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上海医药1类创新药司妥吉仑正式获批上市 攻坚破局高血压治疗
Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Suojirolin, 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 Clinical Significance - The National Medical Products Administration (NMPA) has officially approved Suojirolin (brand name: Xintuoan), a first-class innovative drug for the treatment of primary hypertension [1]. - Suojirolin is a new generation of oral non-peptide small molecule renin inhibitors, designed to meet unmet clinical needs, providing a new treatment option for over 300 million patients with primary hypertension in China [1]. - Clinical trials have shown that Suojirolin demonstrates good efficacy and safety, with its Phase II trial results published in the authoritative journal "Hypertension Research," indicating growing global academic interest in Chinese innovative drugs [1]. Group 2: Research and Development Strategy - Shanghai Pharmaceuticals has positioned research and development (R&D) innovation at its strategic core, with a planned R&D investment of 2.818 billion yuan for 2024, leading the industry in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, including 45 innovative drug pipelines, establishing a comprehensive and tiered R&D team [2]. - The company has several innovative drugs in advanced clinical stages, including a CD20 injection for neuromyelitis optica and a traditional Chinese medicine for cervical spondylosis, indicating a robust pipeline [2]. Group 3: Collaborative Innovation and Market Strategy - Shanghai Pharmaceuticals has established the Shanghai Frontier Biomedical Innovation Center to foster an open innovation ecosystem by collaborating with top universities and research institutions [3]. - The company has created a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces and municipalities in China, ensuring effective market access for Suojirolin [3]. - The integration of online and offline pharmaceutical services enhances the company's ability to reach patients quickly and efficiently [3].
上海医药:关于硫酸羟氯喹片获得菲律宾药品注册证书的公告
Core Viewpoint - Shanghai Pharmaceuticals has received approval for its Hydroxychloroquine Sulfate Tablets from the Philippines Food and Drug Administration, allowing the product to be marketed [1] Group 1 - The product is manufactured by Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., a subsidiary of Shanghai Pharmaceuticals [1] - The approval signifies a potential expansion of the company's market presence in the pharmaceutical sector [1]
12月15日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-15 10:19
Group 1 - Shareholder Zhang Yu of Kehua Holdings plans to reduce his stake by up to 3%, amounting to no more than 5.83 million shares within three months [1] - Shanghai Ailu has signed a strategic cooperation agreement with Southern Road Machinery to provide packaging products for the dry-mixed mortar industry [2] - Xingyuan Zhuomei appointed Gong Chunming as the new deputy general manager [3] Group 2 - Tongyi Zhong's shareholder has set a preliminary transfer price of 15.47 yuan per share for a total of 4.27 million shares [4] - Anada's shareholder did not implement the planned share reduction of up to 2% by the deadline [5] - Rongchang Bio plans to repurchase shares worth between 20 million to 40 million yuan at a price not exceeding 95 yuan per share [6] Group 3 - Hainan Airport reported an 8.16% year-on-year increase in passenger throughput for November, totaling 2.09 million passengers [7] - Lanjian Intelligent plans to apply for a bank credit line of up to 1.2 billion yuan for various financial operations [8] - Xinlei Co. received a total of 561.43 million yuan in land acquisition and compensation payments [9] Group 4 - Foster reported a surplus of 321 million yuan from four fundraising projects, which will be used to supplement working capital [10] - China Southern Airlines experienced a 10.42% year-on-year increase in passenger turnover for November [12] - China National Airlines reported a 10.1% year-on-year increase in passenger turnover for November [17] Group 5 - Sanyou Chemical plans to register and issue mid-term notes not exceeding 1.3 billion yuan [18] - Quanyuan Spring used 60 million yuan of idle funds to purchase structured deposits [19] - Su Keng Agricultural Development appointed Zou Yi as the new deputy general manager [20] Group 6 - Jingneng Real Estate received approval to register mid-term notes totaling up to 2 billion yuan [21] - Dechang Co. received approval from the CSRC for a targeted issuance of shares [23] - Jiufeng Bio obtained a medical device registration certificate for its fructosamine testing kit [24] Group 7 - Jinzi Ham's president Guo Bo resigned for personal reasons, while Zheng Hu was appointed as the new president [25] - China Eastern Airlines reported a 10.35% year-on-year increase in passenger turnover for November [26] - Fengfan Co.'s controlling shareholder is in the process of acquiring 17.32% of the company's shares [27] Group 8 - Zhenghai Bio signed a technical development contract with the Chinese Academy of Agricultural Sciences for a collagen product project worth 12 million yuan [28] - Xinhua Insurance reported a 16% year-on-year increase in cumulative original insurance premium income for the first 11 months [29] - Jingjia Microelectronics' subsidiary completed key stages of its AI SoC chip project [30] Group 9 - Shanghai Pharmaceuticals' hydrochloride sotalol tablets passed the consistency evaluation for generic drugs [31] - Heshun Technology's subsidiary's carbon fiber project has entered a stable operational phase [32] - Spring Airlines reported an 18.02% year-on-year increase in passenger turnover for November [33] Group 10 - Huaxin New Materials proposed a mid-term dividend plan of 1 yuan per 10 shares [34] - Keda Li plans to increase capital by 300 million yuan for its wholly-owned subsidiary [35] - Jinguang Electric won a bid for a high-voltage direct current transmission project worth 84.86 million yuan [36] Group 11 - XGIMI Technology's subsidiary received a development notification for a vehicle-mounted projection project from a well-known domestic automotive manufacturer [37]
上海医药盐酸索他洛尔片通过仿制药一致性评价
Bei Jing Shang Bao· 2025-12-15 10:08
北京商报讯(记者 王寅浩 宋雨盈)12月15日,上海医药发布公告称,公司下属常州制药厂有限公司的 盐酸索他洛尔片收到国家药品监督管理局颁发的《药品补充申请批准通知书》,该药品通过仿制药质量 和疗效一致性评价。根据公告,盐酸索他洛尔片主要用于转复、预防室上性心动过速,心房扑动、心房 颤动以及各种室性心律失常等。 ...
上海医药(02607):硫酸羟氯喹片获得菲律宾药品注册证书
智通财经网· 2025-12-15 09:41
Core Viewpoint - Shanghai Pharmaceuticals (02607) has received a drug registration certificate from the Philippines Food and Drug Administration for its Hydroxychloroquine Sulfate Tablets, allowing the company to sell the product in the Philippines, which is expected to positively impact its overseas market expansion [1] Group 1: Product Approval - 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 product was developed by Concordia Pharmaceuticals Inc and was first launched in the United States in 1955 [1] - Shanghai Pharmaceuticals' Hydroxychloroquine Sulfate Tablets were approved for domestic sale in China in December 1999 and passed the consistency evaluation for generic drugs in December 2021 [1] Group 2: Financial Aspects - The company has not incurred additional R&D expenses for the product's launch in the Philippines, with only registration-related costs amounting to approximately RMB 50,000 [1] - According to IQVIA data, the total sales revenue for Hydroxychloroquine Sulfate Tablets (200 mg) in the Philippines is projected to be USD 4.13 million in 2024 [1] Group 3: Market Impact - The approval signifies the company's qualification to sell the product in the Philippine market, which is expected to have a positive impact on the company's overseas market expansion and accumulate valuable experience [1]
上海医药(02607.HK):硫酸羟氯喹片获得菲律宾药品注册证书
Ge Long Hui· 2025-12-15 09:41
Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) announced that its subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate from the Philippines Food and Drug Administration for Hydroxychloroquine Sulfate Tablets, which are now approved for market launch [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 triggered or exacerbated by sunlight [1]
上海医药硫酸羟氯喹片获得菲律宾药品注册证书
Group 1 - Shanghai Pharmaceuticals (601607) subsidiary, Shanghai Shiyou Zhongxi Pharmaceutical Co., Ltd., has received a drug registration certificate from the Philippines Food and Drug Administration for Hydroxychloroquine Sulfate Tablets, allowing the product to be marketed [1] - Hydroxychloroquine Sulfate Tablets are primarily used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, as well as skin diseases triggered or exacerbated by sunlight [1]
上海医药(02607) - 海外监管公告
2025-12-15 09:35
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) 香港交易及結算所有限公司和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分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。 (股份代碼:02607) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於硫酸羥氯喹片獲得菲律賓藥品註冊證書的公告》、 《上海醫藥集團股份有限公司關於鹽酸索他洛爾片通過仿製藥一致性評價的公告》僅供參 閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海,2025 年 12 月 16 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 ...
上海医药(601607) - 上海医药集团股份有限公司关于盐酸索他洛尔片通过仿制药一致性评价的公告
2025-12-15 08:30
证券代码:601607 证券简称:上海医药 编号:临 2025-116 上海医药集团股份有限公司 关于盐酸索他洛尔片通过仿制药一致性评价的公告 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。 申请人:常州制药厂有限公司 审批结论:本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 盐酸索他洛尔片主要用于:1、转复,预防室上性心动过速,特别是房室结 折返性心动过速,也可用于预激综合征伴室上性心动过速。2、心房扑动,心房 颤动。3、各种室性心律失常,包括室性早搏,持续性及非持续性室性心动过速。 4、急性心肌梗死并发严重心律失常。2024 年 11 月,常州制药厂就该药品仿制 药质量和疗效一致性评价向国家药品监督管理局提出补充申请并获得受理。截至 本公告日,公司针对该药品的一致性评价已投入研发费用约为人民币 460 万元。 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")的盐酸索他洛尔片(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 ...
上海医药(601607) - 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
2025-12-15 08:30
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 ...