Shanghai Henlius Biotech (HKG:2696) obtained approval for a new indication of its serplulimab injection from the European Commission, according to a Thursday Hong Kong bourse filing.
The approved indication is for serplulimab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.
The new indication has been approved in all EU member states as well as in Iceland, Liechtenstein, and Norway.