证券代码：601607 证券简称：上海医药 公告编号：临2025-090 上海医药集团股份有限公司 关于多西环素胶囊获得美国 FDA 批准文号的公告 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。 二、该药品相关信息 多西环素胶囊（40mg），内含两种类型的多西环素微丸（30mg 速释微丸和 10mg 迟释微丸）,主要用于成人患者的玫瑰痤疮（红斑痤疮）的炎症性病变（丘 疹和脓疱）。原研由 GALDERMA LABORATORIES LP 研发，于 2006 年在美国 上市。2024 年 09 月，常州制药厂就该药品向美国 FDA 提出 ANDA 申请，并于 近日获得批准上市。截至本公告日，公司针对该药品已投入研发费用约人民币 1,083.33 万元。 1 三、该药品市场竞争情况 截至本公告日，除前述原研药厂外，该药品已有仿制药在美国上市，上市的 企业包括 Apotex Inc、Alembic Pharmaceuticals Ltd、Lupin Inc、Dr. Reddy's Laboratories Inc、Macleo ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received a drug registration certificate from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for rivaroxaban tablets, which have been approved for market launch [1]. Group 1 - Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1]. - The drug is also indicated for the treatment and prevention of deep vein thrombosis (DVT) [1]. - Additionally, rivaroxaban is used for the treatment of pulmonary embolism (PE) and for the prevention of venous thromboembolism (VTE) in acutely ill patients [1].

Core Insights - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received FDA approval for its abbreviated new drug application (ANDA) for Doxycycline Capsules (40mg), which is primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The same subsidiary has also obtained a drug registration certificate from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for Rivaroxaban Tablets, allowing it to be marketed in Malaysia [1] Company Developments - The approval of Doxycycline Capsules by the FDA marks a significant milestone for Shanghai Pharmaceuticals, enhancing its product portfolio in the dermatological segment [1] - The registration of Rivaroxaban Tablets in Malaysia indicates the company's expansion into international markets, potentially increasing its revenue streams [1] Industry Impact - The approval of generic drugs like Doxycycline and Rivaroxaban reflects the ongoing trend in the pharmaceutical industry towards increasing access to essential medications through generics [1] - The successful registration of these products may position Shanghai Pharmaceuticals favorably within the competitive landscape of the pharmaceutical industry, particularly in the Asian markets [1]

格隆汇10月14日丨上海医药(601607.SH)公布，公司下属常州制药厂有限公司(称"常州制药厂")收到美国食品药品监督管理局(称"美国FDA")的通知，其关于多西环素胶囊(基本情况详阅正文 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received a drug registration certificate from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for rivaroxaban tablets, allowing the product to be marketed [1] Group 1 - Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation [1] - The drug is also indicated for the treatment and prevention of deep vein thrombosis (DVT) [1] - Additionally, it is used for the treatment of pulmonary embolism (PE) and for the prevention of venous thromboembolism (VTE) in acutely ill patients [1]

Core Insights - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, has received FDA approval for the abbreviated new drug application (ANDA) for Doxycycline capsules, which are primarily used for treating inflammatory lesions (papules and pustules) of rosacea in adult patients [1] Financial Summary - As of the announcement date, Changzhou Pharmaceutical Factory has invested approximately RMB 10.83 million in research and development for Doxycycline capsules [1] - The projected sales revenue for Doxycycline capsules in the U.S. for 2024 is approximately $130 million [1]

格隆汇10月14日丨上海医药(601607.SH)公布，公司下属常州制药厂有限公司(称"常州制药厂")收到美国 食品药品监督管理局(称"美国FDA")的通知，其关于多西环素胶囊(基本情况详阅正文，称"该药品")的 简略新药申请("ANDA"，即美国仿制药申请)已获得批准，多西环素胶囊(40mg)，内含两种类型的多西 环素微丸(30mg速释微丸和10mg迟释微丸),主要用于成人患者的玫瑰痤疮(红斑痤疮)的炎症性病变(丘疹 和脓疱)。 ...

Core Insights - Shanghai is leading the nation in the innovation of pharmaceuticals and medical devices, with 30 approved domestic Class I innovative drugs from 2021 to September 2025, accounting for 17% of the national total [1] - The biopharmaceutical industry in Shanghai reached a scale of 500.57 billion yuan in the first half of this year, with expectations to surpass 1 trillion yuan for the full year [2] - Shanghai's License-out transactions for innovative drugs reached 38 in 2024, representing 35% of the national total, with a transaction value of 30.7 billion USD, accounting for 47% of the national total [3] Industry Growth - The biopharmaceutical industry in Shanghai has shown consistent growth, increasing from 761.71 billion yuan in 2021 to an estimated 984.70 billion yuan in 2024, with a compound annual growth rate of 8.94% [2] - By the end of 2024, Shanghai is expected to have 2,183 biopharmaceutical enterprises, covering manufacturing, services, and wholesale [2] - Shanghai has seen 46 companies go public from 2021 to 2024, with 4 new listings in 2023 alone [2] International Recognition - Since 2021, 9 drugs have been approved in international markets such as the US and Japan, indicating the global recognition of Shanghai's innovative capabilities [3] - Major international pharmaceutical and medical device companies have established headquarters or R&D centers in Shanghai, with 19 out of the top 20 in each category present [2] Policy Support - Shanghai has implemented various policies to support the biopharmaceutical industry, including regulations and action plans focused on synthetic biology, cell and gene therapy, and AI in medicine [4] - A biopharmaceutical industry mother fund with a total scale of 22.5 billion yuan has been established, along with a 10 billion yuan merger fund targeting strategic acquisitions in traditional Chinese medicine, vaccines, and high-end medical devices [4] - From 2021 to 2024, Shanghai's biopharmaceutical sector has secured 238.37 billion yuan in financing, ranking among the top in the country [4] Innovation Ecosystem - Shanghai has built a comprehensive innovation ecosystem that spans from research to clinical application, providing new momentum for high-quality development in the biopharmaceutical industry [5]

Core Insights - The eighth Pujiang Pharmaceutical Health Industry Innovation Development Summit was held with the theme "Open Source Innovation · Collaborative Chain Symbiosis" [1] - The summit serves as a flagship event of the "Shanghai Biopharmaceutical Industry Week" and has become a leading platform for innovation in China's pharmaceutical and health industry [1] - The event gathered over 300 influential guests from government, industry, academia, research, and investment sectors to discuss the future of the pharmaceutical health industry [1] Industry Overview - The summit showcased the latest trends and insights in the pharmaceutical industry, emphasizing Shanghai's strategic position as a global biopharmaceutical innovation hub [1] - The event highlighted the importance of integrating the entire industry chain, innovation chain, and capital chain to accelerate the global reach of Chinese innovative drugs [1] Company Initiatives - Shanghai Pharmaceuticals, as a core platform of the Shanghai Shendi Group's life and health industry, is playing a "chain leader" role in promoting the construction of the Shanghai Frontier Innovation Center [2] - The company has implemented a "one table" mechanism to consolidate resources from government, industry, academia, research, and investment, attracting multiple multinational pharmaceutical companies and national-level institutions [2] - Shanghai Pharmaceuticals aims to assist Shanghai in building a world-class biopharmaceutical industry cluster [2]

作为上海生物医药产业的"链主"企业，上海医药已经连续6年入选了财富世界500强榜单，2024年实现了营业收入2752.51亿元，跑出了发展加速 度。 在上海医药执行董事、总裁沈波看来，生物医药全链条创新突破，将成为行业的发展主线。加强前沿领域源头创新和关键核心技术的攻关，抢占 产业发展的制高点，强化产业链的自主可控，将成为未来发展的重要方向。 生物医药创新如何更快落地？产业如何更强链接？资本如何更好赋能？记者从10月11日召开的第八届浦江医药健康产融创新发展峰会（以下简称 浦江峰会）上获悉，上海将持续加大政策供给，汇聚各方力量，全力推动基础研究、孵化转化、临床试验、审评、审批落地生产推广应用的全链 条加速，加快建设世界级生物医药创新高地和产业集群。 作为上海国际生物医药产业周的重要组成部分，浦江峰会已成为引领中国医药健康产业发展的创新风向标，亦是汇聚全球智慧、促进产学研深度 融合的高端学术平台。 本届峰会由上实集团、中国医药企业管理协会指导，上海医药主办，上海前沿承办，汇聚了来自政、产、学、研、资的300余位参会嘉宾，线上参 与人数超万人，共绘医药健康产业的未来蓝图。 上海市科委副主任黄红介绍，生物医药产业是 ...