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Merck’s Lagevrio Receives Emergency Conditional Approval from China’s NMPA
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced receiving emergency conditional approval from the National Medical Products Administration (NMPA) for its oral COVID-19 therapy Lagevrio (molnupiravir). The drug is approved for the treatment of adult patients with mild to moderate COVID-19 who have high-risk factors for severe…
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NHSA and CNIPA Issue Opinions on Strengthening IP Protection in Drug Procurement
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The National Healthcare Security Administration (NHSA) and the China National Intellectual Property Administration (CNIPA) have issued an Opinions paper titled “Strengthening the Protection of Intellectual Property Rights within Centralized Pharmaceutical Procurement.” The focus is on enhancing the protection of intellectual property (IP) rights during the drug procurement process. Coordination and…
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Legend Biotech’s Carvykti Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) website indicates that a market approval filing from Legend Biotech Corporation (NASDAQ: LEGN) for its BCMA-directed chimeric antigen receptor (CAR) T cell therapy Carvykti (ciltacabtagene autoleucel) has been accepted for review. This makes Carvykti the third BCMA CAR-T therapy to be filed for marketing…
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F-star Therapeutics and Sino Biopharmaceutical Face Delays in Proposed Acquisition
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UK-based biotech F-star Therapeutics (NASDAQ: FSTX) released an SEC filing indicating that the proposed acquisition by China’s Sino Biopharmaceutical (HKG: 1177) faces further delays. The notice indicates that on December 28, 2022, the US Committee on Foreign Investment to the US (CFIUS) issued an interim order warning the companies that…
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CSPC’s ALMB-0168 Receives NMPA Approval for Osteoarthritis Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate ALMB-0168 in osteoarthritis. ALMB-0168, a connexin 43-targeted monoclonal antibody developed in-house by subsidiary AlaMab Therapeutics Inc., is under development to treat acute…
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RemeGen’s RC108 Receives FDA Go-Ahead for Phase I Clinical Study
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing…
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Simcere Receives NMPA Clearance for SIM0348 Clinical Study
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors. Mechanism of Action and DesignSIM0348 is designed to block the interaction between…
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Skynor Medical Raises RMB 100 Million in Financing Round for Market Expansion
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Skynor Medical, a Shanghai-based manufacturer of nerve and peripheral blood vessel implantation and interventional devices, has reportedly raised RMB 100 million (USD 14.37 million) in a new financing round. Investors include Zhangjiang Hi-Tech Park Development, Pudong Capital, Zhangjiang Haoheng Innovative Equity Investment, and Suxin Venture Capital. The proceeds will be…
