Haisco(SZ:002653) Zheng Quan Zhi Xing·2025-09-01 08:56Core Viewpoint - The company, Haikang (002653.SZ), has received FDA approval for clinical trials of its innovative drug HSK47977, which targets BCL6 protein for lymphoma treatment [1] Group 1: FDA Approval - Haikang announced that it received a Study May Proceed Letter from the FDA, allowing the clinical trials for HSK47977 to commence [1] - The clinical trial application for HSK47977 met the necessary requirements for drug registration as per FDA regulations [1] Group 2: Drug Details - HSK47977 is an orally administered small molecule PROTAC that targets and degrades BCL6 protein, aiming to inhibit tumor cell development [1] - Preclinical studies have shown that HSK47977 exhibits strong anti-tumor activity, high target selectivity, and an ideal safety window [1] - This drug is the first of its kind targeting BCL6 to enter clinical trials in China, positioning it as a potential First-In-Class product [1] Group 3: Clinical Trial Progress - HSK47977 received its clinical trial approval from the National Medical Products Administration on August 11, 2025, and the first subject was enrolled on August 28, 2025 [1]