临床前研究表明，HSK50042在较低剂量下即可有效改善模型小鼠的肺部疾病病理症状，具有良好的药 效作用，同时也表现出了良好的耐受性和较大的安全窗，是一款极具开发潜力的药物，有望为呼吸疾病 患者提供一种高效、安全的新型治疗选择。 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：HSK50042片。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。 ...

证券代码：002653 证券简称：海思科 公告编号：2025-114 海思科医药集团股份有限公司 关于创新药 HSK39297 片纳入 突破性治疗药物程序的公告 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"）于 2025 年 10 月 13 日获悉，HSK39297 片正式被国家药品监督管理局药品审评中 心（CDE）纳入《突破性治疗品种名单》，将极大的推动该领域新药 的研发历程，为我国肾脏/泌尿系统疾病的治疗带来新的希望。 月 11 日完成公示，正式纳入《突破性治疗品种名单》。 HSK39297 片在纳入突破性治疗后，有望在上市申报阶段获得优 先审评资格，加速本品的上市。 一、研发项目简介 HSK39297 是公司自主研发的一种口服、强效和高选择性的补体 因子 B 小分子抑制剂。临床拟用于治疗补体参与介导的溶血性疾病及 补体参与介导的原发性或继发性肾小球疾病等。 目前 HSK39297 片在原发性 IgA 肾病患者中开展Ⅱ期临床研究中 并完成了 12 周的核心治疗期，临床结果显示达到预设终点。HSK39297 ...

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]