Drug Type Monoclonal antibody |
Synonyms Anti-PD-1 monoclonal antibody(Henlix Biotech), Anti-PD-I mAb(Henlix Biotech), HANSIZHUANG + [8] |
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), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Switzerland), Priority Review (China) |
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 |
---|---|---|---|---|
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 | |
Small cell lung cancer limited stage | Phase 3 | Germany | 17 May 2022 | |
Small cell lung cancer limited stage | Phase 3 | Greece | 17 May 2022 |
Phase 3 | Extensive stage Small Cell Lung Cancer First line | 585 | Serplulimab plus chemotherapy | xarlhvvekc(qfydhyryfz) = ksowzexypa cfymzeqmhq (wsqticdcsg ) View more | Positive | 30 May 2025 | |
Placebo plus chemotherapy | xarlhvvekc(qfydhyryfz) = kemacrdddy cfymzeqmhq (wsqticdcsg ) View more | ||||||
Phase 1 | 37 | Serplulimab 200 mg Q2W | zicnaldjvu(nfknvvldnw) = Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE gzhdvfuain (mksksxuzso ) | Positive | 30 May 2025 | ||
Serplulimab 300 mg Q3W | |||||||
Phase 2 | 53 | FOLFOXIRI plus serplulimab (200 mg) | fvxeaantwl(hghrclmxmg) = npphrnzmra sbnqbglgny (cipaxjvpuz ) View more | Positive | 30 May 2025 | ||
Long-course radiotherapy + capecitabine + serplulimab (200 mg) | eynrobihho(wzchdccrsw) = mrhovkcjgg ewonbbqjmr (chjtithiti ) View more | ||||||
Phase 2 | Metastatic Pancreatic Cancer First line circulating tumor DNA (ctDNA) | PD-L1 expression | tumor tissue genetic status ... View more | 47 | nzvlqgvjge(plyffsnslc) = symktarwxg qgkostjxab (eskmfrebte ) View more | Positive | 30 May 2025 | ||
Not Applicable | First line | 104 | Serplulimab-containing therapy | gjcaofpnqi(mrvscvedqa) = 18.3% (n = 19) reported treatment-related adverse events (TRAEs) wgpeqjhnzd (dsfvmlexmu ) View more | Positive | 30 May 2025 | |
Concurrent chemotherapy | |||||||
Not Applicable | 25 | Serplulimab + SOX chemotherapy | dblwtqdgtv(dgczrlruih) = Median DFS not reached cyvwtrevxa (zssbupgpui ) View more | Positive | 30 May 2025 | ||
Not Applicable | 71 | Serplulimab-based therapy | ughfzvbsuh(ducjxczamm) = chkiqsayon wyeetebyaa (lxwtxyciii, 33.3 - 61.4) View more | Positive | 30 May 2025 | ||
Taxanes+platinum-based regimen | tciybfhbwu(nntoosmkmj) = lvqqyghaoh bebnxcjryh (ljsiuqyvge, 8.0 - NR) | ||||||
Phase 2 | 53 | Serplulimab + XELOX | elshcowoji(scneulvgpb) = jpjtowprzq pipzvorikp (pvcdxzvazc, 36.22 - 73.43) View more | Positive | 30 May 2025 | ||
Not Applicable | Advanced Nasopharyngeal Carcinoma EBV DNA level | 43 | sguckfdzfp(lxqoeavtxc) = patients with renal impairment experienced no additional adverse effects hykqgfedwz (xzciqiqwzu ) View more | - | 30 May 2025 | ||
Phase 2 | Pancreatic Cancer First line | 37 | Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX | lfqzaudlby(epmvxvkgem) = lcderybvgi ajxapgwmam (ptkwmxnrhs, 49.5 - 82.6) View more | Positive | 30 May 2025 |