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赛升药业:截至2025年12月10日公司股东户数为35036户
Zheng Quan Ri Bao Wang· 2025-12-15 13:15
证券日报网讯12月15日,赛升药业(300485)在互动平台回答投资者提问时表示,截至2025年12月10 日,公司股东户数为35036户。 ...
赛升药业:子公司达格列净二甲双胍缓释片上市许可申请获受理
Zheng Quan Ri Bao· 2025-12-04 12:44
Group 1 - The core point of the article is that Sai Sheng Pharmaceutical has received a notice from the National Medical Products Administration regarding the acceptance of its application for the production registration of Dapagliflozin Metformin Extended-Release Tablets [2] Group 2 - The announcement was made on the evening of December 4, indicating a significant step in the company's product development process [2] - The product in question, Dapagliflozin Metformin Extended-Release Tablets, is aimed at the domestic market, highlighting the company's focus on local production and regulatory compliance [2] - This development may enhance the company's portfolio in the diabetes treatment segment, potentially leading to increased market share and revenue growth [2]
12月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-04 10:31
Group 1 - China Pacific Insurance has received approval from the financial regulatory authority for Wang Yuhua to serve as a director [1] - Shanghai Bank announced that the regulatory authority has approved Chen Lei's qualification as vice president [2] - Shanghai HuGong has decided to terminate the "Aerospace Equipment Manufacturing Base" fundraising project due to significant changes in project feasibility [3] Group 2 - Dongwang Times plans to reduce its stake by up to 1.20% through share sales [4] - Zhinancun intends to increase its capital by 100 million yuan in its wholly-owned subsidiary, Maigao Securities [5] - Jinxinnong reported a sales revenue of 115 million yuan from pig sales in November [6] Group 3 - Tiantan Biological has completed the Phase III clinical trial of its human prothrombin complex, showing good efficacy and safety for hemophilia B patients [7] - Beijete's subsidiary has signed a framework agreement for equity acquisition to gain control of Yunnan Wenye Nonferrous Metals [8] - Zhongsheng Pharmaceutical's RAY1225 injection has received approval for a new clinical trial indication for treating metabolic-associated fatty liver disease [9] Group 4 - Enhua Pharmaceutical's hydrochloride sulpiride tablets have passed the consistency evaluation for generic drugs [10] - Shenkong Co. plans to invest 60 million yuan in a semiconductor industry fund [11] - Lianhuan Pharmaceutical's subsidiary has received approval for its drug to pass the consistency evaluation for generic drugs [12] Group 5 - Dazhong Transportation has received approval to issue debt financing tools totaling 4.5 billion yuan [13] - Jintian Titanium Industry plans to invest 50 million yuan in an industry merger and acquisition fund [14] - Changchun Gas has committed over 1.7 billion yuan to gas facility upgrades [15] Group 6 - Laimei Pharmaceutical's innovative anti-cancer drug "Nano Carbon Iron" has received approval for clinical trials [16] - Longquan Co. has signed supply contracts worth approximately 50.76 million yuan for nuclear power components [17] - Igor plans to distribute a cash dividend of 1 yuan per 10 shares [18] Group 7 - Xingfa Group's subsidiary has signed a processing agreement for 80,000 tons of lithium iron phosphate [20] - Yunjigroup's director Wang Wanfeng has resigned for personal reasons [21] - Saiseng Pharmaceutical's application for the listing of a new drug has been accepted by the regulatory authority [22] Group 8 - Xinhua Medical has obtained registration certificates for two new medical devices [23] - Chaoying Electronics plans to invest 100 million USD in its Thai subsidiary for an AI circuit board expansion project [24] - Suzhou Planning's application to acquire 100% of Dongjin Aviation has been accepted by the Shenzhen Stock Exchange [25]
赛升药业:达格列净二甲双胍缓释片注册上市许可申请获受理
Core Viewpoint - The announcement by Sai Sheng Pharmaceutical regarding the acceptance of the production registration application for Dapagliflozin Metformin Extended-Release Tablets marks a significant step in expanding its product portfolio in the diabetes treatment market [1] Group 1: Company Developments - Sai Sheng Pharmaceutical's subsidiary, Sai Er Biological, has received a notice from the National Medical Products Administration regarding the acceptance of the production registration application for Dapagliflozin Metformin Extended-Release Tablets [1] - The combination of SGLT-2 inhibitor Dapagliflozin and Metformin is developed by AstraZeneca and was approved by the FDA in 2014 [1] Group 2: Industry Insights - SGLT-2 inhibitors function through a non-insulin-dependent mechanism, reducing glucose reabsorption in the kidneys and promoting glucose excretion through urine, which helps lower blood sugar levels [1] - The combination of SGLT-2 inhibitors with Metformin has shown better glycemic control and lower side effects [1]
赛升药业:达格列净二甲双胍缓释片药品注册上市许可申请获受理
Zhi Tong Cai Jing· 2025-12-04 08:16
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]
赛升药业(300485.SZ):达格列净二甲双胍缓释片药品注册上市许可申请获受理
智通财经网· 2025-12-04 08:10
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]
赛升药业(300485) - 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
2025-12-04 08:00
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 ...
赛升药业:子公司达格列净二甲双胍缓释片上市申请获受理
Xin Lang Cai Jing· 2025-12-04 07:59
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]
赛升药业(300485.SZ):子公司收到药品注册上市许可申请受理通知书
Ge Long Hui A P P· 2025-12-04 07:59
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]
赛升药业:截至11月20日股东户数37118户
Zheng Quan Ri Bao Wang· 2025-11-25 09:48
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]