Hetronifly set to strengthen Accord’s EU injectable oncology portfolio

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab).

This product, which is approved under the brand name Hansizhuang in China, is a recombinant humanized anti-PD-1 monoclonal antibody (MAb) injection and is the first innovative MAb developed by Chinese firm Henlius, part of Shanghai Henlius Biotech (HKG: 2696). 

Hetronifly has been granted orphan drug status designation by the US Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of small cell lung cancer (SCLC).