HSK47977片是海思科自主研发的一种口服BCL6(人B 细胞淋巴瘤因子 6)PROTAC 小分子制剂，可以靶 向结合和降解BCL6 蛋白，进而抑制肿瘤细胞的发生和发展，拟用于淋巴瘤的治疗。在多项临床前研究 中，HSK47977均展现出强效的抗肿瘤活性，同时也表现出较强的靶点选择性和理想的安全窗。本项目 国内尚无同靶点药物进入临床阶段，是潜在的 First-In-Class 产品。同时，HSK47977 片已于2025年8月 11日获得国家药品监督管理局下发的《临床试验批准通知书》，并于8月28日完成首例受试者入组。 智通财经APP讯，海思科(002653.SZ)发布公告，公司于近日收到HSK47977 片美国食品药品监督管理局 (FDA)下发的StudyMayProceed Letter(药物临床试验批准通知书)。根据FDA相关规定，经审查， HSK47977片临床试验申请符合药品注册的有关要求，同意本品开展临床试验。 （原标题：海思科(002653.SZ)：创新药HSK47977片获得FDA药物临床试验批准） ...

证券代码：002653 证券简称：海思科 公告编号：2025-096 海思科医药集团股份有限公司 关于创新药 HSK47977 片获得 FDA 药物临床试验批准的公告 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 HSK47977 片美国食品药品监督管理局（FDA）下发的 Study May Proceed Letter（药物临床试验批准通知书）。根据 FDA 相关规定， 经审查，HSK47977 片临床试验申请符合药品注册的有关要求，同意 本品开展临床试验。 一、 研发项目简介 HSK47977 片是海思科自主研发的一种口服 BCL6（人 B 细胞淋巴 瘤因子 6）PROTAC 小分子制剂，可以靶向结合和降解 BCL6 蛋白，进 而抑制肿瘤细胞的发生和发展，拟用于淋巴瘤的治疗。在多项临床前 研究中，HSK47977 均展现出强效的抗肿瘤活性，同时也表现出较强 的靶点选择性和理想的安全窗。本项目国内尚无同靶点药物进入临床 阶段，是潜在的 First-In-Class 产品。 同时，HSK47977 片 ...

Core Viewpoint - HSK47977, a novel oral BCL6 PROTAC small molecule developed by the company, has received FDA approval to proceed with clinical trials, indicating progress in lymphoma treatment [1] Group 1: FDA Approval - The company announced on September 1 that it received a Study May Proceed Letter from the FDA for HSK47977 [1] - The FDA's review confirmed that the clinical trial application for HSK47977 meets the requirements for drug registration [1] Group 2: Product Details - HSK47977 is designed to target and degrade the BCL6 protein, which is involved in the development of tumor cells [1] - The drug is intended for the treatment of lymphoma, highlighting its potential therapeutic application in oncology [1]

Core Viewpoint - The company has received FDA approval to proceed with clinical trials for its self-developed oral BCL6PROTAC small molecule drug, HSK47977, aimed at treating lymphoma [1] Group 1 - The FDA issued a Study May Proceed Letter to the company, allowing the clinical trial for HSK47977 to commence [1] - HSK47977 has also received clinical trial approval from the National Medical Products Administration (NMPA) in August [1] - The company has successfully enrolled the first subject for the clinical trial [1]

Core Insights - Company Haisco (002653) has filed an international patent application for a new compound titled "A Crystal Form of Quinoxalinone Derivatives and Its Preparation Method and Application" with the application number PCT/CN2025/077968, published internationally on August 28, 2025 [1] Group 1 - Haisco has announced a total of 24 international patent applications this year [3] - In the first half of 2025, Haisco invested 342 million yuan in research and development, representing a year-on-year increase of 59.22% [3]

Core Viewpoint - Dongwu Securities report indicates that Hisco achieved a net profit attributable to shareholders of 129 million yuan in the first half of 2025, a year-on-year decrease of 21.79% [1] Financial Performance - Overall gross margin stands at 72.96%, an improvement compared to the projected 71.46% for the entire year of 2024 [1] - Sales expenses for the first half of 2025 amounted to 727 million yuan, with a stable expense ratio of 36.35% [1] - Research and development expenses reached 342 million yuan, reflecting a year-on-year increase of 59.22%, supporting the development of the company's innovative drug pipeline [1] Revenue Breakdown - Revenue from anesthesia products in the first half of 2025 was 796 million yuan, showing a year-on-year growth of 54% [1] - Parenteral nutrition revenue was 206 million yuan, a year-on-year decline of 19.39% [1] - Revenue from antiemetic drugs for cancer reached 163 million yuan, marking a year-on-year increase of 19.9% [1] Strategic Outlook - The core anesthesia product, remifentanil, is experiencing rapid sales growth, facilitating the company's transition towards innovative drug sales [1] - Remifentanil is expected to be launched overseas soon, with multiple pipelines already included in medical insurance, which will become a new growth point for performance [1] - The company has sufficient catalysts for future innovative pipelines, maintaining a "buy" rating [1]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The sales of anesthetic products meet expectations, and the innovative pipeline is entering a commercialization phase [8] - The company reported a total revenue of 2.001 billion yuan in the first half of 2025, representing an 18.63% year-on-year growth, while the net profit attributable to shareholders decreased by 21.79% to 129 million yuan [8] - The core anesthetic product, Remifentanil, has rapidly gained market share, with a 22.3% share in the intravenous anesthetic market as of Q1 2025, surpassing competitors [8] - The company has multiple innovative pipelines progressing, with several clinical registrations underway, including HSK21542 and HSK16149, which are expected to contribute to future revenue growth [8] Financial Summary - Total revenue forecast for 2025 is 4.583 billion yuan, with a year-on-year growth of 23.15% [1][9] - The net profit attributable to shareholders is projected to be 522 million yuan in 2025, with a growth rate of 31.93% [1][9] - The earnings per share (EPS) is expected to be 0.47 yuan in 2025, with a price-to-earnings (P/E) ratio of 127.50 [1][9] - The company’s gross margin is expected to improve to 73.50% by 2026 [9]

Group 1 - A-share market sees a decline in several innovative drug concept stocks, with Yuekang Pharmaceutical dropping over 10% [1] - Guangshengtang falls by 8%, while Lifang Pharmaceutical and Haishike decrease by over 7% [1] - Saili Medical declines by over 6%, and Huiyu Pharmaceutical drops by over 5% [1] - Jingxin Pharmaceutical experiences a decline of over 4%, with Shutaishen, Haiteshengwu, and Xinlitai all falling by over 3% [1]

Investment Rating - The investment rating for the company is "Outperform the Market" [5][16]. Core Viewpoints - The company has seen a significant revenue increase of 54% in its anesthesia products, with total revenue reaching 2.001 billion yuan in the first half of 2025, representing an 18.6% year-on-year growth [1][8]. - The company is entering a harvest period for its innovative drugs, with multiple products approved for commercialization, including pain management and diabetes treatment medications [2][16]. - The company maintains a strong pipeline with ongoing clinical trials for various indications, indicating robust future growth potential [3][16]. Financial Performance Summary - In the first half of 2025, the company reported a gross margin of 71.5%, a net profit margin of 10.6%, and an overall expense ratio of 63.5% [2][12]. - Revenue breakdown by product area shows anesthesia products generating 796 million yuan, parenteral nutrition at 206 million yuan, antiemetic drugs at 163 million yuan, and other indications at 340 million yuan [1][8]. - The company forecasts net profits of 546 million yuan, 692 million yuan, and 866 million yuan for 2025, 2026, and 2027 respectively, with corresponding P/E ratios of 122, 96, and 77 [4][16].

证券研究报告|公司点评报告 [Table_Date] 2025 年 08 月 25 日 [Table_Title] 聚焦创新药研发，长期增长动能强劲 [Table_Title2] 海思科(002653) [Table_Summary] 事件概述 2025H1 公司实现营收 20.0 亿元（yoy+18.6%），归母净利润 1.3 亿 元 （ yoy -21.8% ）， 扣 非 归 母 净 利 润 1.4 亿 元 （ yoy +90.8%）。单 Q2 营收 11.1 亿元（yoy+18.7%），归母净利润 0.8 亿元（yoy+13.0%），扣非归母净利润 0.9 亿元（yoy+104.8%）； 业绩符合我们预期。 盈利能力方面，2025H1 公司毛利率 73.0%（+1.0pcts），其中自 产产品毛利率高达 80.36%，合作产品毛利率为 50.13%；归母净 利率 6.4%（-3.3pcts），扣非归母净利率 7.2%（+2.7pcts）；单 Q2 毛 利 率 75.1% （ -3.01pcts ）， 归 母 净 利 率 7.4% （ - 0.4pcts），扣非归母净利率 8.5%（+3.6pcts）。 ...