Sino Biopharmaceutical Limited (1177) reported that its independently developed national Category 1 innovative drug, benmelstobart (marketed as Andewei®), received approval from the National Medical Products Administration for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after platinum-based chemoradiotherapy and who do not carry known EGFR or ALK alterations.

The approval was based on positive findings from the R-ALPS study presented at the 2025 ASCO Annual Meeting (#LBA8004). This phase III clinical trial examined patients who received either benmelstobart or placebo as maintenance therapy following concurrent or sequential chemoradiotherapy. According to blinded independent central review, median progression-free survival reached 9.69 months in the benmelstobart group versus 4.17 months with placebo (HR=0.53, p<0.0001), indicating a 47% reduction in the risk of disease progression or death. Overall survival data remain immature (HR=0.76), and the rate of Grade ≥3 treatment-related adverse events was 29.4% in the benmelstobart arm compared to 19.7% in the placebo group.

Benmelstobart is now the third domestic PD-L1 inhibitor approved in China for consolidation therapy following chemoradiotherapy in locally advanced/unresectable NSCLC. Sino Biopharmaceutical Limited states that it intends to further its research in lung cancer by advancing its pipeline, covering multiple molecular subtypes and treatment scenarios.