海思科医药集团股份有限公司

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].