On September 21, 2024 Intas Pharmaceuticals Limited ("Intas") reported 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 (Press release, Intas Pharmaceuticals, SEP 21, 2024, View Source [SID1234646790]).

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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.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of 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."

Paul Tredwell, Executive Vice President of EMENA at Accord, said "I am thrilled with the CHMP’s positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis."

Alex Falgas, Senior Vice President of Business Development at Accord 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. This strengthens our oncology portfolio and reinforces Accord’s commitment to alleviating the global cancer burden, ensuring greater access to innovative therapies for those in need."

According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer cases, and is associated with early metastasis, rapid disease progression, and an extremely poor prognosis.

The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated 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 ES-SCLC.