{"entity":{"id":"serplulimab","kind":"drug","name":"Serplulimab","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Serplulimab"},{"label":"NICE TA1167: serplulimab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1167"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":["limited-extensive-stage"],"trials":["astrum-005","nct05353257","nct04547166","nct05468489","nct07253142","nct07269782","nct06848699","nct06349980","nct05787613"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Hansizhuang / Hetronifly","code":"HLX10","modality":"Monoclonal antibody (anti-PD-1)","mechanism":"Humanised IgG4 anti-PD-1.","approvals":[{"region":"China","year":2022,"indication":"First-line ES-SCLC with chemotherapy"},{"region":"EU","year":2025,"indication":"First-line ES-SCLC with carboplatin-etoposide"},{"region":"England (NICE)","year":2026,"indication":"Untreated extensive-stage small-cell lung cancer, with carboplatin and etoposide","note":"TA1167, published 18 June 2026 (ASTRUM-005); must be funded in England within 90 days of publication."}],"mechanismSteps":["Binds PD-1 on exhausted T cells","Blocks PD-L1/PD-L2 engagement","Restores cytotoxic T-cell function against antigens released by chemotherapy"],"dosing":{"route":"Intravenous","schedule":"4.5 mg/kg every 3 weeks with carboplatin-etoposide, then maintenance until progression or 2 years"},"toxicity":[{"event":"Immune-related adverse events (any)","anyGradePct":37},{"event":"Hypothyroidism","anyGradePct":12},{"event":"Pneumonitis","anyGradePct":4}],"access":[],"regulatoryEvents":[{"date":"2025-02","type":"approval","region":"EU","note":"European Commission approval for ES-SCLC","source":"https://www.henlius.com/en/NewsDetails-5903-26.html"},{"date":"2025","type":"approval","region":"UK","note":"MHRA approval","source":"https://www.henlius.com/en/NewsDetails-5324-26.html"}]},"route":"/drugs/serplulimab/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint 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