普乐沙福注射液
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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
2 1 Shi Ji Jing Ji Bao Dao· 2025-11-20 00:04
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]
益佰制药恢复小儿止咳糖浆的生产销售
Zheng Quan Shi Bao Wang· 2025-09-17 12:56
Group 1 - Yibai Pharmaceutical received a notice from the Guizhou Provincial Drug Administration on September 16, 2025, lifting the suspension of production and sales of its children's cough syrup due to resolved safety concerns [1] - The company had previously suspended the production and sales of the children's cough syrup in August 2025, following a notification from the same authority [1] - Revenue from the children's cough syrup for the years 2021, 2022, 2023, and 2024 was 3.42 million, 4.32 million, 8.38 million, and 1.51 million respectively, accounting for 0.10%, 0.16%, 0.30%, and 0.07% of the company's total revenue during those years, indicating a relatively small impact on overall performance [1] Group 2 - In the first half of the year, the company reported a revenue of 993 million, a year-on-year decrease of 14.99%, and a net loss attributable to shareholders of 19.90 million [2] - The primary reason for the loss was a decrease in sales of major products, while costs remained higher than revenue; however, improved cost control measures led to a reduction in losses compared to the previous year [2] - The company is actively expanding into chemical drugs, traditional Chinese medicine, and biological drugs, focusing on building a robust R&D system and integrating advantageous resources for innovative drug development [2] Group 3 - The company is exploring existing products with unique or similar exclusivity and conducting research on ancient classic formula compound preparations [3] - Research efforts include safety re-evaluation studies for Ginkgo Biloba injection and quality studies for Aidi injection, with preliminary completion of quality standard enhancement for Ginkgo Biloba injection [3] - As of June 30, 2025, the company completed the registration of 412 new products, including 248 national standard products and 164 provincial standard products [3]