HENLIUS (02696.HK): NMPA Approves Phase I Trial for HLX37 (PD-L1/VEGF Bispecific) Plus Chemotherapy or HLX43 (PD-L1 ADC) in Solid Tumours

NewTimeSpace News: On 10 July 2026, HENLIUS (02696.HK) released a voluntary announcement. The application for Phase I clinical trial of self-developed HLX37 (recombinant humanized anti-PD-L1 and anti-VEGF bispecific antibody injection) combined with chemotherapy or HLX43 for injection (PD-L1 targeted antibody-drug conjugate) in the treatment of advanced/metastatic solid tumours has obtained approval from the National Medical Products Administration.

HLX37 is a bispecific antibody co-targeting PD-L1 and VEGF. It simultaneously blocks immune checkpoint and angiogenesis pathways within one molecule to deliver synergistic anti-tumour effects. The monotherapy Phase I trial of HLX37 was approved in November 2025 with first patient dosing completed. HLX43 is a PD-L1 directed ADC. Its monotherapy and combination Phase I/II studies are ongoing across multiple indications including non-small cell lung cancer, colorectal cancer, cervical cancer and oesophageal squamous cell carcinoma, some of which are international multi-centre trials. As at the date of the announcement, no comparable combination therapy has been approved worldwide. The Company reminds investors that successful development and subsequent commercialisation cannot be assured.