Shanghai, China, June 25, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in its Japanese bridging study (NCT06812260) of its self-developed innovative anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®).
Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, benefiting over 110,000 patients to date. The Japanese bridging studyis, led by Professor Takayasu Kurata of Kansai Medical University Hospital, aims to evaluate the efficacy and safety of serplulimab in combination with chemotherapy for the first-line treatment of extensive-stage SCLC (ES-SCLC) in Japanese patients. This milestone lays a foundation for future regulatory submissions in Japan.
Lung cancer is the leading cause of cancer-related deaths worldwide. According to the latest GLOBOCAN data, it is the second most commonly diagnosed cancer in Japan, with over 136,000 new cases and more than 83,000 deaths reported in 2022, making it the country’s top cause of cancer-related mortality[1]. SCLC accounts for 15%–20% of all lung cancers and is characterized by high malignancy, early metastasis, and rapid disease progression, with a dismal prognosis. ES-SCLC accounts for 40%–50% of SCLC cases in Japan, and fewer than 4% of these patients survive five years post-diagnosis[2,3].
Henlius previously conducted ASTRUM-005, a randomized, double-blind, placebo-controlled, global phase 3 study evaluating serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. The results were first presented as an oral presentation at the 2022 ASCO Annual Meeting and subsequently published in JAMA, one of the world's top four medical journals—marking the first SCLC immunotherapy study to be published in the journal's main issue. At the 2025 ASCO Annual Meeting, final analysis results of the study were presented: as of December 31, 2024 (median follow-up: 42.4 months), the 4-year overall survival (OS) rate was 21.9% in the serplulimab group versus 7.2% in the control group, with a manageable safety profile, further underscoring the long-term survival benefit of serplulimab for ES-SCLC patients.
Driven by the strong clinical data from ASTRUM-005, serplulimab has been approved for first-line treatment of ES-SCLC in China, Europe, and multiple Southeast Asian countries. In parallel, Henlius is conducting a head-to-head bridging study in the U.S. comparing serplulimab to the current standard-of-care, atezolizumab, to support its potential U.S. regulatory submission.
Henlius remains committed to science-based development and will continue advancing localized strategies to enable precision treatment, aiming to deliver clinically relevant therapeutic options for patients in Japan and around the world.
Reference
[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] Sawabata N, Asamura H, Goya T, et al; Japanese Joint Committee for Lung Cancer Registry. Japanese Lung Cancer Registry Study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol. 2010 Sep;5(9):1369-75.
[3] Oze I, Ito H, Nishino Y, et al. Trends in Small-Cell Lung Cancer Survival in 1993-2006 Based on Population-Based Cancer Registry Data in Japan. J Epidemiol. 2019 Sep 5;29(9):347-353.
About NCT06812260
This is a single-arm, open-label, phase 2 bridging trial conducted in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). Eligible patients will be administrated once every three weeks with HANSIZHUANG in combination with chemotherapy (carboplatin-etoposide). The primary objective of the study is to evaluate the efficacy of HANSIZHUANG in combination with chemotherapy in Japanese patients with previously untreated ES-SCLC. The secondary objectives are to evaluate the safety, pharmacokinetics, and immunogenicity of HANSIZHUANG in combination with chemotherapy. The primary endpoint is the response (complete response (CR) or partial response (PR)) rate at week 24. Secondary endpoints include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity parameters.