NMPA approves IND for HLX48 clinical trial in patients with advanced solid tumors
Shanghai Henlius Biotech, Inc. (2696.HK) announced that its independently developed c-Met/EGFR bispecific antibody–drug conjugate (ADC), HLX48 for injection, has been approved by the National Medical Products Administration (NMPA), for the treatment of advanced and metastatic solid tumors. Recently, it has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). To accelerate the evaluation of HLX48’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 HLX48’s safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
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