- HANSIZHUANG (serplulimab) is the world’s first anti-PD-1 mAb for first-line treatment of ES- SCLC –
- HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 monoclonal antibody available in
Europe for first-line treatment of ES- SCLC – - HANSIZHUANG (serplulimab) has already been approved in
China ,Indonesia ,Cambodia , andThailand , benefiting around 80,000 patients
Dr.
Innovative Approach to Address Clinical Needs of SCLC
According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases.[1] Small cell lung cancer (SCLC) accounts for 15%“20% of the total number of lung cancer, which is featured by high malignancy, early metastasis, and rapid disease progression, with extremely poor prognosis. SCLC is divided into limited-stage and extensive-stage, with approximately 30%-40% of patients diagnosed at the limited stage and the rest at the extensive stage. With a prevalence of 1-5 per 10,000 people in the European community, SCLC has an orphan disease designation.[2] In
The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. The study has set up a total of 128 sites in various countries including
Global Strategy to Fuel Innovation-driven Expansion
HANSIZHUANG, Henlius’ first innovative mAb developed in-house, focuses on high-incidence cancers such as lung cancer and gastrointestinal tumours. In
Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to sqNSCLC and ES-SCLC, HANSIZHUANG’s marketing application for first-line treatment of non-squamous NSCLC (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). Additionally, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). Henlius is also running a bridging head-to-head trial in the
The global expansion of HANSIZHUANG is accelerating. It has already been approved in several countries, including
Looking ahead, Henlius will continue to prioritize patient needs, address unmet clinical demands, and accelerate efforts to deliver high-quality biologics from
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
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first