InnoCare Pharma Gets Approval for ICP-B381 Clinical Trials

BEIJING, Sept. 08, 2026 /CourierPR/ -- InnoCare Pharma, a biopharmaceutical company focusing on cancer and autoimmune diseases, has announced a significant milestone in its clinical development pipeline. The Chinese regulatory body, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), has approved InnoCare's Investigational New Drug (IND) application to initiate clinical trials for ICP-B381, a novel bispecific antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA) and steap1.

ICP-B381 is InnoCare's first bispecific ADC and the third ADC to enter clinical trials. The drug is designed to address heterogeneous tumor cell populations by engaging both PSMA and steap1 simultaneously, 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 single-target PSMA-ADC and STEAP1-ADC treatments at the same dose, with favorable tolerability.

Prostate cancer is a significant health concern, with an estimated 1.5 million new cases in 2024, making it one of the most common malignancies among men. The approval of ICP-B381 marks an important step for InnoCare in advancing its proprietary ADC platform and addressing the unmet medical needs of patients globally. Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, stated, "The IND approval of ICP-B381, our first bispecific ADC, is a significant milestone for our proprietary ADC platform and reflects the progress we have made in building differentiated ADC candidates."

ICP-B381 builds on InnoCare's existing pipeline, which includes three approved drugs and over ten innovative drug candidates in clinical development. The company has established comprehensive innovation platforms for drug discovery, with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. ICP-B381's approval is particularly significant given that no bispecific ADC targeting both PSMA and steap1 has been approved for marketing globally.

InnoCare's focus on developing innovative treatments for cancers and autoimmune diseases underscores its commitment to advancing medical research and improving patient outcomes. The company's next steps will involve advancing ICP-B381 into clinical trials, with the goal of bringing a potentially transformative therapy to patients suffering from prostate cancer and other solid tumors.