GeneScience Pharmaceutical gets FDA nod for solid tumor drug trial

Changchun High & New Technology Industry Group announced its subsidiary, Changchun GeneScience Pharmaceutical Co., Ltd., received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application of GenSci143 for injection. This approval permits a clinical trial in the United States for advanced solid tumors.

GenSci143 is an independently developed bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA. Classified as a Class 1 therapeutic biological product, it is designed for the treatment of various advanced solid tumors, including prostate and lung cancer. The drug aims to overcome tumor heterogeneity and drug resistance through its dual-target design and efficient cell killing mechanism.

This clinical trial approval follows an earlier approval for clinical trials in China for advanced solid tumors. The company stated that a successful clinical trial could broaden its business structure and enhance its core competitiveness, though it cautioned investors about inherent risks in pharmaceutical research and development.