Serplulimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | PD-1 |
| Clinical data | |
| Trade names | Hansizhuang |
| Other names | HLX10 |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Serplulimab, sold under the brand name Hansizhuang among others, 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 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 2024, it was approved by the China National Medical Products Administration (NMPA) for the treatment of non-squamous non-small cell lung cancer (nsqNSCLC)[6] .
In December 2023, the Indonesian Food and Drug Authority approved serplulimab for medical use in Indonesia.[7]
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]
In November 2025, serplulimab (Olizu) was approved for medical use in Peru for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).[8] It is the first and only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC in the LATAM.[8]
In May 2026, the European Commission approved two additional indications for serplulimab (Hetronifly) for the first-line treatment of non-squamous non-small cell lung carcinoma and esophageal squamous cell carcinoma.[1][9]
In June 2026, serplulimab (Hansizhuang) was approved by the China National Medical Products Administration (NMPA) for the perioperative treatment of resectable gastric cancer. This makes it the world’s first anti-PD-1 monoclonal antibody approved for this indication, replacing traditional adjuvant chemotherapy with immunotherapy monotherapy.[10]
As of June 2026, serplulimab has been approved in 50 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru.[11]
Names
Serplulimab is the International nonproprietary name.[12]
Serplulimab is sold under the brand names Hansizhuang, Hetronifly, and Olizu.
References
- 1 2 3 4 5 6 7 "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.
- 1 2 "Hetronifly PI". Union Register of medicinal products. 6 February 2025. Retrieved 4 March 2025.
- ↑ Lee A (July 2022). "Serplulimab: First Approval". Drugs. 82 (10): 1137–1141. doi:10.1007/s40265-022-01740-0. PMID 35796953.
- ↑ "Henlius' Novel Anti-PD-1 mAb Hansizhuang (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC" (Press release). Henlius. Retrieved 14 November 2024 – via PR Newswire.
- ↑ "Henlius' Novel Anti-PD-1 mAb Hansizhuang (Serplulimab) Approved for the Treatment of ESCC-Media" (Press release). Henlius. 22 September 2023. Retrieved 21 September 2024.
- ↑ "Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of nsNSCLC-Media". www.henlius.com.
- ↑ "Kalbe Luncurkan Serplulimab Untuk Obati Kanker Paru Sel Kecil - WartaTransparansi". www.wartatransparansi.com (in Indonesian). 10 March 2024. Retrieved 14 November 2024.
- 1 2 "Serplulimab Approved in Peru, Expanding into LATAM" (Press release). Henlius. 14 November 2025. Retrieved 12 July 2026.
- ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026". European Medicines Agency (EMA). 27 March 2026. Retrieved 12 July 2026.
- ↑ "Henlius' Serplulimab Approved for Perioperative Gastric Cancer, Pioneering a Chemotherapy-Sparring Adjuvant Approach". Henlius (Press release). 9 June 2026. Retrieved 12 July 2026.
- ↑ "Henlius' Serplulimab Approved for Perioperative Gastric Cancer, Pioneering a Chemotherapy-Sparring Adjuvant Approach-Media". Henlius (Press release). 9 June 2026. Retrieved 15 July 2026.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). 2020. 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.