Henlius and Intas get CHMP nod for HETRONIFLY® in Europe as first-line treatment for extensive-stage small cell lung cancer

Intas Pharmaceuticals Limited announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of HETRONIFLY® (serplulimab) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in Europe. Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody, is the first innovative monoclonal antibody developed by Henlius and has been granted orphan drug status by both the U.S. FDA and the European Commission for the treatment of SCLC. This approval is a major step forward for Henlius and Intas in their commitment to making innovative cancer treatments available globally.

Serplulimab will be marketed by Intas through its subsidiary, Accord Healthcare Ltd (Accord), in over 30 European countries. Accord is a significant player in the global oncology market, supplying around one-third of injectable oncology medicines in Europe. This positive CHMP opinion brings Henlius and Intas closer to providing advanced treatment options for cancer patients in Europe, offering new hope to people with limited current options.

Dr. Jason Zhu, Executive Director and CEO of Henlius, emphasized that this positive CHMP opinion is a crucial milestone in expanding the global reach of their products and underscores Henlius' patient-centered research and development approach. He expressed optimism about the forthcoming formal approval of this treatment in Europe, which would provide more treatment options to patients across the region and globally.

Paul Tredwell, Executive Vice President of EMENA at Accord, expressed his excitement about the CHMP's positive opinion, highlighting that this development strengthens Accord's ongoing partnership with Henlius. It also indicates that serplulimab is on track to become part of the treatment options for extensive-stage small cell lung cancer patients, who currently have very few alternatives and face a grim prognosis.

Alex Falgas, Senior Vice President of Business Development at Accord, described the CHMP's positive opinion on serplulimab as a pivotal moment in Accord's mission to provide top-tier cancer treatments to patients in Europe. He noted that this development enhances Accord's oncology portfolio and reinforces their commitment to reducing the global cancer burden by ensuring greater access to innovative therapies.

According to GLOBOCAN 2022, lung cancer is the most frequently diagnosed cancer and the leading cause of cancer mortality worldwide, with over 2.48 million new cases in 2022, accounting for 12.4% of all new cancer cases. Small cell lung cancer (SCLC) makes up 15%-20% of these cases and is known for its early metastasis, rapid progression, and very poor prognosis.

The CHMP's positive opinion is primarily based on the results of the ASTRUM-005 clinical study, a randomized, double-blind, placebo-controlled international multi-center trial. This study evaluated the efficacy and safety profile of the PD-1 inhibitor serplulimab in combination with chemotherapy, compared to a placebo with chemotherapy, as a first-line treatment for patients with ES-SCLC.

Henlius, a global biopharmaceutical firm, has launched six products in China and three in overseas markets, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Intas is a leading multinational pharmaceutical company with a strong presence in over 85 countries, contributing about 69% of its revenue from global business. It ranks sixth in the Indian pharmaceutical market and is known for its extensive R&D and manufacturing capabilities.

Intas' facilities, accredited by top global regulators, produce a wide range of products, including CNS, cardiovascular, diabetology, plasma therapy, cell and gene therapy, gastroenterology, urology, and oncology medications. Every year, Intas invests a significant portion of its revenue in R&D, maintaining a strategic pipeline of high-value products.