Shanghai Henlius Biotech, Inc. (HKG: 2696) announced first patient dosing in a Phase Ib/II clinical study evaluating HLX43, a PD-L1-targeting antibody-drug conjugate (ADC), in combination with HLX07 (anti-EGFR mAb) or HanSiZhuang (serplulimab, PD-1 mAb) for advanced or metastatic colorectal cancer (CRC). The trial marks Henlius’s entry into ADC-based immuno-oncology combinations, leveraging its self-developed antibody platforms and licensed toxin-linker technology.
T-DXd (Enhertu), sacituzumab govitecan (Trodelvy) lead in solid tumors; HLX43 PD-L1 targeting offers differentiation vs. HER2/TROP2 ADCs
China CRC Market
>380,000 new cases annually; limited targeted therapy options beyond anti-EGFR (RAS wild-type); significant unmet need in RAS-mutant population
Global Potential
MSS CRC represents largest immunotherapy-resistant population globally; China-first data supports US/EU partnership discussions
Forward‑Looking Statements This brief contains forward‑looking statements regarding HLX43 clinical development in colorectal cancer, combination therapy efficacy in MSS tumors, and Henlius Biotech’s ADC platform validation. Actual results may differ due to Phase Ib/II safety outcomes, competitive dynamics with established ADCs, and biomarker discovery success.-Fineline Info & Tech
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