NMPA Approves IND for HLX43 in Combination with Serplulimab
“Shanghai Henlius Biotech announced that the investigational new drug (IND) application for a phase 1b/2 clinical trial of HLX43 for Injection, the antibody-drug conjugate (ADC) product that developed by the company based on the collaboration with MediLink Therapeutics, in combination with the company’s independently developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced/metastatic solid tumours. In December 2024, a phase 1b/2 clinical trial of HLX43 has been approved by the NMPA for monotherapy or combination therapy to treat patients with advanced/metastatic solid tumours. At present, no PD-L1 targeting ADC has been approved for marketing globally.”
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