SINO BIOPHARM announced that the new indication for the group's self-developed national Class 1 innovative drug, Bemusubain Injection (trade name: Andewei®), has received marketing approval from the National Medical Products Administration (NMPA) of China. The approval is for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed after platinum-based concurrent or sequential chemoradiotherapy and who do not carry known EGFR sensitive mutations or ALK rearrangements.
This approval is based on positive results from the R-ALPS study, which were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study enrolled patients with locally advanced/unresectable Stage III NSCLC who had not progressed after concurrent/sequential chemoradiotherapy. Participants received either Bemusubain or a placebo as consolidation therapy until disease progression, with the primary endpoint being progression-free survival (PFS) as assessed by blinded independent central review.
Results showed that after a median follow-up of 19.4 months, the median PFS was 9.69 months in the Bemusubain group compared to 4.17 months in the placebo group, representing a 47% reduction in the risk of disease progression or death. Prespecified subgroup analyses demonstrated consistent benefit trends across different patient groups. Overall survival data were not yet mature, but a trend favoring the Bemusubain group was observed. Regarding safety, the incidence of Grade 3 or higher treatment-related adverse events was 29.4% in the Bemusubain group versus 19.7% in the placebo group.
Bemusubain is the third PD-L1 inhibitor approved in China for consolidation therapy following definitive chemoradiotherapy for locally advanced/unresectable NSCLC. The group will continue to deepen its innovation efforts in the lung cancer treatment field, developing a product pipeline that covers multiple molecular subtypes and treatment scenarios to improve patient survival outcomes.
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