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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…
