Sino Biopharm wins China approval for new benmelstobart use in lung cancer
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
Sino Biopharmaceutical has secured Chinese regulatory approval for a new indication of its Category 1 innovative PD-L1 inhibitor benmelstobart injection, marketed as Andewei, as maintenance therapy after chemoradiotherapy in patients with unresectable stage III non-small cell lung cancer lacking EGFR or ALK alterations. The approval was supported by positive phase III R-ALPS trial data showing significantly prolonged progression-free survival versus placebo and a manageable safety profile.
The approval makes benmelstobart the third domestic PD-L1 inhibitor cleared for this setting. Sino Biopharmaceutical said the decision strengthens the group’s competitive position in China’s lung cancer market and advances its strategy to build a diversified oncology pipeline.
Sino Biopharmaceutical Limited is a Hong Kong-listed pharmaceutical group focused on innovative drug research, development, manufacturing and commercialization, with a strong presence in oncology. The company develops proprietary therapies for the China market, targeting major diseases such as lung cancer with advanced biologic and small-molecule treatments.