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(688553.SH)发布公告，公司子公司Seacross Pharmaceuticals Ltd.于近期分别收到巴基斯坦药品 监督管理局、英国药品和健康产品管理局和北马其顿药品和医疗设备管理局核准签发的公司产品普乐沙 福注射液、注射用塞替派、注射用阿扎胞苷、注射用唑来膦酸浓溶液、唑来膦酸注射液的上市许可。 ...

智通财经APP讯，汇宇制药(688553.SH)发布公告，公司子公司Seacross Pharmaceuticals Ltd.于近期分别 收到巴基斯坦药品监督管理局、英国药品和健康产品管理局和北马其顿药品和医疗设备管理局核准签发 的公司产品普乐沙福注射液、注射用塞替派、注射用阿扎胞苷、注射用唑来膦酸浓溶液、唑来膦酸注射 液的上市许可。 ...

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]

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]

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]

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]

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].

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]

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]