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China’s NMPA Seeks Feedback on Drug Quality Management Provisions
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China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Provisions on the Supervision and Administration of Marketing Authorization Holder Implementing Drug Quality Subject Responsibilities,” and is soliciting public feedback until December 9. The document aims to enhance the quality management responsibilities of Marketing Authorization Holders (MAHs) in…
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Luye Pharma’s Shandong Boan Bio Files for Hong Kong IPO
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange. Key details of the IPO filing remain undisclosed at this stage. Company BackgroundFounded in 2013, Boan Bio has previously raised a total of…
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Luca Healthcare Partners with Cambridge Cognition to Launch Cognitive Tools in China
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China-based digital health solutions provider Luca Healthcare has announced a strategic partnership and license agreement with UK firm Cambridge Cognition. Under the agreement, Luca has secured a 10-year exclusive license to commercialize Cambridge Cognition’s suite of cognitive assessment tools in mainland China. Financial details of the agreement were not disclosed.…
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Luye Pharma’s Biosimilar to Amgen’s Xgeva Launched in China
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China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the…
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Assure Tech Wins Japanese PDMA Approval for Pen-Type COVID-19 Antigen Test
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China-based Assure Tech (Hangzhou) Co., Ltd (SHA: 688075) has announced receiving marketing approval from Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) for its novel coronavirus antigen detection reagent (pen type). This approval marks a significant milestone for the company in expanding its presence in the global diagnostics market. Product DetailsThe…
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Double-Crane Pharma Gains NMPA Approval for COVID-19 Drug CX2101A Clinical Trials
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its COVID-19 treatment candidate, CX2101A. This marks a significant step forward in the development of new therapeutic options for COVID-19 in China. CX2101A Technology and DevelopmentCX2101A is a…
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Lepu Medical Wins NMPA Approval for Disposable Pressure Microcatheter
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving Category III device approval (No. 20223071559) from the National Medical Products Administration (NMPA) for its in-house developed disposable pressure microcatheter. This approval marks a significant milestone in the company’s efforts to enhance precision in…
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China’s NMPA Shifts to Electronic Drug Filings from January 2023
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China’s National Medical Products Administration (NMPA) has released a notification indicating the initiation of electronic drug filings, replacing paper filings, starting from January 2023. This move aims to streamline the drug registration process and enhance efficiency. Implementation DetailsApplicants are required to prepare electronic application materials in accordance with relevant regulations…
