药品研发与注册
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北京福元医药股份有限公司关于联苯苄唑溶液获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-07-29 17:34
Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received a drug registration certificate for its Benzyl Benzoate solution, which is expected to enhance the company's product line and market competitiveness [1][4]. Drug Registration Certificate Details - The drug registration certificate was issued by the National Medical Products Administration, allowing the production of Benzyl Benzoate solution (1% concentration, 10 mL: 0.1 g) [1]. - The drug is indicated for the treatment of various skin fungal diseases, including tinea pedis, tinea corporis, tinea cruris, and candidiasis [6]. R&D Investment - The total R&D investment for this drug has reached approximately RMB 3.0496 million (unaudited) as of the announcement date [2]. Market Situation for Similar Drugs - According to data from Minet, the sales revenue of Benzyl Benzoate solution in China's three major terminal markets is approximately RMB 375.26 million in 2024. The breakdown is as follows: - Sales in urban public hospitals and county-level public hospitals: RMB 76.55 million - Sales in urban community centers and township health clinics: RMB 41.96 million - Sales in urban pharmacies and online pharmacies: RMB 256.75 million [3]. Impact on the Company - The approval of the drug registration certificate is expected to enrich the company's product line and enhance its market competitiveness. However, the sales performance may be influenced by national policies and market environment changes, leading to significant uncertainty [4].
华北制药:腺苷钴胺胶囊(0.5mg)获得药品注册证书
Xin Lang Cai Jing· 2025-07-29 10:06
Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Adenosylcobalamin capsules (0.5mg), which are expected to have significant therapeutic benefits in treating neurological conditions [1] Company Summary - The approved product, Adenosylcobalamin capsules, is designed to inhibit abnormal fat synthesis in nerve myelin, block the occurrence and development of nerve fiber demyelination, and promote the synthesis of proteins and lipids to repair damaged nerves [1] - The capsules also lower abnormal TNFα levels, inhibit the occurrence of SACD, participate in the tricarboxylic acid cycle, and promote the metabolism of three major substances to maintain normal cellular functions [1] - The product normalizes glutathione levels to protect nerve cells and participates in heme synthesis to improve anemia [1] - The company has invested a total of 10.9382 million yuan in research and development for this product to date (unaudited) [1]
九洲药业:控股子公司获得枸橼酸西地那非口崩片药品注册证书
news flash· 2025-07-01 07:46
Core Viewpoint - The company, Jiuzhou Pharmaceutical, announced that its subsidiary, Zhejiang Jiuzhou Biopharmaceutical Co., Ltd., has received the drug registration certificate for Sildenafil Citrate Orally Disintegrating Tablets from the National Medical Products Administration of China [1] Group 1: Company Developments - The drug is an iterative formulation of Sildenafil developed by Pfizer, which was approved for import in China in 2019 [1] - Jiuzhou Pharmaceutical has invested approximately 13.52 million RMB in the research and development of Sildenafil Citrate Orally Disintegrating Tablets [1] - The acquisition of the drug registration certificate enhances the company's product pipeline and market competitiveness, although it is not expected to have a significant impact on the company's performance in the short term [1] Group 2: Market Context - The total sales revenue (end-user price) of Sildenafil Citrate tablets in the domestic medical and retail market reached 5.217 billion RMB in 2023 [1] - Major competitors in the market that have also received the drug registration certificate include Sichuan Kelun Pharmaceutical Co., Ltd. and Guangdong Tianenkang Pharmaceutical Co., Ltd. [1]
福元医药:盐酸贝尼地平片获药品注册证书
news flash· 2025-07-01 07:35
Core Viewpoint - The company has received the drug registration certificate for Benidipine Hydrochloride Tablets (8mg) from the National Medical Products Administration, which will enhance its product line and market competitiveness [1] Group 1: Drug Approval and Market Impact - The drug was first approved in Japan in 1991 and received domestic approval in 2004 for the treatment of primary hypertension and angina [1] - The company received the acceptance notice for the application on March 5, 2024, and has recently been granted approval [1] - The estimated sales revenue for Benidipine Hydrochloride Tablets in China's three major terminal markets is approximately 1.007 billion yuan in 2024 [1] Group 2: R&D Investment - The total research and development investment for this drug by the company amounts to 5.2737 million yuan [1]
股票简称:华海药业 股票代码:600521 公告编号:临2025-077号 债券简称:华海转债 债券代码:110076
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-06-30 23:14
Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. has received the drug registration certificate for Nimodipine Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1][4] - Nimodipine Tablets are indicated for improving low motivation due to sequelae of cerebral infarction and are particularly effective in early treatment of vascular dementia [2] - The company has invested approximately RMB 8.99 million in the research and development of Nimodipine Tablets [3] Drug Information - Drug Name: Nimodipine Tablets - Dosage Forms: Tablets - Specifications: 5mg, 10mg - Registration Category: Class 3 Chemical Drug - Approval Numbers: National Drug Approval Code H20254671, H20254672 [1][2] Market Impact - The approval of Nimodipine Tablets enhances the company's product line and market competitiveness, contributing positively to its business development [4] - The domestic market sales for Nimodipine Tablets are projected to be approximately RMB 555 million in 2024 [2]
白云山:分公司收到药品注册证书
news flash· 2025-06-06 08:44
Core Viewpoint - Baiyunshan Pharmaceutical has received the drug registration certificate for Tadalafil tablets (2.5mg, 5mg) from the National Medical Products Administration, enhancing its product offerings in the male medication market [1] Summary by Categories Company Developments - Baiyunshan Pharmaceutical's subsidiary, Baiyunshan Pharmaceutical Factory, has invested approximately RMB 2.54 million and RMB 4.30 million in the research and development of Tadalafil tablets (2.5mg and 5mg) respectively [1] Market Impact - The approval of the drug registration certificate is expected to enrich the variety of male medication products offered by Baiyunshan Pharmaceutical, thereby improving its competitiveness in the male medication sector [1]
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]