Haisco Pharmaceutical's HSK47977 gets FDA clinical trial green light

Haisco Pharmaceutical Group Co., Ltd. announced that its innovative drug, HSK47977 tablets, has received a "Study May Proceed Letter" from the U.S. Food and Drug Administration (FDA), approving its clinical trial application. This approval indicates the application meets necessary requirements for drug registration.

HSK47977 is an orally administered small molecule compound targeting BCL6 protein, developed to inhibit the growth of tumor cells. It is intended for the treatment of lymphoma. Preclinical studies showed strong anti-tumor activity, high target selectivity, and a favorable safety profile. The company states there are no other drugs with the same target currently in clinical stages in China, positioning HSK47977 as a potential First-In-Class product.

In addition to the FDA approval, HSK47977 previously received a Clinical Trial Approval Notice from China's National Medical Products Administration on August 11, 2025, and the first subject enrollment was completed on August 28, 2025. Haisco Pharmaceutical also issued a risk warning regarding the long development cycle and high risks associated with innovative drugs.