InnoCare announced approval in China to initiate clinical trials of ICP-B381, a novel PSMA/STEAP1-targeting bispecific ADC

CAR-T Digest - August 2020

09 September 2026: InnoCare announced approval in China to initiate clinical trials of ICP-B381, a novel PSMA/STEAP1-targeting bispecific ADC

InnoCare Pharma announced that China’s NMPA has approved the clinical trial application for ICP-B381, a novel bispecific ADC targeting PSMA and STEAP1 for the treatment of solid tumors, including prostate cancer, marking the company’s first bispecific ADC to enter clinical development
The NMPA clearance enables InnoCare to initiate clinical development of ICP-B381, with first-in-human studies planned to evaluate its safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with advanced solid tumors
The program addresses a key challenge in solid tumors, particularly prostate cancer, where tumor heterogeneity and loss or variable expression of a single antigen can limit the durability of targeted therapies, creating a need for approaches that can address heterogeneous tumor cell populations

ICP-B381 is a PSMA/STEAP1 bispecific ADC incorporating a humanized bispecific antibody that simultaneously targets PSMA and STEAP1, with an internally developed linker and cytotoxic payload designed to enable dual-antigen targeting and reduce the risk of tumor escape
Strategically, the IND approval marks an important milestone for InnoCare’s proprietary ADC platform, advancing its first bispecific ADC into the clinic and expanding the company’s ADC pipeline into next-generation dual-targeting approaches for prostate cancer and other solid tumors

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