Group 1 - Company has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the innovative drug HSK47388, which is intended for the treatment of autoimmune diseases [1] - HSK47388 is an orally administered, potent, and highly selective drug that has shown significant efficacy in preclinical studies, particularly in rat models of enteritis, demonstrating dose-dependent effects and good tolerability [1] - The application for HSK47388 represents a new clinical trial for an additional indication in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] Group 2 - The clinical trial application for HSK47388 was accepted in June 2025, indicating compliance with the relevant drug registration requirements [1] - The drug is classified as a tablet form and is aimed at treating autoimmune diseases, with the registration number CXHL2500600 for domestic production [1]

Core Viewpoint - The company received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets, which are intended for the treatment of autoimmune diseases [1] Group 1 - The clinical trial approval was granted for HSK47388 tablets, which are a self-developed oral medication with high selectivity and potency [1] - The application represents a new indication for HSK47388 in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] - The approval was based on the compliance of HSK47388 with drug registration requirements as of June 2025 [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its self-developed drug HSK47388, aimed at treating autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an oral, potent, and highly selective drug [1] - Preclinical studies have shown significant efficacy in a rat model of colitis [1] - The drug demonstrates good tolerability and a large safety window [1] Group 2: Market Implications - This application represents a new indication for HSK47388 in the field of autoimmune diseases [1] - The drug is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]

智通财经APP讯，海思科(002653.SZ)发布公告，公司于近日收到国家药品监督管理局下发的《药物临床 试验批准通知书》，经审查，2025年6月受理的HSK47388片符合药品注册的有关要求，同意本品开展临 床试验。 HSK47388片是公司自主研发的口服、强效、高选择性的药物，拟用于自身免疫疾病的治疗。临床前研 究结果显示，HSK47388在大鼠肠炎模型中剂量依赖地呈现出显著的药效，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HSK47388片在自身免疫疾病领域中又一 新适应症的临床试验申请，有望为自身免疫疾病患者提供一种新的治疗选择。 ...

| 药品名称 | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | | HSK47388 | 片剂 | 拟用于自身免 | 境内生产药品 | CXHL2500600 | | | | 疫疾病的治疗 | 注册临床试验 | CXHL2500601 | 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 6 月受理的 HSK47388 片符合药品注册的有关要求，同意本品开展 临床试验。 证券代码：002653 证券简称：海思科 公告编号：2025-097 海思科医药集团股份有限公司 关于获得创新药 HSK47388 片新适应症 《药物临床试验批准通知书》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"）于近日收到 国家药品监督管理局下发的《药物临床试验批准通知书》，相关情况 如下： 海思科医药集团股份有限公司董事会 2025 年 9 月 4 日 2 一、研发项目简介 HSK47388片是公司自主研发的口服、强效、高选择性的药物，拟 用于自身免疫 ...

HSK47388片是公司自主研发的口服、强效、高选择性的药物，拟用于自身免疫疾病的治疗。临床前研 究结果显示，HSK47388在大鼠肠炎模型中剂量依赖地呈现出显著的药效，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HSK47388片在自身免疫疾病领域中又一 新适应症的临床试验申请，有望为自身免疫疾病患者提供一种新的治疗选择。 海思科（002653）(002653.SZ)发布公告，公司于近日收到国家药品监督管理局下发的《药物临床试验 批准通知书》，经审查，2025年6月受理的HSK47388片符合药品注册的有关要求，同意本品开展临床试 验。 ...

Investment Rating - The investment rating for the biotechnology industry is "Positive" (maintained) [1] Core Insights - The small molecule GLP-1RA market is expected to provide new incremental space for weight loss and diabetes management, with significant interest from multinational corporations (MNCs) accelerating their involvement in this sector [7][25] - The leading product in the small molecule GLP-1RA space is Orforglipron from Eli Lilly, which has completed multiple global Phase III clinical trials and is positioned to submit a New Drug Application (NDA) in the second half of 2025 [25][26] - Domestic companies are making substantial progress in the small molecule GLP-1RA pipeline, with several candidates entering late-stage clinical trials, indicating strong potential for commercialization and international expansion [19][25] Summary by Sections 1. Development Prospects of Small Molecule GLP-1RA - Oral GLP-1 drugs offer advantages such as ease of use and high patient compliance, with over 75% of initial treatment patients preferring daily oral therapy [14] - The small molecule GLP-1RA market is characterized by low costs and flexibility in usage scenarios, with significant recent business development (BD) transactions [14][23] 2. MNCs Accelerating Small Molecule GLP-1RA Pipeline - Eli Lilly's Orforglipron is the fastest progressing small molecule GLP-1RA product globally, with three Phase III trials achieving primary endpoints [25][27] - Other major pharmaceutical companies like AstraZeneca and Roche are also advancing their small molecule GLP-1RA pipelines, with several candidates in Phase II trials [29][30] 3. Pharmacokinetic Characteristics Impacting Efficacy - Pharmacokinetic features are crucial for the efficacy of small molecule GLP-1RA, with companies exploring new formulations to enhance solubility and absorption [6][19] 4. Investment Recommendations - The report recommends several companies as potential beneficiaries in the small molecule GLP-1RA space, including Innovent Biologics, East China Pharmaceutical, and others, highlighting their strong clinical development and commercialization potential [7][19]

Group 1 - The core announcement is that HSK47977, an innovative drug developed by the company, has received FDA approval for clinical trials, indicating progress in its development [1][2]. - HSK47977 is an oral BCL6 PROTAC small molecule formulation aimed at targeting and degrading the BCL6 protein to inhibit tumor cell development, specifically for lymphoma treatment [1]. - The drug has shown strong anti-tumor activity and selectivity in preclinical studies, and it is positioned as a potential First-In-Class product, with no similar drugs in clinical stages in the domestic market [1]. Group 2 - The company also received a clinical trial approval notice from the National Medical Products Administration on August 11, 2025, and completed the enrollment of the first subject on August 28, 2025 [2].

Core Viewpoint - HSK47977, an innovative oral BCL6 PROTAC small molecule developed by the company, has received FDA approval for clinical trials, marking a significant milestone in its development for lymphoma treatment [1][2]. Group 1: Product Development - HSK47977 is designed to target and degrade the BCL6 protein, which is crucial in the development of tumor cells, thereby potentially inhibiting tumor growth [2]. - The drug has demonstrated strong anti-tumor activity and selectivity in preclinical studies, indicating a promising safety profile [2]. - HSK47977 is positioned as a potential First-In-Class product, as there are currently no other drugs targeting the same mechanism in clinical stages in China [2]. Group 2: Regulatory Approval - The company received a Study May Proceed Letter from the FDA, confirming that the clinical trial application for HSK47977 meets the necessary requirements for drug registration [1]. - The National Medical Products Administration (NMPA) in China also granted clinical trial approval for HSK47977 on August 11, 2025, with the first subject enrolled on August 28, 2025 [2].

Core Viewpoint - The company Haisco has received FDA approval for clinical trials of its self-developed drug HSK47977, which targets BCL6 protein to treat lymphoma [1] Group 1 - HSK47977 is an oral BCL6 PROTAC small molecule formulation developed by Haisco [1] - The FDA's Study May Proceed Letter indicates that the clinical trial application meets the requirements for drug registration [1] - The drug aims to target and degrade BCL6 protein, thereby inhibiting the occurrence and development of tumor cells [1]