India-based pharmaceutical company Intas Pharmaceuticals Limited announced on Saturday a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending approval of HETRONIFLY (serplulimab, approved as Hansizhuang in China) in Europe.

Serplulimab is a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection developed by Chinese biopharmaceutical company Henlius (HKG:2696). It has received orphan drug designation from the US Food and Drug Administration (FDA) and the European Commission for the treatment of Small Cell Lung Cancer (SCLC).

Intas subsidiary Accord Healthcare Ltd will commercialise the treatment across more than 30 countries in Europe.

The positive CHMP opinion was primarily based on ASTRUM-005, a randomised, double-blind, placebo-controlled international multi-centre clinical study that assessed the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy, compared with placebo plus chemotherapy as first-line treatment in patients with extensive stage SCLC.