Henlius (02696.HK): NMPA Approves Clinical Trial Application for HLX43 Combined with Bevacizumab in Solid Tumors

NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) issued a voluntary announcement on July 31, 2026, disclosing that the NMPA has approved the clinical trial application for HLX43 for Injection, a PD-L1-targeted antibody-drug conjugate, in combination with bevacizumab with or without chemotherapy for the treatment of advanced/metastatic solid tumors. The Company plans to initiate relevant clinical trials in China when conditions permit.

HLX43 is an ADC developed by the Company through the conjugation of a novel DNA topoisomerase I inhibitor small-molecule toxin with its self-developed PD-L1-targeted antibody. The pooled NSCLC analysis previously presented at the ASCO 2026 Annual Meeting showed: in EGFR wild-type non-squamous NSCLC patients (2.5 mg/kg), a confirmed objective response rate (ORR) of 36.8% and a median progression-free survival (PFS) of 6.67 months; in squamous NSCLC patients who had failed docetaxel treatment (2 mg/kg), a confirmed ORR of 33.3% and a median PFS of 6.34 months. HLX43 delivered consistent and robust efficacy regardless of PD-L1 expression levels, with a favorable safety profile. As of the announcement date, no combination therapy regimen of the same class has been approved for marketing globally.

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