证券代码：002653 证券简称：海思科 公告编号：2025-113 急性疼痛定义为持续时间最长30天的疼痛，通常由某种形式的组 织损伤引起，例如创伤或手术。手术后疼痛是手术后早期发生的急性 伤害性疼痛，包括躯体痛、内脏痛和躯体/内脏混合性疼痛，通常持 续不超过37天，创伤大的手术或需较长时间功能锻炼的关节置换等手 术，有时疼痛持续数周。这种急性疼痛控制不充分可影响患者的循环、 呼吸、消化和泌尿系统功能，影响患者睡眠和术后恢复，甚至可能发 展为慢性疼痛。 1 海思科医药集团股份有限公司 关于获得创新药注射用 HSK55718 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 | | --- | --- | --- | --- | --- | | HSK55718 | 注射剂 | 镇痛 | 境内生产药品 | CXHL250 ...

一、研发项目简介 炎症性肠病（IBD）是一组慢性胃肠道非特异性炎性疾病，包括 溃疡性结肠炎（UC）和克罗恩病（CD），主要临床表现包括腹痛、腹 泻、黏液脓血便、瘘管以及肛周病变，病情缓解与复发交替，可伴随 患者终生。IBD常用的治疗药物有氨基水杨酸、激素、硫唑嘌呤、环 孢素、沙利度胺等传统制剂，以及英夫利昔单抗、阿达木单抗、维得 利珠单抗等生物制剂，但这些治疗对很大一部分患者疗效不佳，或因 不良反应太大导致患者无法耐受。对于难治性IBD，患者亟需有效的 《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 | | --- | --- | --- | --- | --- | --- | | HSK45019 | 片 | 片剂 | 炎症性肠病 | 境内生产药品 | CXHL2501072 | | | | | | 注册临床试验 | CXH ...

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].

Group 1 - He Eye Hospital's subsidiary has signed a share subscription agreement to acquire Japan's Ido Medical, marking a significant step in its international expansion in ophthalmology [1] - The investment requires approval from multiple regulatory bodies in both China and Japan, highlighting the complexities and high barriers of cross-border medical investments [1] Group 2 - Jin Cheng Pharmaceutical's actual controller and chairman, Zhao Yeqing, received a notice of administrative penalty for violating securities laws, resulting in a fine of 3 million yuan, with Zhao personally liable for 1.5 million yuan and a four-year market ban [2] - This incident raises concerns about the company's governance and internal control, potentially impacting its reputation and market confidence [2] Group 3 - Two senior executives at Nuo Si Ge have resigned from their vice president positions but will continue to lead subsidiary companies, indicating an internal management restructuring aimed at enhancing operational efficiency and strategic execution [3] Group 4 - Haikang Pharmaceutical's subsidiary has received acceptance for an IND application for HSK36357 capsules, a new small molecule drug with independent intellectual property rights, showing significant analgesic effects and potential in treating muscular dystrophy [4] - The dual mechanism of HSK36357 could provide a new treatment option for patients with Duchenne muscular dystrophy, indicating substantial market potential if clinical validation is achieved [4] Group 5 - Changfeng Pharmaceutical has successfully listed on the Hong Kong Stock Exchange with an IPO price of 14.75 HKD per share, focusing on the research, production, and commercialization of inhalation technologies for respiratory diseases [5] - The company's stock surged over 200% on its debut, reflecting strong market recognition of its leading position in the inhalation drug sector [6]

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]

Core Viewpoint - The company 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 skeletal muscle contraction and improve recovery from fatigue in Duchenne Muscular Dystrophy (DMD) model mice [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 treatment of muscular dystrophies [1] Group 2: Regulatory Status - The drug is classified as a Class 1 chemical drug according to the National Medical Products Administration's regulations on chemical drug registration [1]

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 | ...