European Commission Approves Hetronifly® (Serplulimab) for Extensive-Stage Small Cell Lung Cancer “`

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3bb5cbfc6514ea8ecc31d8400a5bd97a Accord Healthcare: Hetronifly® (Serplulimab) receives Marketing Authorisation from the European Commission (EC), for the treatment of Extensive-Stage Small Cell Lung Cancer (ES- SCLC)
  • Hetronifly is the first anti-PD-1 monoclonal antibody globally approved for initial ES-SCLC treatment (with carboplatin and etoposide).
  • Hetronifly is Europe’s sole approved anti-PD-1 mAb for ES-SCLC treatment; it’s also approved in China and several Southeast Asian nations.
  • In December 2022, the EC granted Hetronifly orphan drug designation for SCLC treatment, renewed in 2025.
  • The European Society for Medical Oncology (ESMO) rates serplulimab 4 out of 5 on its magnitude of clinical benefit scale (MCBS) for ES-SCLC.

LONDON, Feb. 6, 2025 — Accord Healthcare Limited (Accord) today announced the European Commission’s (EC) approval of the anti-PD-1 mAb, serplulimab (Hetronifly® in Europe), for first-line ES-SCLC treatment in combination with carboplatin and etoposide.

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This marks the first European approval of an anti-PD-1 monoclonal antibody for ES-SCLC treatment.

Henlius Biotech originated serplulimab. In 2023, Henlius partnered with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialize serplulimab in over 50 countries across Europe and India. This approval encompasses all 27 EU member states and European Economic Area countries (Norway, Iceland, and Liechtenstein). Accord will lead European commercialization.

Serplulimab received EC orphan drug designation for SCLC treatment in December 2022, recently renewed.

ESMO rates serplulimab 4 out of 5 on its magnitude of clinical benefit scale (MCBS) for ES-SCLC.

Commenting on the news, Paul Tredwell, Accord Healthcare’s Executive Vice-President, EMENA, stated:

“Accord is dedicated to improving patient lives. Hetronifly’s approval offers a crucial new treatment option for extensive-stage small cell lung cancer patients. It also highlights our commitment to expanding our specialty business and oncology innovation, a field where we have a strong legacy.

“Our partnership with Henlius ensures that severely ill lung cancer patients can benefit, gaining precious time with loved ones. We will continue collaborating to expand our innovative medicine pipeline, reinforcing our dedication to developing specialty medicines that truly impact patient lives in Europe and beyond.”

About Serplulimab
Serplulimab (recombinant humanized anti-PD-1 monoclonal antibody injection) is the first anti-PD-1 mAb for first-line SCLC treatment, approved in China and several Southeast Asian countries. It’s also approved by China’s National Medicinal Products Administration (NMPA) for 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). The FDA and EC granted serplulimab orphan drug designations for SCLC treatment; a bridging head-to-head US trial comparing serplulimab to atezolizumab (anti-PD-L1 mAb) for first-line ES-SCLC treatment is underway.

Four pivotal serplulimab trials were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell, and British Journal of Cancer. Serplulimab is also recommended in 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 key guidelines, offering valuable clinical diagnosis and treatment references for tumors.

About Lung Cancer
Lung cancer is the world’s most common cancer by incidence and mortality. GLOBOCAN 2022 reported over 2.48 million new lung cancer cases globally in 2022 (12.4% of all new cancer cases).1

Small cell lung cancer (SCLC), representing 15% to 20% of all lung cancers, is highly malignant, metastasizes early, progresses rapidly, and has a poor prognosis.

Approximately 30% to 40% of SCLC patients are diagnosed at a limited stage; the rest are in the extensive stage.

SCLC prevalence in Europe 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

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