Serplulimab

Serplulimab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	PD-1
Clinical data
Trade names	Hetronifly
Other names	HLX10
Routes of administration	Intravenous
Drug class	Antineoplastic agent
ATC code	L01FF12 ( WHO )
Legal status
Legal status	EU:Rx-only [1] [2] CN: Rx-only
Identifiers
CAS Number	2231029-82-4
DrugBank	DB17451
UNII	S3GQZ2K36V
KEGG	D12751

Serplulimab, sold under the brand name Hetronifly, is a monoclonal antibody used for the treatment of cancers. ^{[1] [3]}

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. ^[1]

Society and culture

Legal status

It was approved for medical use in China in 2022, for the treatment of microsatellite instability-high solid tumors ^[3] and squamous non-small cell lung cancer, ^[4] and in 2023 for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma. ^[5]

In December 2023, the Indonesian Food and Drug Authority approved serplulimab for medical use in Indonesia. ^[6]

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). ^[1] The applicant for this medicinal product is Henlius Europe GmbH. ^[1] Serplulimab was authorized for medical use in the European Union in February 2025. ^{[1] [2]}

Names

Serplulimab is the International nonproprietary name. ^[7]

References

1. "Hetronifly EPAR". European Medicines Agency (EMA). 19 September 2024. Retrieved 21 September 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
2. "Hetronifly PI". Union Register of medicinal products. 6 February 2025. Retrieved 4 March 2025.
3. Lee A (July 2022). "Serplulimab: First Approval". Drugs. 82 (10): 1137–1141. doi:10.1007/s40265-022-01740-0. PMID   35796953.
4. Henlius. "Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC". www.prnewswire.com (Press release). Retrieved 14 November 2024.
5. "Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC-Media". Henlius (Press release). 22 September 2023. Retrieved 21 September 2024.
6. "Kalbe Luncurkan Serplulimab Untuk Obati Kanker Paru Sel Kecil - WartaTransparansi". www.wartatransparansi.com (in Indonesian). 10 March 2024. Retrieved 14 November 2024.
7. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .

Further reading

• Qin S, Li J, Zhong H, Jin C, Chen L, Yuan X, et al. (December 2022). "Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial". British Journal of Cancer. 127 (12): 2241–2248. doi:10.1038/s41416-022-02001-3. PMC   9726893 . PMID   36261583.
• Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, et al. (2022). "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". JAMA. 328 (12): 1223–1232. doi:10.1001/jama.2022.16464. PMC   9516323 . PMID   36166026.
• Wang ZX, Peng J, Liang X, Cheng Y, Deng Y, Chen K, et al. (September 2024). "First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial". Med (New York, N.Y.). 5 (9): 1150–1163.e3. doi:10.1016/j.medj.2024.05.009. PMID   38870931.
• Xiang G, Jiang T, Gan L, Wu Y, Zhang N, Xing H, et al. (2023). "Cost-effectiveness of serplulimab as first-line therapy for extensive-stage small cell lung cancer in China". Frontiers in Immunology. 14 1223020. doi: 10.3389/fimmu.2023.1223020 . PMC   10501445 . PMID   37720211.