Intas Pharmaceuticals announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of HETRONIFLY® (serplulimab), marking a significant milestone in the treatment of extensive-stage small cell lung cancer (ES-SCLC).

Serplulimab, also known as Hansizhuang in China, is a recombinant humanized anti-PD-1 monoclonal antibody (mAb) developed by Henlius. It is the first anti-PD-1 mAb to be approved for first-line treatment of ES-SCLC in China and is expected to become the first anti-PD-1 therapy available in Europe for this condition. The therapy has already received orphan drug designation from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC).

Through its subsidiary, Accord Healthcare Ltd, Intas will commercialize HETRONIFLY® across more than 30 countries in Europe. Accord is a leader in oncology, supplying approximately one in three injectable oncology medicines in Europe, and is well-positioned to deliver this important treatment to patients.

Key Executive Statements

Dr. Jason Zhu, Executive Director and CEO of Henlius, commented: “The positive CHMP opinion is a major milestone for our global strategy. It validates our commitment to patient-centered innovation and marks a significant step towards making serplulimab available to patients in Europe and beyond.”

Paul Tredwell, Executive Vice President of EMENA at Accord, added: “We are thrilled by the CHMP’s positive opinion, as it brings us closer to offering a new therapeutic option to patients with ES-SCLC, a disease with very limited treatment options and poor prognosis.”

Alex Falgas, Senior VP of Business Development at Accord, stated: “This pivotal moment reinforces Accord’s dedication to alleviating the global cancer burden. Serplulimab’s approval will enhance our oncology portfolio, providing much-needed treatments to patients across Europe.”

Lung Cancer: A Global Health Challenge

According to GLOBOCAN 2022, lung cancer is the most diagnosed and deadliest cancer globally, with over 2.48 million new cases reported in 2022, accounting for 12.4% of all cancer diagnoses. Small cell lung cancer (SCLC), which represents 15%-20% of lung cancer cases, is associated with rapid disease progression and poor outcomes, highlighting the urgent need for innovative treatments like HETRONIFLY®.

Clinical Study Supporting Approval

The positive CHMP opinion is based on the results of ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-center study. This Phase 3 trial demonstrated the efficacy and safety profile of serplulimab combined with chemotherapy as a first-line treatment for patients with ES-SCLC, compared to chemotherapy alone.

Intas and Henlius eagerly await the European Commission’s final approval, which is expected later this year, bringing hope to thousands of patients facing limited options in the fight against ES-SCLC.