注射用唑来膦酸浓溶液
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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]
四川汇宇制药股份有限公司2025年第一次临时股东大会决议公告
Shang Hai Zheng Quan Bao· 2025-09-15 21:15
Group 1 - The company held its first extraordinary general meeting of shareholders in 2025 on September 15, where several key resolutions were passed, including the cancellation of the supervisory board and amendments to the company's articles of association [2][10] - All resolutions presented at the meeting were approved without any being rejected, indicating strong support from shareholders [2][3] - The meeting was conducted in compliance with the Company Law and the company's articles of association, with all board members and supervisors present [3][4] Group 2 - The company elected Ren Yongchun as the employee representative director for the second board, with his term starting from the date of the employee representative meeting [11] - Ren Yongchun has a background in management and does not hold any direct shares in the company, although he has an indirect stake of 0.0864% [12] - The composition of the second board remains compliant with legal requirements, ensuring that the number of employee representatives does not exceed half of the total board members [11] Group 3 - The company and its subsidiaries received marketing approvals for several products, including albumin-bound paclitaxel injection and cyclophosphamide injection, from regulatory authorities in Denmark, Germany, Uzbekistan, and Bangladesh [13][19] - The approved products are intended for various cancer treatments, enhancing the company's product pipeline and international market presence [14][15][16][17][18] - The company has initiated preparations for the sales of these products, although future revenue generation remains uncertain due to market competition and other factors [19][20]
汇宇制药及下属公司多项产品取得境外上市许可
Zhi Tong Cai Jing· 2025-09-15 10:05
Core Viewpoint - The company, Huili Pharmaceutical (688553.SH), and its subsidiaries have received marketing approvals for several pharmaceutical products from various regulatory authorities in Europe and Asia [1] Group 1: Regulatory Approvals - Huili Pharmaceutical and its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have recently obtained marketing licenses for the following products: injectable paclitaxel (albumin-bound), injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid concentrated solution, and injectable azacitidine [1]
汇宇制药(688553.SH)及下属公司多项产品取得境外上市许可
智通财经网· 2025-09-15 10:04
Core Viewpoint - The company, Huyou Pharmaceutical (688553.SH), and its subsidiaries have received marketing approvals for several products from various regulatory authorities in Europe and Asia [1] Group 1: Regulatory Approvals - Huyou Pharmaceutical and its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have recently obtained marketing licenses for the following products: - Injectable Paclitaxel (Albumin-Bound) - Injectable Cyclophosphamide - Paclitaxel Injection - Injectable Zoledronic Acid Concentrate - Injectable Azacitidine [1]
汇宇制药:多个产品获境外上市许可
Zheng Quan Shi Bao Wang· 2025-09-15 09:58
Core Viewpoint - The company, Huyou Pharmaceutical, has received marketing approvals for several of its products from various regulatory authorities in Europe and Asia, indicating a significant expansion of its market presence and product portfolio [1]. Group 1: Regulatory Approvals - Huyou Pharmaceutical and its subsidiaries, Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd., have recently obtained marketing approvals from the Danish Medicines Agency, the German Federal Institute for Drugs and Medical Devices, the Uzbekistan Drug Regulatory Authority, and the Bangladesh Drug Regulatory Authority [1]. - The approved products include injectable paclitaxel (albumin-bound), injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid solution, and injectable azacitidine [1].
汇宇制药:多个产品获得境外上市许可
Ge Long Hui· 2025-09-15 09:52
Core Viewpoint - The company, Huyou Pharmaceutical, has received marketing approvals for several of its products from regulatory authorities in Denmark, Germany, Uzbekistan, and Bangladesh, enhancing its international market presence and product pipeline [1] Group 1: Product Approvals - Huyou Pharmaceutical and its subsidiaries Seacross Pharma (Europe) Ltd. and Seacross Pharmaceuticals Ltd. have obtained marketing licenses for the following products: injectable paclitaxel (albumin-bound), injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid concentrated solution, and injectable azacitidine [1] - The approvals were granted by the Danish Medicines Agency, the German Federal Institute for Drugs and Medical Devices, the Uzbekistan Drug Regulatory Authority, and the Bangladesh Drug Regulatory Authority [1] Group 2: Market Impact - The recent approvals are expected to enrich the company's product pipeline in international markets, enhance its brand image, and facilitate the continuous expansion of its international business [1] - These developments lay a solid foundation for the sustainable growth of the company in the international market [1]
汇宇制药:多国批准公司五种药品上市
Xin Lang Cai Jing· 2025-09-15 09:48
Core Viewpoint - The company and its subsidiaries have recently obtained drug marketing approvals in Denmark, Germany, Uzbekistan, and Bangladesh for several injectable medications, which will aid in expanding the product line and enhancing brand image in international markets [1] Group 1: Drug Approvals - The company has received marketing approvals for injectable paclitaxel, injectable cyclophosphamide, paclitaxel injection, injectable zoledronic acid solution, and injectable azacitidine [1] - These drugs have been registered in multiple countries, indicating a successful expansion strategy [1] Group 2: Market Preparation - The company has conducted preliminary preparations for the market launch of these products [1] - Future performance remains uncertain due to market competition and other influencing factors [1]
6月23日午间公告一览:温州宏丰控股子公司获得实用新型专利证书
news flash· 2025-06-23 04:07
Group 1 - Wenzhou Hongfeng (300283) announced that its subsidiary, Zhejiang Hongfeng Copper Foil Co., Ltd., has received a utility model patent certificate from the National Intellectual Property Administration for a "Polishing Device for the Edge of a Copper Foil Machine" [1] - The patent number is "ZL202422197490.0," with an application date of September 9, 2024, and an authorization announcement date of June 20, 2025 [1] - The patent has a validity period of ten years from the application date, which will enhance the company's and its subsidiaries' competitive edge through the establishment of a continuous innovation mechanism [1] Group 2 - Yipin Hong (300723) announced that its wholly-owned subsidiary has obtained a registration certificate for injectable zoledronic acid concentrated solution, which is classified as a Category B product under the national medical insurance scheme [1] - The approved injectable zoledronic acid concentrated solution was registered as a Class 4 chemical drug, which is considered equivalent to passing the consistency evaluation [1]