Core Insights - Haisco has transformed from a specialized pharmaceutical company to an integrated innovative drug research, production, and sales group since its establishment in 2000, focusing on key therapeutic areas such as anesthesia, respiratory, and chronic diseases [1][2] - The company has developed a diversified pipeline of innovative drugs, with several projects like HSK31858 and HSK39297 in late-stage clinical development, and its first innovative drug,环泊酚, received FDA acceptance for listing in the U.S. in July 2025 [1][2] Financial Performance - In Q3 2025, Haisco achieved a revenue of 3.3 billion yuan, representing a year-on-year growth of 19.95% [1] - By the end of 2025, Haisco's market capitalization reached 57.5 billion yuan, ranking first in the Tibet region [1] Capital Operations - In February 2023, Haisco raised 800 million yuan through its first private placement to support the approval and inclusion of two innovative drugs,考格列汀片 and 苯磺酸克利加巴林胶囊, in the medical insurance system by 2024 [1] - The company has established a full-process technical system from early drug discovery to commercialization, enabling rapid product volume growth through academic marketing and channel integration [2] Investor Relations - Haisco has implemented a shareholder return plan for 2025-2027, committing to annual cash dividends of no less than 10% of the distributable profits or a cumulative cash dividend of no less than 30% of the average net profit over the last three years [2] - Since its listing, Haisco has distributed over 3.67 billion yuan in cash dividends, achieving a dynamic balance between corporate development and shareholder returns [2] Future Outlook - Haisco aims to continue focusing on the core innovative drug sector, leveraging its full-process R&D platform and capital operations to accelerate the implementation of ongoing projects and strengthen its international market presence [2]

Core Viewpoint - The company, Haikang (002653), announced that its subsidiary Sichuan Haikang Pharmaceutical Co., Ltd. received a notice from the National Medical Products Administration regarding the acceptance of the registration application for the drug HSK39297, aimed at treating adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitors [1] Group 1 - The drug HSK39297 is classified as a Class 1 chemical drug according to China's new chemical drug registration classification regulations [1] - HSK39297 is the first-tier CFB inhibitor targeting PNH in China, addressing a significant unmet clinical need [1] - The market outlook for HSK39297 is positive due to the high demand for treatment options in this therapeutic area [1]

Core Viewpoint - The company announced that its subsidiary, Sichuan Hisun Pharmaceutical Co., Ltd., received a Notice of Acceptance from the National Medical Products Administration for its drug HSK39297, a selective complement factor B inhibitor aimed at treating diseases mediated by abnormal complement activation [1] Group 1 - HSK39297 is a self-developed small molecule inhibitor that effectively inhibits the activity of complement factor B, blocking the activation of the alternative pathway and the complement amplification cycle [1] - The drug is designed to control both C3b-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) [1] - HSK39297 acts at the proximal end of the complement cascade's alternative pathway, targeting the mechanisms that lead to hemolysis [1]

Core Viewpoint - Company Sichuan Haisco Pharmaceutical Co., Ltd. received a Notice of Acceptance from the National Medical Products Administration for HSK39297 tablets, which are intended for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1] Group 1 - The acceptance notice was issued on January 6, 2026 [1] - HSK39297 is specifically designed for adult patients with a history of not being treated with complement inhibitors [1]

Core Viewpoint - Company Sichuan Hisun Pharmaceutical Co., Ltd., a subsidiary of Hisun Pharmaceutical (002653.SZ), received a Notice of Acceptance from the National Medical Products Administration for the drug HSK39297 tablets, aimed at treating adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1] Group 1 - The drug HSK39297 is specifically indicated for adult patients with PNH [1] - The acceptance notice was issued on January 6, 2026 [1] - The drug is intended for patients who have not undergone prior treatment with complement inhibitors [1]

Group 1 - The core point of the article is that the company, Hisun Pharmaceutical (002653), announced that its subsidiary, Sichuan Hisun Pharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for a new drug application [1] - The drug in question is named HSK39297 tablets, which is intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1]

Core Viewpoint - The announcement indicates that the company has received a marketing authorization for its innovative drug HSK39297, which targets a significant unmet clinical need in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitors [1] Group 1: Company Information - The company, Haikang Pharmaceutical, has a subsidiary named Sichuan Haikang Pharmaceutical Co., Ltd., which is responsible for the development of HSK39297 [1] - HSK39297 is positioned as a first-tier CFB inhibitor specifically for the treatment of PNH, highlighting its competitive edge in the market [1] Group 2: Market Potential - There is a substantial unmet clinical demand for treatments targeting PNH, suggesting a favorable market outlook for HSK39297 [1] - The drug's approval is expected to enhance the company's market presence in the therapeutic area of PNH, which is currently underserved [1]

Core Viewpoint - The announcement indicates that the subsidiary Sichuan Haisco Pharmaceutical Co., Ltd. has received a notice from the National Medical Products Administration regarding the acceptance of the drug application for HSK39297, which is aimed at treating adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitors [1] Group 1 - HSK39297 is classified as a Class 1 chemical drug according to China's new chemical drug registration classification regulations [1] - The drug is a highly efficient selective complement factor B (FB) small molecule inhibitor developed by the company [1] - HSK39297 works by inhibiting FB activity to block the activation of the alternative pathway (AP) and the complement amplification cycle, thereby suppressing the overall activity of the complement pathway [1]

海思科医药集团股份有限公司 证券代码：002653 证券简称：海思科 公告编号：2026-003 《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， 临床研究结果表明，HSK39297 安全耐受性良好；在不同年龄、 性别、PNH 病程时长、治疗前 Hb 水平的亚组人群中均可观察到良好 的疗效，表明不同亚群的患者均可显著获益。HSK39297 在改善贫血、 减少输血需求、缓解疲劳症状等方面较依库珠单抗均有显著的治疗优 势，且疗效可长期维持。 没有虚假记载、误导性陈述或重大遗漏。 关于获得创新药 HSK39297 片上市许可 海思科医药集团股份有限公司（以下简称"公司"）子公司四川 海思科制药有限公司于 2026 年 1 月 6 日收到国家药品监督管理局下 发的《受理通知书》，现将相关情况公告如下： | | 片 | | 药品注册 | CXHS2600002 | | --- | --- | --- | --- | --- | | | | 制剂治疗的阵发性睡眠性血红蛋白尿 | | | | 药品名称 HSK39297 | 剂型 | 适应症 本品适用于治疗既往未接受过补体抑 症（PNH）成人 ...

格隆汇1月5日丨海思科(002653.SZ)公布，为进一步整合和优化现有资源配置，提升公司经营质量，决 定注销开曼子公司HEXGENPHARMACEUTICAL GROUP LIMITED（简称"海思锦医药"）和其下属全 资美国子公司 HEXGEN PHARMACEUTICAL HOLDING LIMITED（简称"美国海思锦"），并授权公司 经营管理层办理相关注销事宜。 ...