Henlius(02696.HK): HLX3902 Injection (STEAP1xCD3xCD28 Trispecific Antibody) Gets NMPA Approval for Phase I Clinical Trial in Metastatic Castration-Resistant Prostate Cancer
NewTimeSpace News: On 17 June 2026, Shanghai Henlius Biotech, Ltd. (02696.HK) released a voluntary announcement. The Investigational New Drug (IND) application for HLX3902 Injection, an in-house developed STEAP1xCD3xCD28 trispecific antibody, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors has been approved by the National Medical Products Administration (NMPA).
HLX3902 is an innovative trispecific T-cell engager independently developed by the Company, capable of binding three targets: STEAP1, CD3 and CD28 simultaneously. It delivers both primary activating signal via CD3 and co-stimulatory signal via CD28 to T cells, strengthening T-cell lysis capacity against STEAP1-positive tumor cells, optimizing T-cell activation signaling, and elevating T-cell activation, proliferation and persistence to sustain anti-tumor responses. Preclinical data validated robust anti-tumor activity and a well-tolerated safety profile.
Back in May 2026, the same Phase I trial secured ethics committee approval and completed Clinical Trial Notification registration with Australia’s Therapeutic Goods Administration (TGA), paving the way for overseas clinical research parallel to domestic trials.
As of the date of the announcement, no trispecific antibodies targeting STEAP1, CD3 and CD28 have been approved for marketing worldwide. The Company reminds investors that it cannot guarantee the successful clinical development and subsequent commercialization of HLX3902, and clinical development risks remain.
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