SHANGHAI, December 3, 2024 – Henlius announced that 汉斯状 (generic name: serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, has been officially approved by the National Medical Products Administration (NMPA) of China for the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) that is negative for epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK) rearrangement, in combination with pemetrexed and carboplatin. This marks the fifth indication approved for 汉斯状 in China, and the third indication approved for the product in the field of lung cancer following squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), which is expected to bring more treatment options to numerous lung cancer patients.
Basis for the Approval
This approval is mainly supported by a randomized, double-blind, multicenter Phase 3 clinical trial (ASTRUM-002). The study results showed that first-line treatment with 汉斯状 plus chemotherapy (carboplatin-pemetrexed) significantly prolonged progression-free survival (PFS) compared with chemotherapy alone (carboplatin-pemetrexed) in patients with advanced non-squamous non-small cell lung cancer (NSCLC), meeting the predefined superiority criteria. The regimen demonstrated a favorable safety profile, with no new safety signals identified.
Current Status of Lung Cancer
Lung cancer is the malignant tumor with the highest incidence and mortality worldwide. According to the latest data from the National Cancer Center of China, there were 1,060,600 new lung cancer cases and 733,000 lung cancer deaths in China in 2022, ranking first among all cancers in both incidence and mortality. Non-small cell lung cancer (NSCLC) accounts for approximately 80–85% of lung cancer cases in China, and about 70% of NSCLC cases are non-squamous NSCLC.
In recent years, the emergence of immunotherapy represented by PD-1/PD-L1 immune checkpoint inhibitors has provided more treatment options and survival benefits for patients with advanced NSCLC. The regimen of anti-PD-1 monoclonal antibody combined with chemotherapy as first-line treatment for non-squamous NSCLC has been recommended by authoritative domestic and international guidelines, including the National Comprehensive Cancer Network (NCCN) and the Chinese Society of Clinical Oncology (CSCO). The approval of 汉斯状 offers a new therapeutic choice for Chinese patients with advanced non-squamous NSCLC, helping to further improve the treatment landscape of lung cancer.
