Intas and Henlius receive Positive CHMP Opinion for HETRONIFLY

HETRONIFLY (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC 

Intas Pharmaceuticals 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), in European markets.

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

Serplulimab will be commercialised by Intas through its subsidiary, Accord Healthcare Ltd (Accord), across more than 30 countries in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe. This positive opinion from CHMP marks another step closer for both Henlius and Intas to provide serplulimab for patients in Europe.

Binish Chudgar, Vice-Chairman and MD, Intas Pharmaceuticals, said, "The CHMP's positive opinion on serplulimab is a pivotal moment in our mission to provide world-class cancer treatments to patients in Europe and across multiple geographies. This strengthens our differentiated oncology portfolio and reinforces Accord's commitment to alleviating the global cancer burden by ensuring innovative high-quality affordable treatment for those in need."

Paul Tredwell, Executive Vice President, EMENA at Accord, said, " Accord is proud to be the leading generic oncology company in Europe, this approval highlights Accords' continued strategy to build out its speciality business across the region, driving innovation in oncology."

Dr Jason Zhu, Executive Director and CEO, Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius' patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide."