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同和药业:公司原料药通过CDE审批
Xin Lang Cai Jing· 2026-02-04 09:57
Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, tolvaptan, which is now registered for use in formulations [1] Group 1: Approval Details - The active pharmaceutical ingredient "Tolvaptan" has been approved by the NMPA [1] - The registration number for the product is Y20240000672 [1] - The product is manufactured domestically by Jiangxi Tonghe Pharmaceutical Co., Ltd [1] Group 2: Product Information - The product name is tolvaptan, which is intended for use in approved formulations [1] - The approval rating from the review process is A, indicating it is approved for use in marketed formulations [1]
同和药业:甲苯磺酸艾多沙班原料药通过CDE审批
Zhi Tong Cai Jing· 2026-02-04 09:55
同和药业(300636)(300636.SZ)公告,公司提交的"甲苯磺酸艾多沙班"原料药通过了CDE审批。甲苯磺 酸艾多沙班是一种口服抗凝药物,主要用于预防非瓣膜性房颤患者的卒中及全身性栓塞,以及治疗或预 防深静脉血栓和肺栓塞。 ...
同和药业(300636.SZ):甲苯磺酸艾多沙班原料药通过CDE审批
智通财经网· 2026-02-04 09:52
智通财经APP讯,同和药业(300636.SZ)公告,公司提交的"甲苯磺酸艾多沙班"原料药通过了CDE审批。 甲苯磺酸艾多沙班是一种口服抗凝药物,主要用于预防非瓣膜性房颤患者的卒中及全身性栓塞,以及治 疗或预防深静脉血栓和肺栓塞。 ...
同和药业(300636.SZ):“甲苯磺酸艾多沙班”原料药通过CDE审批
Ge Long Hui A P P· 2026-01-26 14:32
Core Viewpoint - Tonghua Pharmaceutical (300636.SZ) has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, tolvaptan, which is an oral anticoagulant used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1] Group 1 - The company has recently confirmed the approval of its active pharmaceutical ingredient, tolvaptan, through the CDE's public platform [1] - Tolvaptan is primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation [1] - The drug is also indicated for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1]
九洲药业添新品 甲苯磺酸艾多沙班获批
Zheng Quan Ri Bao Wang· 2025-11-25 13:13
Core Viewpoint - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Tofisopam, an oral anticoagulant drug, which will enhance the company's product portfolio and market competitiveness [1][1][1] Summary by Relevant Sections Product Approval - The company has obtained the "Chemical Raw Material Drug Marketing Application Approval Notice" for Tofisopam, indicating compliance with national drug registration requirements [1][1] - The drug is primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as for treating or preventing deep vein thrombosis and pulmonary embolism [1][1] Market Potential - In 2023, the sales revenue of Tofisopam in domestic sample hospitals and retail pharmacies was approximately 361 million yuan [1][1] - The company submitted the marketing application to the Center for Drug Evaluation in July 2024 and has invested about 6.69 million yuan in the research and development of Tofisopam to date [1][1] Strategic Impact - The approval of Tofisopam is expected to enrich the company's product structure and enhance its market competitiveness [1][1]
九洲药业:关于公司收到化学原料药上市申请批准通知书的公告
Zheng Quan Ri Bao· 2025-11-24 11:42
Core Viewpoint - Jiuzhou Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Tofacitinib, indicating a significant milestone for the company in expanding its product portfolio [2] Group 1 - The company announced the receipt of the approval notice for Tofacitinib, with the notification number 2025YS01026 [2]
11月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-24 10:21
Group 1 - Huafeng Co., Ltd. announced a stock suspension due to a potential change in control after signing a share transfer intention agreement [1] - Keshida plans to reduce its shareholding by up to 424,000 shares, representing 0.07% of its total share capital [1] - Jinqilin intends to distribute a cash dividend of 0.10 yuan per share, totaling 19.61 million yuan [1] Group 2 - Rejingshi Biotech has repurchased 904,100 shares, accounting for 0.98% of its total share capital, with a total expenditure of 150 million yuan [2] - Yishitong has repurchased 1,236,500 shares, representing 0.619% of its total share capital, with a total expenditure of approximately 33.49 million yuan [2] Group 3 - Hanjia Design announced the release of a detention on its subsidiary's chairman, allowing him to resume duties [4] - Qingmu Technology plans to acquire 65.83% of Vitalis Pharma AS for 300 million Norwegian Krone (approximately 212 million yuan) [4] - Anda Intelligent's shareholder plans to reduce its stake by up to 2.74% [4] Group 4 - Wansheng Intelligent is a candidate for a project with a pre-bid amount of approximately 42.99 million yuan, representing 4.56% of its audited revenue for 2024 [4] - Yipin Hong received a drug registration certificate for a medication used to treat Alzheimer's symptoms [4] Group 5 - *ST Sansheng received a total of 254 million yuan from restructuring investors [4] - Haichuang Pharmaceutical received approval for clinical trials of HP518 tablets for advanced prostate cancer treatment [4] Group 6 - Ningbo Huaxiang's subsidiary plans to invest 5 million yuan in a venture capital fund focusing on intelligent industries [4] - Petty Co. plans to repurchase shares worth 50 to 70 million yuan [4] Group 7 - Tongji Technology's subsidiary won a construction project with a bid price of 866 million yuan [4] - Prolo Pharmaceutical received a drug registration certificate for a generic drug [4] Group 8 - Jingyan Technology plans to use up to 1.6 billion yuan of idle funds for financial management [4] - Furan De received government subsidies totaling 34.65 million yuan [4] Group 9 - David Medical's subsidiary's medical device registration has been accepted [4] - Jusaylong plans to increase its subsidiary's capital by 170 million yuan through debt-to-equity conversion [4] Group 10 - Heng Rui Pharmaceutical's application for a drug license has been accepted by the National Medical Products Administration [4] - Lege Co. plans to increase its stake in the company by 40 to 80 million yuan [4] Group 11 - New Beiyang's subsidiary won a project with the Bank of Communications [4] - Jiangxi Changyun plans to publicly transfer land use rights and buildings with a starting price of 7.79 million yuan [4] Group 12 - Shenqi Pharmaceutical's subsidiary has paid approximately 16.67 million yuan in tax and penalties [4] - Panjiang Co. plans to invest 1.334 billion yuan in a power plant project [4] Group 13 - Fashilong's vice president resigned for personal reasons [4] - Chunxue Food received government subsidies of 3.79 million yuan [4] Group 14 - China Galaxy completed the repayment of a short-term financing bond totaling 3.025 billion yuan [4] - Jiuzhou Pharmaceutical received approval for a chemical raw material drug [4] Group 15 - Longqi Technology's subsidiary plans to invest 30 million yuan in a venture capital fund [4]
九洲药业(603456.SH):公司收到化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-11-24 09:31
Core Viewpoint - Jiuzhou Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of Tofisopam Tosylate, an oral anticoagulant drug aimed at preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as treating or preventing deep vein thrombosis and pulmonary embolism [1] Company Summary - The company submitted the marketing application for Tofisopam Tosylate to the National Medical Products Administration in July 2024 and has recently obtained the approval notification [1] - Cumulative research and development investment in Tofisopam Tosylate has reached approximately RMB 6.69 million [1] Industry Summary - The main manufacturers of Tofisopam Tosylate in China include Xiansheng Pharmaceutical Co., Ltd. and Shandong New Era Pharmaceutical Co., Ltd. [1] - Sales of Tofisopam Tosylate tablets in domestic sample hospitals and urban pharmacies amounted to approximately RMB 361 million in 2023 [1]
九洲药业:收到甲苯磺酸艾多沙班化学原料药上市申请批准通知书
Xin Lang Cai Jing· 2025-11-24 08:47
Core Viewpoint - The approval of tolvaptan sulfate by the National Medical Products Administration enhances the company's product portfolio and competitiveness, although it is expected to have no significant short-term impact on performance due to uncertainties in drug production and sales [1] Summary by Categories Regulatory Approval - The company has received the approval notice for the listing application of tolvaptan sulfate from the National Medical Products Administration [1] - The drug is an oral anticoagulant, with the listing application submitted in July 2024 [1] Research and Development Investment - The company has invested approximately 6.69 million yuan in the research and development of this active pharmaceutical ingredient [1] Market Performance - In 2023, the sales revenue of tolvaptan sulfate tablets in domestic sample hospitals and urban pharmacies was approximately 361 million yuan [1] - The approval is expected to enrich the company's product structure and enhance competitiveness [1]
九洲药业:收到化学原料药上市申请批准通知书
Core Viewpoint - Jiuzhou Pharmaceutical has received approval from the National Medical Products Administration for the marketing application of tolvaptan sulfate, an oral anticoagulant drug [1] Group 1: Company Information - Jiuzhou Pharmaceutical (603456) announced the receipt of a marketing approval notification for tolvaptan sulfate on November 24 [1] - Tolvaptan sulfate is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1]