#None #Accord Healthcare #Serplulimab #Hetronifly

Accord Healthcare's Groundbreaking Approval for Hetronifly®

Accord Healthcare has made a significant leap in oncology with the recent approval of its monoclonal antibody, Hetronifly® (serplulimab), by the European Commission. This notable achievement positions Hetronifly® as the world's first anti-PD-1 monoclonal antibody officially designated for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), in combination with carboplatin and etoposide.

What Sets Hetronifly® Apart?

This groundbreaking therapy not only stands out as the sole anti-PD-1 monoclonal antibody approved in Europe for ES-SCLC, but it has also garnered recognition in China and several Southeast Asian nations. The European approval encompasses 27 EU member states as well as countries in the European Economic Area, including Norway, Iceland, and Liechtenstein, marking a critical expansion for Accord Healthcare.

In December 2022, the drug received the orphan designation from the European Commission, particularly aimed at advancing treatment options for those battling SCLC. This designation was reaffirmed in 2025, underscoring the drug's critical position in the treatment landscape.

Clinical Validation

Hetronifly® has also received a remarkable score of 4 out of 5 from the European Society for Medical Oncology (ESMO) on their scale assessing clinical benefit magnitude (MCBS) for ES-SCLC patients. This marks a vital endorsement, validating its potential efficacy and positioning it as a front-runner in cancer therapies.

Future Prospects

Paul Tredwell, Executive Vice President of Accord Healthcare for the EMENA region, expressed optimism regarding the impact of Hetronifly®. He emphasized the commitment of Accord to improving patients' lives with this new therapeutic option for those suffering from advanced small cell lung cancer. This approval reflects Accord's dedication to expanding its specialty business and driving innovation within the oncology sphere, where they have a rich legacy.

"Working alongside our partners at Henlius, we are poised to provide significant benefits to some of the most severely affected lung cancer patients, helping them spend more cherished time with their families," Tredwell remarked. "Together, we will continue to strive toward broadening our innovative drug portfolio, reinforcing our commitment to developing specialized medications that genuinely enhance patient lives in Europe and beyond."

Details on Serplulimab

Serplulimab is an injectable humanized recombinant monoclonal antibody targeting PD-1, previously approved in China for treating various types of advanced lung cancer. The National Medicinal Products Administration (NMPA) in China recognizes serplulimab for its efficacy against non-small cell lung cancer and squamous lung cancer, among others. Furthermore, it has been designated as an orphan drug by both the FDA and European Commission for SCLC treatment.

Ongoing studies, including head-to-head trials comparing serplulimab to atezolizumab (another anti-PD-L1 monoclonal antibody), continue to bolster its presence in oncological research, with pivotal findings already published in top-tier medical journals.

Understanding Lung Cancer

Lung cancer remains a predominant global health concern, being the most common cancer worldwide by incidence and mortality rate. According to GLOBOCAN 2022, there were over 2.48 million new lung cancer cases registered globally in 2022, accounting for 12.4% of the total new cancer cases. Among them, small cell lung cancer (SCLC), which constitutes approximately 15-20% of all lung cancers, is characterized by its aggressive nature, early metastasis, rapid progression, and generally poor prognosis.

In Europe, the prevalence of SCLC ranges between 1 and 5 cases per 10,000 people. The introduction of Hetronifly® represents a hopeful stride toward addressing this pressing health challenge, potentially transforming treatment protocols and improving patient outcomes significantly.

By delivering this innovative treatment, Accord Healthcare not only showcases its commitment to advancing oncological care but also charts a path toward greater hope for patients and families affected by this challenging illness.