达比加群酯胶囊
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中国医药:子公司天方药业达比加群酯胶囊获药品注册证书
Cai Jing Wang· 2026-02-03 06:05
Core Viewpoint - China Medical announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for two drug registration certificates for Dabigatran Etexilate Capsules, a direct thrombin inhibitor used for various thromboembolic conditions [1] Group 1: Product Information - Dabigatran Etexilate is primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevent DVT and PE recurrence [1] - The drug was developed by Boehringer Ingelheim and was launched in Germany and the UK in March 2008, received FDA approval in October 2010, and was launched in China in February 2013 [1] Group 2: Market Context - As of the announcement date, besides Tianfang Pharmaceutical, 13 other companies, including Chengdu Baitai Pharmaceutical Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd., and Chengdu Yuandong Biopharmaceutical Co., Ltd., have obtained production licenses for this drug in China [1] - According to a third-party database, the sales revenue of this drug in China's three major terminal markets is projected to be approximately 571 million yuan in 2024, with an estimated 375 million yuan in the first three quarters of 2025 [1]
证券代码:600056 证券简称:中国医药 公告编号:临2026-011号
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-02 23:00
Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Dabigatran Etexilate Capsules, which will enhance its product portfolio and provide valuable experience for future generic drug development [1][6]. Group 1: Drug Registration Information - The drug name is Dabigatran Etexilate Capsules, with acceptance numbers CYHS2401330 and CYHS2401331, and registration certificate numbers 2026S00242 and 2026S00243 [1]. - The drug is available in capsule form with specifications of 150mg and 110mg [1]. - The approval was granted based on compliance with the relevant requirements of the Drug Administration Law of the People's Republic of China [1]. Group 2: Drug Characteristics and Market Situation - Dabigatran Etexilate is a direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent recurrence of these conditions [2]. - The drug was developed by Boehringer Ingelheim and was first launched in Germany and the UK in March 2008, received FDA approval in October 2010, and was launched in China in February 2013 [2]. - As of the announcement date, 13 other companies, including Chengdu Better Pharmaceutical Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd., have also obtained production licenses for this drug [5]. - The sales revenue of the drug in China was approximately 571 million yuan in 2024, with about 375 million yuan in the first three quarters of 2025 [5]. Group 3: Financial Investment - The total investment in the raw material and formulation project for the drug is approximately 28 million yuan (unaudited) [4].
中国医药子公司天方药业达比加群酯胶囊两款规格获药品注册证书
Xin Lang Cai Jing· 2026-02-02 21:09
Core Viewpoint - China National Pharmaceutical Group Co., Ltd. announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the registration of Dabigatran Etexilate Capsules, which will enhance the company's product line and development experience in generic drugs [1] Group 1: Product Approval and Specifications - The approved drug includes two specifications: 110mg and 150mg [1] - The drug is primarily used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism [1] Group 2: Financial and Market Impact - The drug registration application was accepted in May 2024, with a total investment of approximately 28 million RMB [1] - According to data from Minet, the estimated sales revenue for the drug in China's three major terminal markets in 2024 is approximately 571 million RMB [1] Group 3: Competitive Landscape and Future Outlook - Currently, there are 14 manufacturers, including Tianfang Pharmaceutical, that have obtained approval for this drug in China [1] - The company indicated that future sales may be influenced by national policies and market conditions, which could lead to performance that does not meet expectations [1]
中国医药子公司达比加群酯胶囊获得药品注册证书
Zhi Tong Cai Jing· 2026-02-02 13:47
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical (600253) has received two drug registration certificates for Dabigatran Etexilate capsules from the National Medical Products Administration [1] Group 1: Product Approval - Tianfang Pharmaceutical received approval for two specifications of Dabigatran Etexilate capsules: 150mg and 110mg [1] - Dabigatran Etexilate is a direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] Group 2: Indications and Uses - The drug is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1] - It is also used to lower the risk of recurrence of DVT and PE, as well as for the prevention of DVT and PE following hip replacement surgery [1]
2月2日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-02 10:16
Group 1 - Far East Holdings announced that its subsidiary won a contract order worth 3.075 billion yuan, including contracts for green building cables and smart manufacturing cables [1] - Yifan Pharmaceutical received a drug registration certificate for Vitamin K1 injection, which is used to treat vitamin K deficiency-related bleeding [2] - Guangdong Electric Power A's Maoming Bohua Power Plant's Unit 4 has successfully commenced commercial operation, with a total investment of 7.484 billion yuan and an expected annual power generation of 8.6 billion kWh [4] Group 2 - Longfly Fiber reported that the global fiber optic cable industry market environment is normal, with product price fluctuations needing comprehensive assessment [25] - Shanghai Yizhong's net profit for 2025 increased by 819.42%, with total revenue of 317 million yuan, a growth of 82.72% [22] - Guizhou Power's subsidiary received a government subsidy of 200 million yuan [8] Group 3 - Zhongxing Communications plans to invest 117 million yuan in the Jianxing Zhanlu Fund, which focuses on new information technology and advanced manufacturing [10] - Suwen Electric Power's subsidiary established a joint investment fund with a total commitment of 68.5 million yuan, with Suwen contributing 5 million yuan [26] - ST Kaiyuan announced that its stock may face delisting risk due to expected negative net assets for 2025 [27]
中国医药:“达比加群酯胶囊”产品取得注册证
Mei Ri Jing Ji Xin Wen· 2026-02-02 09:10
Group 1 - China National Pharmaceutical Group announced that its wholly-owned subsidiary, Tianfang Pharmaceutical, received two drug registration certificates for Dabigatran Etexilate Capsules from the National Medical Products Administration [1] - The product name is "Dabigatran Etexilate Capsules" [1] Group 2 - Automotive sales giant Baolide, previously known for selling luxury cars like Rolls-Royce and Porsche, is now undergoing bankruptcy liquidation [1] - The headquarters in Hangzhou has been vacated, and the subsidiary in Yiwu has been sealed [1]
中国医药(600056.SH)子公司达比加群酯胶囊获得药品注册证书
智通财经网· 2026-02-02 09:00
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary Tianfang Pharmaceutical Co., Ltd. has received two drug registration certificates for Dabigatran Etexilate Capsules from the National Medical Products Administration [1] Group 1: Product Approval - Tianfang Pharmaceutical received approval for Dabigatran Etexilate Capsules in two specifications: 150mg and 110mg [1] - Dabigatran Etexilate is a direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] Group 2: Indications and Uses - The drug is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1] - It also helps lower the risk of recurrence of DVT and PE, and is used for the prevention of DVT and PE following hip replacement surgery [1]
中国医药(600056.SH):子公司获得药品注册证书
Ge Long Hui A P P· 2026-02-02 08:57
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., received two drug registration certificates for Dabigatran Etexilate Capsules from the National Medical Products Administration, which is expected to enhance the company's product line and provide valuable experience for future generic drug development [1] Group 1 - The drug Dabigatran Etexilate is a direct thrombin inhibitor used primarily to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and lower the risk of recurrence of these conditions [1] - The approval of Dabigatran Etexilate Capsules will enrich the company's product matrix and further improve its product layout [1] - The experience gained from this approval will be beneficial for the company's future generic drug development [1]
中国医药:子公司天方药业获得达比加群酯胶囊药品注册证书
Xin Lang Cai Jing· 2026-02-02 08:57
Core Viewpoint - The company Tianfang Pharmaceutical, a wholly-owned subsidiary of China Pharmaceutical, has received approval from the National Medical Products Administration for two drug registration certificates for Dabigatran Etexilate Capsules, indicating a significant advancement in its product pipeline [1] Group 1 - The National Medical Products Administration accepted the registration application for the drug in May 2024 [1] - The total investment in the raw materials and formulation projects for this drug has reached approximately 28 million RMB (unaudited) [1]
中国医药:子公司获得药品注册证书
Ge Long Hui· 2026-02-02 08:53
Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., has received two drug registration certificates for Dabigatran Etexilate Capsules from the National Medical Products Administration, which is expected to enhance the company's product line and provide valuable experience for future generic drug development [1] Group 1 - The drug Dabigatran Etexilate is a direct thrombin inhibitor used primarily to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and lower the risk of recurrence of these conditions [1] - The approval of Dabigatran Etexilate Capsules will enrich the company's product matrix and further improve its product layout [1] - The experience gained from this approval will be beneficial for the company's future generic drug development [1]