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The CTA of Anti-PD-1 mAb Serplulimab for MRCT Phase 3 Studies on First-Line LS-SCLC Patients Approved in EU


Shanghai, China, November 18, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial application (CTA) of international multi-centre phase 3 studies of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). Up to now, clinical trials have been approved for serplulimab in China, the US, the Europe, and Australia, and more clinical approvals are being sought in many other countries and regions.

According to GLOBOCAN 2020, lung cancer (LC) is the second commonly diagnosed and the first mortality cancer around the world. There were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is still the leading cause of cancer deaths[1]. SCLC accounts for 15%–20% of the total number of LC, which is featured by high malignancy, strong invasiveness, early metastasis, and rapid disease progression, with extremely poor prognosis. LC is divided into two stages, including limited stage and extensive stage, and 30%–40% patients are in limited stage at the time of diagnosis. The standard treatment regimens for LS-SCLC is surgery, chemotherapy and concurrent radiotherapy. Traditional chemotherapeutic drugs did not exhibit significant progress in patients with LS-SCLC, and most patients tend to develop drug resistance or rapid relapse[2–4]. The advent of immune checkpoint inhibitors has been proven to bring hope to patients with ES-SCLC, but has not yet to show benefit in those with LS-SCLC. The company is continuing to explore immuno-oncology therapy for LS-SCLC, with the goal of delivering more effective treatment for patients.


HANSIZHUANG is the first innovative mAb developed by Henlius. It has been approved by the NMPA for the treatment of MSI-H solid tumours and non-small cell lung cancer. With HANSIZHUANG as the backbone, Henlius conducts and accelerates various clinical trials with immuno-oncology combination therapies worldwide and covers the full range of first-line treatments of LC. In addition to LS-SCLC, two global multi-centre phase 3 clinical trials regarding squamous non-small cell lung cancer (sqNSCLC) and ES-SCLC have been conducted in China, Turkey, Poland, Georgia, and other countries and regions, with over 30% of the total enrolled subjects being White, providing more diverse cases for clinical research. The NMPA has approved serplulimab for the treatment of sqNSCLC based on related study results. What’s more, ASTRUM-005, the international multi-centre study in patients with ES-SCLC, has been published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world, demonstrating the high level of academic acclaim on a global scale. HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.


In the future, the company will continue to emphasize unmet clinical needs and actively promote the combination immunotherapy of serplulimab and international regulatory registration to benefit more patients around the world.


[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2] Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125.

[3] Wang Z, Wan J, Liu C, Li L, Dong X, Geng H. Sequential Versus Concurrent Thoracic Radiotherapy in Combination With Cisplatin and Etoposide for N3 Limited-Stage Small-Cell Lung Cancer. Cancer Control. 2020 Jan-Dec;27(1):1073274820956619.

[4] Ha IB, Jeong BK, Jeong H, Choi HS, Chai GY, Kang MH, Kim HG, Lee GW, Na JB, Kang KM. Effect of early chemoradiotherapy in patients with limited stage small cell lung cancer. Radiat Oncol J. 2013 Dec;31(4):185-90.