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科兴生物收到纳斯达克退市通知;广誉远副总裁离任
Policy Developments - The National Medical Products Administration (NMPA) is focusing on the quality supervision of selected drugs in centralized procurement, emphasizing the importance of quality safety and compliance in production [1] - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, optimizing work mechanisms and exploring risk monitoring [1] - The NMPA acknowledges the development of the medical device industry in Chongqing and stresses the need for a robust quality safety responsibility system [2] Drug and Device Approvals - Baiyunshan's subsidiary Zhongyi Pharmaceutical received a registration certificate for the traditional medicine An Gong Niu Huang Wan from Vietnam's Ministry of Health, aiding market expansion [3] - Huyou Pharmaceutical announced that its subsidiary Seacross Pharmaceuticals Ltd. received marketing approvals for multiple products from regulatory authorities in Pakistan, the UK, and North Macedonia [4] - Zhifei Biological's recombinant herpes zoster vaccine (ZFA01) clinical trial application has been accepted by the NMPA, which may enhance vaccine efficacy [5] Capital Market Activities - Puluo Pharmaceutical plans to repurchase shares worth between RMB 180 million and RMB 360 million, with a maximum price of RMB 23 per share [6][7] - Sinovac Biotech received a delisting notice from NASDAQ due to failure to submit its annual report by the deadline, with potential trading suspension imminent [8] Industry Developments - Researchers published a detailed immune response map following pig kidney transplants in brain-dead patient models, identifying key factors for transplant success [9] - Haizheng Pharmaceutical's subsidiary plans to collaborate with the East China Institute for the biomanufacturing of heparin, with a project budget not exceeding RMB 120 million [10] Public Sentiment Alerts - Guangyuyuan announced the resignation of Vice President Wang Junbo due to work adjustments, effective immediately [11] - Medici's shareholder Chen Guoxing plans to reduce his stake by up to 1.64% through trading methods due to personal financial needs [12]
汇宇制药:多款产品获得境外上市许可
Zhi Tong Cai Jing· 2025-11-19 07:47
Core Viewpoint - Seacross Pharmaceuticals Ltd., a subsidiary of the company, has received marketing approvals for several products from regulatory authorities in Pakistan, the UK, and North Macedonia [1] Group 1 - The approved products include Plasmapheresis Injection, Injection of Setipiprant, Injection of Azacitidine, Concentrated Solution of Zoledronic Acid, and Zoledronic Acid Injection [1]
汇宇制药(688553.SH):多款产品获得境外上市许可
智通财经网· 2025-11-19 07:45
Core Viewpoint - Seacross Pharmaceuticals Ltd., a subsidiary of 汇宇制药 (688553.SH), has received marketing approvals for several products from regulatory authorities in Pakistan, the UK, and North Macedonia [1] Group 1: Regulatory Approvals - The company has obtained marketing licenses for the following products: - 普乐沙福注射液 (Plerixafor Injection) - 注射用塞替派 (Injectable Setipiprant) - 注射用阿扎胞苷 (Injectable Azacitidine) - 注射用唑来膦酸浓溶液 (Injectable Zoledronic Acid Concentrate) - 唑来膦酸注射液 (Zoledronic Acid Injection) from the respective drug regulatory agencies [1]