药品研发与注册
Search documents
株洲千金药业股份有限公司关于子公司获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-04-24 23:08
Core Viewpoint - The announcement highlights that Zhuzhou Qianjin Pharmaceutical Co., Ltd.'s subsidiary, Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., has received drug registration certificates for Fumarate Bisoprolol Tablets (2.5mg, 5mg) from the National Medical Products Administration, indicating successful compliance with drug registration requirements [1][2]. Group 1: Drug Information - Drug Name: Fumarate Bisoprolol Tablets - Dosage Forms: Tablets - Specifications: 2.5mg, 5mg - Registration Classification: Class 4 Chemical Drug - Approval Numbers: National Drug Approval Code H20253939, H20253940 - License Holder: Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. [1][2]. Group 2: Market Context - Fumarate Bisoprolol Tablets are selective β-receptor blockers used for treating hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular function (ejection fraction ≤ 35%). - The drug was first launched in Germany in 1986 and entered the Chinese market in 1998. Other manufacturers with registration include Merck Germany and Chengdu Yuandong Biological Pharmaceutical Co., Ltd. - The domestic market sales for Fumarate Bisoprolol Tablets in 2023 are approximately RMB 1.342 billion [2]. Group 3: Company Impact - The receipt of the drug registration certificate for Fumarate Bisoprolol Tablets signifies passing the consistency evaluation, enhancing the company's product pipeline and supporting sustainable development. - The company has invested a total of RMB 7.1965 million in the research and development of Fumarate Bisoprolol Tablets (2.5mg, 5mg) [2][3].
华润双鹤:子公司获得注射用替加环素药品注册证书
news flash· 2025-04-24 08:45
Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its wholly-owned subsidiary, Double Crane Pharmaceutical (Hainan) Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for injectable Tigecycline. This drug is clinically used to treat complex skin and soft tissue infections and complicated intra-abdominal infections caused by sensitive bacteria [1] Group 1 - The research and development for the generic version of injectable Tigecycline was initiated in December 2021, with a total R&D investment of 10.27 million yuan (1,027.05 thousand) as of the announcement date [1] - The global sales of injectable Tigecycline reached 218 million USD in 2023, while the total sales in the domestic market amounted to 848 million yuan [1]
津药药业股份有限公司关于子公司获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-03-17 18:52
Group 1 - The company announced that its subsidiary, Hubei Jinyao Pharmaceutical Co., Ltd., has received the drug registration certificate for Naloxone Hydrochloride Injection from the National Medical Products Administration [1] - The drug is an opioid receptor antagonist, and the company has invested approximately 4.2 million yuan in the research and development of this product [1][2] - The domestic sales of Naloxone Hydrochloride Injection were 413 million yuan in 2022 and are projected to be 535 million yuan in 2023, indicating a growth in market demand [2] Group 2 - The approval of the drug registration certificate enhances the company's formulation product portfolio and is expected to positively impact the company's performance in the domestic formulation market [3] - However, the sales timeline, scale, and future expansion of the drug in the domestic market remain uncertain due to competitive market conditions [3]