关于获得创新药 HSK50042 片 IND 申请 《受理通知书》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司（以下简称"公司"）子公司上海 海思盛诺医药科技有限公司于近日收到国家药品监督管理局下发的 《受理通知书》，基本情况如下： | 药品名称 | | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | --- | | HSK50042 | 片 | 片剂 | 呼吸系统疾病 | 境内生产药品 | CXHL2501081 | | | | | | 注册临床试验 | CXHL2501080 | 根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 一、 研发项目简介 HSK50042片是公司自主研发的口服、强效、高选择性小分子抑制 剂药物，拟用于呼吸系统疾病的治疗。根据国家药品监督管理局关于 发布《化学药品注册分类及申报资料要求》的通告（2020年第44号） 中化学药品注册分类的规定，本品属于化学药品1类。 证券代码：002653 证券简称：海思科 ...

海思科公告，子公司上海海思盛诺医药科技有限公司近日收到国家药品监督管理局下发的《受理通知 书》。药品名称为HSK55718，剂型为注射剂(冻干粉针剂)，适应症为镇痛，申请事项为境内生产药品 注册临床试验，受理号分别为CXHL2501077和CXHL2501078。HSK55718是公司自主研究的具有独立知 识产权的小分子非阿片类创新镇痛药物，有望为急性疼痛患者提供更加安全有效的镇痛选择。 ...

Core Viewpoint - The stock of Haisco Pharmaceutical Group Co., Ltd. has experienced fluctuations, with a year-to-date increase of 53.27% but a recent decline in the last five and twenty trading days [1][2]. Financial Performance - For the first half of 2025, Haisco achieved a revenue of 2 billion yuan, representing a year-on-year growth of 18.63%, while the net profit attributable to shareholders decreased by 21.79% to 129 million yuan [2]. - Cumulatively, Haisco has distributed 3.673 billion yuan in dividends since its A-share listing, with 687 million yuan distributed over the past three years [3]. Shareholder Structure - As of June 30, 2025, the number of Haisco's shareholders increased by 25.93% to 11,400, while the average circulating shares per person decreased by 28.64% to 42,147 shares [2]. - The top ten circulating shareholders include several funds, with notable increases in holdings from China Europe Medical Health Mixed A and ICBC Frontier Medical Stock A [3]. Stock Market Activity - On October 13, Haisco's stock price fell by 2.05% to 50.55 yuan per share, with a trading volume of approximately 54.66 million yuan and a turnover rate of 0.22% [1]. - The stock's market capitalization stands at 56.612 billion yuan, with a net inflow of main funds amounting to 2.05 million yuan [1].

点评：赵叶青作为公司董事长，其个人严重违法行为必然会影响公司声誉和市场信心，暴露出公司在治 理和内控方面可能存在一些问题。这对于所有上市公司的"关键少数"都是一次严肃的警示。 NO.3 诺思格高级管理人员变动 每经记者｜陈星 每经编辑｜张海妮 丨 2025年10月10日 星期五 丨 NO.1 何氏眼科披露收购日本医道医疗株式会社进展 何氏眼科披露，近日，公司全资子公司广东横琴澳星启明国际医疗管理有限公司正式与株式会社医道メ ディカル及阴山泰成签署了《股份认购协议》。本次对株式会社医道メディカル投资事项涉及海外投 资，资金的汇出尚需经过国内的发改委、商务主管部门、外汇主管部门等境内主管机关以及日本相关政 府部门的批准或备案。 点评：何氏眼科跨境投资医道メディカル，是眼科医疗国际化布局的关键一步。交易需中日两国多部门 审批，凸显跨境医疗投资的高门槛与合规复杂性。 NO.2 金城医药实际控制人收到行政处罚事先告知书 近日，金城医药实际控制人、董事长赵叶青等人因违反证券法相关规定，被处以300万元罚款。其中， 赵叶青承担150万元，并被实施4年市场禁入措施。 免责声明：本文内容与数据仅供参考，不构成投资建议，使用前请 ...

Core Viewpoint - Company Haisco (002653.SZ) has received a notice from the National Medical Products Administration regarding the acceptance of its clinical trial application for the drug "HSK36357 capsules," which is a new small molecule drug with independent intellectual property rights developed by the company [1] Group 1: Drug Development - HSK36357 has shown significant analgesic effects in non-clinical studies and can enhance the contraction force of skeletal muscles in Duchenne Muscular Dystrophy (DMD) model mice, improving muscle recovery after fatigue [1] - The drug is intended for the treatment of muscular dystrophies, including Becker Muscular Dystrophy and Duchenne Muscular Dystrophy [1] - HSK36357 has already been approved for clinical trials for the indication of "peripheral neuropathic pain," and the current acceptance is for the clinical trial application for muscular dystrophies [1] Group 2: Regulatory Classification - According to the National Medical Products Administration's announcement on the classification and application requirements for chemical drug registration (2020 No. 44), HSK36357 is classified as a Class 1 chemical drug [1]

HSK36357是公司自主研发的一个全新的具有独立知识产权的小分子药物。非临床研究表明，HSK36357 具有显著的动物体内镇痛药效，还可以增强杜氏肌营养不良(DMD)模型小鼠骨骼肌的收缩力并改善肌肉 疲劳后恢复能力，临床拟用于治疗肌营养不良症(包括贝氏肌营养不良症和杜氏型肌营养不良症)。根据 国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告(2020年第44号)中化学药品 注册分类的规定，本品属于化学药品1类。 HSK36357"周围神经病理性疼痛"适应症已获批临床，本次获得受理的为治疗肌营养不良症(包括贝氏肌 营养不良症和杜氏型肌营养不良症)的临床试验申请。 智通财经APP讯，海思科(002653.SZ)发布公告，公司子公司上海海思盛诺医药科技有限公司于近日收到 国家药品监督管理局下发的《受理通知书》，涉及药品："HSK36357胶囊"。 ...

Core Viewpoint - Haisco (002653.SZ) announced that its subsidiary, Shanghai Haisco Shennuo Pharmaceutical Technology Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for a new drug application for HSK36357 capsules, a novel small molecule drug with independent intellectual property rights [1] Group 1 - HSK36357 is a self-developed drug that has shown significant analgesic effects in non-clinical studies [1] - The drug has demonstrated the ability to enhance skeletal muscle contraction and improve recovery from fatigue in a mouse model of Duchenne Muscular Dystrophy (DMD) [1] - HSK36357 is intended for clinical use in treating muscular dystrophies, including Becker muscular dystrophy and Duchenne muscular dystrophy [1]

证券代码：002653 证券简称：海思科 公告编号：2025-110 海思科医药集团股份有限公司 关于获得创新药 HSK36357 胶囊新适应症 IND 申请 《受理通知书》的公告 | 本公司及董事会全体成员保证信息披露内容的真实、准确、完整， | | --- | | 没有虚假记载、误导性陈述或重大遗漏。 | 1 HSK36357"周围神经病理性疼痛"适应症已获批临床，本次获得 受理的为治疗肌营养不良症（包括贝氏肌营养不良症和杜氏型肌营养 不良症）的临床试验申请。 二、风险提示 创新药研发周期长、环节多、风险高，容易受到一些不确定性因 素的影响，敬请广大投资者谨慎决策，注意防范投资风险。公司将根 据该项目的后续进展及时履行信息披露义务。 特此公告。 海思科医药集团股份有限公司董事会 海思科医药集团股份有限公司（以下简称"公司"）子公司上海 海思盛诺医药科技有限公司于近日收到国家药品监督管理局下发的 《受理通知书》，基本情况如下： | 药品名称 | | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | --- | | HSK36357 | 胶囊 | ...

Core Viewpoint - Company Haisco (002653) has received a notice from the National Medical Products Administration regarding the acceptance of a clinical trial application for a new drug, HSK36357, which is developed for treating muscular dystrophy [1] Group 1: Drug Development - HSK36357 is a new small molecule drug with independent intellectual property rights developed by the company [1] - The drug has already been approved for clinical trials for the indication of "peripheral neuropathic pain" [1] - The current acceptance is specifically for clinical trials aimed at treating muscular dystrophy, including Becker muscular dystrophy and Duchenne muscular dystrophy [1]

Core Viewpoint - The company announced that its subsidiary, Shanghai Haisco Shenno Pharmaceutical Technology Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the drug HSK36357 capsules, which are intended for the treatment of muscular dystrophy [1] Group 1 - The drug HSK36357 is a new small molecule developed independently by the company [1] - The clinical application of HSK36357 is aimed at treating muscular dystrophy, including Becker muscular dystrophy and Duchenne muscular dystrophy [1] - The acceptance numbers for the clinical trial registration are CXHL2501059 and CXHL2501060 [1]