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上海医药(601607) - 上海医药集团股份有限公司关于马来酸阿伐曲泊帕片获得批准生产的公告
2026-01-23 08:00
证券代码:601607 证券简称:上海医药 编号:临 2026-007 上海医药集团股份有限公司 关于马来酸阿伐曲泊帕片获得批准生产的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"公司")下属上海上药信谊 药厂有限公司(以下简称"上药信谊")的马来酸阿伐曲泊帕片(以下简称"该 药品")收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品注 册证书》(证书编号:2026S00156),该药品获得批准生产。 一、该药品基本情况 药品名称:马来酸阿伐曲泊帕片 剂型:片剂 规格:20mg(以 C29H34Cl2N6O3S2计) 注册分类:化学药品 4 类 药品批准文号:国药准字 H20263130 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 二、该药品相关的信息 1 IQVIA 数据库显示,2024 年中国大陆医院采购马来酸阿伐曲泊帕片的金额 为人民币 56,656 万元。 三、对上市公司影响及 ...
上海医药(601607) - 上海医药集团股份有限公司关于普瑞巴林胶囊获得新加坡药品注册证书的公告
2026-01-23 08:00
证券代码:601607 证券简称:上海医药 编号:临2026-006 上海医药集团股份有限公司 关于普瑞巴林胶囊获得新加坡药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"上海医药"或"公司")下 属常州制药厂有限公司(以下简称"常州制药厂")生产的普瑞巴林胶囊(以下 简称"该药品")收到新加坡食品药品监督管理局(HSA)颁发的药品注册证书, 该药品获得批准上市。 一、该药品基本情况 药品名称:普瑞巴林胶囊 剂型:胶囊 规格:50mg、75mg、150mg 注册分类:化学仿制药 生产厂家:常州制药厂有限公司 注册证号:50mg:SIN17444P;75mg:SIN17443P;150mg:SIN17442P 二、该药品相关的信息 普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外周神经痛、纤维肌 痛和脊髓损伤引起的神经性疼痛以及癫痫的辅助治疗。 2019 年 10 月,常州制药厂完成普瑞巴林胶囊的研发工作;2021 年 7 月,该 药品获得美国食品药品监督管理局 ...
上海医药(601607.SH):马来酸阿伐曲泊帕片获得批准生产
Ge Long Hui A P P· 2026-01-23 07:58
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration for the production of Maleate Avatrombopag Tablets, which are indicated for adult patients with chronic liver disease-related thrombocytopenia and chronic primary immune thrombocytopenia (ITP) [1] Group 1: Product Approval - The Maleate Avatrombopag Tablets are approved for use in adult patients undergoing elective diagnostic procedures or surgeries related to chronic liver disease [1] - The product is also suitable for adult patients with chronic primary immune thrombocytopenia who have previously shown poor response to treatments such as corticosteroids and immunoglobulins [1] - The drug was originally developed by AkaRx Inc. in the United States and was launched in the U.S. market in 2018 [1] Group 2: Development and Investment - Shanghai Pharmaceuticals submitted the registration application for the drug to the National Medical Products Administration in August 2024, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 9.8961 million in the research and development of this product [1] Group 3: Market Competition - The main domestic manufacturers of this drug in China include Fosun Pharma (Jiangsu) Pharmaceutical Group Co., Ltd., Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., and Qilu Pharmaceutical Co., Ltd. [1]
上海医药:马来酸阿伐曲泊帕片获得批准生产
Core Viewpoint - Shanghai Pharmaceuticals (601607) has received regulatory approvals for two of its products, indicating a positive development in its product pipeline and potential for revenue growth [1]. Group 1: Product Approvals - The company's subsidiary, Shanghai Pharmaceuticals Holding Co., Ltd., has obtained a Drug Registration Certificate from the National Medical Products Administration for its drug, Avatrombopag Maleate Tablets, allowing it to commence production [1]. - Additionally, the company's Changzhou Pharmaceutical Factory has received a Drug Registration Certificate from the Health Sciences Authority of Singapore for its drug, Prucalopride Capsules, enabling it to be marketed [1].
上海医药:普瑞巴林胶囊获得新加坡药品注册证书
Ge Long Hui· 2026-01-23 07:41
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for its Pregabalin capsules, allowing the product to be marketed [1] Group 1: Product Approval - The Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunct therapy for epilepsy [1] - The product's research and development were completed by Changzhou Pharmaceutical Factory in October 2019, and it received approval from the U.S. Food and Drug Administration in July 2021 [1] Group 2: Market Expansion - The Pregabalin capsules also received approval from the Thai Food and Drug Administration for market entry by June 2025 [1] - The company has invested approximately RMB 2.19 million in research and development for the product's launch in Southeast Asian markets, including Thailand, Singapore, Malaysia, and the Philippines [1]
上海医药:普瑞巴林胶囊获新加坡药品注册证书
Xin Lang Cai Jing· 2026-01-23 07:38
Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for the launch of Pregabalin capsules, indicating a significant milestone in the company's product portfolio expansion in Southeast Asia [1] Group 1: Product Approval and Indications - Pregabalin capsules are approved for the treatment of postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunctive treatment for epilepsy [1] - The drug development for Pregabalin capsules was completed by Changzhou Pharmaceutical Factory in October 2019, and it received approval from the U.S. Food and Drug Administration (FDA) in July 2021 [1] Group 2: Market Expansion and Investment - The approval in Singapore follows the drug's approval in Thailand in June 2025, indicating a strategic focus on expanding into Southeast Asian markets, including Thailand, Singapore, Malaysia, and the Philippines [1] - The company has invested approximately RMB 2.19 million in research and development for this drug in the Southeast Asian market as of the date of the announcement [1]
医药商业板块1月22日涨0.94%,华人健康领涨,主力资金净流出8213.57万元
证券之星消息,1月22日医药商业板块较上一交易日上涨0.94%,华人健康领涨。当日上证指数报收于 4122.58,上涨0.14%。深证成指报收于14327.05,上涨0.5%。医药商业板块个股涨跌见下表: | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 301408 | 华人健康 | 23.17 | 6.24% | 34.71万 | | 7.81亿 | | 301017 | 激玉平民 | 17.71 | 4.67% | 18.88万 | | 3.28亿 | | 002462 | 幕事堂 | 16.89 | 4.65% | C 20.59万 | | 3.44亿 | | 002788 | 醫症医药 | 16.75 | 3.14% | 47.30万 | | 7.83亿 | | 301126 | 达嘉维康 | 13.92 | 3.11% | 15.80万 | | 2.19亿 | | 600272 | 开开实业 | 14.56 | 2.46% | 6.88万 | | 9913.17万 | ...
上海医药集团股份有限公司关于B023细胞注射液获得临床试验批准通知书的公告
Group 1 - The core project is the B023 cell injection, which has received approval for clinical trials from the National Medical Products Administration (NMPA) for treating inoperable, locally advanced, or metastatic solid tumors that have failed standard treatments [1][2] - B023 is an innovative Class I biological product developed by Shanghai Pharmaceutical Group's subsidiary, with a total research and development investment of approximately 39.26 million RMB [2] - The active component of B023 is invariant natural killer T (iNKT) cells, which can be used universally without causing graft-versus-host disease due to the lack of polymorphism in CD1d among the population [2] Group 2 - As of the announcement date, there are no other drugs with the same indication and type available in the global market [3] - The approval for clinical trials does not significantly impact the company's current operations, and the company will continue to advance the project in accordance with national regulations [3]
上海医药:目前公司整体运营规范有序,各项业务稳步推进
Zheng Quan Ri Bao Wang· 2026-01-20 11:11
Group 1 - The core viewpoint of the article is that Shanghai Pharmaceuticals (601607) is currently operating in an orderly manner, with steady progress in various business segments and stable performance [1] Group 2 - The company has responded to investor inquiries on its interactive platform, indicating confidence in its overall operations [1] - Business operations are reported to be advancing steadily, suggesting a positive outlook for future performance [1] - The company's performance is described as stable, which may indicate resilience in its financial results [1]
上海医药B023细胞注射液临床试验获批
Bei Jing Shang Bao· 2026-01-20 11:05
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed "B023 cell injection" for treating locally advanced or metastatic solid tumors that are inoperable and have no effective treatment options after standard therapy failure [1] Group 1 - The "B023 cell injection" is aimed at patients with locally advanced or metastatic solid tumors [1] - The approval allows the company to conduct clinical trials for a treatment that currently lacks effective options [1] - This development highlights the company's commitment to advancing innovative therapies in oncology [1]