Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of HSK44459 tablets, a new drug for treating inflammatory bowel disease, indicating significant development potential in this therapeutic area [1] Group 1: Drug Development - HSK44459 tablets are independently developed by the company and possess independent intellectual property rights [1] - The drug targets inflammatory bowel diseases, including ulcerative colitis and Crohn's disease, showing promising preclinical results in terms of efficacy and safety [1] - The approval for clinical trials suggests a high benefit/risk ratio for clinical application, highlighting the drug's potential to address the current shortage of effective treatments in this field [1]

SK50042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。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。本次申请为 HSK50042片在呼吸系统疾病领域中又一新适应症的临床试验申请，有望为呼吸疾病患者提供一种高 效、安全的新型治疗选择。 HSK55879片是公司自主研发的具有独立知识产权的口服小分子激动剂药物，拟用于代谢系统疾病的治 疗。临床前研究数据表明，HSK55879在相关动物模型中表现出显著的药效活性，作用机制明确，且在 不同剂量下均显示出良好的耐受性，同时拥有较大的安全窗。综合现有结果，HSK55879具备明确的开 发价值和良好的转化前景，有望为临床患者提供一种高效、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》，涉及产品："HSK50042"、"HSK55879"。 ...

Core Viewpoint - The company Haishi Ke (002653) has received approval from the National Medical Products Administration for clinical trials of its drug HSK44459 for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn's disease [1] Group 1 - The National Medical Products Administration issued a "Clinical Trial Approval Notification" for HSK44459, indicating that the application for the new indication meets the requirements for drug registration [1] - Haishi Ke's subsidiary, Shanghai Haishi Shengnuo Pharmaceutical Technology Co., Ltd., has also received a "Acceptance Notification" for its clinical trial applications for HSK50042 and HSK55879 [1]

Core Viewpoint - The company, HaiSiKe (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of its new drug HSK44459, aimed at treating inflammatory bowel diseases, including ulcerative colitis and Crohn's disease [1] Group 1: Drug Development - HSK44459 is a novel drug developed independently by the company, possessing its own intellectual property rights [1] - Preclinical research indicates that HSK44459 has a clear target, definite efficacy, and good safety profile, making it a drug with significant development potential [1] - The drug is expected to address the current shortage of effective treatments for inflammatory bowel diseases, presenting a high benefit/risk ratio for clinical application [1] Group 2: Market Potential - The clinical application of HSK44459 is anticipated to have broad prospects, potentially becoming an effective treatment option for inflammatory bowel diseases [1]

Core Viewpoint - The company, Haishi Ke (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of its new drug HSK44459, aimed at treating inflammatory bowel diseases, including ulcerative colitis and Crohn's disease [1] Group 1: Drug Development - HSK44459 is a novel small molecule drug developed independently by the company, possessing independent intellectual property rights [1] - The drug has shown clear targets, definite efficacy, and good safety in preclinical studies, indicating high development potential [1] - The clinical application of HSK44459 is expected to address the current shortage of effective treatments for inflammatory bowel diseases [1] Group 2: Clinical Trial Approval - The clinical trial application for HSK44459 was accepted in October 2025 and meets the requirements for drug registration as per the relevant regulations [1] - The approval allows the company to proceed with clinical trials, which is a significant step in the drug development process [1]

SK50042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。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。本次申请为 HSK50042片在呼吸系统疾病领域中又一新适应症的临床试验申请，有望为呼吸疾病患者提供一种高 效、安全的新型治疗选择。 HSK55879片是公司自主研发的具有独立知识产权的口服小分子激动剂药物，拟用于代谢系统疾病的治 疗。临床前研究数据表明，HSK55879在相关动物模型中表现出显著的药效活性，作用机制明确，且在 不同剂量下均显示出良好的耐受性，同时拥有较大的安全窗。综合现有结果，HSK55879具备明确的开 发价值和良好的转化前景，有望为临床患者提供一种高效、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》，涉及产品："HSK50042"、"HSK55879"。 ...

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 two new drug applications [1] Group 1: Drug Development - HSK50042 is an oral, potent, and highly selective small molecule inhibitor intended for the treatment of respiratory diseases [1] - HSK55879 is an oral small molecule agonist aimed at treating metabolic system diseases [1] - Both drugs are classified as Category 1 chemical drugs [1]

Core Viewpoint - The company, Haishi Ke (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of HSK44459 tablets, a new drug for treating inflammatory bowel diseases, including ulcerative colitis and Crohn's disease [1] Group 1: Drug Development - HSK44459 tablets are independently developed by the company and possess independent intellectual property rights [1] - The drug has shown clear targets, definite efficacy, and good safety in preclinical studies, indicating high development potential as a small molecule drug [1] - The drug is expected to address the current shortage of effective treatments for inflammatory bowel diseases, offering a favorable benefit/risk ratio for clinical applications [1]

Core Viewpoint - Company Haisco (002653.SZ) has received clinical trial acceptance notifications from the National Medical Products Administration for two new drug candidates, HSK50042 and HSK55879, indicating progress in its drug development pipeline [2]. Group 1: Drug Development - HSK50042 is an oral, potent, and highly selective small molecule inhibitor intended for the treatment of respiratory system diseases [2]. - HSK55879 is an oral small molecule agonist aimed at treating metabolic system diseases [2]. - Both drug candidates are classified as Category 1 chemical drugs [2].

证券代码：002653 证券简称：海思科 公告编号：2025-136 海思科医药集团股份有限公司 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。本次申请为 HSK50042片在呼吸系统疾病领域中又一新适应症的临床试验申请，有 望为呼吸疾病患者提供一种高效、安全的新型治疗选择。 关于获得创新药 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 | 申请事项 | 适应症 | 受理号 | | --- | --- | --- | --- | --- | | HSK50042 | 片剂 | | 呼吸系统疾病 | CXHL2501481 CXHL2501486 | | | | 境内生产药品 | | CXHL2501482 | | HSK558 ...