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Henlius Biotech Gets EU Clearance for New Indication of Serplulimab Combo

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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.

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