Henlius HLX37 bispecific antibody approved for solid tumor trial

Shanghai Henlius Biotech, Inc. announced today that its investigational new drug (IND) application for HLX37 has been approved by the National Medical Products Administration (NMPA) for a phase 1 clinical trial. HLX37 is a recombinant humanized anti-PD-L1 and anti-VEGF bispecific antibody developed by the company for the treatment of patients with advanced/metastatic solid tumors.

HLX37's mechanism of action involves simultaneously blocking both PD-1/PD-L1 binding, to restore T-cell activity, and the angiogenesis pathway by inhibiting VEGF, thereby limiting tumor growth and metastasis. Pre-clinical studies have demonstrated the antibody's ability to inhibit tumor growth with a favorable safety profile.

According to IQVIA MIDAS data, worldwide sales volume for bispecific antibodies targeting PD-1/PD-L1 and VEGF in 2024 was approximately $0.92 million, with the first product approved in May 2024. The company cautions shareholders and potential investors that there is no guarantee of successful development and commercialization of HLX37.