#None #Accord Healthcare #Serplulimab #Hetronifly®

Hetronifly® Secures European Commission Approval

Accord Healthcare Limited has announced that their monoclonal antibody, Serplulimab, marketed as Hetronifly® in Europe, has received official approval from the European Commission (EC) for its use in treating extensive-stage small cell lung cancer (ES-SCLC). This marks a historic moment as Hetronifly® becomes the first PD-1 monoclonal antibody authorized in Europe for this specific condition, demonstrating Accord’s commitment to providing innovative treatment options for patients.

Key Details of the Approval

Hetronifly® is now approved to be used in combination with Carboplatin and Etoposide as a first-line treatment for ES-SCLC, a cancer type that is generally recognized for its aggressive nature and poor prognosis. Notably, Hetronifly® holds the distinction of being the only PD-1 antibody authorized in Europe for this purpose. The approval extends across all 27 EU member states as well as the European Economic Area, covering countries such as Norway, Iceland, and Liechtenstein.

This authorization follows the Orphan-Drug designation granted to Hetronifly® by the European Commission in December 2022 and its recent renewal in 2025. This status is specifically aimed at facilitating the development of treatments for rare conditions, emphasizing the significance of Hetronifly® in the fight against rare cancers like ES-SCLC.

Clinical Evaluation

The European Society for Medical Oncology (ESMO) has rated Serplulimab's clinical benefit at 4 out of 5 on their Magnitude of Clinical Benefit Scale (MCBS) for ES-SCLC, highlighting its potential impact on therapy outcomes.

Paul Tredwell, Executive Vice-President for EMENA at Accord Healthcare, expressed his optimism regarding this approval. He stated that “this regulatory milestone enables us to provide a much-needed new treatment option for patients battling extensive-stage small cell lung cancer, underlining our commitment to expanding our specialty business and driving innovation in oncology.”

Developer Collaboration

Hetronifly® is the culmination of research by Henlius Biotech. In a strategic collaboration established in 2023 between Henlius and Intas Pharmaceuticals, Intas obtained exclusive rights to develop and market the treatment in over 50 countries across Europe and India. This partnership is set to enhance the reach of Hetronifly® and improve access to vital therapies for lung cancer patients.

Scientific Background

Serplulimab is a recombinant humanized monoclonal anti-PD-1 antibody injection. Apart from its recent approval in Europe, it is already registered in China and several Southeast Asian nations for multiple cancers, including non-small cell lung cancer (sqNSCLC) and esophageal squamous cell carcinoma (ESCC). Additionally, ongoing bridging studies in the U.S. aim to compare the efficacy of Serplulimab against the standard treatment Atezolizumab, highlighting its significant role in clinical research.

Burden of Small Cell Lung Cancer

Small cell lung cancer accounts for 15% to 20% of all lung cancer incidences and possesses some of the worst prognoses among cancer types due to its rapid progression and early metastasis. According to GLOBOCAN 2022, over 2.48 million new lung cancer cases were reported globally, making this disease a critical health concern. In Europe, the prevalence of SCLC reaches up to five cases per 10,000 individuals, necessitating more effective treatment solutions.

Conclusion

The approval of Hetronifly® represents a pivotal development in the treatment landscape for extensive-stage small cell lung cancer in Europe. It stands to positively change the lives of many patients navigating this challenging illness, providing hope for extended time with family and continued fight against relentless disease progression. Accord Healthcare, in collaboration with its partners, is poised to further its efforts in expanding innovative oncology treatments, thereby enhancing patient care in Europe and beyond.