Shanghai Henlius Biotech, Inc. (HENLIUS) announced that China’s National Medical Products Administration has cleared a new indication for Hansizhuang (serplulimab injection). The anti-PD-1 antibody, administered with oxaliplatin and S-1 as neoadjuvant therapy and followed by Hansizhuang monotherapy after surgery, is now approved for resectable gastric cancer patients whose tumours exhibit PD-L1 CPS ≥ 5.
The application was supported by a randomised, double-blind, multi-centre Phase 3 trial in which the Hansizhuang-based regimen delivered a statistically significant improvement in event-free survival versus full-course chemotherapy, while also demonstrating a more favourable safety profile.
Hansizhuang is already authorised in mainland China for first-line treatment of squamous and non-squamous non-small cell lung cancer, extensive-stage small cell lung cancer and esophageal squamous cell carcinoma, as well as for perioperative gastric cancer therapy. Outside China, the product holds approvals in the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore and India, and carries orphan-drug status in the US, Switzerland and South Korea.
Ongoing clinical development spans international Phase 2/3 or bridging studies in small cell lung cancer, metastatic colorectal cancer and other solid tumours, with combination regimens that include bevacizumab, HLX07 and HLX43.
IQVIA MIDAS™ data indicate that global sales of PD-1-targeted monoclonal antibodies are projected to reach approximately US$50.87 billion in 2025, underscoring the commercial potential of new indications.
Management highlighted that this is the first globally approved perioperative gastric cancer regimen that substitutes adjuvant chemotherapy with immune monotherapy, a milestone expected to strengthen Hansizhuang’s competitive positioning and expand treatment options for patients in mainland China.
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