Serplulimab
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.
ASTRUM-005: OS 15.4 vs 10.9 months with carboplatin-etoposide. Approved in China (2022, first PD-1 for ES-SCLC), EU (2025), UK, India, Korea. US bridging trial versus atezolizumab (ASTRIDE) fully enrolled; FDA decision pending. Henlius, with Accord in Europe.
1.Binds PD-1 on exhausted T cells
- Route
- Intravenous
- Schedule
- 4.5 mg/kg every 3 weeks with carboplatin-etoposide, then maintenance until progression or 2 years
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
- Commercial insurance
- unknown
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.
- Notes
- MHRA-licensed 2025 for extensive-stage SCLC; NICE position not yet researched.
Sources: NICE search: serplulimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2022 | First-line ES-SCLC with chemotherapy |
| EU | 2025 | First-line ES-SCLC with carboplatin-etoposide |
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
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