一、药品基本情况 药品名称：硫酸羟氯喹片 证券代码：601607 证券简称：上海医药 编号：临2025-115 上海医药集团股份有限公司 关于硫酸羟氯喹片获得菲律宾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 属上海上药中西制药有限公司（以下简称"上药中西"）生产的硫酸羟氯喹片（以 下简称"该药品"）收到菲律宾食品药品监督管理局颁发的药品注册证书，该药 品获得批准上市。 剂型：片剂 规格：200 mg 注册分类：化学药品 申请事项：新产品上市 生产厂家：上海上药中西制药有限公司 三、药品市场竞争情况 注册证号：DRP-17305 二、药品相关的信息 硫酸羟氯喹片主要用于类风湿关节炎、青少年慢性关节炎、盘状和系统性红 斑狼疮、以及由阳光引发或加剧的皮肤疾病，由 Concordia Pharmaceuticals Inc 研发，于 1955 年在美国上市。1999 年 12 月，上药中西的硫酸羟氯喹片在国内 获批上市，并于 2021 年 ...

Group 1 - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received a drug registration certificate from the Philippines Food and Drug Administration for Hydroxychloroquine Sulfate Tablets, allowing the product to be marketed [1] - For the first half of 2025, Shanghai Pharmaceuticals' revenue composition is as follows: distribution accounts for 91.5%, industrial for 8.59%, retail for 2.97%, other businesses for 0.34%, and other for 0.08% [1] - As of the report date, Shanghai Pharmaceuticals has a market capitalization of 66.6 billion yuan [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received a drug registration certificate from the Philippines Food and Drug Administration for Hydroxychloroquine Sulfate Tablets, allowing the company to market this product in the Philippines, which is expected to positively impact its overseas market expansion and provide valuable experience [1] Group 1 - The Hydroxychloroquine Sulfate Tablets are primarily used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin diseases exacerbated by sunlight [1] - The approval of the 200mg Hydroxychloroquine Sulfate Tablets signifies the company's qualification to sell this drug in the Philippine market [1] - This development is seen as a step forward for the company in expanding its international presence [1]

Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, received the approval notice for the supplementary application of Sotalol Hydrochloride Tablets from the National Medical Products Administration, indicating that the drug has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approval of Sotalol Hydrochloride Tablets is expected to expand the market share of the drug and enhance its market competitiveness [1] - The drug's market performance may be affected by uncertainties related to national policies and market conditions, leading to potential sales not meeting expectations [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Changzhou Pharmaceutical Factory, received a Drug Supplement Application Approval Notice from the National Medical Products Administration for its Sotalol Hydrochloride Tablets, which passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Sotalol Hydrochloride Tablets are primarily used for: 1) conversion and prevention of supraventricular tachycardia, especially atrioventricular nodal reentrant tachycardia; 2) atrial flutter and atrial fibrillation; 3) various ventricular arrhythmias, including premature ventricular contractions and sustained/non-sustained ventricular tachycardia; 4) acute myocardial infarction complicated by severe arrhythmias [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., received a drug registration certificate from the Philippines Food and Drug Administration for Hydroxychloroquine Sulfate Tablets, allowing the product to be marketed [1] Group 1 - The approved drug, Hydroxychloroquine Sulfate Tablets, is primarily used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, as well as skin diseases exacerbated by sunlight [1]

（原标题：上海医药现2笔大宗交易 合计成交28.10万股） | 成交量 | 成交金 额 | 成交价 | 相对当日 收盘折溢 | 买方营业 | | | --- | --- | --- | --- | --- | --- | | （万 | | 格 | | | 卖方营业部 | | 股） | （万 | （元） | 价 | 部 | | | | 元） | | （%） | | | | 15.59 12.51 | 281.46 225.75 | 18.05 18.05 | 0.00 0.00 | 机构专用 机构专用 | 瑞银证券有限责任公司上海花园石桥路证券营业 部 瑞银证券有限责任公司上海花园石桥路证券营业 部 | 上海医药12月12日大宗交易平台共发生2笔成交，合计成交量28.10万股，成交金额507.21万元。成交价 格均为18.05元。从参与大宗交易营业部来看，机构专用席位共出现在2笔成交的买方或卖方营业部中， 合计成交金额为507.21万元，净买入507.21万元。 注：本文系新闻报道，不构成投资建议，股市有风险，投资需谨慎。 证券时报•数据宝统计显示，上海医药今日收盘价为18.05元，上涨1.35%，日换手率为1 ...

| 交易日期 | 证券調移 | 证券代码 | 成交价(元) 成交金额(万元) 成交量( *) 买入营业部 | | | | | 类出营业部 是否为专场 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 2025-12-12 | 上海医药 | 601607 | 18.05 | 281.46 | 15.59 | 机构专用 | និង និងប្រទេស | 客 | | 2025-12-12 | 上海医药 | 601607 | 18.05 | 225.75 | 12.51 | 机构专用 | ​​​ | Ka | 12月12日，上海医药大宗交易成交28.1万股，成交额507.21万元，占当日总成交额的0.89%，成交价 18.05元，较市场收盘价18.05元持平。 ...

Core Insights - Shanghai Pharmaceuticals has received approval for its innovative drug, Suojirolin tablets, aimed at treating primary hypertension, marking a significant achievement in its commitment to innovation in the pharmaceutical sector [2] Group 1: Drug Development and Approval - The innovative drug Suojirolin has been in clinical research since 2016 and is expected to be commercially available by 2025, addressing unmet clinical needs for over 300 million patients with primary hypertension in China [2] - The Phase II clinical trial results for Suojirolin have been published in the authoritative cardiovascular journal "Hypertension Research," with ongoing efforts to publish Phase III study results, highlighting the global academic interest in Chinese innovative drugs [2] Group 2: Research and Development Investment - Shanghai Pharmaceuticals plans to invest a total of 2.818 billion yuan in research and development in 2024, emphasizing its strategic focus on innovation [2] - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, with 45 of these being innovative drug pipelines, establishing a comprehensive and tiered R&D structure [2] Group 3: Collaborative Innovation Ecosystem - The company has established the "Shanghai Frontier" life sciences innovation incubation engine in collaboration with universities and top research institutions, attracting numerous renowned research and service organizations since its launch in September of last year [3][4] - Shanghai Pharmaceuticals aims to continue investing in innovative R&D, focusing on urgent clinical needs in areas such as oncology, immunology, cardiovascular health, mental health, digestive metabolism, and anti-infection, while enhancing the collaborative innovation ecosystem [4]

Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Sitojilun, aimed at treating primary hypertension, marking a significant achievement in its commitment to independent innovation in the pharmaceutical industry [1][2]. Group 1: Product Approval and Market Strategy - The innovative drug Sitojilun (SPH3127), a new generation oral non-peptide small molecule renin inhibitor, has been approved for market launch, addressing unmet clinical needs in hypertension treatment [1]. - Shanghai Pharmaceuticals has established a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces, municipalities, and autonomous regions in China, ensuring effective market access for Sitojilun [1]. Group 2: Research and Development Investment - In 2024, Shanghai Pharmaceuticals plans to invest 2.818 billion yuan in R&D, positioning itself among the industry leaders in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, with 45 of these being innovative drugs, demonstrating a robust pipeline and commitment to long-term innovation [2]. Group 3: Collaborative Innovation Ecosystem - The company has established the Shanghai Frontier Life Science Innovation Center to foster collaboration with top universities and research institutions, creating an open innovation ecosystem [3]. - Since its launch in September of last year, the center has attracted numerous renowned research institutions and pharmaceutical companies, enhancing the innovation landscape [3]. - Shanghai Pharmaceuticals aims to continue investing in R&D focused on urgent clinical needs in areas such as oncology, immunology, cardiovascular health, and infectious diseases, with the goal of transforming innovative results into marketable products [3].