证券代码：601607 证券简称：上海医药 编号：临 2025-093 上海医药集团股份有限公司 关于子公司成为氨磺必利口崩片上市许可持有人的公告 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 属上海上药中西制药有限公司（以下简称"上药中西"）收到国家药品监督管理 局（以下简称"国家药监局"）颁发的《药品补充申请批准通知书》（通知书编 号：2025B04804、2025B04815），其同意将氨磺必利口崩片（以下简称"该药 品"）上市许可持有人变更为上海上药中西制药有限公司。 一、该药品的基本情况 药品名称：氨磺必利口崩片 二、该药品的相关信息 氨磺必利口崩片是赛诺菲（Sanofi）公司于 1986 年在法国上市的氨磺必利 片的改良剂型，用于治疗成人精神分裂症。2025 年 9 月，上药中西就该药品上 市许可持有人变更向国家药监局提出注册上市申请并获受理。截至本公告日，公 司针对该药品已投入约人民币 3,150 万元。 截至本公告日，中国境内氨磺必利口 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration to change the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to its subsidiary, Shanghai Pharmaceuticals Zhongxi Pharmaceutical Co., Ltd. This move is expected to enhance the company's product line and market competitiveness [1]. Group 1 - The National Medical Products Administration issued a "Drug Supplement Application Approval Notice" allowing the change of marketing authorization holder for Amisulpride Orally Disintegrating Tablets [1]. - Amisulpride Orally Disintegrating Tablets is an improved formulation of Amisulpride, originally launched by Sanofi in France in 1986, used for treating adult schizophrenia [1]. - The change in marketing authorization holder to Shanghai Pharmaceuticals Zhongxi is anticipated to enrich the company's product offerings and strengthen its competitive position in the market [1].

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd. (referred to as "Shiyou Zhongxi"), has received a notification from the National Medical Products Administration (NMPA) approving the change of the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to Shiyou Zhongxi [1] Group 1 - The NMPA has granted approval for the change of marketing authorization holder for Amisulpride Orally Disintegrating Tablets [1] - Amisulpride Orally Disintegrating Tablets are an improved formulation of Amisulpride Tablets, which were launched by Sanofi in France in 1986, and are used for the treatment of adult schizophrenia [1] - Shiyou Zhongxi submitted the registration application for the change of marketing authorization holder to the NMPA in September 2025, which has been accepted [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the change of the marketing authorization holder for Amisulpride Orally Disintegrating Tablets to Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd. [1] Group 1 - The Amisulpride Orally Disintegrating Tablets are an improved formulation of Amisulpride Tablets, which were originally launched by Sanofi in France in 1986 for the treatment of adult schizophrenia [1] - The application for the change of marketing authorization holder was submitted to the National Medical Products Administration in September 2025 and has been accepted [1]

Economic Overview - Shanghai's GDP for the first three quarters reached 40,721.17 billion yuan, with a year-on-year growth of 5.5% [1] - The industrial production maintained a growth trend, with the industrial added value increasing by 5.2% year-on-year [2] Industrial Performance - The total industrial output value for large-scale industries in Shanghai grew by 5.7% year-on-year, with an acceleration of 0.1 percentage points compared to the first half of the year [2] - Key sectors such as railway, shipbuilding, aerospace, and other transportation equipment manufacturing saw a significant increase of 15.9% [2] - Electrical machinery and equipment manufacturing grew by 14.3%, while computer, communication, and other electronic equipment manufacturing increased by 12.1% [2] Investment Trends - Industrial investment in Shanghai rose by 20.3%, outpacing the overall fixed asset investment growth rate of 14.3 percentage points [2] - The resilience and internal driving force of industrial growth have been enhanced, indicating a positive investment outlook for future production [2] Emerging Industries - The three leading industries in Shanghai experienced an 8.5% increase in output value, surpassing the overall industrial growth by 2.8 percentage points [3] - The artificial intelligence manufacturing sector grew by 12.8%, and integrated circuit manufacturing increased by 11.3% [3] - High-tech manufacturing output value rose by 10.3%, with aerospace and communication equipment manufacturing growing by 20.6% and 13.4%, respectively [3] Strategic Initiatives - Shanghai is focusing on enhancing its artificial intelligence industry by aiming for a tripling of innovative enterprises, industry scale, and talent [4] - The city has established 12 national-level intelligent factories and 254 advanced intelligent factories, leading the nation in smart manufacturing [4] - In the biopharmaceutical sector, Shanghai's industry scale is expected to exceed 1 trillion yuan this year, with significant advancements in innovative drug approvals [5] Future Industry Development - Shanghai aims to cultivate a number of future industry clusters and lead in disruptive technologies by 2027 [5] - The city plans to nurture around 20 leading enterprises in future industries and establish itself as a globally influential hub by 2030 [5]

Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.48% from October 13 to October 17, underperforming the broader market index, the CSI 300, which fell by 2.22% [3][8] - There is a sustained enthusiasm for business development (BD) transactions in innovative drugs, with several companies entering agreements with international pharmaceutical firms [3][12] - The ESMO conference held from October 17 to 21 showcased positive advancements in multiple studies, particularly in immunotherapy and antibody-drug conjugates (ADCs), highlighting the potential of domestic biotech companies [3][11] Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly decline of 2.48%, with offline pharmacies and traditional Chinese medicine showing slight gains of 0.59% and 0.38%, respectively [8] - Medical research outsourcing, medical devices, and other biological products faced significant declines, with drops of 6.46%, 5.37%, and 3.6% respectively [8][9] - Notable stock performances included Asia-Pacific Pharmaceutical with a rise of 36.7%, while Betta Pharmaceuticals saw a decline of 17.0% [11] Industry News and Key Company Announcements Important Industry Events - On October 18, Kangfang Biologics presented data on a PD-1/VEGF dual antibody in non-small cell lung cancer at the ESMO conference, showing significant improvement in progression-free survival (PFS) [11] - On October 16, Hansa Biopharma announced a licensing agreement with Roche for the global exclusive rights to develop and commercialize HS-20110, with an upfront payment of $80 million [12] - On October 16, Prigen Biologics entered a collaboration with Gilead's Kite Pharma, receiving an upfront payment of $120 million [12][13] Company Announcements - Huayuan Biologics reported a slight decrease in total revenue for the third quarter, amounting to 936 million yuan, a 0.2% year-on-year decline [14] - Shanghai Pharmaceuticals received FDA approval for Doxycycline capsules, with projected sales of approximately $130 million in the U.S. for 2024 [14][16]

格隆汇10月17日丨上海医药(02607.HK)宣布，董事会会议将于2025年10月30日（星期四）举行，藉以 （其中包括）批准本公司及其附属公司截至2025年9月30日止九个月的第三季度业绩及其发布，并考虑 派发中期股息（如有）。 ...

（股份代碼：02607） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容 而產生或因依賴該等內容而引致的任何損失承擔任何責任。 中國上海，二零二五年十月十七日 於本公告日期，本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明先生； 非執行董事為張文學先生；以及獨立非執行董事為顧朝陽先生、霍文遜先生、王忠先生 及萬鈞女士。 上海醫藥集團股份有限公司 Shanghai Pharmaceuticals Holding Co., Ltd.* （於中華人民共和國註冊成立的股份有限公司） 董事會會議通告 上海醫藥集團股份有限公司（「本公司」）董事會（「董事會」）謹此宣佈， 董事會會議將於二零二五年十月三十日（星期四）舉行，藉以（其中包括）批 准本公司及其附屬公司截至二零二五年九月三十日止九個月之第三季度業績及 其發佈，並考慮派發中期股息（如有）。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 * 僅供識別 ...

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for doxycycline capsules, marking a significant step in expanding its overseas market presence [1] Summary by Categories Company Developments - The company has invested approximately 10.83 million yuan in the research and development of doxycycline capsules as of the announcement date [1] - The approval of the ANDA is expected to provide valuable experience for the company in navigating international markets [1] Market Implications - The approval is seen as a positive development for the company, enhancing its ability to expand into overseas markets [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for the marketing of its rivaroxaban tablets, indicating a significant milestone for the company in expanding its product offerings in international markets [2] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., is responsible for the production of the rivaroxaban tablets that have now been registered for sale in Malaysia [2] Industry Summary - The approval of rivaroxaban tablets in Malaysia reflects the growing demand for anticoagulant medications in the Southeast Asian market, highlighting potential growth opportunities for pharmaceutical companies operating in this region [2]