Drug Type Monoclonal antibody |
Synonyms Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG + [11] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (22 Mar 2022), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Switzerland), Breakthrough Therapy (China), Orphan Drug (Mexico), Priority Review (China) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Serplulimab | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Small Cell Lung Cancer | South Korea | 01 Jul 2026 | |
| PD-L1 positive Stomach Cancer | China | 03 Jun 2026 | |
| Locally Advanced Lung Non-Small Cell Carcinoma | European Union | 13 May 2026 | |
| Locally Advanced Lung Non-Small Cell Carcinoma | Iceland | 13 May 2026 | |
| Locally Advanced Lung Non-Small Cell Carcinoma | Liechtenstein | 13 May 2026 | |
| Locally Advanced Lung Non-Small Cell Carcinoma | Norway | 13 May 2026 | |
| metastatic non-small cell lung cancer | European Union | 13 May 2026 | |
| metastatic non-small cell lung cancer | Iceland | 13 May 2026 | |
| metastatic non-small cell lung cancer | Liechtenstein | 13 May 2026 | |
| metastatic non-small cell lung cancer | Norway | 13 May 2026 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | European Union | 10 May 2026 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Iceland | 10 May 2026 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Liechtenstein | 10 May 2026 | |
| Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Norway | 10 May 2026 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | European Union | 10 May 2026 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Iceland | 10 May 2026 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Liechtenstein | 10 May 2026 | |
| Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Norway | 10 May 2026 | |
| PD-L1 positive Esophageal Squamous Cell Carcinoma | European Union | 10 May 2026 | |
| PD-L1 positive Esophageal Squamous Cell Carcinoma | Iceland | 10 May 2026 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Non-Small Cell Lung Cancer | NDA/BLA | European Union | 26 Mar 2026 | |
| Esophageal Carcinoma | NDA/BLA | China | 26 Aug 2022 | |
| MSS/MSI-L/pMMR cancer | NDA/BLA | China | 23 Apr 2021 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | China | 31 Dec 2025 | |
| Metastatic Colorectal Carcinoma | Phase 3 | China | 30 Jan 2023 | |
| Stomach Cancer | Phase 3 | China | 30 Jan 2023 | |
| Advanced Cervical Carcinoma | Phase 3 | China | 30 Sep 2022 | |
| Small cell lung cancer limited stage | Phase 3 | United States | 17 May 2022 | |
| Small cell lung cancer limited stage | Phase 3 | China | 17 May 2022 | |
| Small cell lung cancer limited stage | Phase 3 | Austria | 17 May 2022 |
Phase 3 | Extensive stage Small Cell Lung Cancer First line | 585 | Serplulimab+Chemotherapy | nkoavtaosg(qkpfjpymuc) = zilxvfhltm eudqbfeher (ytaksebmzu ) View more | Positive | 04 Jun 2026 | |
Placebo+Chemotherapy | nkoavtaosg(qkpfjpymuc) = njymkxowsa eudqbfeher (ytaksebmzu ) View more | ||||||
Phase 2 | 51 | Serplulimab plus nab-paclitaxel and SOX | upttfniecw(ainunvjkeq) = cttskhvxry ibszpghdxf (subovspuky ) View more | Positive | 29 May 2026 | ||
Placebo plus nab-paclitaxel and SOX | upttfniecw(ainunvjkeq) = fuobrvtzyv ibszpghdxf (subovspuky ) View more | ||||||
Phase 2 | 101 | Serplulimab + nab-paclitaxel + epirubicin | ornxeyhjox(qphrbjamyj) = qcoovcnoyy vrwoexznmv (sdazjdyrzn, 15.3 - 32.4) View more | Positive | 29 May 2026 | ||
Serplulimab + nab-paclitaxel + epirubicin (PD-L1 positive) | ornxeyhjox(qphrbjamyj) = yoaeaveewr vrwoexznmv (sdazjdyrzn, 30.0 - 59.9) | ||||||
Phase 3 | 588 | Serplulimab plus chemo | annfxequcw(fivyucubeh) = kyhshwcbom mlxouktnnu (xjdgwnttce, 43.0 - NE) View more | Positive | 29 May 2026 | ||
Placebo plus chemo | annfxequcw(fivyucubeh) = zakexyifko mlxouktnnu (xjdgwnttce, 20.5 - NE) View more | ||||||
Phase 2 | 107 | Immunotherapy combined with SCRT and CAPOX chemotherapy | kgmnsemukx(xxvqfobzqf) = gvnazbtuvg luwyxjuwui (nqxavokzse ) View more | Positive | 29 May 2026 | ||
Chemotherapy alone (CAPOX) | kgmnsemukx(xxvqfobzqf) = wmlnhgxtve luwyxjuwui (nqxavokzse ) View more | ||||||
Phase 2 | Small cell lung cancer limited stage Consolidation | 296 | uhirghbslr(jyuelamqnq) = hhnxhitsbb wtepoghwvb (jmuqtpfzxc ) View more | Positive | 25 Mar 2026 | ||
Hypo-cCRT alone | - | ||||||
Not Applicable | Non-small cell lung cancer stage IIIB Neoadjuvant | 82 | Serplulimab plus platinum-doublet chemotherapy | uptzftkfol(fwzwntthqw) = ifsbblilpx pzpstvjbae (izgiceojcv ) View more | Positive | 25 Mar 2026 | |
Not Applicable | Squamous non-small cell lung cancer First line | 132 | Serplulimab plus platinum-based therapy | qxcyikhaml(aikkgagkuu) = ouljpwreie cjsqkrpsto (jueiqnxlsu ) View more | Positive | 25 Mar 2026 | |
Serplulimab plus platinum-based therapy | duhnhvtofd(mgoblashyv) = jqkjckqvvs lesxuremum (gofcavuuru ) | ||||||
Phase 2 | Locally Advanced Gastric Adenocarcinoma Neoadjuvant | 30 | fkxvlwputw(vomqopbvdb) = bncjuhjovt nqtvccojuh (octxddrvfd ) View more | Positive | 26 Feb 2026 | ||
Phase 2 | 28 | mFOLFOX6 +serplulimab | fgwyhcodbf(vpuqhfjnpl) = pmwakdjhrv kncrsfbptp (yfzfadqsck ) View more | Positive | 12 Jan 2026 | ||
mFOLFOX6 +serplulimab (high LARC (>10 cm from anal verge, ineligible for nCRT)) | fgwyhcodbf(vpuqhfjnpl) = otsdxgfqio kncrsfbptp (yfzfadqsck ) View more |






