Shanghai Henlius Biotech (2696) Obtains NMPA Approval for HLX43 Combination Therapy Trial in Advanced Solid Tumors

Bulletin Express01-27

Shanghai Henlius Biotech, Inc. (2696) announced that the National Medical Products Administration has approved a clinical trial application for HLX43 (an anti-PD-L1 antibody-drug conjugate) in combination with HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) and HANSIZHUANG (serplulimab injection). The trial targets advanced solid tumors in Chinese Mainland. According to the announcement, the company intends to begin relevant clinical trials once conditions permit.

HLX43 has shown encouraging data in previous trials. In phase 1 studies, HLX43 demonstrated a 37.0% objective response rate (ORR) and 87.0% disease control rate (DCR) among non-small cell lung cancer patients who had progressed on prior therapies. Phase 2 results in advanced cervical cancer revealed a 41.4% ORR in the overall population and 70% at the 3.0 mg/kg dose, while a separate phase 2 study in esophageal squamous cell carcinoma reported a 30.3% ORR overall and 61.5% at the 3.0 mg/kg dose. HLX07 is intended for advanced solid tumors and has shown safety and tolerability in early clinical research. HANSIZHUANG, an anti-PD-1 therapy, has gained approval in multiple regions for several indications, including lung and esophageal cancers. Currently, no similar combination therapy has received marketing approval worldwide, and shareholders and potential investors are advised to exercise caution in related dealings.

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