• Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC

• The product has been approved in 40 countries and regions, covering close to half of the world’s population

• Serplulimab’s approval in Peru becomes Henlius’ fourth product to be approved in the Latin America market

Recently, Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly^®) has been approved in Peru by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval establishes serplulimab as the first and only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC in the LATAM. Serplulimab will be commercialized by Henlius’ partner, Abbott, in Peru under the brand name Olizu^®.

The approval was primarily supported by the European Commission (EC) approval of serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC, along with the clinical results from the ASTRUM-005 study.

The ASTRUM-005 study is a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study, evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 and 42.4 months of median follow-up data were presented. As of data cutoff on May 7, 2024, median OS was 15.8 in the serplulimab arm vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) in the placebo arm; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.

Lung cancer continues to be malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, lung cancer mortality ranked 4th among all cancer types in Latin America. Latin America witnessed approximately 105,000 new lung cancer cases and 91,000 deaths in 2022^[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. The approval of serplulimab in Peru will bring a new first-line immunotherapy option to local lung cancer patients, and is expected to fill the long-standing treatment gap in this field.

Following the commercialization of HLX02 (trastuzumab), HLX01 (rituximab) and HLX04 (bevacizumab) in the Latin American market, serplulimab has become the Henlius’ fourth product to be approved there through diverse partnership agreements. It is also the company's first innovative product approved in this area, signifying a pivotal milestone in the company's strategic expansion into emerging markets. As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in 40 countries and regions including China, the UK, Germany, India, Indonesia and Singapore, covering close to half of the world’s population. Looking ahead, Henlius will continue to collaborate with global partners to enhance accessibility and bring more innovative therapies to patients worldwide.

【Reference】

[1] Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. DOI: 10.3322/caac.21834