Workflow
药品研发与注册
icon
Search documents
华海药业:获得托伐普坦片药品注册证书
news flash· 2025-06-04 09:48
Core Insights - Huahai Pharmaceutical (600521) has received the drug registration certificate for tolvaptan tablets from the National Medical Products Administration [1] - Tolvaptan tablets are indicated for the treatment of hyponatremia and fluid retention caused by heart failure, with an estimated domestic market sales amount of approximately 497 million yuan [1] - The company has invested around 9.51 million yuan in research and development for this product [1] - The approval of the registration certificate will enhance the product line and improve market competitiveness [1]
人福医药:黄体酮软胶囊获药品注册证书
news flash· 2025-05-28 08:02
Core Viewpoint - The announcement highlights that Renfu Pharmaceutical's subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., has received approval for the registration certificate of Progesterone Soft Capsules from the National Medical Products Administration, indicating a significant development in the company's product pipeline [1] Group 1: Company Developments - Renfu Pharmaceutical's subsidiary has received the drug registration certificate for Progesterone Soft Capsules, which are used to treat dysfunctions caused by progesterone deficiency and assist in pregnancy [1] - The company submitted the marketing authorization application for the product in December 2023, which has been accepted [1] - Cumulative R&D investment for this project has reached approximately RMB 29 million [1] Group 2: Market Insights - According to data from Minet, the projected national sales for Progesterone Soft Capsules in 2024 are approximately RMB 372 million [1] - Major competitors in the market include Besins Healthcare S.A., Zhejiang Aisheng Pharmaceutical Co., Ltd., and Zhejiang Medicine Co., Ltd. [1]
步长制药: 山东步长制药股份有限公司关于控股子公司获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-05-27 10:21
Group 1 - The company’s subsidiary, Jilin Tiancheng Pharmaceutical Co., Ltd., has received the drug registration certificate for Benzylsuccinate Atracurium Injection from the National Medical Products Administration [1] - Benzylsuccinate Atracurium Injection is classified as a chemical drug (Category 4) and is a prescription drug [1] - The drug is indicated for use in surgeries, other procedures, and intensive care treatment, serving as an adjunct to general anesthesia and providing muscle relaxation for intubation and mechanical ventilation [1] Group 2 - The annual sales of Benzylsuccinate Atracurium Injection are projected to increase from 609.96 million yuan in 2022 to 818.53 million yuan in 2024 [2] - The company has invested approximately 11.15 million yuan in research and development for the Benzylsuccinate Atracurium Injection project [2] - The drug registration certificate is valid until May 19, 2030, and the production enterprise must comply with Good Manufacturing Practice (GMP) requirements [1][3]
鲁抗医药:苯磺酸左氨氯地平片获药品注册证书
news flash· 2025-05-22 09:34
Core Viewpoint - The company has received the drug registration certificate for Amlodipine Besylate Tablets from the National Medical Products Administration, which is expected to enhance its market competitiveness [1] Group 1: Drug Registration and Market Impact - The drug Amlodipine Besylate Tablets is a calcium channel blocker with antihypertensive effects [1] - The estimated domestic sales for the drug in 2024 are approximately 4.671 billion yuan [1] - The company invested around 8.2991 million yuan in the research and development of this drug [1]
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
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
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]