Accord Healthcare: Hetronifly® (Serplulimab) receives Marketing Authorisation from the European Commission (EC), for the treatment of Extensive-S

-- Hetronifly is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC (in combination with carboplatin and etoposide). -- Hetronifly is the only anti-PD-1 mAb approved in Europe for the treatment of ES-SCLC and is already approved in China, and several Southeast Asian countries. -- In December 2022, Hetronifly received orphan drug designation from the EC for the treatment of SCLC, which was renewed in 2025. -- The European Society for Medical Oncology (ESMO) scores serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC. LONDON, Feb. 6, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) announced today that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly(®) in Europe, has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment for ES-SCLC.

This makes it the first anti-PD-1 monoclonal antibody to be approved in Europe for the treatment of ES-SCLC.

Serplulimab was originated by Henlius Biotech. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. This latest approval covers all 27 EU member states as well as the European Economic Area countries, including Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be led by Accord.

In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed.

ESMO scores serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC.

Welcoming the news Paul Tredwell, Executive Vice-President, EMENA, Accord Healthcare said:

"At Accord, we are committed to transforming the lives of patients, and this approval of Hetronifly allows us to provide a much-needed new treatment option for patients with extensive stage small cell lung cancer. It also underlines our dedication to building our speciality business and driving innovation in oncology; a therapy area we have huge heritage in.

"With our partners at Henlius, we can now have confidence that some of the most unwell lung cancer patients can benefit, giving them more precious time with their families and loved ones. Together, we will continue to collaborate to expand our pipeline of innovative medicines, further underlying our commitment to developing speciality medicines to provide a real difference to patients' lives in Europe and beyond."

About Serplulimab Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

About Lung Cancer Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.(1)

Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis.

Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in extensive stage.

Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.(2)

References

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 2. Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207 Logo -

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