Intas Pharmaceuticals Receives Positive CHMP Opinion for Cancer Drug

Intas Pharmaceuticals announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of HETRONIFLY® (serplulimab) in European markets. Serplulimab, an anti-PD-1 monoclonal antibody, has been granted orphan drug status for treating Small Cell Lung Cancer. It will be commercialized by Intas' subsidiary Accord Healthcare in over 30 European countries, reinforcing Accord's leadership in the oncology market.

Intas Pharmaceuticals Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY® (serplulimab, approved as HANSIZHUANG in China) for European markets.

Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has obtained orphan drug status from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for treating Small Cell Lung Cancer (SCLC).

This positive CHMP opinion marks a significant milestone for Intas and Henlius. Binish Chudgar, Vice-Chairman and Managing Director of Intas Pharmaceuticals, highlighted the importance of this decision in providing world-class cancer treatments across Europe. Paul Tredwell, Executive Vice President of EMENA at Accord, and Dr. Jason Zhu, CEO of Henlius, emphasized the strategic significance and commitment to innovation in oncology.

(With inputs from agencies.)