Shanghai Henlius Biotech, Inc. (HENLIUS) announced that the National Medical Products Administration has cleared the investigational new drug (IND) application to initiate mainland China trials of HLX43—an antibody-drug conjugate (ADC) targeting PD-L1—in combination with bevacizumab with or without chemotherapy for patients with advanced or metastatic solid tumours.\n\nHLX43 couples a HENLIUS-developed anti-PD-L1 monoclonal antibody with a licensed DNA topoisomerase I inhibitor payload via a peptide linker. The molecule is already under evaluation across a broad clinical programme:\n• Phase 1 monotherapy study in mainland China;\n• International Phase 1 thymic carcinoma cohort spanning Japan and the United States;\n• Global Phase 2 trial in advanced non-small-cell lung cancer (NSCLC) across China, the US, Australia, Japan and the EU;\n• Multiple Phase 2 studies in metastatic colorectal cancer, cervical cancer and oesophageal squamous cell carcinoma in China; and\n• Combination studies with HANSIZHUANG (anti-PD-1) and HLX07 (anti-EGFR) in colorectal and squamous NSCLC.\n\nThe latest ASCO 2026 presentation pooled data from 205 heavily pre-treated NSCLC patients enrolled in the first-in-human Phase 1 and global Phase 2 studies. Key blinded independent central review (BICR) outcomes included:\n• EGFR wild-type nonsquamous NSCLC at 2.5 mg/kg (n = 19): confirmed objective response rate (cORR) 36.8%, confirmed disease control rate (cDCR) 94.7%, median progression-free survival (mPFS) 6.67 months.\n• Squamous NSCLC post-docetaxel at 2 mg/kg (n = 33): cORR 33.3%, mPFS 6.34 months; third-line or later subgroup (n = 15): cORR 46.7%, cDCR 80.0%, mPFS 6.90 months.\n• PD-L1-positive tumours (n = 29) vs. PD-L1-negative/unevaluable (n = 39): cORR 37.9% vs. 33.3%; mPFS 6.80 vs. 5.49 months, indicating activity irrespective of PD-L1 status. Safety remained consistent across doses and populations.\n\nNo comparable HLX43 + bevacizumab regimen has received marketing approval worldwide, underscoring the novelty of the upcoming study.\n\nHENLIUS cautions that successful development and commercialisation of HLX43 are not guaranteed and advises investors to exercise prudence when dealing in the company’s shares.
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