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Sinopharm Expands Partnership with Guizhou Government to Boost Health Industry
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strengthened partnership with the government of Guizhou province. This collaboration expands upon previous achievements in promoting cooperation in biomedicine, traditional Chinese medicine R&D, and the construction of grassroots public health systems. Comprehensive Cooperation in Pharmaceutical and HealthcareThe two parties…
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Coherent Biopharma and C-Ray Therapeutics Partner to Advance Peptide-Drug Conjugate Development
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China-based Coherent Biopharma and C-Ray Therapeutics have announced a strategic partnership to delve into the development of peptide-drug conjugates (PDCs), with a particular focus on bispecific-ligand drug conjugates (bi-XDCs). The collaboration aims to leverage the strengths of both companies to advance in this innovative field of drug development. Financial details…
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CANbridge Pharmaceuticals Reports Positive Phase Ib Results for Omoprubart in PNH Treatment
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China-based rare disease firm CANbridge Pharmaceuticals Inc., (HKG: 1228) has published the preliminary results of a Phase Ib clinical study for its pipeline drug candidate omoprubart (CAN106), a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The drug candidate is under development as a potential treatment for paroxysmal…
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Sino Medical Sciences Technology Secures FDA Thailand Approval for NC Rockstar Balloon Catheter
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received market approval from the Food and Drug Administration of Thailand for its NC Rockstar noncompliant balloon catheter. This development marks a significant step for the company’s expansion into the Southeast Asian medical device market. Product Composition…
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Haisco Pharmaceutical’s HSK31679 Receives Clinical Trial Approval for NASH Treatment
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its in-house developed Category 1 drug candidate, HSK31679, has obtained clinical trial approval for the treatment of non-alcoholic steatohepatitis (NASH). HSK31679: A Selective THR-β Agonist for Lipid MetabolismHSK31679 is a highly selective thyroid hormone β receptor (THR-β) agonist that…
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NMPA Approves XZenith Biopharm’s Anaprazole for Duodenal Ulcer Treatment
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The National Medical Product Administration (NMPA) has granted marketing approval for anaprazole, a proton pump inhibitor (PPI) developed by China-based XZenith Biopharm. This home-grown Category 1 drug is now approved for use in treating duodenal ulcers. Anaprazole’s Mechanism of Action and Clinical AdvantagesAnaprazole, a benzimidazole compound, functions by inhibiting gastric…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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Shionogi’s Acquisition of Qpex Impacts Brii Biosciences’ Rights to Anti-infective Drugs
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Japan’s Shionogi & Co., Ltd (TYO: 4507) announced on June 26, 2023, its planned acquisition of US anti-infectives specialist Qpex Biopharma Inc., for USD 100 million upfront and an additional USD 40 million based on certain development and regulatory milestones. This deal has significant implications for China-based biotech Brii Biosciences…
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Innovent Biologics and RemeGen Partner on Clinical Study for PD-1 Inhibitor and ADC Drugs
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China-based Innovent Biologics Inc., (HKG: 1801) has entered into a clinical study and supply cooperation agreement with compatriot firm RemeGen (HKG: 9995). The collaboration will pair Innovent’s programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab injection) with RemeGen’s antibody drug conjugate (ADC) drug candidates RC88 and RC108 in a clinical study. Clinical…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
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Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
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US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
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S-Evans Biosciences Receives NMPA Tacit Approval for Stem Cell Therapy in ARDS
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S-Evans Biosciences, a stem cell specialist based in Hangzhou, has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA) for its “human umbilical cord mesenchymal stem cell injection” in the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Product Development and ARDS OverviewThe in-house developed…
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Kite Pharma’s Yescarta Marketing Rights Transferred to Gilead Sciences K.K. in Japan
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US immunotherapy specialist Kite Pharma, Inc. has announced that the Marketing Authorization for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. (TYO: 4568) to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc (NASDAQ: GILD). History of Yescarta and…
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Hopstem Biotechnology’s hNPC01 Receives Tacit Approval for Stroke Sequelae Treatment from CDE
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Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists from Johns Hopkins University, has announced receiving tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for its hNPC01. This induced pluripotent stem cells (iPSC) derived cell therapy is intended for the treatment…
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Edding Pharma Aims for Fifth IPO Attempt on Hong Kong Stock Exchange
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China-based Edding Pharma is gearing up for its fifth attempt to hold an initial public offering (IPO) on the Hong Kong Stock Exchange. The company reported revenues of RMB 2.074 billion (USD 289 million) last year, with net profits reaching RMB 306.3 million (USD 42.67 million), primarily from a portfolio…
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Sciwind Biosciences Leads China’s Anti-Obesity Drug Market with GLP-1 Analog Ecnoglutide
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Sino-US biotech Sciwind Biosciences Co., Ltd has positioned itself as a frontrunner in China’s race to market anti-obesity drugs. The company made a significant impact at the American Diabetes Association (ADA) conference with three poster presentations, including a late-breaking presentation, highlighting its glucagon-like peptide-1 (GLP-1) analog, ecnoglutide (XW003). Ecnoglutide: An…
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Aureka Biotechnologies Secures $10 Million in Seed Funding for AI-Driven Biotechnology
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Aureka Biotechnologies Inc., a California-based artificial intelligence (AI)-empowered biotech company, has successfully raised USD 10 million through a seed financing round led by K2 Venture Partners and Newerli Capital, both China-based private equity funds. The funds will be directed towards the research and development of an AI+high-throughput digital biotechnology macromolecular…
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Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab from conditional approval to full approval for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with sorafenib or chemotherapy. Camrelizumab’s Approval History and IndicationsCamrelizumab, which received first approval…
