On September 8, 2026 InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate clinical trials for ICP-B381, the novel bispecific ADC targeting PSMA and STEAP1, for the treatment of solid tumors including prostate cancer. ICP-B381 is InnoCare’s first bispecific ADC to enter the clinic and the third ADC to enter clinical trials.
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ICP-B381 is InnoCare’s first bispecific ADC built on its proprietary ADC technology platform, comprising a humanized anti- PSMA/STEAP1 antibody conjugated to a potent proprietary payload via a next-generation irreversible linker. By engaging PSMA and STEAP1 simultaneously, ICP-B381 is designed to address heterogeneous tumor cell populations and reduce the risk of tumor escape, potentially benefiting a broader range of patients. In preclinical studies, ICP-B381 demonstrated robust and dose-dependent antitumor activity in a 22Rv1 human prostate cancer xenograft model, outperforming the corresponding single-target PSMA-ADC and STEAP1-ADC at the same dose, with favorable tolerability.
PSMA and STEAP1 are significantly overexpressed in prostate cancer cells with limited expression in normal tissue, making them highly promising therapeutic targets, particularly in metastatic castration-resistant prostate cancer (mCRPC). Currently, no bispecific ADC targeting PSMA and STEAP1 has been approved for marketing globally.
Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, "The IND approval of ICP-B381, our first bispecific ADC, is an important milestone for our proprietary ADC platform and reflects the progress we have made in building differentiated ADC candidates. We look forward to advancing ICP-B381 into the clinic and to developing more differentiated ADC candidates to address the needs of patients globally."
Prostate cancer is one of the most common malignancies among men worldwide with an estimated 1.5 million new cases in 2024. It is the most frequently diagnosed cancer in men in nearly two-thirds of the world’s countries.
(Press release, InnoCare Pharma, SEP 8, 2026, View Source [SID1234670658])