Henlius recently held an investigator meeting in Kobe, Japan for the bridging study of serplulimab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The meeting brought together leading Japanese oncologists from 10 clinical sites in Japan, and Henlius team.
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 ongoing bridging study, NCT06812260, is designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy in Japanese patients with ES-SCLC, and to further support the product’s regulatory submission in Japan. The study has completed its first patient dosing. During the meeting, the Henlius’ team presented the global development of serplulimab, study design, and project timelines for the bridging trial in Japan. Investigators also engaged in in-depth discussions on key elements of study implementation and shared valuable insights, laying a solid foundation for the high-quality execution of the study.
Professor Takayasu Kurata, principal investigator of the study from Kansai Medical University Hospital, said: “This is an important study, and we hope all sites will work together to accelerate the enrollment and achieve the goals. It’s encouraging to see Henlius introducing such a promising product to the Japanese clinical setting. Chinese companies have made impressive progress in oncology drug development, and I look forward to seeing more innovative medicines benefiting patients around the world.”
Tomohisa Hayakawa, Japan General Manager of Henlius, said: “We are actively advancing multiple clinical studies of serplulimab in Japan, including this bridging trial, which has gained strong support from local investigators. By closely collaborating with domestic researchers, we aim to accelerate project execution and bring timely benefits to patients.”
Jing Li, Vice President of Global Product Development at Henlius, shared the company’s broader expectations for the study: “We sincerely thank all the investigators for attending the meeting and for sharing valuable insights. The internationalization of serplulimab is grounded in scientific evidence. We look forward to advancing its development through localized efforts and close collaboration with local research institutions, so that this high-quality therapy can benefit more patients in Japan as soon as possible. Moving forward, we will continue working to bring more innovative and high-quality medicines to Japan at earlier stages.”
Henlius will continue to uphold its patient-centric mission, leveraging its in-house innovation and global collaboration platform to expand the global development and accessibility of serplulimab, helping more patients gain timely access to high-quality and affordable innovative therapies.
About HANSIZHUANG
HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe ) is the first anti-PD-1 mAb for the first-line treatment of SCLC. To date, HANSIZHUANG has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, licensed out to over 100 countries and regions, including the U.S., Europe, Southeast Asia, the Middle East, and North Africa, benefiting over 110,000 patients. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved for the treatment of 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). Additionally, Serplulimab was granted orphan drug designations from the FDA, the EC and Swissmedic for the treatment of SCLC, as well as from the Korean Ministry of Food and Drug Safety (MFDS) for the treatment of ES-SCLC. Its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.
The results of 4 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was respectively recommended by 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 definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.
