Serplulimab
{{Short description|Medication}}
{{Use American English|date=September 2024}}
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| type = mab
| mab_type = mab
| source = zu/o
| target = PD-1
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| tradename = Hetronifly
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| routes_of_administration = Intravenous
| class = Antineoplastic agent
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| ATC_suffix = FF12
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| legal_EU = Rx-only
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| legal_status = CN: Rx-only
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| CAS_number = 2231029-82-4
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| DrugBank = DB17451
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| UNII = S3GQZ2K36V
| KEGG = D12751
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Serplulimab, sold under the brand name Hetronifly, is a monoclonal antibody used for the treatment of cancers.{{cite journal |vauthors=Lee A |date=July 2022 |title=Serplulimab: First Approval |journal=Drugs |volume=82 |issue=10 |pages=1137–1141 |doi=10.1007/s40265-022-01740-0 |pmid=35796953}}
Medical uses
Serplulimab, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer.
Society and culture
= Legal status =
It was approved for medical use in China in 2022, for the treatment of microsatellite instability-high solid tumors and squamous non-small cell lung cancer,{{Cite press release |last=Henlius |title=Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC |url=https://www.prnewswire.com/news-releases/henlius-novel-anti-pd-1-mab-hansizhuang-serplulimab-receives-nmpa-approval-for-the-treatment-of-sqnsclc-301664766.html |access-date=2024-11-14 |website=www.prnewswire.com |language=en}} and in 2023 for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma.{{cite press release | title=Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC-Media | website=Henlius | date=22 September 2023 | url=https://www.henlius.com/en/NewsDetails-4283-26.html | access-date=21 September 2024}}
In December 2023, the Indonesian Food and Drug Authority approved serplulimab for medical use in Indonesia. {{Cite web |date=2024-03-10 |title=Kalbe Luncurkan Serplulimab Untuk Obati Kanker Paru Sel Kecil - WartaTransparansi |url=https://www.wartatransparansi.com/2024/03/10/kalbe-luncurkan-serplulimab-untuk-obati-kanker-paru-sel-kecil.html |access-date=2024-11-14 |website=www.wartatransparansi.com |language=id}}
In September 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hetronifly, intended for the treatment of extensive-stage small cell lung cancer (ES-SCLC). The applicant for this medicinal product is Henlius Europe GmbH.{{cite web | title=Hetronifly EPAR | website=European Medicines Agency (EMA) | date=19 September 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly | access-date=21 September 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Serplulimab was authorized for medical use in the European Union in February 2025.{{cite web | title=Hetronifly PI | website=Union Register of medicinal products | date=6 February 2025 | url=https://ec.europa.eu/health/documents/community-register/html/h1870.htm | access-date=4 March 2025}}
= Names =
Serplulimab is the International nonproprietary name.{{cite journal | vauthors = ((World Health Organization)) | year = 2020 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83 | journal = WHO Drug Information | volume = 34 | issue = 1 | hdl = 10665/339768 | hdl-access = free | author-link = World Health Organization }}
References
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Further reading
- {{cite journal | vauthors = Qin S, Li J, Zhong H, Jin C, Chen L, Yuan X, Fan Q, Chen K, Cao P, Xiao J, Jiang D, Zhang T, Zhang H, Wang X, Wang W, Han L, Wang Q, Zhu J | title = Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial | journal = British Journal of Cancer | volume = 127 | issue = 12 | pages = 2241–2248 | date = December 2022 | pmid = 36261583 | pmc = 9726893 | doi = 10.1038/s41416-022-02001-3 }}
- {{Cite journal |vauthors=Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J |title=Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. |url=https://jamanetwork.com/journals/jama/fullarticle/2796691 |journal=JAMA |date=2022 |volume=328 |issue=12 |pages=1223–1232 |doi=10.1001/jama.2022.16464|pmid=36166026 |pmc=9516323 }}
- {{cite journal | vauthors = Wang ZX, Peng J, Liang X, Cheng Y, Deng Y, Chen K, Zhang M, Zhang J, Wang W, Cao B, Jin Y, Sun M, Lin Y, Luo S, Li Z, Yang L, Ke Y, Yu H, Li J, Wang Q, Zhu J, Wang F, Xu RH | title = First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial | journal = Med (New York, N.Y.) | volume = 5 | issue = 9 | pages = 1150–1163.e3 | date = September 2024 | pmid = 38870931 | doi = 10.1016/j.medj.2024.05.009 }}
- {{cite journal | vauthors = Xiang G, Jiang T, Gan L, Wu Y, Zhang N, Xing H, Su H, Li Y, Peng D, Ni R, Liu Y | title = Cost-effectiveness of serplulimab as first-line therapy for extensive-stage small cell lung cancer in China | journal = Frontiers in Immunology | volume = 14 | issue = | pages = 1223020 | date = 2023 | pmid = 37720211 | pmc = 10501445 | doi = 10.3389/fimmu.2023.1223020 | doi-access = free }}
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