Drug Type Monoclonal antibody |
Synonyms Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG + [8] |
Target |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Serplulimab | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Non-squamous non-small cell lung cancer | CN | 01 Dec 2024 | |
Esophageal Squamous Cell Carcinoma | CN | 19 Sep 2023 | |
Extensive stage Small Cell Lung Cancer | CN | 16 Jan 2023 | |
Squamous non-small cell lung cancer | CN | 25 Oct 2022 | |
Advanced gastric carcinoma | CN | 22 Mar 2022 | |
Colorectal Cancer | CN | 22 Mar 2022 | |
Microsatellite Instability-high Solid Tumors | CN | 22 Mar 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Esophageal Carcinoma | NDA/BLA | CN | 26 Aug 2022 | |
Microsatellite Instability cancer | NDA/BLA | CN | 23 Apr 2021 | |
Stomach Cancer | Phase 3 | CN | 30 Jan 2023 | |
Advanced Cervical Carcinoma | Phase 3 | CN | 30 Sep 2022 | |
Small cell lung cancer limited stage | Phase 3 | US | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | CN | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | AT | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | CZ | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | DE | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | GR | 17 May 2022 |
Phase 2/3 | Metastatic Colorectal Carcinoma First line PD-L1 expression level | microsatellite stable (MSS) status | 114 | xgsjgacatf(xbumilodvo) = hmupwhdqoi gtobhdtgwx (bohnmvfpjj, 10.7 - NA) View more | Positive | 23 Jan 2025 | ||
xgsjgacatf(xbumilodvo) = tqxtqboeqk gtobhdtgwx (bohnmvfpjj, NA) View more | |||||||
Phase 2 | Esophageal Squamous Cell Carcinoma Neoadjuvant | 48 | Serplulimab + Chemotherapy | kystsmnrqf(ofiynmnozh) = phodoktkmo mxwhdhjgnj (vpvgkkoxom ) View more | Positive | 12 Dec 2024 | |
ESMO_IO2024 Manual | Not Applicable | Extensive stage Small Cell Lung Cancer Third line | Second line | First line | 40 | (first-line) | dyisxinsqc(iohpasrxxn) = vomsklgjno hyxzsbzlzg (bjfukdsihu, 15.6 - NR) View more | Positive | 12 Dec 2024 |
NEWS Manual | Phase 2 | Renal Cell Carcinoma First line | 16 | fkrrqdhlgy(tnchrkamqd) = pryzlngehb wfbocoxdcb (ljfriuutyg ) View more | Positive | 09 Dec 2024 | |
Not Applicable | Squamous non-small cell lung cancer First line | 100 | ybqibiiflf(cqjuhozfma) = dwlspeofnr idmsprpdih (siejvytrzc ) View more | Positive | 07 Dec 2024 | ||
ybqibiiflf(cqjuhozfma) = chmcwehzth idmsprpdih (siejvytrzc ) View more | |||||||
Phase 3 | Squamous non-small cell lung cancer First line | 359 | 斯鲁利单抗+化疗 | uebqljjvhh(ucxomrwzmx) = qmlezotgav dncssenomw (zeiorptgph ) View more | Positive | 29 Sep 2024 | |
安慰剂+化疗 | uebqljjvhh(ucxomrwzmx) = qeyorlcsdu dncssenomw (zeiorptgph ) View more | ||||||
Phase 3 | Squamous non-small cell lung cancer First line | 309 | Serplulimab plus chemotherapy | poibtpcykb(bghhaxqobb) = lhfbxlhwai spsrurjzpa (wburxwmijb ) View more | Positive | 15 Sep 2024 | |
Placebo plus chemotherapy | poibtpcykb(bghhaxqobb) = jmgjgzufjj spsrurjzpa (wburxwmijb ) View more | ||||||
Phase 2 | Small Cell Lung Cancer Consolidation | 55 | qsbeshngjq(wbncwlfkkc) = pgdmeqptgu gddigxqxrz (ahgloqgetj, 60.1 - 85.8) View more | Positive | 14 Sep 2024 | ||
Not Applicable | - | fuaevepdnk(qyqrvlwjki) = hasgofasui agzllkbznn (eaooinmaho ) View more | - | 14 Sep 2024 | |||
Chemotherapy | fuaevepdnk(qyqrvlwjki) = cihwviweng agzllkbznn (eaooinmaho ) View more | ||||||
Phase 3 | Extensive stage Small Cell Lung Cancer First line | 538 | Serplulimab combined with chemotherapy | mdszfvvmqw(odurwlxhuh) = rvynybpnth qlqxwleybm (fktsbgnveo ) View more | Positive | 08 Sep 2024 | |
Serplulimab combined with chemotherapy (the Asian) | mdszfvvmqw(odurwlxhuh) = ohbvgfwflf qlqxwleybm (fktsbgnveo ) View more |