Chemistry:Serplulimab
Serplulimab, sold under the brand name Hansizhuang among others, is a monoclonal antibody used for the treatment of cancers.[1][2]
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,[3] and in 2023, for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma.[4] 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)[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][7]
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
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Hetronifly EPAR". 19 September 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Serplulimab: First Approval". Drugs 82 (10): 1137–1141. July 2022. 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.
- ↑ https://www.henlius.com/en/NewsDetails-4787-26.html
- ↑ "Kalbe Luncurkan Serplulimab Untuk Obati Kanker Paru Sel Kecil - WartaTransparansi" (in id). 10 March 2024. https://www.wartatransparansi.com/2024/03/10/kalbe-luncurkan-serplulimab-untuk-obati-kanker-paru-sel-kecil.html.
- ↑ "Hetronifly PI". 6 February 2025. https://ec.europa.eu/health/documents/community-register/html/h1870.htm.
- ↑ 8.0 8.1 "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". 27 March 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-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.
Further reading
- "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. December 2022. doi:10.1038/s41416-022-02001-3. PMID 36261583.
- "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. 2022. doi:10.1001/jama.2022.16464. PMID 36166026. PMC 9516323. https://jamanetwork.com/journals/jama/fullarticle/2796691.
- "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. September 2024. doi:10.1016/j.medj.2024.05.009. PMID 38870931.
- "Cost-effectiveness of serplulimab as first-line therapy for extensive-stage small cell lung cancer in China". Frontiers in Immunology 14. 2023. doi:10.3389/fimmu.2023.1223020. PMID 37720211.
 |  |
