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Lung cancer continues to be the malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, Southeast Asia witnessed approximately 186,000 new lung cancer cases and 166,000 deaths in 2022. Notably, lung cancer mortality ranked highest among all cancer types in both Singapore and Malaysia^[1]. Small cell lung cancer (SCLC), accounting for roughly 15% of all lung cancer cases, stands as one of its most aggressive subtypes. It is classified into limited-stage (LS-SCLC) and ES-SCLC. Statistics indicate that nearly 80% of patients are diagnosed at the extensive stage, with rapid clinical deterioration and poor overall prognosis^[2]. In recent years, advances in immunotherapy, particularly PD-1/PD-L1 immune checkpoint inhibitors, have expanded treatment options and improved survival outcomes for SCLC patients.

Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of SCLC, having been approved for marketing in over 30 countries and regions worldwide, benefiting over 110,000 patients. This approval of serplulimab in Singapore and  Malaysia is primarily based on the ASTRUM-005 study, which established 128 trial centers globally and enrolled 585 subjects. The study results were first released via oral presentation at the 2022 American Society of Clinical Oncology (ASCO) annual meeting and published in the Journal of the American Medical Association (JAMA), one of the world's four top-tier medical journals, making it the world's first SCLC immunotherapy clinical research published in JAMA's main journal. At this year's ASCO conference, the ASTRUM-005 trial, for the first time, reported the 4-year overall survival (OS) rate. Long-term follow-up data (median follow-up: 42.4 months) showed a 4-year OS rate of 21.9% in the serplulimab-treated group versus 7.2% in the control group, further confirming that this regimen can bring significant long-term survival benefits to ES-SCLC patients.

In 2019, Henlius entered into an exclusive licensing agreement with KGbio for serplulimab, granting KGbio exclusive rights to develop, register and commercialize serplulimab for certain indications and therapies across 10 ASEAN countries. Building on this partnership, the collaboration expanded in August 2023 with KGbio securing exclusive commercialization rights for two indications – including ES-SCLC – in 12 Middle East and North Africa (MENA) countries, notably Saudi Arabia, UAE, Egypt, Qatar, Jordan, and Morocco. Accelerated by this strategic collaboration, serplulimab's global rollout has achieved significant milestones. In December 2023, serplulimab achieved its first overseas approval, receiving authorization from the Indonesian Food and Drug Administration (BPOM) for the treatment of ES-SCLC. This made it the first China-developed anti-PD-1 monoclonal antibody approved for marketing in Southeast Asia. In April and July 2024, serplulimab was successively approved for the treatment of ES-SCLC in Cambodia and Thailand. In January 2025, serplulimab received additional approvals for squamous non-small cell lung cancer (sqNSCLC) in Indonesia and Thailand, further expanding its influence in the Southeast Asian market.

Beyond the Southeast Asia, serplulimab's global deployment is accelerating across multiple key markets. To date, the drug has gained four Chinese approvals for the treatment of sqNSCLC, ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). A pivotal milestone was achieved in February 2025 when the European Commission approved serplulimab as first-line therapy for ES-SCLC – making it the first and only anti-PD-1 mAb authorized for this indication in the EU. This authorization represents a landmark breakthrough for China-developed biologics in Western regulated markets. To support US registration, the company is steadily advancing the bridging head-to-head trial in the US to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. Furthermore, serplulimab has earned Orphan Drug Designations for SCLC from the US FDA, European Commission, and Swissmedic, along with specific designation for ES-SCLC from Korea's Ministry of Food and Drug Safety (MFDS).