Henlius(02696.HK):Phase 2 Clinical Trial of HLX43 Combined with Serplulimab for Neoadjuvant Treatment of NSCLC Approved in Australia

NewTimeSpace · 2026/06/16 17:19 · By Zeyu Wu

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) announced that the Phase 2 clinical trial of HLX43 for Injection, a PD-L1-targeted antibody-drug conjugate (ADC), in combination with Hansizhu® (serplulimab injection) for neoadjuvant therapy of non-small cell lung cancer (NSCLC), has obtained approval from the relevant Human Research Ethics Committee (HREC) of Australia and completed Clinical Trial Notification (CTN) filing with the Therapeutic Goods Administration (TGA). Previously, key subgroup data of HLX43 in NSCLC were presented as a rapid oral abstract at the 2026 ASCO Annual Meeting.

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) released a voluntary announcement on 16 June 2026, disclosing that its Phase 2 clinical trial evaluating HLX43 combined with Hansizhu^® for neoadjuvant treatment of NSCLC has been approved for conduct in Australia.

HLX43 is an ADC developed by conjugating an in-licensed novel small-molecule payload of DNA topoisomerase I inhibitor with the Company’s self-developed PD-L1-targeted monoclonal antibody. Hansizhu^® is an innovative anti-PD-1 monoclonal antibody independently developed by the Company, which has been approved for marketing in China, the European Union, the United Kingdom, Southeast Asia and multiple other regions.

Earlier, key subgroup clinical data of HLX43 for the treatment of non-small cell lung cancer were released via a rapid oral abstract presentation at the 2026 ASCO Annual Meeting. As of 28 February 2026, a total of 205 patients with advanced NSCLC were enrolled in the study (99% had prior platinum-based chemotherapy, and 82% received prior immunotherapy). Among patients with EGFR wild-type non-squamous NSCLC, the confirmed objective response rate (ORR) reached 36.8%, with a median progression-free survival (mPFS) of 6.67 months. For squamous NSCLC patients who progressed after prior docetaxel treatment, the confirmed ORR stood at 33.3% and mPFS hit 6.34 months. HLX43 demonstrated a consistent and manageable safety profile across the overall population.

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HENLIUS 02696.HK HLX43 Clinical Trial