#London #UK #Accord Healthcare #Serplulimab #Hetronifly

Accord Healthcare Receives European Approval for Hetronifly®

On February 6, 2025, Accord Healthcare Limited announced a significant milestone in the fight against extensive-stage small cell lung cancer (ES-SCLC) with the European Commission's (EC) approval of their drug, Hetronifly® (serplulimab). This innovative treatment combines serplulimab with carboplatin and etoposide, marking it as the world's first anti-PD-1 monoclonal antibody approved for first-line therapy in ES-SCLC.

The Breakthrough Treatment

Hetronifly is unique in its category; it is currently the only anti-PD-1 monoclonal antibody sanctioned in Europe for ES-SCLC. This approval expands its indications significantly, as it has already received recognition in China and various Southeast Asian markets. The drug was originally created by Henlius Biotech, which has since partnered with Intas Pharmaceuticals to facilitate further development and commercialization across over 50 countries, including Europe and India.

The approval encompasses all 27 EU member states and the European Economic Area nations, including Norway, Iceland, and Liechtenstein, indicating a broad avenue for patient access across Europe. The addition of serplulimab to the treatment options for ES-SCLC patients is crucial, given the high lethality and rapid progression associated with this cancer type.

Regulatory Milestones

Back in December 2022, Hetronifly received orphan drug designation from the EC for SCLC treatment, a status reaffirmed in 2025 as part of the review process. The European Society for Medical Oncology (ESMO) has also recognized serplulimab's efficacy, awarding it a score of 4 out of 5 on their magnitude of clinical benefit scale (MCBS), which is reflective of the drug's potential impact in enhancing patient survival rates.

Paul Tredwell, the Executive Vice-President for Europe, the Middle East, and North Africa (EMENA) at Accord Healthcare, expressed enthusiasm over the approval, stating that they are devoted to changing the lives of patients through innovative therapies. He emphasized how this drug not only provides a crucial new treatment paradigm for patients enveloped by the challenges of extensive-stage lung cancer but also showcases Accord's firm commitment to advancing oncology solutions and fostering collaborations that improve patient care.

Clinical Studies and Impact

Serplulimab (recombinant humanized anti-PD-1 monoclonal antibody) has also received endorsements across several clinical research publications, including the Journal of the American Medical Association (JAMA) and Nature Medicine. Studies suggest that serplulimab holds substantial promise, having been recognized and recommended in various clinical practice guidelines, providing essential information for the treatment of multiple cancer types.

As for lung cancer, it remains the leading form of cancer globally in terms of both incidence and death rates. According to GLOBOCAN 2022, there were over 2.48 million newly diagnosed lung cancer cases worldwide, constituting 12.4% of all newly identified cancers. Small cell lung cancer represents a significant 15-20% share of all lung cancer cases, characterized by swift metastasis and severe outcomes. Within Europe, the prevalence of SCLC stands at about 1 to 5 per 10,000 individuals, indicating the necessity of effective treatment options like Hetronifly.

Conclusion

The arrival of Hetronifly in the European market provides new hope to those affected by ES-SCLC, paving the way for potentially improved survival outcomes and quality of life. The commitment shown by Accord Healthcare enhances the oncology treatment landscape, offering innovative solutions to combat one of the toughest cancer types faced today. With collaborations geared towards striving for better outcomes, the fight against lung cancer continues to gain essential momentum.

References:
1. Bray F, et al.