Weekly Top 5 in China (0317-0323)
China National Biotec Group and ImmunoBiology Collaborate to Develop Next Generation Vaccine against Pneumococcal Infection
Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria. It is a major cause of mortality with approximately 1.5 million deaths every year. There are around 100 serotypes of Streptococcus pneumoniae, and current vaccines are targeting a limited number of approximate 97 serotypes. Studies showed that the relative prevalence rates between strains changed over time. The emergence of new serotypes is an ongoing challenge. Reports indicated that pneumococcal bacteria are resistant to one or more antibiotics in 30% of the cases, leading to treatment failures.
ImmunoBiology Ltd (ImmBio), a vaccine company based near Cambridge, the UK, recently signed a licensing agreement with LIBP (Lanzhou Institute of Biological Product), a subsidiary of China National Biotec Group (CNBG). This partnership will enable the two companies to jointly develop ImmBio’s proprietary PnuBioVax vaccine against pneumococcal disease and launch the vaccine in the Greater China area after completion of the clinical studies. The goal of the PnuBioVax vaccine is to be the first vaccine on the market for all S. pneumonia serotypes, potentially addressing antibiotic resistance at the source.
CNBG is the leading vaccine manufacturer in China, having multiple production sites in major Chinese cities, focusing on R&D, manufacture and marketing of biological products. The portfolio of CNBG includes vaccines, plasma-derived products, as well as medical aesthetics products and diagnostic reagents. LIBP was founded in 1934 and is a subsidiary of CNBG.
About ImmunoBiology Ltd
ImmunoBiology Ltd is a vaccine company developing the next generation of anti-infective vaccines. The company focuses on areas of high unmet need, where the risk and consequence of infection are severe.
AkaRx Signs Exclusive Distribution Agreement with Fosun Pharma
AkaRx, Inc., a subsidiary of Dova Pharmaceuticals, Inc., signed an agreement granting Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., the exclusive development and distribution rights of avatrombopag in mainland China and Hong Kong. The contract includes an upfront payment, milestone payments, and a fixed transfer price for product supplied. Under the agreement, Fosun Pharma Industrial has the right to exclusively develop and commercialize and to assist AkaRx with the registration of avatrombopag for chronic liver disease patients with thrombocytopenia in mainland China and Hong Kong. Fosun Pharma Industrial will also support the development of avatrombopag for expanded indications.
About Dova Pharmaceuticals, Inc.
Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia.
About Fosun Pharma
Shanghai Fosun Pharmaceutical (Group) Co., Ltd., known as Fosun Pharmaceutical or Fosun Pharma is a Chinese pharmaceutical company.
The company covers the key sectors of the pharmaceutical and healthcare industrial chain, including R&D pharmaceutical manufacturing, medical diagnosis, medical devices, pharmaceutical distribution and retailing, and medical services.
CStone Approved to Start Trial of HDAC6 Inhibitor in China
CStone Pharmaceuticals Co., Ltd. announced that the National Medical Products Administration (NMPA) recently approved the company’s histone deacetylase 6 (HDAC6) selective inhibitor CS3003 for Phase I clinical trial in China.
CS3003 is a small molecule inhibitor that selectively targets histone deacetylase 6 (HDAC6). Unlike the other HDAC family members, HDAC6 is mainly located in the cytoplasm and has little effect on DNA histone acetylation. HDAC6 inhibition can enhance acetylation of cytoplasmic tubulin and lose the capability to clear unfolded or misfolded proteins, thereby promoting cell apoptosis. Selective inhibition of HDAC6 produces better efficacy in multiple myeloma.
CS3003 is the ninth drug candidate of CStone with Investigational New Drug approval obtained in China. At present, there are no similar domestic and foreign products approved. CS3003 has the potential to become the first-in-class HDAC6-selective inhibitor in the world.
CStone Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and molecularly-targeted drugs to address unmet medical needs for cancer patients in China and worldwide. CStone was founded in 2016 and is based in Suzhou, China with additional offices in Shanghai and Beijing, China.
Merck and GenScript cooperate to accelerate cell and gene therapy industrialization in China
With more than 130 companies developing cell and gene therapies, and a tremendous acceleration of the regulatory system, China has become the world-leader in cases of cell and gene therapies clinical trials conducted.
Merck, a leading science and technology company, announced the signing of a non-binding Memorandum of Understanding with Chinese biotechnology company GenScript for a strategic alliance focusing on plasmid and viral vector manufacturing, aimed at accelerating the industrialization and commercialization of cell and gene therapies in China.
Merck has made numerous substantial manufacturing investments in China in recent years, leveraging its biopharmaceutical expertise to play a greater role in the biotechnology industry. GenScript, headquartered in Nanjing, China, is seeking to expand into immunotherapy and contract development and manufacturing organization (CDMO).
GenScript plans to create a new plasmid and virus manufacturing service, covering process design to large-scale manufacturing. Manufacturing of high-quality plasmid and viral vectors is one of the most critical components in the commercialization of cell and gene therapy. As Merck is one of the world’s largest manufacturers of viral vectors, this collaboration will give GenScript access to high quality gene and cell therapy manufacturing.
GenScript Biotech Corp., headquartered in Nanjing, China, is a world leader in the biological reagent service industry. With the fast growth in developing biological reagents, the company now expands its business into immunotherapy, contract development and manufacturing organization (CDMO), lab equipment and industrial microbiology applications.
Merck, founded in 1668 in Germany, is a leading science and technology company, operates across healthcare, life science and performance materials. In 2015, Merck acquired Sigma-Aldrich and merged it with Merck Millipore. In the United States and Canada, the life science business is now known as MilliporeSigma.
WuXi Biologics Receives EMA GMP Certificates for the production of Trogarzo™
WuXi Biologics, a leading global biologics company has received EMA GMP certificates for the production of Trogarzo™ at its cGMP Drug Substance (DS) and Drug Product (DP) manufacturing facilities in Wuxi city and its cGMP cell banking facilities in Shanghai. Trogarzo™ is developed by TaiMed Biologics and marketed in the U.S. and EU by Theratechnologies.
Trogarzo is a CD4-directed post-attachment human immunodeficiency virus type 1 (HIV-1) inhibitor, specifically indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant.
WuXi Biologics is providing its global biomanufacturing partners with a robust and high-quality supply chain network through world-class quality system and capacities. The EMA GMP certification further qualifies WuXi Biologics as a leading global biomanufacturing player.
With the recognition from both the U.S. FDA and EMA, WuXi Biologics will continue to enable global partners to accelerate and transform biologics development from concept to commercialization.
About WuXi Biologics
WuXi Biologics, based in Shanghai, China, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing.
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