Shanghai Henlius Biotech, Inc. (HENLIUS, 02696.HK) disclosed that China’s National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application to initiate a Phase 1 clinical trial evaluating the recombinant humanised anti-PD-L1/anti-VEGF bispecific antibody HLX37 in combination with either standard chemotherapy or HLX43, an anti-PD-L1 antibody-drug conjugate (ADC), for patients with advanced or metastatic solid tumours.
HLX37, developed in-house by HENLIUS, simultaneously targets the PD-L1 and VEGF pathways, aiming to restore T-cell–mediated anti-tumour activity while inhibiting tumour angiogenesis. Pre-clinical data demonstrated tumour-growth inhibition and a favourable safety profile. An earlier IND for HLX37 monotherapy in advanced solid tumours was cleared in November 2025, with first-patient dosing achieved in December 2025.
HLX43 couples a HENLIUS-generated anti-PD-L1 antibody with a novel DNA topoisomerase I inhibitor payload. The ADC is already undergoing multiple clinical evaluations, including: • Phase 1 trials for advanced/metastatic solid tumours in mainland China, Japan and the United States. • A multinational Phase 2 study in advanced non-small cell lung cancer. • Additional Phase 2 trials in metastatic colorectal cancer, cervical cancer and oesophageal squamous cell carcinoma in mainland China. • Combination studies with HANSIZHUANG (anti-PD-1 mAb) and HLX07 (anti-EGFR mAb) across colorectal and lung cancer cohorts.
The newly approved study will be conducted in mainland China once operational prerequisites are met. According to HENLIUS, no comparable therapeutic combination—pairing a PD-L1/VEGF bispecific antibody with chemotherapy or an anti-PD-L1 ADC—has yet received marketing authorisation worldwide.
Management reiterated that successful development and commercialisation of HLX37 and HLX43 remain uncertain, in line with Listing Rule 18A.05 disclosure requirements. Investors are advised to exercise caution when dealing in the company’s shares.
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