NMPA approves IND for a Ph 1b/2 Clinical Trial of PD-L1-Targeting ADC HLX43
“Shanghai Henlius Biotech, Inc. 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, has been approved by the China National Medical Products Administration (NMPA), for monotherapy or combination therapy to treat patients with advanced/metastatic solid tumours. In November 2023, a phase 1 clinical trial of HLX43 has completed dosing its first subject, making it the first PD-L1-targeting ADC in China to enter a clinical trial. At present, no PD-L1 targeting ADC has been approved for marketing globally.”
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