstanding operational management capabilities of biomedical enterprises。As a landmark macromolecular drug CDMO enterprise, Hanteng Bio has established complete R&D and production facilities in Guangdong, Shanghai and Germany after years of development。The company has an outstanding international team with extensive experience and strong technical expertise in licensed cell line types, preclinical pharmaceutical process development, commercial production and clinical supply chain services。We are optimistic about the future development and international layout of Hanteng Biology, and believe that the company can provide customers with more high-quality solutions for the whole industry chain and continue to empower customers。”
Following the investment, Yueke Financial Group said: "The domestic innovative drug industry is under pressure in the short term, but the long-term growth logic remains unchanged。As a leading biopharmaceutical macromolecule CDMSO company in the Guangdong-Hong Kong-Macao Greater Bay Area, Hantenbio provides a key support for the continuous innovation of biopharmaceuticals in the region。The team has deep experience in the industry, has an international vision and young vigor, and is committed to entrepreneurship。The rapid growth of Hanteng Bio is of great strategic significance for promoting the R&D outsourcing service strengthening project in Guangdong Province。We are optimistic that Hanteng Bio will consolidate its dominant position in the Greater Bay Area based on its leading cell line development and technology platform。”
Co-investor Taipu Life Sciences Investment said: "Biotechnology is empowering the future。Hanteng Biology has excellent international vision, customer-centric service concept, young management team, highly innovative and efficient technical engineering team, solid and effective technology industrialization capabilities, adhere to the spirit of struggle。As an investment institution that continues to support Hanteng Bio, we believe that the company will contribute to the great development of biotechnology-related industries。”
（信息来源：美通社）
Jinfan Pharmaceutical has completed more than 100 million yuan A round of financing to create a one-stop gene therapy drug CRO/CDMO service platform
9On the 12th, Jingfan Biomedical Technology (Wuhan) Co., Ltd. announced the completion of A round of financing of more than 100 million yuan, and this round of financing was jointly completed by SDIC and Hongxin Capital。It is mainly used for Jinfan to accelerate the construction of cGMP workshop, improve the system construction of R&D, patents, talents, and business promotion, create a globally competitive gene therapy CDMO/CRO platform, and empower partners。
According to public information, Jingfan Medicine is committed to the development of large-scale viral vector preparation and delivery technology, and has established a carrier research and development platform covering adeno-associated viruses, lentiviruses, adenoviruses, oncolytic viruses and other vectors, focusing on creating a one-stop gene therapy drug CRO/CDMO service platform。The company owns the insect baculovirus One-Bac 4.0 System patented technology platform, in the large-scale production of AAV virus and protein drugs, with high activity, high yield, stability advantages。
（信息来源：智通财经）
Nuanjin Biotech announces financing progress to accelerate neoantigen tumor vaccine pipeline
9On October 15, Niuanjin Biological issued a press release saying that the company had signed an investment agreement with Boai New Open Source Medical, and was the first to complete a new round of financing of 50 million leading investors to deliver to the account。This round of financing will facilitate the rapid advancement of the Phase 1 clinical trial of the personalized tumor therapeutic peptide vaccine P01 for injection, the investigator-initiated clinical trial (IIT) of the personalized tumor therapeutic mRNA vaccine iNeo-Vac-R01, and other pipelines。
Founded in 2016, Nuanzin Bio is focused on the development of personalized tumor immunotherapy products based on tumor neoantigens。Since 2017, Niuanjin has carried out scientific and clinical research in a number of first-class hospitals, established a follow-up database of neonatal antigen clinical research, and built a series of cell and animal models, which can quickly complete the non-clinical functional verification of various neonatal antigen products and accelerate the development progress of pipelines。
Among them, P01 for injection is the fastest progressing tumor neoantigen personalized vaccine product under Nuanjin Biological, which is a polypeptide vaccine personalized for each patient with different components。This product has been approved by China's NMPA and the US FDA to enter clinical trials successively in April 2023 and August 2023. The indication is consolidation therapy for postoperative adjuvant therapy for solid tumor patients who have received radical surgery and have high risk of recurrence (including 7 types of cancer).。
2023In August, iNeo-Vac-R01, developed by Nuanjin Biotechnology, has officially opened IIT clinical trials in cooperation with the Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine。The indication of this clinical study is malignant tumor of digestive system, and up to now, several patients have been enrolled。
In addition, the company also has a pipeline reserve of peptide self-assembly vaccines and a series of universal vaccines, which are in the IND preparation stage and plan to apply for IND in 2024。
For the completion of this round of financing, Professor Chen Zhuqing, founder/chairman of Niuanjin Biology, responded that he was very grateful for the support and recognition of new Open Source for Niuanjin Biology。This round of financing will enable the company to complete clinical trials of injectable P01 (personalized tumor therapeutic polypeptide vaccine) and mRNA tumor vaccine products, as well as accelerate the advancement of other pipelines。They believe that these tumor neoantigen immunotherapy products will be successful in clinical trials and commercialization, and benefit the majority of tumor patients。
Zhang Junzheng, Chairman of New Open Source, said: "We have been paying attention to the Nuanjin project since 2019，During the due diligence, we organized a team of experts to study the technology platform and IIT data of Nuanzin，We believe that Nuanzin has an original tumor vaccine technology，Especially optimistic about Nuanzin's tumor neoantigen artificial intelligence analysis platform，That's why we're willing to join forces with Nuanjin，Move the P01 and the rest of Nuzyn forward as soon as possible。Next, we will also create communication mechanisms and platforms to create the best synergies between Nuanjin and other precision medicine projects on the new open source platform。”
（信息来源：医药观澜）
Nephron Pharmaceuticals, a pharmaceutical company, announced the completion of 3.$500 million in funding to manufacture sterile, preservative-free respiratory inhalants
Nephron PharmaceuticalsIs a leading pharmaceutical company headquartered in West Columbia, South Carolina, focused on the development of generic respiratory medicines, blow-filler-seal technologies, and product improvements that enhance safety。
9On Oct. 18, the company announced that it had raised 3.5亿美元的融资资金。The round was led by several investors, including BlackRock Capital Investment Advisors, PNC Bank and the National Association。Nephron Pharmaceuticals plans to use the proceeds of this financing to support the future growth of its pharmaceutical industry。
Under the leadership of Chief Executive Officer Lou Kennedy, Nephron Pharmaceuticals develops and manufactures safe, cost-effective generic inhalation solutions and suspension products, is the industry's leading manufacturer of sterile, preservative-free respiratory inhalation drugs, and is the world's leading manufacturer of 2.25%，0.The sole producer of 5mL racepinephrine。The company's customers include hospitals, retail pharmacies, home care companies, long-term care facilities and mail-order pharmacies, all of which are individually packaged and barcoded for easy bedside scanning。
In addition, Nephron Pharmaceuticals operates a Nephron 503B Outsourcing Facility dedicated to producing 0.5% Albuterol 5 mL, del Nido Cardioplegia, 1% Lidocaine and succinylcholine products to address the shortage of medicines，Provides pre-filled sterile syringes, Luhr lock vials, IV vials and IV bags to hospitals throughout the United States。
Nephron 503B Outsourcing FacilityAbility to produce products in short supply under current Good Manufacturing Practice (cGMP) conditions。Nephron has responded to the ongoing drug shortage problem in the U.S. pharmaceutical supply chain by producing pre-potting-sealed syringes and sterile, small-volume parenteral solution (SVP) packages around the clock。Chief Executive Lou Kennedy said: "We will do everything we can to avoid delaying necessary treatments for patients and continue to develop products on the shortage list while focusing on quality and aseptic production.。”根据DQSA指导草案，Nephron 503B Outsourcing follows cGMP, GDP and all quality requirements，最重要的是，Only after sterile, bacterial endotoxin, particulate matter, environmental monitoring and all other release test data are available and qualified，才会放行产品。
1997Nephron Pharmaceuticals has been committed to providing safe, effective, affordable medicines to patients in need, with more than 20 years of experience in the production of sterile medicines。In addition, the company is a certified women-owned business and is recognized by the National Association of Women Business Owners (NWBOC) as the first certification body for women's businesses, a certification that brings Nephron greater visibility and a new competitive advantage。Lou Kennedy, CEO and owner, said: "This certification allows us to develop new business opportunities with our existing customer base, resulting in more jobs for capable women。”
(Source: 36kR To B Industry Report)
Voluntarily relinquish "blockbuster" rights, a ten-billion dollar Biotech's choice
In the development process of innovative pharmaceutical companies, when to move forward aggressively and when to develop conservatively is a knowledge。
Although there is no right or wrong between the two, if you are radical when you should be conservative and conservative when you should be radical, it is easy to get the enterprise into trouble。
Regarding the balance between conservative and radical, the practice of the American innovative drug company Alnylam is of great significance to the current domestic pharmaceutical companies。
AlnylamYou have a blockbuster drug with excellent early-stage clinical data, and you have enough money in your pocket。Many investors are hoping that Alnylam will choose to develop this drug on its own to maximize its own benefits。
Weighing the pros and cons, however, Alnylam chose the safest approach to drug development: joint research and development with big drug companies to share the risk of failure and also share the profits。
对此，华尔街资金表示不解。Alnylam shares fell after the deal was struck。
But from a business perspective, this is not not a correct choice。In the cold winter of biopharmaceutical, even if the strength of Biotech is strong, there is not too much opportunity to fail in the process of innovative drug research and development。
That's why Alnylam takes every step carefully。This, too, is in sharp contrast to biotech, which has built factories aggressively in the past few years。
Perhaps Alnylam's choice illustrates the idea that, in many cases, aggressive strategies are not necessarily successful;But a steady hand, a good chance of survival。
01、即将到来的降压药革命
In biopharmaceuticals, one blockbuster drug is enough to make a company。For example, Arbocept for regenerin and dupriuzumab for Sanofi。
For Alnylam, zilebesiran, an RNAi blood pressure drug, has the potential to make the class leap。
Following the release of early clinical data, zilebesiran is regarded by many in the industry as a landmark discovery that will profoundly impact the future management and treatment of hypertension。
Specifically, in a clinical study published July 19 in the top medical journal, the New England Journal of Medicine, Zilebesiran:
After a single dose ≥200mg of zilebesiran，Achieved a sustained and sustained reduction in blood pressure over a 24-hour cycle，And the effect lasts up to 6 months;At 800mg，zilebesiran treatment reduced systolic and diastolic blood pressure by an average of 22 per cent at month 6.55.1 mmHg和10.82.7mmHg。
This preliminary clinical data means that zilebesiran's effects can last as long as six months, and two injections a year may become a reality to control high blood pressure。
In recent years, the field of hypertension is still dominated by calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin receptor antagonists and other old faces。
Most of these antihypertensive drugs need to be taken daily, which also leads to poor compliance of patients, and once the medication is missed, the patient's blood pressure may be controlled or may fluctuate greatly。
So, just two injections of zilebesiran a year is enough to change the paradigm of hypertension treatment。
Of course, this is only a phase I clinical trial, so it's too early to tell if zilebesiran will succeed or fail。Surprisingly, zilebesiran's Phase II clinical trial, announced less than two months later, was again successful。
9In a Phase II clinical trial called KARDIA-1, both 300mg and 600mg of Zilebesiran in the trial showed a 24-hour mean systolic blood pressure reduction of more than 15mmHg after three months compared with placebo, meeting the primary endpoint of the clinical trial。
Judging from the first and second phase clinical data released so far, Zilebesiran may be able to solve the problems of large blood pressure fluctuations, lack of monitoring of blood pressure at night, and poor patient compliance, and become a player in the field of hypertension treatment that cannot be ignored。
02Take the initiative to give up blockbuster drug rights and interests
With clinical data coming in, expectations for Zilebesiran's future continue to grow
About 1.2 billion people worldwide have high blood pressure, and 80% of them cannot effectively control their blood pressure and need long-term medication。The patient size is large enough, the medication cycle is long enough,
In this case, if Zilebesiran can succeed in the future, it will undoubtedly bring great imagination to Alnylam Pharmaceutical。
For such a rare but elusive drug, Wall Street investors naturally hope that Alnylam will hold all the rights and interests of the drug in their own hands, and take a chance to promote to a Biophamra。
Even in China, faced with the same situation, I believe that most domestic Biotech will choose to take a risk。
Alnylam's management, however, made a different choice than most people expected。
7On October 24, Alnylam entered into a strategic agreement with Roche.The $100 million upfront payment acquires Zilebesiran's full treatment rights outside the United States and co-treatment rights in the United States。
In America Alnylam commercialised with Roche, with profits split equally.Outside the United States, Roche has an exclusive commercialization interest and Alnylam receives a low double-digit share of sales。
On the research and development side, Alnylam will lead the development program for zilebesiran's first indication, with Alnylam bearing 40% of all costs and Roche 60%。
It looks like Alnylam has found a leg up to share in the risk of the drug failing, but from investors' point of view, it's definitely not a good deal。
Because of zilebesiran's excellent early clinical data and Alnylam's sufficient funding, if Alnylam chooses to develop this drug independently, it will be able to keep all of the future revenue from this drug。
Today, although there is a joint share of the development costs of Roche, but this also means that the future of this "blockbuster" revenue will be equally shared with Roche。Those sales would have accelerated Alnylam's rapid growth from Biotech to Biophamra。
At this point, there is the experience of regeneration in the previous。In 2007, Regeneron teamed up with Sanofi to promote pliuzumab, splitting U.S. rights to the drug。In 2022, this drug revenue 82.3.9 billion euros, of which the regenerator received only 28.56亿美元的销售额分成。
Just imagine, if Regenerated Yuan firmly held the rights and interests of this product in the hand, today's Regenerated Yuan's ranking in the global pharmaceutical companies may be able to move up a few places。
Because of this concern, Alnylam's share price fell 3. 3 percent after the Roche deal was announced.87%。
03Alnylam's trade-offs
However, for Alnylam, its choice to work with Roche also has its own considerations。
AlnylamThe CEO said, "This partnership allows Alnylam to develop zilebesiran in a more robust way。”
While zilebesiran's early clinical data was positive, it was not an easy task for Alnylam to bring zilebesiran to market on its own。
Because of the large number of patients with high blood pressure, zilebesiran's approval is bound to require a large phase 3 clinical trial。Previously, Alnylam mentioned that zilebesiran would enter the CVOT (Cardiovascular Outcomes Trial), which is used to evaluate the drug's impact on cardiovascular events。
In the past, such clinical trials have been more time-consuming and expensive than normal clinical trials。
In terms of timing, analysts predict that zilebesiran's market cycle will be significantly extended, and it is difficult to expect zilebesiran to go public before 2033。In terms of money, historical data shows that doing a Phase 3 CVOT trial costs about $200 million to $300 million。Coupled with the follow-up self-built commercial channels, it is a huge cost。
So far, though, Alnylam has four drugs approved and $2 billion in cash and marketable securities on its books。But considering that Alnylam still has $800 million in current debt and several products to develop, it is clear that pushing forward zilebesiran alone will be a lot of pressure for Alnylam。
But with Roche, things are different。
According to the agreement, Alnylam only needs to pay 40% of the research and development costs, and the subsequent commercialization is all so that in case of clinical failure, it will not hurt Alnylam's vitality, and the company can continue to develop other projects。
Meanwhile, zilebesiran's sales will be higher, according to Alnylam, thanks to Roche's sales network。
Alnylamzilebesiran was previously expected to have a more than $4 billion opportunity in two indications。But after partnering with Roche, Alnylam expects zilebesiran's peak sales potential could be well over $4 billion。
After weighing the pros and cons, Alnylam's choice makes sense。
04、一场保守与激进的对抗
Of course, there's no right or wrong way to judge Alnylam's choice。However, at different time nodes, the different choices made by the enterprise will ultimately determine the fate of the enterprise。
AlnylamChoosing a conservative forward approach can indeed ensure the steady development of the enterprise。In the past, Alnylam also relied on this conservative and robust development strategy to survive in the biopharmaceutical winter and continue to move forward。
But the flip side of that choice is that Alnylam delays the transition from Biotech to biophamra。
In the United States, the opportunity to grow from Biotech to biophamra is rare, and Alnylam will miss such an opportunity and wait until the next opportunity to make the leap to biopharma。
So for US stock investors, there are still some regrets about Alnylam's choice。
Back at home, conservatives like Mr Alnylam are in the minority。More domestic drug companies are radicals and dream of becoming phamra。
Even though many biotech products are far in the future, the preparation work to become pharma has been deployed in advance, and continuous financing is needed to build a commercialization team and expand the plant....
Under the cold winter, the shortcomings of being too aggressive have been exposed, and some pharmaceutical companies have fallen into the dilemma of selling plants to survive。The ability is not enough, but the final result will only make Biotech in a difficult situation。
Not every biotech is cut out to be a pharma, and not every Biotech has to be a Biopharma。Instead of putting yourself in a difficult situation, it is better to learn to choose in time and find a more suitable position for yourself。
（信息来源：氨基观察）
How to deal with the adjustment of the industry cycle in the rapid development of Chinese biomedicine？
Recently, the State Food and Drug Administration issued the "2022 Annual Drug Review Report" pointing out that the annual review recommended the approval of 21 innovative drugs, including 3 First-in-Class new drugs;The overall completion rate in accordance with the review time limit increased to 99 throughout the year.80%，And a number of categories of time-bound settlement rate achieved historic breakthroughs;The recombinant novel coronavirus protein vaccine (CHO cells) and four novel coronavirus treatment drugs were approved for marketing，38 applications for the registration of symptomatic drugs for the treatment of febrile and cough novel coronavirus infection were approved for emergency review;The number of approved drugs for children is 66，创历史新高……
CytivaZhou Mintao, president of China, recently said that the biomedical industry is a high-speed development industry in the world, and it is also in China。The Chinese market as a whole has witnessed explosive growth in the past six to seven years, with the total market value of Chinese Biotech growing from $1 billion in 2016 to $180 billion in 2021。
However, in 2023, when the economy began to gradually pick up, although the pharmaceutical industry has many bright spots of development, it still outperforms the market as a whole and is in a difficult downward cycle of the industry。Zhan Xiaojing, vice president of global drug safety of Junshi Biology, said at the 12th Medidata NEXT China Annual meeting that although China's pharmaceutical innovation has entered the harvest period, it is still a long way to go global。
According to Pharmaprojects®2023According to data from April, there are currently 5,402 drug pipelines in China, accounting for 23 percent of the world's pipelines.6%, an increase of 23 percent over the number of pipelines in 2022.22%，远超全球管线5.89%的增长。In recent years, China's innovative drug research and development strength has increased, the number of IND has increased significantly, and the number of new drugs to sea has also risen。The gap between China and the United States in the number of core clinical applications for new drugs has gradually narrowed, showing that China's innovative drug research and development ability has gradually increased in recent years。
However, at the same time, it can be found that the direction of new drug research and development in China is still focused on fully validated mature targets, and the exploration of emerging targets needs to be improved。At the same time, the proportion of mature targets in China's research targets is much higher than that of the United States and the global average, and 70% of the emerging targets in the world still have no domestic products to enter the clinical stage。
"The target concentration of products in research is high, and the homogenization phenomenon is serious, which also means that enterprises are facing fierce market competition.。It is also under the pressure of price and product "double volume";Under the trend of double-reporting between China and the United States, the R&D capabilities of increasingly mature local pharmaceutical companies need to be improved;Overseas market potential to be tapped;Driven by multiple factors such as talents and regulatory systems that need to be in line with international standards, it is imperative for local enterprises to actively explore the path of global development。”詹骁靖说。
同质化竞争严峻
The report released by Chi Tong Consulting pointed out that at present, the innovation capacity of China's local pharmaceutical companies is still insufficient, and it is necessary to move from "improvement innovation" to "original innovation".。On the one hand, China's innovative drugs can be regarded as a true sense of the world's First-in-Class drugs are still insufficient。So far, FIC new drugs developed by Chinese enterprises have not been fast followed by other domestic and foreign enterprises。Chinese FIC is not successful, the drug is not recognized is only the appearance, the essential reason is that the new target or mechanism behind the drug has not been widely recognized by the industry and academia at home and abroad。
On the other hand, China's pharmaceutical companies are still the most commonly used Fast-follow method, and new drug research and development mostly belongs to Me-too or better Me-Better。Most of China's biopharmaceutical companies are doing generic drug research, which is far from the goal of real innovative large pharmaceutical companies。Among the 11,820 pharmaceutical companies in China, there are only 2,851 companies, or about 24, with new drug research and development projects accounting for more than 50%.1%;In the United States, the ratio is as high as 99 percent.6%。
In the direction of research and development, the targets of innovative drug research and development are too concentrated, and the homogenization competition is serious。根据CDE数据，The top 10 targets for registered clinical trials in 2021 are PD-1, PD-L1, VEGFR, HER2, etc，The number of varieties is up to 71, 59, 46, 43 respectively (the "acceptance number" field does not repeat the count)，More than 90% of drug indications for five of these targets (PD-1, PD-L1, HER2, EGFR, and CD3) are concentrated in the anti-tumor area，Drug indications for the four targets (PD-1, PD-L1, HER2, and EGFR) are all concentrated in the anti-tumor field。
In the view of Zhitong Consulting, the current concentration of hot targets invested and pursued by domestic pharmaceutical companies has resulted in a decrease in the utilization efficiency of medical resources caused by excessively concentrated research and development of limited targets, and even difficulties in patient recruitment, thus affecting the progress of research and development。At the same time, due to the high degree of homogeneity of the pipeline of innovative drug companies in the future, it will also lead to the situation of peer bidding in the later stage of medical insurance collection or national negotiation, if the research and development progress can not take the lead, it will lose the best opportunity to seize market share, and be passive in drug pricing and sales。
In addition, the current changes in overseas approval policies have changed the way the original new drugs are approved, and higher requirements for research and development investment have led to frustration at sea。Of the 3,320 drug clinical trials published on the CDE in 2022, 285 were international multi-center trials, accounting for 8.6%。At present, the clinical trials carried out by Chinese pharmaceutical companies in the United States are still mainly phase I。自2013年至今，Chinese pharmaceutical companies have conducted 659 clinical trials in the United States，Among them, 290 Phase I items (about 44%)，Phase I/II 118 items (about 18%)，Phase II 130 items (about 20%)，Phase II/III 17 projects (3%)，Phase III 104 items (about 16%)。
FDAThe tightening of the new drug evaluation system has also put forward higher requirements for clinical trials of local pharmaceutical companies。詹骁靖指出，There are four main reasons for the rejection of drug marketing applications in the past two years: the clinical benefit is not clear，Insufficient effectiveness (46%);Security data in doubt，Drug toxicity intolerance (12%);Lack of international multi-regional clinical trials (MRCT)，15%);Problems with drug production records and facilities (27%)。
2022Many of China's leading innovative drug companies suffered setbacks in the "sea" of tumor drugs，It is also believed to have a lot to do with the FDA's proposed project optimus plan, which requires more dose exploration and dose optimization, and the project diversities guidelines, which require drug companies to include as many people as possible in clinical trials，This is bound to greatly increase the cost of clinical research for pharmaceutical companies。
Since last year, the innovative drugs of Xinda Biology, Junshi Biology, and Hutchison Pharmaceutical have suffered setbacks when applying for listing overseas;In February this year, the overseas authorization of obitinib, a BTK inhibitor of Noroshing Jianhua, was returned by Bojian, and the "sea" of innovative drugs was once again cast a shadow。How to solve the above series of problems has become an important issue of concern in the industry。
如何多维度把控风险？
In the view of the industry, the root cause of a series of problems facing local innovative pharmaceutical companies is that many market capital is more willing to invest in products with clear targets and can be quickly listed, resulting in China's basic research strength is still weak。The more faced with such an environment, it is also necessary to force innovative drug companies to avoid homogeneous competition, strive to move towards the stage of "original innovation", strengthen the research and development of "First-in-class" innovative drugs, and pay attention to the research and development of important varieties that do not meet the requirements。
Li Jin, director of the Department of Cancer Medicine of Oriental Hospital Affiliated to Tongji University, president of Shanghai Artemon Hospital and chairman of Oriental Clinical Cancer Research Center, mentioned at the above forum that the biopharmaceutical industry is an important pillar of China's economic construction and is closely related to the future development of China。Since 2014, the number of biopharmaceutical enterprises in China has increased significantly, and close cooperation between all parties has continuously promoted the innovation and development of the biopharmaceutical industry。
It is an important trend to strengthen multi-party cooperation between industry, university, research and medicine。Zhou Mintao introduced the recently revised "Shanghai Pilot Program for the import of biomedical research and Development Articles" 2.As an example, the 0 version of the policy is mainly adjusted and improved for the management policy of imported biomedical research and development items。The implementation of the program will help promote the development of the biopharmaceutical industry in Shanghai and promote cooperation and exchanges between domestic and foreign biopharmaceutical research and development institutions and enterprises。
"The implementation of this program will provide Cytiva with more convenient conditions and more opportunities to accelerate the development of technology applications.。At the same time, the plan will also encourage enterprises to strengthen cooperation with domestic research and development institutions and universities to promote the development of domestic research and development needs, the policy will largely facilitate imports, and will help promote biopharmaceutical research and development and extensive cooperation between enterprises。We also hope to carry out more cooperation with more Chinese enterprises。”周敏涛说。
In addition to multi-party cooperation, digital technology is also needed。"Digitalization is a historical inevitability, from eDISC (Intelligent Clinical Research Collaborative system) to EDC (electronic data acquisition system), data interconnection has the characteristics of more secure data, higher efficiency and higher accuracy, which will bring multidimensional improvement to the level of early tumor clinical research.。With a global industry-leading clinical data acquisition and management system, Rave EDC has conducted more than 30,000 clinical studies worldwide, enrolling more than 9 million patients。Li Jin said that Rave EDC, as the preferred EDC solution for clinical trials, is first applied to phase I trials of anti-tumor drugs to optimize data management, help comprehensively improve the efficiency of trial data collection, and enhance the quality and integrity of trial data。
Data acquisition is the first step in digitization and also a solid foundation。"Tall buildings start from the ground, and today, we are also pleased to see the clinical trial industry dare to try and actively try in the application of innovative digital technology.。比如AI。When I arrived at Dongfang Hospital five or six years ago, I realized that we might need to use artificial intelligence。”李进强调，一方面，这是历史的必然，现如今，Artificial intelligence is already in full swing in many industries around the world;On the other hand，With the rapid development of drug clinical trial centers，临床研究也比较多，Doctors work from seven o 'clock in the morning until after nine at night，工作压力非常大。How to reduce the burden of doctors and at the same time to complete the research task？就是要借助人工智能。
"We also hope that the intelligent platform, by integrating intelligent recruitment, clinical trial data management, sample management, data center, etc., can rely on artificial intelligence to input and analyze data, freeing doctors and nurses, especially CRC (Clinical Coordination Researcher)."。”李进说。
CytivaThe Global Biopharmaceutical Resilience Index, conducted in 2023, also found that benefits from digital infrastructure and industrial4.83% of Chinese biopharmaceutical executives surveyed believe that China is equally or very efficient in using advanced digital technologies。
Three steps to open up the path of internationalization
In addition to clinical trials and research and development layout, the problem of commercialization and internationalization "going to sea" has always been the most focused topic。At present, many Biotech companies believe that "going to sea" internationalization can strengthen the hematopoietic function of local innovative pharmaceutical companies。There are also different views that "going to sea" is not suitable for all Biotech companies。
Compared with previous years, it can be found that the overall progress of domestic innovative drugs "going to sea" has slowed down recently。不少企业也愈发认识到，Want to achieve the smooth "sea" of products，一方面，There is a real clinical unmet need to be tapped，Develop truly differentiated competitive advantage products，Avoid being involved in homogeneous competition;On the other hand，需要做好临床前和临床研究，加快海外临床，靠科学数据说话，Increase the likelihood of successful commercialization of the product。
究竟该如何实现？对此，Li Wei, vice president of Dassault Systemes' Life Sciences Division and general manager of Medidata Greater China, said，近几年，We have also witnessed the success of domestic innovative drugs in overseas markets，Supported innovative drug research and development of all 23 large license out in China，Large deals are those worth more than $500 million，Almost all hot and innovative targets are covered。
"It is also noted in this process that China's innovative drugs are the dream of several generations of clinical research practitioners, China's pharmaceutical research and innovation is rapidly in the process of international integration, and hope to go to the front end in some areas, but the global ranking of this innovation, Chinese pharmaceutical companies have not entered the top 50 queue.。Li Wei said that an important part of the so-called "going to sea" is to follow international prevailing regulations, such as ICH (International Technical Coordination Committee for Human Drug Registration).。China does not have a separate regulation, but its drug management system, especially its registration system, is rapidly moving in line with international standards。
"Some time ago, the new ICH regulations were released, and clinical researchers discussed how to implement the new ICH regulations in China。Therefore, the system is not divided, and local pharmaceutical companies need to better rely on companies with global compliance experience and innovative and mature technology support to help them quickly go international。”李威说。
The same consulting also suggested that enterprises need to re-examine strategic planning, distinguish between passive and active sea, not only because in the domestic encountered more than anyone imagined the industry winter is forced to go to sea, but to have enough innovation and operational capacity after the sea。Although a global presence is the true statement of our strength, the Chinese market is still the foundation of Chinese pharmaceutical companies。
Despite facing the challenges of target clustering, fierce market competition, and continuous bottleneck of "going to sea"。However, many people in the industry believe that biomedical companies are still worthy of attention。"We are still very optimistic about the development prospects of China's biopharmaceutical industry。From this point of view, we are also accelerating and strengthening the strategy of localization。The expansion of the science and Innovation center is actually a major measure in the localization strategy, the function of the science and innovation center is also to promote the entire ecosystem, the biggest role is to empower the industry, targeted to solve the current needs of China's biopharmaceutical industry in new therapies, intelligent manufacturing and talent training。而不是为了创造营收。Zhou Mintao pointed out that after experiencing explosive development in the past few years, the biomedical industry has now entered a period of adjustment, which is good for the industry。It is also at this stage that high-quality and efficient development should be promoted。
"Market changes have prompted many immature capital and low-quality enterprises to leave, which is not a bad thing for the development of the industry.。The biomedical industry is a long-term industry, and we believe that in the future, this industry will be good for a long time。”周敏涛强调。
（信息来源：21经济网）
When big pharmaceutical companies cut pipelines into daily life, innovative drug competition has come to a new height
Drug research and development has always been a great success, in the wake of those high-spirited new drugs, many pipelines are abandoned by pharmaceutical companies for various reasons。
2023More than half, the axe of multinational pharmaceutical companies is still not put down。
Layoffs and pipeline cuts have always been the two magic weapons for pharmaceutical companies to reduce their expenditure。If biotech is to save money and survive, big pharmaceutical companies that are not poor in money are to pursue higher efficiency and live better。
Behind the choice, these big pharmaceutical companies are using action to convey such a signal to the market:
The environment is changing, in the present full of uncertainty, everyone is more and more concerned about whether the innovation efficiency is enough, whether the return is sufficient, pharmaceutical companies have become more focused, the pursuit of higher efficiency。It also pushes the competition for innovative drugs to a new level。
01、“瘦身”继续
In the latest semi-annual report, Novartis, Roche, Bristol-Myers Squibb, Abbvie, Bojian and other multinational pharmaceutical companies are still the theme of cost reduction and efficiency。
Bojian's financial report shows that in the first half of the year, the company achieved revenue of 49.$1.9 billion, down 4% from a year ago, net profit of 9.81亿美元，同比下滑23.2%。
At the same time as the earnings release, Bojian announced a "Fit for Growth" plan to save $1 billion in operating expenses by 2025, of which $300 million will be reinvested in product development and commercialization, and the plan will most notably cut about 1,000 jobs。
In this regard, Bojian CEO said that the company is in the process of business transformation, although there is a lot of investment in new pipelines and products, but also need to reduce investment in other areas, I believe that with these changes, Bojian will be better able to maximize growth。
Before Bojian, Novartis has begun to do "subtraction", constantly adjust the structure, exit assets, and 4,000 layoffs in 2022, and this is just the beginning, Novartis had announced 8,000 layoffs in the next three years。
On top of that, Novartis is slashing the pipeline, announcing in the first quarter that it would discontinue 10 percent of its clinical development programs after reviewing its strategic fit and sales potential。
而在最新的半年报中，Novartis terminates development collaborations for NASH therapy PLN-1474 and sickle cell disease drug OTQ923/HIX763;Choose to waive the rights related to TIGIT mab and Oseperimab after paying a down payment of $300 million;Development of the weight-loss drug MBL949 has also been halted。
At the same time, Novartis is also looking for external quality assets, such as the acquisition of biopharmaceutical company Chinook Therapeutics for up to $3.5 billion, betting on kidney disease。
Abbvie is quietly taking a half-step back in the ADC space。
8Abbvie has updated its pipeline by removing two ADC pipelines from its pipeline, including ABBV-011 and ABBV-647 in partnership with Pfizer。
Despite the current popularity of ADC, AbbVie, unlike many companies, has been "retreating".。In the first quarter, because of the mismatch between clinical benefits and risks, just cut a TNF ADC drug ABBV-154, and if you add the previous ABBV-3373, ABBV-414, ABBV-221, ABBV-321, AbBVie has abandoned as many as seven ADCs。
This is for AbbVie, which originally owned Humela, a drug king, with revenues of $50 billion a year，不算什么，但眼下，It is in the transition period of Hummel's patent cliff，一方面需要平稳过渡，The other is to find the next engine of growth，Its self-developed pipeline has not yet emerged to carry the banner of Humele。
After cutting six pipelines in the first quarter, Roche said in its semi-annual report that it would terminate the development of several drug candidates, including Teneplase for stroke indications in Phase III, RG6358 for hemophilia A gene therapy in Phase II, and four new molecular entity drugs in phase I studies。
9On its Research and Development Day, Bristol-Myers Squibb announced cuts to its pipeline, including two Phase 2 clinical programs (HSP47 and one TIGIT solid tumor program) and four Phase 1 clinical programs。
Also announcing the pipeline cut on R&D Day was Moderna, which made a fortune from COVID-19 vaccines。According to the company, it will prioritize pipelines and cull them "when needed.。These include AZD8601, MEDI1191, and mRNA-1653 and mRNA-1703, which Astrazeneca has since abandoned。
The "slimming" of big pharmaceutical companies is still continuing, and many pipelines will be abandoned in the future, silently as if they never existed。
02、取舍之间
If biotech laid off workers and cut down pipelines, it was mainly to save money and survive.Big drug companies, on the other hand, cut pipelines and trade-offs in order to maintain a competitive edge and live better。
In fact, with a huge pipeline in hand, optimizing the pipeline is a routine operation for big pharmaceutical companies, and the reasons are not the same。
Some are passively abandoned because of poor safety or efficacy。For example, Novartis abandoned the development of its weight-loss drug MBL949 because of its poor efficacy。
Unlike most weight-loss drugs, which target GLP-1, MBL949 is a GDF-15 receptor agonist。Previously, Novartis had high expectations for this drug, naming it a high-risk, high-reward project。
If the results of the Phase II clinical trial are positive, Novartis will carry out a broader layout for this drug, including the progress of early drug candidates, the development of combinations, etc., in order to enter the weight loss drug competition。Unfortunately, this new mechanism drug did not bring better weight loss effects, and the performance was mediocre in phase II clinical trials。
Before Novartis, Astrazeneca and Pfizer also stopped the development of their own diet drug products due to efficacy and safety。
这不难理解。On the diet drug track, there are two diabetes giants, Novo Nordisk and Eli Lilly, and there are aggressive newcomers such as Amgen。In this case, if their own products do not have efficacy, safety advantages, it is difficult to spell out a way of life in the track。Based on this, large pharmaceutical companies, including Novartis, have chosen to cut their wrists in time to stop their losses。
For example, Bristol-Myers Squibb discontinued its TIGIT pipeline in Phase 2 for safety reasons。Previously, it was studying the pipeline in non-small cell lung cancer, and the clinical trial enrolled only one patient before terminating, which Bristol-Myers cited for "safety reasons, adverse changes in risk/benefit."。
TIGITTargets can be described as ill-fated, once regarded as the bright and hopeful existence of tumor immunology, but now its high risk has become the consensus of the industry。Bristol-myers Squibb in the face of potential risks, choose to retreat, to a certain extent, is also wise。
Abbvie's retreat from the ADC space is somewhat puzzling by comparison。
One of AbbVie's deleted pipelines, ABBV-011, was just unveiled at the recent ASCO annual meeting。This ADC drug targets SEZ6, which is usually highly expressed in neuroendocrine tumors。
Abbvie has previously evaluated the efficacy of ABBV-011 as a monotherapy or in combination with its PD-1 inhibitor budigalimab for the treatment of relapsed refractory small cell lung cancer (SCLC)。According to its presentation at the ASCO Annual meeting, in Phase I clinical trials, the overall response rate was 25% and the median duration was 4.2个月。
Although these data are preliminary, they suggest that ABBV-011 shows positive efficacy in SCLC。As a result, the pipeline adjustment came unexpectedly。
There could be many reasons for the termination of development, and it could be a voluntary adjustment after evaluating the project's prospects, but as long as the target is not in question, there is hope, after all, AbbVie retains another SEZ6 ADC, the ABBV-706。
One after another, active or passive trade-offs continue, but this will not affect the upward trend of the innovative drug industry。
The system of pharmaceutical companies pursuing innovation will not stop because of one setback after another。Because it's driven by a world that's always looking for growth and breakthrough。
03、效率第一
Everyone is increasingly concerned about the adequacy of the rewards for innovation。
A 2019 study by Deloitte noted that while biopharmaceutical companies have invested heavily in R&D for innovation over the past decade, returns have dropped significantly over the same period, from 10 percent to 10 percent.1%降至1.8%。
Such a trend, big pharmaceutical companies are also difficult to escape。
God is probably fair, it gives big pharmaceutical companies some advantages, there will be other disadvantages。
Because of the advantages of capital and commercialization, big pharmaceutical companies often adopt a buy-buy and wide-spread pipeline layout。The point is, one big hit is worth everything。But it is precisely because of this that the efficiency of some big pharmaceutical companies is becoming low, and the return on research and development is falling as asset prices rise。
In the case of Roche, the research and development day analyzed and summarized the research and development investment, efficiency, strategy and the next direction of improvement。
Roche's analysis model for R&D efficiency, including pipeline success rate, volume, value, investment, cycle time, etc。Specifically, in terms of clinical success rate, Roche's success rate from pre-clinical to market was 9.9%, ranking third among similar enterprises;The Phase III success rate was 58%, lower than the average of 76%。
In terms of product development expenses, Roche's research and development expenses per NME (new molecular entity) averaged $5.7 billion between 2018 and 2022, compared with an average of $4.7 billion。
In terms of research and development cycle, Roche takes about 9 years from pre-clinical to market。2013-2017 from preclinical to market Roche needs 9.4年，而行业平均为8.7 years;2017-2021 from preclinical to market Roche needs 9.2年，而行业平均为9.4年。
It is not difficult to see that although Roche's research and development cycle is getting shorter, compared with the industry average, its phase III clinical success rate and research and development efficiency need to be improved。
This may be the core reason why it is constantly adjusting the pipeline。Roche is now exploring transformational changes in R&D productivity。At the R&D Day, it said it will improve its R&D productivity from the level of effectiveness and efficiency。
In terms of effectiveness, Roche plans to improve success rates based on a review of scientific and commercial risks.Leverage RWD and AI to accelerate the development of additional pipelines and bring in additional external innovation pipelines;Focus on pipelines with the best in-class potential;
At the efficiency level, it will streamline processes, deploy industry-leading data systems and operational management, while leveraging technological change to reduce the interval between clinical phases and increase the speed of development。
At the same time, Roche will also conduct hierarchical management of different assets to accelerate the development of high-potential projects。
In essence, these actions are in pursuit of greater efficiency and further focus on certainty。
Not only Roche, but Novartis is also pursuing higher success rates。Said Shreeram Aradhye, president of global drug development and chief medical officer，The company is downsizing its pipeline based on two considerations，一方面，Identify core treatment areas;On the other hand，To maximize the focus of resources and manpower on the treatment areas of greatest concern，借此进一步加强研发成功率。
In an era of uncertainty, big drug companies are accelerating their retreat from areas where they are not strong and sharpening their focus。
For domestic pharmaceutical companies, further focus, and how to build a pipeline that screens the actual needs of the market should also be a key issue that each needs to think about。
（信息来源：氨基观察）
Traditional pharmaceutical companies in 2023, turn around when
2023In the first half of this year, the performance of innovative pharmaceutical companies exceeded market expectations, and more and more pharmaceutical companies proved their profitability。So what about the performance of traditional drug companies？
In the first half of the year, the overall revenue of the traditional pharmaceutical sector was 2349.4亿元，同比增长5.47%。Under the influence of multiple policies of collection and innovative drug countries to talk about price cuts, it is perhaps not surprising that traditional drug companies maintain a low growth posture。
But at the same time, these companies are also actively embracing innovation and trying to get back on the growth track。未来，谁能率先突围呢？
01、增长引擎开始切换
Overall, the low growth rate is still the norm for traditional pharmaceutical companies。
Among the leaders, Hengrui Pharmaceutical, Stone Pharmaceutical Group and Hanson Pharmaceutical's revenue increased by 9.19%、3.01%及1.73%；
Among the echelons of small and medium-sized enterprises, representative enterprises such as Xinlitai, Jingxin Pharmaceutical, Enhua Pharmaceutical, Hisco, and Beida Pharmaceutical, respectively, increased by 0.97%、3.41%、19.95%和9.81%、4.83%。
At the same time, a relatively positive signal is that the proportion of innovative drug revenue of traditional pharmaceutical companies continues to increase。
典型如恒瑞医药。In the first half of the year, Hengrui Pharmaceutical's innovative drug revenue was 49.6.2 billion yuan, accounting for 44 percent of operating income.43%;In the whole year of 2022, the proportion of innovative drugs in the company was 40.48%。
同样表现的还有翰森制药。In the first half of the year, Hanson Pharmaceutical revenue was about 45 percent.1.1 billion yuan, innovative drug sales revenue of about 27.9.6 billion yuan, accounting for 52 percent from last year.3%上升至61.8%。
After several years of transformation, the growth engine of traditional pharmaceutical companies is gradually switching。
02、费用结构逐步优化
At the same time of the change of income structure, the cost structure of traditional pharmaceutical companies is also gradually optimized。
It can be seen that the sales expense ratio of traditional pharmaceutical companies in the first half of the year was 20%, compared with 20% in the same period last year.49%下降了0.49个百分点。At the same time, the rate of R&D expenses of traditional pharmaceutical companies has decreased from 6.62%增长至7.07%，上升了0.45个百分点。
In the context of generic drug collection, traditional pharmaceutical companies are constantly strengthening their efforts to embrace innovation。This is more clearly reflected in the head pharmaceutical companies。
For example, China's biopharmaceutical sales expense ratio declined by nearly 2.6 percentage points, while the rate of R&D spending increased by nearly 2 percentage points。
Overall, these pharmaceutical companies not only improve product competitiveness by increasing investment in independent innovation, but also actively introduce。今年以来。Hengrui Pharmaceutical, China Biological Pharmaceutical, Stone Pharmaceutical Group, Hansen Pharmaceutical and other pharmaceutical companies have made achievements in the BD field。
For traditional pharmaceutical companies, the trough may not have passed, but the attitude of positive transformation is undoubtedly worthy of affirmation。
（信息来源：氨基观察）
Challenge Ulinumab!Positive results from Phase III studies of AbbVie IL-23 monoclonal antibody
9Abbvie today announced that the Phase III SEQUENCE study of risankizumab versus ustekinumab in moderate to severe Crohn's disease met all primary and secondary endpoints。
SEQUENCEThe study was a multicenter, randomized, head-to-head Phase III clinical trial involving 527 patients with moderate-to-severe Crohn's disease who had been treated with one or more anti-tumor necrosis factor (TNF) drugs。All patients had a baseline Crohn's disease activity index (CDAI) score of 220-450。The primary endpoints of the study were the proportion of patients achieving clinical response (defined as less than 150 CDAI) at week 24 and endoscopic response (defined as reduced Crohn's disease Endoscopic score (SES-CD) score ≤4 and at least 2 points lower than baseline) at week 48，The proportion of patients who cannot score more than 1 point on any sub-assessment。
结果显示，利生奇珠单抗组患者的临床缓解率非劣效于乌司奴单抗组（59%vs40%）；内镜缓解率优效于乌司奴单抗组（32%vs16%，P<0.0001）。
In addition, the safety profile of Lisencizumab was consistent with what had been observed in previous studies, and no new safety risks were identified。The most common adverse events were COVID-19 and headache。
Lisencizumab, an IL-23 monoclonal antibody developed in collaboration with AbbVie and Boehringer Ingelheim, targets the p19 subunit that binds IL-23, thereby blocking IL-23 from binding to its receptor。IL-23 is a cytokine involved in inflammatory processes and is thought to be involved in many chronic immune-mediated diseases。
2019The product was first approved in Japan in March for the treatment of generalized pustular psoriasis, erythrodermic psoriasis, plaque psoriasis and psoriatic arthritis。In June 2022, the indication for Lishengchizumab was expanded to include Crohn's disease。In July this year, Lisencizumab filed for listing in China。
（信息来源：医药魔方）
Broad Pharmaceutical innovative product Ryaltris®The compound nasal spray has completed the Phase III clinical study in China and successfully met the primary endpoint
9On October 13, Broad Pharmaceutical (00512) announced that the group's global innovative drug Ryaltris®The Phase III clinical study (GSP 301-308) of Compound nasal Spray (GSP 301 NS) for the treatment of seasonal allergic rhinitis (SAR) in patients aged 12 years and older in China recently completed and successfully met its primary endpoint，This is another important development in the Group's respiratory and severe anti-infection segment。
GSP 301-308This is a randomized, double-blind, double-simulated, three-arm, multicenter, parallel-controlled Phase III clinical study，A total of 535 SAR patients aged 12 years and older were enrolled，They were randomly assigned to the GSP 301 NS treatment group and the two original positive control groups olopatadine hydrochloride nasal spray (Patanase NS) and Mometasone furoate nasal spray (Nasonate) ata ratio of 1:1:1®NS)To evaluate the efficacy, safety, tolerability and pharmacokinetic characteristics of GSP 301 NS treatment, all of which were administered for 14 days。
GSP 301-308The efficacy was evaluated using the internationally recognized rTNSS and iTNSS scales。The higher the score in the score scale, the more severe the nasal symptoms of the patient, the lower the score after medication indicates the improvement of the patient's symptoms, and the greater the change of the score from the baseline value (the score before medication) indicates the more obvious improvement of the SAR symptoms after treatment。The primary endpoint of efficacy in this clinical study was the change from baseline in self-reported 12-hour morning and afternoon rTNSS in the GSP 301 NS(investigational drug) treatment group over a 14-day period，The change values were compared with those of the two single-side positive controls，If the experimental drug group decreased more than the control group，说明试验用药疗效更明显。The clinical results of this study were GSP 301 NS group, Patanase NS group, and Nasuna group®NSThe least squares mean of change from baseline in self-reported morning and afternoon 12-hour rTNSS during the 14-day treatment period was -3, respectively.84、-2.58和-3.35. According to the statistical data, rTNSS in GSP 301 NS group decreased more than that in Patanase NS group and Neshuna group®NSThe difference between groups was clinically and statistically significant (GSP 301 NSvs).Patanase NS，P<0.0001;GSP 301 NSvs.内舒拿®NS，P=0.0018), it was proved that the efficacy scores of GSP 301 NS were better than those of Patanase NS and Nesunar®NS。At the same time, the safety, tolerability and pharmacokinetic characteristics of the product also reached the preset clinical endpoint。
GSP 301 NSIt is a novel combination nasal spray of antihistamines and corticosteroids for the treatment of SAR in adults and adolescents。As a compound preparation, GSP 301 NS can bring more convenient treatment mode for SAR patients, improve patient compliance, and bring new treatment means for SAR patients。The product was approved by the U.S. Food and Drug Administration (FDA) in January 2022 and has been approved for sale in several countries and regions including Australia, South Korea, Russia, the United Kingdom and the European Union。The GSP 301 NS was approved by the National Medical Products Administration of the People's Republic of China for Phase III clinical trials in October 2021，The first subject will be enrolled in April 2022，All subjects will be enrolled in May 2023，GSP 301-308 is a registered clinical study of GSP 301 NS in China，The successful completion of the study is another important milestone in the implementation of the project in China。
China has one of the highest rates of allergic rhinitis in the world。According to the relevant epidemiological survey results in China, the prevalence rate of allergic rhinitis in Chinese adults is about 17.6%，患病群体已近2.500 million people, of which moderate to severe persistent allergic rhinitis patients about 1.3亿，患者群体庞大。According to the "Allergic Rhinitis and its Effects on Asthma (ARIA)" guidelines，Nasal antihistamines and nasal corticosteroids are the drugs of choice for SAR，对于中、重度SAR患者，A combination of nasal antihistamines and nasal corticosteroids is recommended，At present, the nasal preparations in China are mainly unilateral preparations，临床需求迫切，市场前景巨大。
The field of respiratory and severe anti-infection is one of the core strategic areas of the Group. There are more than 10 products, covering rhinitis, pharyngitis, bronchitis, pneumonia, asthma and other indications, and a relatively complete product portfolio has been formed in the field of respiratory disease treatment。Among them, the Group's star products Cheno and Golden Voice series are the exclusive varieties in China, and have been clearly recommended by a number of guidelines and expert consensus。In terms of product research, the Group has carried out innovative layout for major unmet clinical needs, and has a number of products under research covering allergic rhinitis, sepsis, acute respiratory distress syndrome (ARDS), parainfluenza, and novel coronavirus infection。其中，STC3141, a global innovative drug for severe conditions such as sepsis, has received seven clinical approvals in five countries and regions，Three patient clinical studies were completed，The Phase Ib clinical study for ARDS in China, the Phase IIa clinical study for severe viral infection in Europe, and the Phase Ib clinical study for sepsis in Australia and Belgium have all reached the clinical endpoint.Has been approved to conduct a phase II clinical study for the treatment of sepsis in China;APAD, another global innovation for the treatment of sepsis, has been approved for a Phase I clinical study and completed its first patient enrollment。In the future, the Group will continue to adopt the research and development concept of independent research and development and global expansion to build a product cluster for the whole cycle management of chronic airway diseases and a pipeline of severe anti-infection products, and continue to consolidate the Group's industry position in this field。
The Group has always attached great importance to the research and development of innovative products and advanced technologies，以患者需求为核心，以科技创新为驱动，针对尚未满足的临床需求，Increase investment in global innovative products and advanced technologies，Enrich and improve product pipeline and industrial layout，采用“全球化运营布局，双循环经营发展”策略，A new pattern of domestic and international double cycles of interconnected development and mutual reinforcement has been formed，Give full play to the group's industrial advantages and research and development strength，Quickly put scientific and technological innovation products on the market，To provide more advanced and diverse treatment options for patients around the world。
（信息来源：智通财经）
Abbvie's oral JAK1 inhibitor upatinib is approved for severe alopecia areata in China
Recently, the CDE official website shows that AbbVie's blockbuster JAK1 inhibitor Upatinib tablet for severe alopecia areata clinical trial application was approved by implication。
Alopecia areata is an autoimmune disease characterized by non-cicatricial hair loss that can affect any area with hair。Studies have shown that alopecia areata may originate from the activation of the JAK-STAT pathway, which then causes the breakdown of the immune environment of the hair follicle and carries out an autoimmune attack on the hair follicle。
Upatinib is a selective JAK inhibitor that is currently being investigated in a variety of immune-mediated diseases。Based on enzyme and cell tests, upatinib showed greater inhibitory effect on JAK1 than on JAK2, JAK3 and TYK2。In August 2019, the product was first approved by the FDA for use in moderate-to-severe rheumatoid arthritis and is the first JAK1 inhibitor approved worldwide。
2022In February, Upatinib tablets were approved for the first time in China for the treatment of moderate and severe atopic dermatitis。In March of the same year, two new indications for moderate-to-severe rheumatoid arthritis and active psoriatic arthritis were approved。In February this year, the fourth indication of Upatinib tablets was approved for the treatment of moderate-to-severe active ulcerative colitis。In July, Upatinib tablets received a fifth indication for the treatment of moderate to severe active Crohn's disease。
Since its listing, sales of upatinib have grown rapidly, with sales of 0 in 2019, 2020, 2021 and 2022, respectively.47、7.31、16.51、25.22亿美元。Abbvie expects sales of upatinib to exceed $7.5 billion in 2025。
It is worth mentioning that Eli Lilly's JAK inhibitor Baritinib has been approved by NMPA in March this year for the systemic treatment of severe alopecia areata in adults, becoming the first innovative targeted drug for the systematic treatment of severe alopecia areata in China。
（信息来源：医药魔方）
For weight loss!The new indication of small molecule GLP-1R agonist of East China Medicine was approved
9East China Medicine announced on the 15th that its wholly-owned subsidiary Sino-US East China declared a Class 1 new drug HDM1002 tablet clinical trial application was approved, intended to be used for weight management of overweight or obese people。According to the public information of East China Medicine, HDM1002 is a small molecule GLP-1R agonist developed by the company。
Glucagon-like peptide-1 (GLP-1) is a polypeptide hormone secreted by intestinal cells, which stimulates insulin secretion by binding to GLP-1 receptors and inhibits glucagon secretion, thereby promoting glucose metabolism。It can also slow the emptying of the stomach and suppress appetite。Therefore, GLP-1 is considered a strong target for the treatment of obesity and type 2 diabetes。According to public data, all the GLP-1R agonists listed in China are peptide injections, which have problems such as long-term frequent injection or poor patient compliance。
HDM1002Tablet is a new class 1 chemical drug independently developed by China, Central America and East China. It is a small molecule complete agonist of GLP-1 receptor with oral activity, strong effect and high selectivity。Preclinical studies have shown that HDM1002 can strongly activate GLP-1 receptors and induce cyclic adenosine phosphate (cAMP) production, which has a strong effect on improving glucose tolerance, hypoglycemia and weight loss, and shows good safety。In May 2023, the application for clinical trial of HDM1002 tablets for the treatment of adult type 2 diabetes has been approved by China's NMPA and the US FDA。
It is worth mentioning that for GLP-1 targets, Huadong Pharmaceutical has developed a long-acting and multi-target combination of differentiated product pipelines, including injections and oral preparations。Among them, Liraglutide injection biosimilar has been approved in China for obesity or overweight indications。The company's GLP-1 pipeline also includes the GLP-1R agonist Semaglutidine Injection biosimilar, the double-target agonist HDM1005 and the GLP-1R/GIPR double-agonist SCO-094, the small-molecule oral GLP-1R agonist TTP273, and the GLP-1R/GCGR/FGF21R targeted GLP-1RLong acting three target agonist DR10624 and other products。
（信息来源：医药观澜）
Hengrui initiated HER2 ADC for first-line treatment of HER2-positive breast cancer in Phase III clinical trials
9月15日，Drug clinical trial registration and information publicity platform official website，Shengdia Biologic, a subsidiary of Hengrui Pharmaceuticals, has enrolled in a multicenter, randomized, open, position-controlled Phase III study (code: SHR-A1811-307).，To evaluate the efficacy and safety of SR-A1811 for injection as single agent or in combination with pertuzumab versus trastuzumab plus pertuzumab plus docetaxel in the treatment of HER2-positive recurrent or metastatic breast cancer。
SHR-A1811 for injection is an antibody drug conjugate targeting HER2 independently developed by Hengrui Pharmaceutical，SHR-A1811 for injection can be endocytosed by binding to HER2-expressing tumor cells，The toxin is released by protease shear in tumor cell lysozyme，Induce cell cycle arrest and thus induce tumor cell apoptosis。SHR-A1811 has been conducted in a number of phase I to III clinical studies, covering advanced solid tumors with HER2 expression or mutation, advanced gastric cancer or adenocarcinoma of the gastroesophageal junction, colorectal cancer, advanced non-small cell lung cancer, and metastatic breast cancer。
The primary endpoint of the SHR-A1811-307 study presented in this publication was progression-free survival assessed by blind independent center review in patients treated with SHR-A1811 monotherapy or SHR-A1811+ pertuzumab versus trastuzumab + pertuzumab + docetaxel in first-line treatment of HER2-positive relapsed or metastatic breast cancer。Secondary endpoints included assessing the effectiveness of overall survival, objective response rate, and duration of objective response.Evaluate safety and tolerability and patient quality of life;To evaluate the pharmacokinetic characteristics and immunogenicity of SHR-A1811。The study plans to enroll 864 patients。
In April this year, Hengrui Medicine disclosed positive data from the global multi-center Phase I clinical study of SHR-A1811 in the treatment of advanced solid tumors for the first time at the American Association for Cancer Research (AACR) 2023 Annual meeting。The results showed that, in terms of effectiveness, most patients experienced tumor shrinkage after treatment with SHR-A1811。In patients with HER2-positive breast cancer, the confirmed ORR reached 76.9%, with a 6-month PFS rate of 88.6%;In patients with low HER2 expression breast cancer, the confirmed ORR was 49.4%, with a 6-month PFS rate of 63.8%。The confirmed ORR for other HER2-expressing or mutated solid tumors was 53.6%, with a 6-month PFS rate of 73.4%。
（信息来源：医药魔方）
GCGR/GLP-1RPhase 3 clinical application of double agonist was submitted in China
9Boehringer Ingelheim (Boehringer Ingelheim) submitted to CDE a multi-center clinical trial application for overweight or obese people in China。The trial was designed to further explore the efficacy and safety of the GCGR/GLP-1R double agonist survodutide in Chinese patients。Previously published data from a global multicenter Phase 2 clinical study showed that patients lost up to 19% of their body weight after a 46-week treatment period with survodutide。
Overweight and obesity are complex chronic diseases that involve abnormal or excessive accumulation of fat and pose a threat to an individual's overall health, and have become a public health issue of global concern。Based on the characteristics of Chinese patients, the Chinese Obesity Working Group recommends setting a BMI value of 24.0kg/m2 is the threshold for overweight, 28.0kg/m2为肥胖临界值。According to the Status Report on Nutrition and Chronic Diseases in the Chinese Population (2020), the overweight rate among adults (≥18 years old) is 34.3%、肥胖率为16.4%, more than half of adults are overweight/obese。In absolute terms, 600 million people in China are now overweight and obese。
SurvodutideBoehringer Ingelheim is one of Boehringer Ingelheim's key drugs in the field of cardiorenal metabolic diseases and is jointly developed by the company and Zealand Pharma。This product can simultaneously activate glucagon-like peptide-1 (GLP-1) receptor and glucagon (GCG) receptor, while suppressing appetite, but also improve energy expenditure, thus treating obesity。
Boehringer Ingelheim is also conducting another Phase 2 study to evaluate survodutide in adult patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis (stage F1/F2/F3), regardless of type 2 diabetes。The trial is expected to be completed in the fourth quarter of 2023。The study has been granted fast-track status by the U.S. FDA for its adult NASH indication。
Dr. Wei Zhang, Senior Vice President, Research, Development and Medicine, Boehringer Ingelheim Greater China, said: "Metabolic and cardiovascular and kidney diseases are one of Boehringer Ingelheim's deep disease areas, and we understand that there is a huge unmet clinical need in this area。At present, the clinical research and development team in China is actively preparing to participate in the preliminary work of global multi-center phase 3 clinical trials。At the same time, we also look forward to the early approval of this Chinese clinical trial application, which will produce evidence-based medical evidence of the efficacy and safety of survodutide specifically for overweight and obese patients in China.。”
（信息来源：医药观澜）
Two Eli Lilly diabetes treatments approved in China
9NMPA official website recently announced that Eli Lilly and Company's (Eli Lilly and Company) two diabetes treatment products were approved in China, respectively: long-acting GLP-1R agonist Duloglucopeptide injection and long-acting basic insulin analogue insulin glargine injection。
Durotide is a long-acting GLP-1 receptor agonist, administered once a week, which effectively reduces HbA1c and moderately reduces body weight, in addition to having the advantages of low risk of hypoglycemia and low immunogenicity。First approved by the US FDA in 2014, Dulotide is currently approved worldwide for the control of blood sugar in adults with type 2 diabetes, including monotherapy and combination therapy。In February 2020, the drug was re-approved by the FDA for adults with type 2 diabetes who have cardiovascular disease or multiple cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (MACE)。
在中国，Durolatide was approved for marketing in 2019，For blood sugar control in adults with type 2 diabetes: it can be treated with monotherapy，For adults with type 2 diabetes who have poor glycemic control through diet and exercise alone;Combination therapy is also possible，Used on a diet control and exercise basis，Adults with type 2 diabetes who are treated with metformin and/or sulfonylureas and still have poor glycemic control。
2022In July, Lilly announced that the Chinese Phase 3 AWARD-CHN3 study of Dulotide in combination with insulin met its primary endpoint and all key secondary endpoints。The results of this trial will be used to support the application of a new indication in China for the treatment of type 2 diabetes in adults with combined insulin。
AWARD-CHN3It was a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 clinical trial conducted in China，Targeted at Chinese adults with type 2 diabetes who are receiving stable doses of insulin glargine (with metformin therapy and/or acarbose) to treat their blood glucose and remain poorly controlled，Comparison on the basis of titrated insulin glargine therapy，分别接受度拉糖肽1.Efficacy and safety of 5mg or placebo therapy。A total of 291 adults with type 2 diabetes were included in the study, which was completed at 27 research centers in China。
The results of this study showed that in the 28-week AWARD-CHN3 study, dolaptide combined with titrated insulin glargine in adults with type 2 diabetes significantly reduced HbA1c, body weight, and fasting serum glucose in patients with type 2 diabetes。
Long-acting basal insulin analogs: biosimilars of insulin glargine injection
According to Lilly public information, the company's insulin glargine (trade name Basaglar) is a biosimilar of Sanofi's insulin glargine [rDNA source] injection (trade name: Come), which is a long-acting basal insulin analogue suitable for the treatment of diabetes。
According to Lilly public information, the primary amino acid sequence of Basaglar is the same as the active ingredient of insulin glargine, and the dosage form is the same。It differs from human insulin in that one of the amino acids in the A chain of insulin is replaced (the asparagine is replaced by glycine in the A21 position) and two arginines are added to the C-end of the B chain。Compared to conventional insulin, long-acting insulin analogues (insulin glargine) offer more benefits than previous medications such as intermediate-acting insulin, including reduced incidence of hypoglycemia at night, better fasting glucose control, and improved quality of life。Basaglar 100units/mL first received marketing authorization from the European Medicines Agency in September 2014 and has since been approved in the European Union, the United States, Canada, Australia, Japan and Switzerland。
2020In May, Lilly announced that a 24-week Phase 3 study (14L-GH-ABES) in adults with type 1 diabetes in China met its primary endpoint。The study compared the efficacy and safety of Basaglar and insulin glargine in combination with mealtime insulin in Chinese adults with type 1 diabetes mellitus (T1DM)，The primary study endpoint was combined with proline insulin three times daily (TID) before meals in Chinese adults with T1DM.，Basaglar is not inferior to insulin glargine。A total of 272 patients with T1DM were included in the study, and the study confirmed that 0.The equivalence of Basaglar and insulin glargine was achieved at 4% non-inferiority threshold。There were no statistically significant differences in the overall incidence and rate of overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia between the two treatment groups。The incidence of adverse reactions and injection site reactions during treatment was similar between the two groups。
The study confirmed that Basaglar can provide a well-tolerated and effective once-daily basal insulin option for patients with T1DM in China, with efficacy and safety characteristics similar to those of the original insulin glargine product。
2020In June, Lilly again announced that a 24-week Phase 3 study (14L-GH-ABET) in adults with type 2 diabetes in China met its primary endpoint。This study compared the efficacy and safety of Basaglar and insulin glargine in combination with mealtime insulin in Chinese adults with type 2 diabetes mellitus (T2DM)，The primary study endpoint was combined with oral hypoglycemic agents in Chinese adult T2DM patients，Basaglar is not inferior to insulin glargine。A total of 536 patients with T2DM were included in this study, and the study reached the end point of equivalence of Basaglar and insulin glargine。There were no statistically significant differences in the overall incidence and rate of overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia between the two treatment groups。The incidence of adverse reactions and injection site reactions during treatment was similar between the two groups。
Basaglar provides a once-daily (QD), well-tolerated and effective baseline insulin option for T2DM patients in China, with efficacy and safety characteristics similar to those of insulin glargine。
（信息来源：医药观澜）
Astellas AR inhibitor Enzalutamide new indication was declared for listing in China
9Astellas today announced that CDE has been approved for a new indication for the marketing of Lienzalutamide softgel capsule (trade name Acotan) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).。According to public information, Enzalutamide is a specific androgen receptor (AR) inhibitor that has previously been approved in China for the treatment of castration-resistant prostate cancer。This application is also the third application accepted by Enzalutamide in the field of advanced prostate cancer treatment in China。
Prostate cancer is a common cancer of male genitourinary system。Once prostate cancer has spread to other parts of the body beyond the prostate, such as distant lymph nodes, bones, lungs and liver, it is considered metastatic cancer。Male patients are considered to be hormone-sensitive (or castration-sensitive) if they still respond to medication or surgical treatment to lower testosterone levels。The median survival of men with metastatic hormone-sensitive prostate cancer (mHSPC) after initiation of androgen deprivation therapy (ADT) is approximately 3-4 years。
enzalutamide (enzalutamide) is an androgen receptor signaling inhibitor, which not only blocks androgen binding to the receptor, but also inhibits the transfer of the receptor into the cell nucleus and the binding of the androgen receptor to DNA。So it's not just an antagonist of the androgen receptor, it also has an inhibitory effect on the androgen signaling pathway。2009年10月，Medivation (now part of Pfizer) signed a commercial agreement with Astellas，Co-development and commercialization of Enzalutamide in the United States，Astellas is responsible for worldwide production and the submission of all additional regulatory approvals，And the commercialization of the product outside the United States。
In China, Enzalutamide has previously been approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC)。In December 2019, the US FDA also approved the extended indication of Enzalutamide for the treatment of patients with metastatic hormone-sensitive prostate cancer。Astellas and Pfizer noted in a press release that the approval makes Enzalutamide an oral treatment for three different forms of advanced prostate cancer (non-metastatic and metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer)。
According to Astellas press release, the new indication application for Enzalutamide in China is based on the results of the Phase 3 ARCHES study in China。这是一项在转移性激素敏感性前列腺癌（mHSPC）男性患者中开展的多中心、随机、双盲、安慰剂对照的3期临床试验，在中国大陆30个研究中心共入组180名中国mHSPC患者。The primary endpoint of the trial was time to prostate-specific antigen (PSA) progression。PSA progression is defined as an increase in PSA levels of ≥25% from the minimum PSA value (i.e. the lowest PSA level observed after or at baseline) with an absolute value of ≥2µg/L(2ng/mL) and was confirmed at the second consecutive test at least 3 weeks later。
The trial data showed that the study met its primary endpoint, confirming a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP)。In the primary analysis, the safety profile of enzalutamide in combination with ADT was generally consistent with the known safety profile of this drug。In addition, the study met key secondary endpoints, showing that enzalutamide combined with ADT significantly reduced the risk of radiographic progression-free survival (rPFS) and increased the percentage of patients with undetectable PSA levels compared with placebo-combined ADT。
（信息来源：医药观澜）
A new indication for Lilly Dola glycopeptide was approved for sale in China
9On October 15, the official website of the FDA showed that the marketing application for the new indication of Lilly Dola glycopeptide injection (trade name: Duyida) was approved。According to Lilly's previously announced Phase III clinical completion in China, it is speculated that the new indication approved for the market is Duloglucopeptide combined with insulin for the treatment of adult type 2 diabetes。
Durolatide is a long-acting human GLP-1 receptor agonist。Dulosin exhibits GLP-1-mediated effects, including glucose-dependent insulin secretion, inhibition of glucagon secretion, delayed gastric emptying, and reduced food intake through central appetite suppression。All of these mechanisms can show hypoglycemic effects。Dulotide, administered once a week, has the advantages of effectively reducing HbA1c, moderate weight loss, low risk of hypoglycemia, and low immunogenicity。
2022In August, Lilly announced that Dulotide significantly reduced HbA1c, body weight, and fasting serum glucose in patients with type 2 diabetes in the 28-week AWARD-CHN3 clinical trial (Dulotide combined with titrated insulin glargine in adults with type 2 diabetes)。The study met the primary and all key secondary endpoints。
Today, Eli Lilly insulin glargine injection is also approved in China for the treatment of type 2 diabetes。
（信息来源：医药魔方）
Shi Pharmaceutical Group irinotecan hydrochloride liposome injection obtained drug registration approval
9Shi Yao Group announced that Irinotecan hydrochloride liposome injection (10ml:43mg) developed by Shi Yao Group Euyi Pharmaceutical Co., LTD., a subsidiary of the Group, has been granted drug registration approval by the State Drug Administration of China。
The product is approved in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic pancreatic cancer who have progressed after gemcitabine therapy。This therapy has obvious survival benefits in the Asian population, and was adjusted to Class I recommendation and Class 1A evidence by the guidelines of the Chinese Society of Clinical Oncology (CSCO) in 2020, which is the highest recommended level and evidence level in the current second-line treatment of pancreatic cancer。
The product adopts a new drug loading technology, which is superior to the traditional ammonium sulfate gradient method, and the drug loading is higher。The Group independently developed key excipients required for new drug loading technologies, solving the problem of excipient sources, while reducing costs and enhancing competitive advantages。
In addition, the approval of this product adds a new weight to the Group's anti-tumor field, further enriching the Group's high-end product line;It will bring new treatment options to patients with advanced pancreatic cancer, improve the availability of drugs, and bring benefits to more patients。
（信息来源：智通财经）
Kangtai Biologic human rabies vaccine approved for market
9The latest announcement on NMPA's official website said that the listing application of freeze-dried human rabies vaccine (human diploid cells) submitted by Minhai Biology, a wholly-owned subsidiary of Kangtai Biotechnology, has been approved。Public information shows that this vaccine is suitable for the prevention of rabies。
Rabies virus is a ribonucleotide type rhabdovirus, which is highly virulent in mammals such as dogs and cats。Infection with the virus can cause rabies, which is an acute infectious disease of humans and animals. Clinical manifestations are unique fear of water, wind, pharyngeal muscle spasm, progressive paralysis, etc. Once symptoms appear, the fatality rate is close to 100%。At present, there is a lack of effective clinical treatment for rabies, so post-exposure prophylaxis is crucial, mainly through vaccination of human rabies vaccine and injection of passive immune agents。
According to a press release issued by Kangtai Biology earlier, the freeze-dried human rabies vaccine (human diploid cells) developed by Minhai Biology uses a fixed strain of rabies virus (PM1503-3M) to vaccinate human diploid cells, without foreign viruses and potential tumorigenic risk。The product was cultured, harvested, concentrated, inactivated virus, purified, and freeze-dried with appropriate stabilizer to prevent rabies。The clinical results show that the vaccine has good safety, immunogenicity and immune persistence。
According to China Drug clinical trial registration and information publicity platform，Previously, Minhai had completed a randomized, blind and parallel controlled phase 3 trial，The objective was to evaluate freeze-dried human rabies vaccine (human diploid cells) in the age range of 10 to 60 years (above 10 to below 61 years)，下同）健康人群中，Safety and immunogenicity of vaccination according to the traditional Essen method (1-1-1-1) and the simplified Zagreb method (2-1-1)。The trial involved 1,840 participants in China and was led by Yuemei Hu, chief physician at the Jiangsu Provincial Center for Disease Control and Prevention。
（信息来源：医药观澜）
Two new drugs were also recommended by the European Commission
9月15日，The two new drugs were also recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)，CHMP support Quizartinib was approved in the European Union (EU)，For the treatment of newly diagnosed FLT3-ITD positive adult patients with acute myeloid leukemia (AML)，This drug can be combined with standard cytarabine + anthracycline induced remission therapy and cytarabine consolidation therapy，And monotherapy for continued treatment after consolidation。The CHMP also supported the approval of a new indication for Enhertu (trastuzumab for injection) in the European Union for adult patients with unresectable or metastatic HER2-positive non-small cell lung cancer (NSCLC) who have previously received at least one systemic therapy。
QuizartinibAn oral, selective second-generation FLT3 inhibitor, CHMP is positive about the results of the Phase III trial codenamed QuANTUM-First, published in The Lancet。QuANTUM-First is a randomized, double-blind, placebo-controlled Phase III study to evaluate the OS benefit of Quizartinib in adult patients with newly diagnosed FLT3-ITD-positive AML。Patients were randomly assigned 1:1 to receive either Quizartinib or placebo combined with standard cytarabine + anthracycline induced remission and cytarabine consolidation, as well as post-consolidation monotherapy。The primary endpoint of the study was OS, and secondary endpoints included event-free survival (EFS), induced complete response rate, and combined complete response rate。
In patients with newly diagnosed FLT3-ITD-positive AML, the Quizartinib group reduced the risk of death by 22% compared to standard chemotherapy (HR=0).78，95% CI:0.62-0.98；p=0.032)。中位随访39.At 2 months, the median overall survival of patients treated with Quizartinib was 31.9 months (n=268;95% CI: 21.0-NE），对照组为15.1 month (n=271;95% CI: 13.2-26.2）。
EnhertuAn antibody drug conjugate (ADC) targeting HER2, CHMP is positive about the primary results of the Phase II trial code-named DESTINY-Lung02。Results published at WCLC 2023 showed that, as evaluated by a blind Independent Center Review (BICR), Detrastuzumab for injection 5.4mg/kg治疗组和6.Confirmed objective response rates (ORR) in the 4mg/kg treatment group were 49.0%（95% CI：39.0-59.1）和56.0%（95% CI：41.3-70.0）。
5.4mg/kg治疗组中观察到1例（1.0%) complete response (CR) and 49 (48.0%) Partial response (PR), 6.Two cases were observed in the 4mg/kg treatment group (4.0%) total response and 26 patients (52.0%）部分缓解。5.The disease control rate (DCR) in the 4mg/kg dose group was 93.1%(86.4-97.2)，6.4mg/kg剂量组为92.0%(80.8-97.8)。5.The median duration of response (DoR) in the 4mg/kg treatment group was 16.8个月（95%CI：6.4- Unestimable [NE]), 6.The 4mg/kg treatment group did not achieve a median duration of response (95%CI: 8).3-NE）。
Ken Takeshita, MD, global Head of Research and Development at Daiichi Sankyo, said: "Enhertu is the first therapy to show a strong and durable tumor response in previously treated patients with advanced NSCLC with HER2 mutations，HER2 is a feasible target for the treatment of lung cancer，And support much-needed treatment options for these patients。The CHMP's opinion is a positive step forward in advancing HER2 ADC drugs for these patients, and we look forward to the European Commission's decision.。”
（信息来源：医药魔方）
My first!GSK's new drug for myelofibrosis and anemia receives FDA approval
9GSK today announced that the FDA has approved Ojjaara (momelotinib) for the treatment of moderate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (polycythemia realis and primary thrombocythemia) in adult patients with anemia。Ojjaara is the first and only treatment for patients with myelofibrosis and anemia。
MomelotinibIt is a new drug targeting JAK1, JAK2 and ALK2 with a differentiated mechanism of action, and can improve systemic symptoms and splenomegaly by inhibiting JAK1 and JAK2。Unlike other JAK inhibitors，momelotinib also inhibits ALK2，Overexpression of ferrimodulin in myelofibrosis can lead to anemia，momelotinib can improve inflammatory anemia，This is because the drug can inhibit liver ALK2-mediated ferrimodulin expression，动员细胞内的铁进入血液，从而刺激红细胞生成，And improve the anemia associated with myelofibrosis。
MomelotinibFirst developed by Sierra Oncology, GSK acquired the product in July 2022 for about $1.9 billion。
The approval is based on positive results from the pivotal Phase III MOMENTUM study and a subpopulation of adult anemia patients from the Phase III SIMPLIFY 1 trial。
MOMENTUMThe study was a randomized, double-blind, global Phase III clinical trial designed to evaluate the safety and efficacy of momelotinib in the treatment and reduction of key features of the disease, including symptoms, blood transfusions (due to anemia), and spleen enlargement。The trial included 195 patients with symptoms and anemia and who had previously received JAK inhibitors and were randomized 2:1 to either momotinib (n=130) or Danazole (n=65).。
The primary endpoint of the study was a reduction of ≥50% in TSS from baseline in the 28 days leading up to the end of week 24, according to the myelofibrosis Symptom Assessment Table。Key secondary endpoints included TI rate ≥12 weeks before the end of week 24, hemoglobin level ≥8g/dL, and SRR of ≥35% reduction in spleen volume from baseline at week 24。
Results showed that the trial met its primary and key secondary endpoints, including total symptom score (TSS), transfusion independence (TI) rate, and spleen response rate (SRR).。Specifically, the proportion of patients with TSS≥50% in momotinib vs control group was 25%vs9% (p=0.0095), independent of blood transfusion: 31%vs20% (p=0.0064, non-inferiority), SRR≥35% : 23%vs3% (p=0.0006）。
Myofibrosis is a rare blood cancer caused by dysregulated JAK signaling pathways and transcriptional protein signaling activators, and is characterized by systemic symptoms, significant splenomegaly, and progressive anemia。Myelofibrosis affects about 20,000 patients in the United States, about 40% of whom are already anemic at the time of diagnosis, and nearly all will eventually develop anemia。Currently approved JAK inhibitors can only solve systemic symptoms and splenomegaly, and have marrow suppression effect, which can easily lead to the deterioration of anemia. If the dose is reduced for this reason, the therapeutic effect will be greatly reduced。
（信息来源：医药魔方）
百济神州百泽安®获欧洲、美国积极注册进展
9Bazean, Bazean, Bazean State, October 19®(PD-1 antibody tirellizumab) has been actively registered in Europe and the United States, causing market shocks。
According to the announcement, the European Commission has approved Biotron®It is indicated as a single agent for the treatment of unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) in adult patients who have previously received platinum-containing chemotherapy。美国FDA则已受理百泽安®A marketing authorization application for the first-line treatment of unresectable locally advanced, relapsed or metastatic ESCC patients。
如若最终获批上市，百泽安®It will be the first PD-1 product in China to go to sea。
It is worth noting that on the same day, Beigene also announced the termination of cooperation with Novartis and the recovery of Beigene®的全球权益。
Under the agreement, Beigene Switzerland regains full global rights to develop, manufacture and commercialize tirellizumab without royalty payments。Novartis may continue ongoing clinical trials and may conduct additional tirellizumab combination trials in the future with the company's consent。The company agreed to continue to provide Novartis with investigational treatment for tirellizumab to support its clinical trials。
For these two blockbuster news, in Beigene's view, from the cooperation authorization to the sea to the independent sea, means that its global commercialization capability is about to take a new level。
Start a new war in the overseas PD-1 market
2021年1月，Beigene had a $2.2 billion partnership with Novartis for the PD-1 antibody tirellizumab，Beigene Switzerland grants Novartis the right to develop, manufacture and commercialize tislelizumab in the United States, Canada, Mexico, member States of the European Union, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan。Under the licensing agreement, Novartis is responsible for the registration application in the authorized country and has the right to launch commercialization activities upon approval。
不过，随着百泽安®Breakthrough in the European and American markets, as well as Novartis's recent global structure adjustment, Beigene also told the media that the termination of cooperation with Novartis is a strategic adjustment, after taking back global rights, Beigene will not only Beigene on®The development of the company is more autonomous, and it can quickly rely on the original sales team in the overseas market layout to continue to promote the follow-up commercialization。
At present, the global PD-1 market has been born 20 billion players。In 2022, Merck's K drug sales of 20.9 billion yuan, 22% growth is still strong, is about to win the king of medicine。此番百泽安®After breaking the zero record of domestic innovative drugs PD-1, it is necessary to compete for a broader market。Beigene President, chief operating officer and general manager of China Wu Xiaobin in response to media questions, said that the global PD-1 market space of up to 50 billion US dollars, only occupy 1% to 2% of the market share, is a blockbuster product。
As the core product of Beigene, Beizean®The first half of this year has achieved 18 in the domestic market.36亿元的销售额。Beigene said that although Beigene®It is the seventh PD-1/L1 product listed in China, but within two years, it has obtained the first place in the domestic market share, according to third-party estimates®Its sales share is about 25%, and its patient market share is close to 35%。In other words, for every 10 cancer patients treated with immunotherapy in China, there may be one who has received Baecer®的治疗。
眼下，针对百泽安®The product is being used in combination with more than 20 immunotherapy and targeted molecules, including TIGIT, LAG3, TIM3, OX40, etc., to form a new round of immunotherapy products。Beigene also said that in the field of solid tumors, the clinical trials promoted by Beigene are basically the same as those of Beigene®After the combination of drugs and the termination of the cooperation with Novartis, these clinical trials will also firmly move forward。
To date, Beigene has initiated more than 20 potential registration clinical trials of tirellizumab, of which 10 Phase 3 randomized trials and four Phase 2 trials have made positive progress。
“退货”不会成为常态
In fact, this is not the first time Beigene and Novartis have terminated cooperation。In July, Beigene and Novartis ended their cooperation on Oseperizumab。However, this termination of cooperation is different from the last time, and the recovery of global interests of Baize®Instead of being blocked from sailing, it was a historic step forward。
In fact, as early as two or three years ago, domestic innovative drugs have opened the road to the sea。Only in the first half of this year, this BD out of the sea tide more turbulent。
Due to the overlapping impact of multiple factors such as geopolitical tensions, capital winter, and the fact that some industry valuations have not yet been adjusted back, the Pharmaceutical Rubik's Cube database shows that in the first half of 2023, the total transaction amount of China's biomedical license-out transaction TOP5 events reached 74.88亿美元。From the point of view of the down payment amount, the first half of 2023 is close to the value of any of the past three years。In terms of the total transaction amount, 133 in the first half of this year.The $300 million is more than the 118 for all of 2020.4亿美元。
However, the number of transactions has risen wildly, and "returns", "lawsuits" and so on will inevitably appear。Wang Lai, senior vice president and head of global research and development at Beigene, said in response to media questions that the "return" of innovative drugs in China will not become the norm。"Everyone's familiar Zebutinib, legendary biology's CAR-T have achieved good results in the global market, and the achievements of domestic innovative drugs on the international stage are very bright.。”
In the past few years, Beigene has also delivered an excellent answer in internationalization。At present, Beigene is one of the few innovative pharmaceutical companies in the industry that can independently carry out global phase 3 clinical trials, and clinical trials have covered 48 markets around the world。
以百悦泽®(Zebutinib) for example, as Beigene's first innovative drug approved in the international market, Beigene®上市以来屡获突破。In 2022, Beigene announced a global phase 3 "head-to-head" clinical study data, showing that zebutinib is superior to the global generation of similar products ibutinib in efficacy and safety, beating the blockbuster products of multinational pharmaceutical giants。
With a global commercialization team based on science, Baiyue Ze®Approved in more than 65 markets worldwide。今年上半年，百悦泽®全球销售额达36.1.2 billion yuan, sales in the US market is more than double。
Today, Beigene has achieved "double hundred" to sea。Wu Xiaobin admitted, "With Beigene's past commercialization capabilities in the global market, we are confident that without the help of Novartis, we can do a good job of Beigene.®的商业化。And "double hundred" is just a prelude to the internationalization of Beigene。”
（信息来源：医药魔方）
亳州市场9月21日快讯
绵茵陈：Gansu unified goods price 16-17 yuan /kg, other production areas unified goods price 14-15 yuan /kg。
燕窝疏盏：The price is 11000-12000 yuan /kg, and the quality of the honey cup is different and the price is 13500-15000 yuan /kg。
东北威灵仙：Unified goods asking price 64-65 yuan /kg, import goods asking price 58-60 yuan /kg。
蒲黄：Due to the different origin of crude powder price 40-45 yuan /kg, fine powder 60-65 yuan /kg, natural powder price 100-150 yuan /kg range。
蕲蛇：The price of unified goods is 1800-1900 yuan /kg。
陈皮：The price of single goods is 11-12 yuan /kg, and the price of tangerine peel cutting is 13-15 yuan /kg
猪苓：Shaanxi unified goods price 125-130 yuan /kg。
金蝉花陈：The price of unified goods is 450-500 yuan /kg, and the price of high-quality goods is 550-600 yuan /kg。
江西蔓荆子：150-170Yuan /kg, imported vitex 100 yuan /kg。
冬瓜子：Affected by the listing of new goods, the market price fell slightly, and now Bozhou market bilateral unified goods 28-32 yuan /kg;The supply of unilateral goods is still small, and the market price is 38-40 yuan /kg。
贡菊花：In recent days, the supply of goods is mostly small batch trading, the market is weak, the current Bozhou market Huangshan tribute chrysanthemum general goods in 100-110 yuan /kg。
（信息来源：康美中药网）
安国市场9月21日快讯
兔儿伞：The market is small varieties, the annual sales volume is not large, mostly for the cold back line sporadic sales, the recent business attention to the general, the holder Shouting price and the previous period to maintain stability, the market rabbit umbrella cold back line drink piece goods price at 22 yuan。
榕树叶：Most of the cold back line sporadic sales, mainly the annual sales of this product is not large, the recent holders shout price and the previous period is flat, the current market ficus leaf cold back line retail price at 8 yuan。
铜绿：Market sales are not large, merchants pay attention to the general, the recent normal purchase and sale of goods, the market and the previous period remained stable, the current market patina retail price between 68 and 70 yuan。
地产菊花：There is still some time from the production of new, the recent normal purchase and sale of goods, the market and the previous period remained stable, the market is now the real estate chrysanthemum sulfur goods Shouting price between 33-35 yuan。
黄芪：Market bulk varieties, the recent supply of goods is in a normal state of purchase and sale, business attention is general, the current market price of Astragalus wool and Astragalus unified goods is 25 yuan, and the price of gross two is about 20 yuan。
凤仙透骨草：Recently, the supply of goods is in a normal state of purchase and sale, and the Shouting price of the business is flat with the previous period, and the Shouting price of the Phoenix immortal bone grass is better than 16 yuan。
虎杖：The market is small varieties, business attention is general, the supply is in a normal state of purchase and sale, the recent market and the previous period remain stable, the market knotweed pharmaceutical factory price is 9 yuan, and the price of decoction pieces is between 12-13 yuan。
冬虫夏草：This year, the production volume of goods is not large, the recent price is running in the firm, and the current market of Qinghai cordyceps 2000 goods price is 22.50,000, 4,000 pieces of goods at 150,000;The price of goods in Tibet is high, and the price of 2000 goods is 240,000。
黄连：Recent business attention is not reduced, affected by the small amount of new goods production, the recent price is still running in the firm, the market is now chicken feet Huanglian price between 320-330 yuan, the single branch price is about 350 yuan。
枸杞子：This year, the market rose after the new production, the recent price is still running in the firm, the market is now genuine Ningxia first 280 grain goods price at 72 yuan, 380 grain goods price at 65 yuan;The price of 280 grains of Ningxia is 47 yuan, and the price of 380 grains is 37 yuan。
黄芩：Currently entering a new period of production, the price of fresh goods this year is between 11-12 yuan, businesses have attention, the dry price is between 35-37 yuan, and the price of the series is between 40-42 yuan。
北龙胆：Near the new production, businesses have attention, the recent normal purchase and sale of goods, the price is running in the firm, the current market north Gentian unified goods price is about 105 yuan。
(Information source: Chinese Herbal Medicine World)
All our efforts are for our customers -
Enhance competitive advantages and jointly create sustainable long-term benefits
| 
