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Serplulimab is a Chinese PD-1 antibody with the largest survival gain of any first-line small-cell lung cancer immunotherapy trial, approved in China, Europe, and the UK but not yet the US.
Serplulimab is a humanised IgG4 antibody against PD-1, given at 4.5 mg/kg every 3 weeks with carboplatin-etoposide and then as maintenance for up to 2 years. In ASTRUM-005 it produced OS 15.4 versus 10.9 months (HR 0.63) in extensive-stage SCLC, the largest survival gain among the first-line chemo-immunotherapy trials. It is approved in China (2022, the first PD-1 antibody for ES-SCLC), the EU (2025), the UK, India and Korea; Henlius develops it with Accord in Europe. In the US a bridging trial versus atezolizumab (ASTRIDE) has fully enrolled and the FDA decision is pending. Immune-related adverse events occurred in 37% of patients, with hypothyroidism in 12% and pneumonitis in 4%. It is a PD-1 drug whose data match or exceed the established Western options, but whose reach still depends on regulators outside China.
Humanised IgG4 anti-PD-1. Connects to PD-1.
1.Binds PD-1 on exhausted T cells
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE TA1167. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| China | 2022 | First-line ES-SCLC with chemotherapy |
| EU | 2025 | First-line ES-SCLC with carboplatin-etoposide |
| England (NICE) | 2026 | Untreated extensive-stage small-cell lung cancer, with carboplatin and etoposide · TA1167, published 18 June 2026 (ASTRUM-005); must be funded in England within 90 days of publication. |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Immune-related adverse events (any) | 37% | - |
| Hypothyroidism | 12% | - |
| Pneumonitis | 4% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Serplulimab" OR ABSTRACT:"Serplulimab" OR TITLE:"Hansizhuang" OR ABSTRACT:"Hansizhuang" OR TITLE:"Hetronifly" OR ABSTRACT:"Hetronifly" OR TITLE:"HLX10" OR ABSTRACT:"HLX10") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Serplulimab, not a curated reading list.
Shares Jilin Cancer Hospital, Ying Cheng, ASTRUM-005, Small-cell lung cancer.
Shares ASTRUM-005, Limited-stage vs extensive-stage (small-cell lung cancer), Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage, Ying Cheng, Limited-stage vs extensive-stage (small-cell lung cancer), Small cell lung cancer (KEGG map).