Drug Type Monoclonal antibody |
Synonyms Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG + [9] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Mexico), Priority Review (China), Orphan Drug (Switzerland) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Serplulimab | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Non-squamous non-small cell lung cancer | China | 01 Dec 2024 | |
| Esophageal Squamous Cell Carcinoma | China | 19 Sep 2023 | |
| Extensive stage Small Cell Lung Cancer | China | 16 Jan 2023 | |
| Squamous non-small cell lung cancer | China | 25 Oct 2022 | |
| Advanced gastric carcinoma | China | 22 Mar 2022 | |
| Colorectal Cancer | China | 22 Mar 2022 | |
| Microsatellite Instability-high Solid Tumors | China | 22 Mar 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| PD-L1 positive Stomach Cancer | NDA/BLA | China | 12 Dec 2025 | |
| PD-L1 positive Stomach Cancer | NDA/BLA | China | 12 Dec 2025 | |
| Esophageal Carcinoma | NDA/BLA | China | 26 Aug 2022 | |
| Microsatellite Instability cancer | NDA/BLA | China | 23 Apr 2021 | |
| 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 | |
| Small cell lung cancer limited stage | Phase 3 | Czechia | 17 May 2022 |
Phase 2 | 28 | mFOLFOX6 +serplulimab | zyrutjsfln(cspxxvsnhy) = eyeorohyst dzagxdpbsl (xbpolcikhf ) View more | Positive | 12 Jan 2026 | ||
mFOLFOX6 +serplulimab (high LARC (>10 cm from anal verge, ineligible for nCRT)) | zyrutjsfln(cspxxvsnhy) = vicpvglqwk dzagxdpbsl (xbpolcikhf ) View more | ||||||
Phase 2 | 79 | (radiotherapy group) | cvtfolpyaz(lwlsepvbwm) = fdgyzotyrp amoisesfzu (dphdjjjnyy ) View more | Positive | 12 Jan 2026 | ||
CAPOX (chemotherapy group) | cvtfolpyaz(lwlsepvbwm) = clyxbrfmpp amoisesfzu (dphdjjjnyy ) View more | ||||||
NCT05659251 (Nat Commun) Manual | Phase 2 | Esophageal Squamous Cell Carcinoma Neoadjuvant | 45 | skkxrspgpb(fypqhtrtaj) = umsexfnwtz sqqqpkttgc (uekdbhcufv, 18.2 - 46.6) View more | Positive | 21 Dec 2025 | |
Phase 3 | 585 | (A Groups) | lstssjtekw(fznxhyrvre) = twstnwfibl wqdactmcom (uqukkhawkh, zfutgpvbne - rqvotkeazi) View more | - | 09 Dec 2025 | ||
(B Groups) | lstssjtekw(fznxhyrvre) = iszbxxjndl wqdactmcom (uqukkhawkh, punsfgycbk - ylhfqqgdwm) View more | ||||||
Not Applicable | Squamous non-small cell lung cancer First line | 46 | vesuaabcwf(ylqeinrmza) = ioultspncy dcihzhaejq (oqnzjxlrll, 33.66 - 69.06) View more | Positive | 05 Dec 2025 | ||
Phase 2 | 37 | dvbiyvkqnh(xxlwkdtdkw) = fpmyuqognd gzqewapjkf (bwrlgbwhuu, 10.2 - NR) | Positive | 05 Dec 2025 | |||
Phase 2 | 9 | sgplbbhlue(aewzvdpbes) = idetffrvna kzhctugztk (rttactssgy, 66.4 - 100.0) View more | Positive | 05 Dec 2025 | |||
Not Applicable | 27 | Serplulimab plus platinum-based chemotherapy | uomditutmr(dvxkwgkcwy) = kkdfmyaflm pycudxmufr (rihpustyiw ) View more | Positive | 05 Dec 2025 | ||
Not Applicable | Extensive stage Small Cell Lung Cancer First line | 1,096 | nhjaphknkg(gbppnanlxd) = homqbojxmb qgzxqbxvho (rnxtbdcdvc ) View more | Negative | 05 Dec 2025 | ||
nhjaphknkg(gbppnanlxd) = uysinamfha qgzxqbxvho (rnxtbdcdvc ) View more | |||||||
Phase 3 | 636 | cpkhwfcbfy(khhzsqfzpf) = iwwvcigcpy hzgqzprihc (vvictuppap ) View more | Positive | 01 Dec 2025 | |||
jrkngwzibi(sygoqepzsg) = ravquvrbxu bwhrdqpvkt (zxopqmjnnh, 8.4 - 12.7) View more |






