IND application for HLX3902 approved in China for treatment of metastatic CRPC and solid tumors
Shanghai Henlius Biotech, Inc. (2696.HK) announced that its second innovative T cell engager (TCE), HLX3902—a tri-specific antibody targeting STEAP1×CD3×CD28 developed on the company’s proprietary immune cell engager platform, has been approved by the National Medical Products Administration (NMPA), for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumours. Recently, it has also received clinical trial authorization in Australia. To accelerate the evaluation of HLX3902’s preliminary efficacy and safety in humans, the company plans to initiate multi-regional clinical trials (MRCT) simultaneously in China, Australia, and other regions to evaluate HLX3902’s safety, tolerability, and preliminary efficacy in patients with advanced solid tumours，including prostate cancer.
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