Changchun High-Tech subsidiary GenSci gains clinical trial approvals for two new drugs

Changchun High & New Technology Industry Group Co., Ltd. announced that its subsidiary, Changchun GenSci Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the domestic clinical trial application of GenSci134 injection. This Class 1 biologic is intended to treat growth hormone deficiency in children. The company previously announced that GenSci134 was approved for adult growth hormone deficiency trials, which are currently underway.

In a separate announcement, GenSci also secured approval for the domestic clinical trial of GenSci143 for injection, a Class 1 biologic aimed at treating advanced solid tumors, including prostate and lung cancers. GenSci143 is a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, designed to overcome tumor heterogeneity and enhance anti-tumor efficacy. An overseas production application for the same drug was accepted by the U.S. FDA.

These approvals are expected to expand the company’s business structure and product portfolio, enhancing its core competitiveness. However, the company cautioned investors about the inherent risks associated with pharmaceutical R&D, including the lengthy and complex development, clinical trial, and production cycles, emphasizing the potential for uncertainties in the clinical trial process.