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上海医药:多西环素胶囊简略新药申请获美国FDA批准
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]
上海医药(601607.SH):多西环素胶囊获得美国FDA批准文号
Ge Long Hui· 2025-10-14 10:37
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 ...
上海医药:利伐沙班片获得马来西亚药品注册证书
Ge Long Hui· 2025-10-14 10:33
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")生产 的利伐沙班片(称"该药品")收到马来西亚药品监督管理局(NPRA)颁发的药品注册证书,该药品获 得批准上市。 利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险;用于治疗和预防深静脉血栓形成 (DVT);用于治疗肺栓塞(PE);用于预防急性病患者静脉血栓栓塞(VTE)等。 ...
上海医药:多西环素胶囊获美国FDA批准文号
Xin Lang Cai Jing· 2025-10-14 10:32
上海医药公告,下属常州制药厂有限公司的多西环素胶囊简略新药申请(ANDA)已获得美国食品药品 监督管理局(FDA)批准。该药品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)。截至公告日,常州制药厂已投入研发费用约人民币1083.33万元。2024年多西环素胶囊在美国的 销售额约为1.3亿美元。 ...
上海医药:多西环素胶囊获得美国FDA批准文号
Ge Long Hui· 2025-10-14 10:24
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)。 ...
国际TOP20药企、医疗器械企业各有19家在上海设立总部或研发中心 产业规模逐年增长 上海生物医药越来越有显示度
Jie Fang Ri Bao· 2025-10-14 01:36
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]
第八届浦江产融峰会在沪隆重举行
Zheng Quan Ri Bao Wang· 2025-10-13 08:46
上海医药执行董事、总裁沈波在发言中表示:作为上实集团生命健康产业核心平台,上海医药以"链 主"角色推动上海前沿创新中心建设,通过"一张桌"机制聚合政产学研医资力量,已吸引多家跨国药企 及国家级机构入驻。正如本届浦江峰会以"开源创新·聚链共生"为主题,上海医药将持续助力上海打造 世界级生物医药产业集群。 本报讯 (记者金婉霞)日前,以"开源创新·聚链共生"为主题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")召开。作为"上海生物医药产业周"的旗舰活动,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,也是汇聚全球智慧、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(601607)主办,上海前沿承办,汇聚了来自政、产、 学、研、资的300余位重量级嘉宾,共绘医药健康产业的未来蓝图。 本届浦江峰会延续全链条、全生态的视野,充分展现产业"风向标"的引领作用。今年峰会在嘉宾规格、 议题设置与形式创新上全面升级,呈现产业最新趋势与前沿洞见,彰显上海作为全球生物医药创新高地 的战略格局。未来,浦江峰会将持续发挥平台效应,深化产业链、创新链与资本链高效对接,助力中 ...
上海:“链主”带动,开源聚链!加快打造世界级生物医药产业高地
Ke Ji Ri Bao· 2025-10-12 07:14
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 ...
“开源创新·聚链共生” 第八届浦江产融峰会在沪举行
Zhong Zheng Wang· 2025-10-11 12:57
跨界思维 前沿议事 政策前沿 权威发声 在开场致辞环节,上海医药执行董事、总裁沈波致欢迎辞,上海市浦东新区区委常委、区政府党组副书 记、副区长徐徕、上海市科学技术委员会副主任黄红、中国医药企业管理协会会长,国家工信部消费品 工业司原副司长、一级巡视员吴海东、以及来自国际科学界的诺贝尔化学奖得主亚利耶·瓦谢尔(Arieh Warshel)依次发言。政策制定者、行业权威、产业领军者与科学家们同台汇聚,以全球视野与前瞻远 见为浦江峰会启幕定调,共同奏响医药创新发展的恢宏序曲。 国家卫生健康委医药卫生科技发展研究中心主任顾金辉在主题演讲中指出,科技创新正以前所未有的力 度重塑面向人民生命健康的创新格局。在此背景下,浦江峰会紧密对接国家战略,构建起全链条协作平 台,有力推动科技与卫生领域的深度融合,共同培育生物医药创新生态,充分展现出其在行业中的引领 作用与重大战略价值。 前沿议题 多维解读 本届浦江峰会延续全链条、全生态的视野,议题设计全面覆盖医药健康产业的关键环节,充分展现产 业"风向标"的引领作用。院士科学家、龙头企业掌门人、全球资本机构与投资界嘉宾同台交流,从政策 到实践、多维探讨医药健康产业的未来方向。通过政 ...
医药商业板块10月10日涨0.17%,国发股份领涨,主力资金净流出1.61亿元
Core Insights - The pharmaceutical commercial sector saw a slight increase of 0.17% on October 10, with Guofa Co., Ltd. leading the gains [1] - The Shanghai Composite Index closed at 3897.03, down 0.94%, while the Shenzhen Component Index closed at 13355.42, down 2.7% [1] Stock Performance - Guofa Co., Ltd. (600538) closed at 5.85, up 4.28% with a trading volume of 178,800 shares and a transaction value of 103 million yuan [1] - Other notable gainers included Dajia Weikang (301126) up 1.89%, Yingte Group (000411) up 1.77%, and Liuyao Group (603368) up 1.75% [1] - Conversely, the sector also experienced declines, with Saily Medical (603716) down 4.51% and Jianfa Zhixin (301584) down 4.01% [2] Capital Flow - The pharmaceutical commercial sector experienced a net outflow of 161 million yuan from institutional investors, while retail investors saw a net inflow of 214 million yuan [2] - The data indicates that while institutional investors were pulling back, retail investors were actively buying into the sector [2] Individual Stock Capital Flow - Shanghai Pharmaceuticals (601607) had a net inflow of 27.32 million yuan from institutional investors, while it faced a net outflow of 32.58 million yuan from speculative funds [3] - Dajia Weikang (301126) saw a net inflow of 4.95 million yuan from institutional investors, but also faced outflows from speculative funds [3] - Guofa Co., Ltd. (600538) had a net inflow of 4.07 million yuan from institutional investors, indicating some level of interest despite the overall outflow trend [3]