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Guangdong Zhongsheng Completes Enrollment for RAY1216 Phase III Study in COVID-19
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China – based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the completion of enrollment for its Phase III study of RAY1216, a drug candidate for the treatment of mild SARS – CoV – 2 infection. The randomized, double – blind, placebo – controlled study has enrolled 1,360 subjects…
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CDE Releases 65th Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 65th batch of chemical generic reference preparations, adding 35 new specifications to the list and updating information on 44 previously published specifications. This batch reflects the CDE’s ongoing efforts to expand and refine the availability of generic drugs in the market.…
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Viking Therapeutics Sues Ascletis Pharma Over Alleged Trade Secret Theft
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US – based Viking Therapeutics (NASDAQ: VKTX) is set to take China’s Ascletis Pharma Inc. (HKG: 1672) to court in the United States over alleged theft of trade secrets and breach of contract. Viking has filed separate complaints with the US District Court of Southern California and the US International…
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Shuwen Biotech Partners with Nottingham University Hospitals for MammaTyper
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China – based diagnostic specialist Shuwen Biotech Co., Ltd and its German wholly – owned subsidiary Cerca Biotech GmbH have entered into a collaboration agreement with Nottingham University Hospitals (NUH). The agreement is designed to bolster the clinical study, application, and promotion of Shuwen’s core product, MammaTyper. Financial details of…
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Chinagene Tech’s ZVS101e Receives FDA IND Approval for Bietti’s Crystalline Dystrophy
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Beijing – based Chinagene Tech, a specialist in hereditary ophthalmopathy diagnosis and gene therapy, has announced obtaining Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy ZVS101e. The therapy is designed to treat Bietti’s crystalline dystrophy (BCD), a rare genetic eye disease. ZVS101e, a Category…
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Jiangxi Leads 16-Province VBP Alliance with Winning Bids Announced
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The Jiangxi Province Healthcare Security Administration has released a notification regarding the winning bids of the 16 – province (municipalities, regions) alliance volume – based procurement (VBP). The event, initiated on November 18, 2022, and led by Jiangxi, included Inner Mongolia, Jilin, Heilongjiang, Zhejiang, Henan, Hunan, Guangxi, Hainan, Chongqing, Guizhou,…
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NMPA Approves 172 Medical Devices for Marketing in November 2022
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The National Medical Products Administration (NMPA) approved 172 medical devices for marketing in November 2022. This approval marks a significant step in expanding the availability of medical devices in the market, addressing various healthcare needs. Breakdown of Approved DevicesAmong the approved devices, there were 121 domestic Category III products, 22…
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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…
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Sichuan Kelun Completes RMB 1.5 Billion Financing Round for Kelun-Biotech
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced the completion of a financing round at RMB 1.5 billion (USD 215.53 million) for its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Kelun maintains majority control of the subsidiary with a 59.75% stake, increased from 55.41%. Merck, Sharp & Dohme (MSD;…
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Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE
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China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review status for the New Drug Application (NDA) of Nefecon (targeted-release formulation-budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk…
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BrightGene Receives NMPA Approval for BGM0504 Clinical Trial
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its BGM0504, a dual agonist targeting GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin-stimulating polypeptide). The targeted indications for BGM0504 are weight loss and type…
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Anhui Anke Biotechnology Receives NMPA Approval for AK2017 Clinical Study
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China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human growth hormone Fc fusion protein injection AK2017. The drug will be assessed for treating children with growth deficiencies due to endogenous…
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AstraZeneca’s Nexium Approved by NMPA for Adolescent GERD Treatment
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UK-based pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Nexium (esomeprazole) to treat gastroesophageal reflux disease (GERD) in adolescents. This marks the proton pump inhibitor’s (PPI) first approval for a pediatric indication in China. Incidence and Treatment of GERD…
