重庆华森制药股份有限公司关于子公司获得创新药《药物临床试验批准通知书》的公告

Core Viewpoint - Chongqing Huasen Pharmaceutical Co., Ltd. announced that its subsidiary, Huasen Inno Biotech Co., Ltd., has received the Clinical Trial Approval Notification for the innovative drug HSN002066C1 from the National Medical Products Administration, marking a significant milestone in the company's drug development efforts [1]. Group 1: Drug Approval Details - Huasen Inno has been granted approval for HSN002066C1, a selective small molecule inhibitor of PARP7, intended for oral administration in the treatment of advanced malignant solid tumors [1]. - The drug has shown high exposure levels in mice and significant tumor suppression activity in various tumor models, either as a monotherapy or in combination therapy [1]. Group 2: Impact on the Company - HSN002066C1 is the first Class 1 innovative drug project approved for clinical trials by Huasen Inno, establishing a solid foundation for the company's strategy of combining innovation and generics [1]. - The company acknowledges that the drug development process is subject to various uncertainties, including technical, regulatory, and market competition factors, which may affect the clinical trial progress and the eventual market approval [1].