By Fineline Cube 
Shanghai Henlius Biotech Inc. (HKG: 2696) today announced that its phase 3, randomized, double‑blind, multi‑center study of serplulimab (HANSIZHUANG) plus standard SOX chemotherapy has met the primary endpoint of event‑free survival (EFS) at a planned interim analysis, as confirmed by the Independent Data Monitoring Committee (IDMC). The data support an early New Drug Application (NDA) submission for serplulimab in the adjuvant setting for early‑stage gastric cancer.
Clinical Highlights
- Primary Endpoint Met – In the interim analysis, serplulimab + SOX achieved a statistically significant improvement in EFS versus placebo + SOX, satisfying the pre‑defined efficacy criteria set by the IDMC.
- Pathologic Complete Response (pCR) – The pCR rate in the serplulimab arm exceeded that of the control group by over threefold, translating into a markedly lower risk of recurrence.
- Safety Profile – No new safety signals were observed; the adverse event profile was consistent with that seen in serplulimab’s approved indications for squamous non‑small‑cell lung cancer and other solid tumors.
Strategic Implications
- Regulatory Momentum – The early positive data position Henlius to file an expedited NDA in China, potentially accelerating patient access to a novel immunotherapy for gastric cancer.
- Portfolio Expansion – Serplulimab’s success in a new therapeutic area strengthens Henlius’s pipeline and underscores the versatility of its anti‑PD‑1 platform.
- Market Opportunity – With gastric cancer remaining a leading cause of cancer mortality worldwide, an effective adjuvant therapy could capture a significant share of a high‑growth market.-Fineline Info & Tech