Fosun Pharma (SHA: 600196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) unveiled the final Phase III ASTRUM‑002 data at the 2025 European Society for Medical Oncology (ESMO) Congress. The results confirm that Hetronifly (Serplulimab), an independently developed anti‑PD‑1 monoclonal antibody, achieves a median overall survival (mOS) of 26.8 months when combined with chemotherapy for first‑line treatment of advanced non‑squamous non‑small‑cell lung cancer (nsq‑NSCLC), surpassing the two‑year survival threshold.
Key Highlights
- Phase III Final Analysis – Presented as a Late‑Breaking Abstract (LBA) with the first oral presentation of OS data.
- Median OS – 26.8 months for Serplulimab + chemo vs. 18.0 months for standard chemotherapy (HR = 0.67; 95 % CI 0.52‑0.85; P < 0.001).
- Survival Benefit – 44 % reduction in risk of death over the study period.
- Regulatory Status – Approved in China for first‑line chemo combinations in sq‑NSCLC, ES‑SCLC, ESCC, and nsq‑NSCLC.
About Hetronifly (Serplulimab)
- Independent Development – First‑in‑class anti‑PD‑1 antibody from Henlius.
- Mechanism – Blocks PD‑1/PD‑L1 interaction, reactivating T‑cell mediated tumor killing.
- Global Pipeline – Under investigation in multiple tumor types, including colorectal, gastric, and head‑and‑neck cancers.
Implications for Oncology Practice
- Extended Survival – Provides clinicians with a robust first‑line option for advanced nsq‑NSCLC.
- Patient Benefit – 26.8‑month OS represents a meaningful improvement over existing chemo‑only regimens.
- Strategic Positioning – Reinforces Henlius’s portfolio in the highly competitive lung‑cancer immunotherapy arena.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
