Haisco(002653)
Search documents
海思科:创新药HSK47977片临床试验申请获批
Zheng Quan Shi Bao Wang· 2025-08-12 07:52
HSK47977是公司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,拟用于非霍奇金淋巴瘤的治疗。 人民财讯8月12日电,海思科(002653)8月12日晚间公告,公司近日收到国家药监局下发的《药物临床 试验批准通知书》,创新药HSK47977片临床试验申请均符合药品注册的有关要求,同意开展临床试 验。 ...
海思科:获得创新药HSK47977片《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-12 07:52
每经AI快讯,8月12日,海思科(002653)(002653.SZ)公告称,公司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》,同意HSK47977片开展临床试验。该药品为公司自主研发的口服 BCL6PROTAC小分子制剂,用于治疗非霍奇金淋巴瘤。HSK47977片国内尚无同靶点药物进入临床阶 段,是潜在的First-In-Class产品。此外,该药品已完成与FDA的Pre-IND沟通和IND申报递交,正在审评 中,未来有望实现中美同步开发。创新药研发周期长、风险高,存在不确定性,投资者需谨慎决策。 ...
海思科(002653) - 关于获得创新药HSK47977片《药物临床试验批准通知书》的公告
2025-08-12 07:45
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》,基本情况 如下: | 药品名称 | 剂型 | 申请事项 | 适应症 | 受理号 | | --- | --- | --- | --- | --- | | HSK47977 | 片 | 境内生产药品 | 非霍奇金淋巴瘤 | CXHL2500544 | | | | 注册临床试验 | | CXHL2500545 | 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HSK47977 片临床试验申请均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:2025-089 海思科医药集团股份有限公司 关于获得创新药 HSK47977 片 《药物临床试验批准通知书》的公告 特此公告。 海思科医药集团股份有限公司董事会 2025 年 8 月 13 日 一、 研发项目简介 HSK47977是公司自主研发的一种口服BCL6(人B细胞淋巴瘤因子 6)P ...
海思科20250809
2025-08-11 01:21
Summary of Haishike's Conference Call Company Overview - Haishike was established in 2000 and is headquartered in Chengdu, with over 5,300 employees. The company initially focused on specialized fields such as parenteral nutrition, liver disease, and anti-infection, and is now transitioning towards innovation and international development [9] Industry and Product Pipeline - Haishike has a robust domestic commercialization pipeline, including already launched products such as Remifentanil (环泊芬), 21,542, 16,149, and DPP-4, along with the anticipated launch of 22,542 in 2025. The company expects a revenue growth of 15%-20% in 2025 [2][3] - Remifentanil is projected to achieve sales of 1.6-1.7 billion CNY in 2025, with a sales volume of 25 million units, solidifying its position as the leader in the domestic intravenous anesthetics market [2][4] - The innovative drug 21,542, an opioid analgesic with lower addiction potential, is expected to reach peak sales of 4 billion CNY domestically. The new generation analgesic 16,149, launched in May 2024, is projected to achieve peak sales of 1.5 billion CNY [2][6] - DPP-4, a long-acting hypoglycemic agent, has been approved in China and is entering the volume release phase under medical insurance [2][6] Market Performance and Competitive Advantages - Remifentanil has significant clinical advantages, including deeper anesthesia and higher safety, with a market share leading position. A simple renewal negotiation for medical insurance is expected by the end of the year, with a potential price reduction of less than 10% [5][11] - 21,542 is the only white prescription opioid, making it easier for doctors to prescribe. It is expected to replace traditional opioids like Dezocine, which is gradually exiting medical insurance [12] - 16,149 is positioned to replace Pregabalin in chronic pain treatment, with expected peak sales of 1-1.5 billion CNY [14] Research and Development - Haishike's R&D investment has been increasing since 2018, with a significant acceleration in 2022. The company has a rich pipeline of innovative drugs, including four major launched products and several in late-stage clinical trials [10] - Products with international market potential include PDE34 and PDE4B for COPD and interstitial pneumonia, and an oral interleukin-23 receptor peptide for autoimmune diseases, which are expected to yield data by the end of the year [7] Financial Projections and Valuation - The projected net profit for Haishike from 2025 to 2027 is 570 million, 780 million, and 910 million CNY, respectively, with corresponding price-to-earnings (PE) ratios of 110x, 81x, and 70x [8] - The target market capitalization is set at 71 billion CNY, maintaining a buy rating [8][26] Additional Insights - The textile drug market is expected to stabilize in profit growth, with projected profits of 574 million CNY this year, nearing 800 million CNY next year [25] - The competitive landscape for COPD treatments in China includes several players, with Haishike's PDE34 expected to read out phase II data by the end of the year [24] This summary encapsulates the key points from Haishike's conference call, highlighting the company's strategic positioning, product pipeline, market performance, and financial outlook.
101只个股连续5日或5日以上获主力资金净买入
Zheng Quan Shi Bao Wang· 2025-08-08 03:14
(文章来源:证券时报网) 据iFind统计,截至8月7日,沪深两市共有101只个股连续5日或5日以上获主力资金净买入。连续获主力 资金净买入天数最多的股票是倍加洁、青松建化、老凤祥、华塑股份,均已连续12个交易日获净买入; 连续获主力资金净买入天数较多的还有中南传媒、巨星农牧、信达地产、大秦铁路、腾达建设、海思 科、首药控股、ST起步等股,分别获11个、10个、10个、10个、10个、9个、9个、8个交易日净买入。 ...
中国移动上半年净利润同比增长5%;中芯国际二季度营收环比下滑丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-07 13:32
Group 1: Company Performance - SMIC reported Q2 revenue of $2.21 billion, a 16% year-over-year increase, but a 1.7% decrease quarter-over-quarter [1] - China Mobile achieved a net profit of 84.2 billion yuan in the first half of 2025, a 5% year-over-year increase, with a mid-term dividend of 2.75 HKD per share, up 5.8% [2] - Huahong Semiconductor's Q2 revenue was $566.1 million, an 18.3% year-over-year increase, with Q3 revenue guidance of $620 million to $640 million [3] Group 2: Business Operations and Developments - Chuangzhong Technology clarified that it does not engage in the production of liquid-cooled servers, only participating in testing platforms, with no revenue generated from this segment in H1 2025 [4] - Shuo Beid announced it has sent samples of liquid-cooled server plates to Taiwanese clients, but the ability to pass testing and achieve mass production remains uncertain [5] - Furi Electronics stated that its subsidiary provides JDM/OEM services for service robots, but this revenue accounts for less than 1% of the company's total revenue [6] Group 3: Industry Trends and Market Movements - Sales of new energy vehicles by Seres reached 44,581 units in July, reflecting a 5.7% year-over-year increase [7] - Longyuan Power completed a power generation of 6,328.76 MWh in July, marking a 2.44% year-over-year growth [8] - Jianglong Shipbuilding won a bid for the "Blue Granary" marine economic development project, indicating ongoing infrastructure investments [8]
海思科:HSK47388片获准开展临床试验
Zhi Tong Cai Jing· 2025-08-07 10:21
Core Viewpoint - Company received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets, intended for the treatment of autoimmune diseases [1] Company Summary - Company: 海思科 (002653.SZ) - Recent development: Approval for clinical trials of HSK47388 tablets [1] - Indication: Treatment for autoimmune diseases [1]
海思科(002653.SZ):HSK47388片获准开展临床试验
智通财经网· 2025-08-07 10:21
Group 1 - The company, Haikang Technology (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets [1] - The drug is intended for the treatment of autoimmune diseases [1]
海思科(002653) - 关于获得创新药HSK47388片《药物临床试验批准通知书》的公告
2025-08-07 10:15
海思科医药集团股份有限公司 关于获得创新药 HSK47388 片 《药物临床试验批准通知书》的公告 证券代码:002653 证券简称:海思科 公告编号:2025-088 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: | 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 | CXHL2500521 | | | | 疫疾病的治疗 | 注册临床试验 | CXHL2500522 | 根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 5 月受理的 HSK47388 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 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。根据国家药品监督管理局关于发布《化学 药品注册分类及 ...
海思科(002653.SZ):获得创新药HSK47388片的药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-07 10:13
格隆汇8月7日丨海思科(002653.SZ)公布,公司于近日收到国家药品监督管理局下发的HSK47388的《药 物临床试验批准通知书》。 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。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。 临床前研究结果显示,HSK47388可以剂量依赖地抑制大鼠炎症反应,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,有望为自身免疫疾病患者提供一种新的治疗选择。 ...