Hisense: HSK47977 tablets approved by FDA for drug clinical trials
Hisun Pharmaceuticals announced that it recently received a Study May Proceed Letter (SPL) from the U.S. Food and Drug Administration (FDA) for HSK47977 tablets. According to FDA regulations, after review, the clinical trial application for HSK47977 tablets was found to meet the relevant drug registration requirements and the FDA has approved the product for clinical trials. HSK47977 tablets is an oral BCL6 (human B-cell lymphoma factor 6) PROTAC small molecule formulation independently developed by Hisun Pharmaceuticals. It can target and degrade the BCL6 protein, thereby inhibiting the occurrence and progression of tumor cells, and is intended for the treatment of lymphoma. In multiple preclinical studies, HSK47977 has demonstrated potent anti-tumor activity, strong target selectivity, and an ideal safety window. This project, with no other drugs targeting the same target entering clinical trials in China, is a potential first-in-class product.