On September 9, InnoCare (688428.SH; 09969.HK) announced that its self-developed bispecific ADC drug ICP-B381, targeting PSMA and STEAP1, has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to conduct clinical trials for the treatment of solid tumors including prostate cancer. This is the company's first bispecific ADC approved for clinical trials and its third ADC innovative drug to enter the clinical stage.
ICP-B381 is the first bispecific ADC developed by InnoCare based on its proprietary ADC platform, consisting of a humanized anti-PSMA/STEAP1 antibody, the company's self-developed next-generation irreversible linker, and a potent payload. PSMA (prostate-specific membrane antigen) and STEAP1 (six-transmembrane epithelial antigen of prostate 1) are both highly expressed on the surface of prostate cancer cells. By simultaneously targeting these two antigens, ICP-B381 can effectively cover heterogeneous tumor cells, reduce tumor escape risk, and potentially benefit more patients. Preclinical studies have shown that ICP-B381 exhibits significant anti-tumor activity in the 22Rv1 human prostate cancer xenograft model.
InnoCare currently has three ADC innovative drugs in the clinical stage: ICP-B794 targeting B7-H3 is undergoing Phase I dose escalation trials, with preclinical data selected for the 2026 AACR Annual Meeting; ICP-B208 targeting CDH17 completed its first patient dosing in July 2026 and can be developed for various gastrointestinal cancers including colorectal and gastric cancer; the newly approved ICP-B381 focuses on solid tumors such as prostate cancer. The company expects to submit the U.S. IND application for ICP-B381 in September 2026, steadily advancing its global clinical.

Source: Jiemian News / InnoCare Announcement | http://m.toutiao.com/group/7683331845366284843/