According to GLOBOCAN 2020, lung cancer (LC) is the second most 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]. Small cell lung cancer (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 are 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 shown benefit in those with LS-SCLC. Recently, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer for the treatment of ES-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, non-small cell lung cancer (sqNSCLC) and ES-SCLC and esophageal squamous cell carcinoma (ESCC), and has since seen benefits in 40,000 patients in China. Regarding unmet clinical needs as a core, Henlius covers the full range of first-line treatments of LC. Two global multi-centre phase 3 clinical trials regarding 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. ASTRUM-005, the international multi-centre, phase 3 study in patients with ES-SCLC, has been published in The Journal of the American Medical Association (JAMA), one of the top four medical journals in the world, making ASTRUM-005 became the first study published in JAMA on SCLC immunotherapy. Moreover, HANSIZHUANG has been granted orphan-drug designations for the treatment of SCLC by the United States Food and Drug Administration (FDA) and the European Commission (EC), respectively. The European Medicines Agency (EMA) has validated the application for HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC. It is worth mentioning that the first patient has been dosed in a bridging head-to-head trial in the US to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards US market approval further.

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