Core Viewpoint - The company has received a notice from the National Medical Products Administration regarding the acceptance of the registration application for the domestic production of Dapagliflozin Metformin Extended-Release Tablets [1] Group 1: Company Developments - The subsidiary Beijing Sai'er Biological Pharmaceutical Co., Ltd. has received the acceptance notice for the drug registration application [1] - Dapagliflozin and Metformin combination tablets were developed by AstraZeneca and were approved by the FDA in 2014 [1] Group 2: Industry Insights - SGLT-2 inhibitors work through a non-insulin-dependent mechanism, reducing glucose reabsorption in the kidneys and promoting glucose excretion through urine [1] - The combination of SGLT-2 inhibitors with Metformin has shown better glycemic control and lower side effects [1]

Core Viewpoint - The company has received a production registration approval notice from the National Medical Products Administration for its product, Dapagliflozin Metformin Extended-Release Tablets, indicating a significant step towards market entry in China [1] Group 1: Company Developments - Subsidiary Beijing Sair Biological Pharmaceutical Co., Ltd. has received the acceptance notice for the drug registration application [1] - The combination of SGLT-2 inhibitor Dapagliflozin and Metformin is expected to provide better glycemic control with fewer side effects [1] Group 2: Industry Context - Dapagliflozin and Metformin combination was developed by AstraZeneca and received FDA approval in 2014 [1] - The SGLT-2 inhibitors work through a non-insulin-dependent mechanism, reducing glucose reabsorption in the kidneys and promoting glucose excretion [1]

证券代码：300485 证券简称：赛升药业 公告编号：2025-051 北京赛升药业股份有限公司 关于子公司收到药品注册上市许可申请受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没 有虚假记载、误导性陈述或重大遗漏。 北京赛升药业股份有限公司（以下简称"公司"）子公司北京赛而生物药业 有限公司（以下简称"赛而生物"）近日收到了国家药品监督管理局下发的达格 列净二甲双胍缓释片境内生产药品注册上市许可申请的《受理通知书》。现将相 关信息公告如下： 一、《受理通知书》主要内容 定予以受理。 受理号：CYHS2504***、CYHS2504*** （二）申请单位：北京赛而生物药业有限公司 申请事项：境内生产药品注册上市许可 产品名称：达格列净二甲双胍缓释片（Ⅱ） 规 格：达格列净2.5mg（以C21H25C106计）和盐酸二甲双胍1000mg 根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决 定予以受理。 受理号：CYHS2504*** （三）申请单位：北京赛而生物药业有限公司 申请事项：境内生产药品注册上市许可 （一）申请单位：北京赛而生物药业有限公司 申请事项：境内生产药 ...

Core Viewpoint - The announcement indicates that the subsidiary of the company, Sai Er Biological, has received a notice of acceptance for the registration application of Dapagliflozin Metformin Extended-Release Tablets from the National Medical Products Administration, marking a significant step in the drug's approval process [1] Group 1 - The registration application involves four specifications (I, II, III, IV) for the drug [1] - The compound tablet was developed by AstraZeneca and was approved for marketing in the United States in 2014, with approval in China occurring in June 2023 [1] - The acceptance of the application means the product is entering the registration review stage, which is expected to have no significant impact on the company's recent performance [1] Group 2 - If the review is successfully passed, it will enrich the product pipeline of Sai Er Biological [1] - The timeline and outcome for drug registration approval remain uncertain [1]

Core Viewpoint - The company, Sai Sheng Pharmaceutical, has received a notice from the National Medical Products Administration for the registration and marketing approval of Dapagliflozin Metformin Extended-Release Tablets, indicating a significant step in expanding its product portfolio in the diabetes treatment market [1] Group 1: Company Developments - Sai Sheng Pharmaceutical's subsidiary, Beijing Sai Er Biological Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application [1] - The combination drug Dapagliflozin and Metformin was developed by AstraZeneca and was approved by the FDA in 2014 [1] - The product was approved for marketing in China in June 2023, highlighting the company's progress in regulatory approvals [1] Group 2: Industry Insights - SGLT-2 inhibitors, like Dapagliflozin, work through a non-insulin-dependent mechanism, reducing glucose reabsorption in the kidneys and promoting glucose excretion through urine [1] - The combination of SGLT-2 inhibitors with Metformin has shown better glycemic control and lower side effects, indicating a potential competitive advantage in the diabetes treatment market [1]

Core Viewpoint - The company, Sai Sheng Pharmaceutical (300485), reported that as of November 20, 2025, the number of shareholders is 37,118 [1] Summary by Categories - **Company Information** - As of November 20, 2025, the total number of shareholders for Sai Sheng Pharmaceutical is 37,118 [1]

Market Overview - The biopharmaceutical sector increased by 0.83% on November 25, with Jindike leading the gains [1] - The Shanghai Composite Index closed at 3870.02, up 0.87%, while the Shenzhen Component Index closed at 12777.31, up 1.53% [1] Top Gainers in Biopharmaceutical Sector - Jinke (688670) closed at 25.75, up 19.99% with a trading volume of 92,200 shares [1] - Hualan Biological (301207) closed at 23.33, up 11.25% with a trading volume of 250,500 shares [1] - Saiseng Pharmaceutical (300485) closed at 11.95, up 5.19% with a trading volume of 168,000 shares [1] - Other notable gainers include Bohui Innovation (300318) at 6.84 (+3.32%) and Dongbao Biological (300239) at 5.72 (+3.25%) [1] Market Capital Flow - The biopharmaceutical sector saw a net inflow of 40.88 million yuan from institutional investors, while retail investors experienced a net outflow of 147 million yuan [2] - The sector's overall capital flow indicates a strong interest from institutional investors despite retail selling pressure [2] Individual Stock Capital Flow - Jinke (688670) had a net inflow of 39.66 million yuan from institutional investors, while retail investors showed a net outflow of 13.72 million yuan [3] - Other stocks like Watson Bio (300142) and Hualan Bio (002007) also experienced significant net inflows from institutional investors, indicating positive sentiment [3] - Conversely, stocks like Dongbao Biological (300239) and Bohui Innovation (300318) faced net outflows from retail investors, suggesting mixed investor sentiment [3]

Group 1 - The demand for flu-related medications is rising significantly as the flu season approaches, with several stocks in the sector experiencing price surges [1] - Notable stocks that have reached their daily limit include Jindike, Peking University Medicine, and Te Yi Pharmaceutical, among others [1] - Data from Alibaba Health indicates a more than 500% week-on-week increase in the number of people purchasing antiviral flu medications, with Mabalosavir showing a remarkable over 600% increase [1] Group 2 - Experts warn that the H3N2 strain circulating this year is different from previous years, leading to lower immunity in the population and increased transmission risk [2] - The flu virus is known to undergo antigenic drift, but current strains are still within seasonal levels and do not indicate a stronger evolution of the virus [2] Group 3 - Companies are actively ensuring the supply of flu medications and vaccines in response to rising demand [3] - Dongyang Sunshine, a major supplier of Oseltamivir, reports comprehensive coverage of its products across hospitals, pharmacies, and online platforms, maintaining sufficient inventory [3] - Hualan Biological has noted a significant increase in demand for flu vaccines since October, with plans to enhance market supply and ensure timely delivery through cold chain logistics [3]

Group 1 - The core point of the article is that Sai Sheng Pharmaceutical announced that its subsidiary, Shenyang Junyuan Pharmaceutical Co., Ltd., has received a drug production license from the Liaoning Provincial Drug Administration [2] - The announcement includes a change in the production manager from Li Li to Liu Huifeng, while other details remain unchanged [2]

Core Viewpoint - The announcement indicates that Junyuan Pharmaceutical, a subsidiary of Saiseng Pharmaceutical, has received a drug production license from the Liaoning Provincial Drug Administration, which is expected to maintain stable production capacity without significant impact on the company's performance [1] Group 1 - Junyuan Pharmaceutical has been granted a drug production license with the license number Liao 20210198, valid until April 7, 2026 [1] - The production manager has been changed from Li Li to Liu Huifeng, while other details remain unchanged [1] - The change is beneficial for maintaining stable production capabilities and ensuring normal business operations [1]