Subsidiary’s GenSci143 for Injection Receives FDA Clinical Trial Approval

November 14, 2025  Source: drugdu 96

"/  China Securities Intelligent Finance Changchun High & New Technology Industries Group(000661) announced on November 14 that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., recently received written notification from the U.S. Food and Drug Administration (FDA) that its clinical trial application for its independently developed injectable GenSci143 has been approved. GenSci143 is a bispecific antibody-drug conjugate targeting B7-H3 and PSMA, with dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy, and is intended for the treatment of various advanced solid tumors such as prostate cancer and lung cancer.
  According to the announcement, the drug binds to B7-H3 or PSMA, internalizes into lysosomes to release TOPO-I inhibitor toxins, and kills tumor cells. Its dual-target synergistic effect can overcome tumor heterogeneity and drug resistance, cover more patients and produce a more durable anti-tumor effect.
  Previously, GenSci143 had been approved in China to conduct clinical trials for advanced solid tumors.
  The announcement stated that if the subsidiary's clinical trial application progresses smoothly, it will help the company broaden its business structure, optimize its product structure, enrich and improve its strategic product line layout, and enhance the company's core competitiveness.
  Changchun High & New Technology Industries Group Co., Ltd.'s main business is the research, development, production, and sales of biopharmaceuticals and traditional Chinese medicines. In the first three quarters, the company achieved total operating revenue of 9.807 billion yuan and net profit attributable to the parent company of 1.165 billion yuan.

https://finance.eastmoney.com/a/202511143564431564.html

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