According to a report, on October 19, 2026 local time, the European Society for Medical Oncology (ESMO) Annual Congress released research abstracts, and a total of 10 studies on the core product innovative anti-PD-1 monoclonal antibody H drug Hansizhuang® (serplulimab, European trade name Hetronifly®) from HENLIUS (02696) were selected for this year's congress, among which the U.S. bridging ASTRIDE study will make a high-profile appearance as an oral presentation, supplementing key clinical evidence from the U.S. local population for this anti-PD-1 monoclonal antibody, the world's first approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
The ASTRIDE study is a head-to-head bridging trial conducted in the United States, comparing the efficacy and safety of serplulimab versus atezolizumab combined with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This study is currently the largest U.S. enrollment among completed ES-SCLC clinical trials, and was independently executed by a local team. Abstract data show that with a median follow-up of 14.1 months, the median overall survival (OS) of the serplulimab group was 12.4 months, better than the 10.2 months of the atezolizumab group; the 24-month OS rates of the two groups were 32.2% and 17.6%, respectively, with overall comparable safety and no new safety signals identified. These results not only confirm the clinical benefit of serplulimab, but also support the conclusion of the global multicenter Phase III ASTRUM-005 study being extrapolatable to the U.S. patient population.
In addition, the H drug has also made positive progress in the field of lung cancer quality of life. The quality-of-life analysis results of the ASTRUM-002 and ASTRUM-004 studies show that serplulimab combined with chemotherapy can prolong the time to deterioration in overall health status/quality of life for non-small cell lung cancer patients, and is associated with improvement in multiple symptoms such as cough, dyspnea, and hemoptysis. In the field of gastrointestinal tumors, the quality-of-life analysis of the ASTRUM-007 study indicates that serplulimab combined with chemotherapy did not adversely affect patients' quality of life; multiple investigator-initiated clinical studies explored the value of the H drug in different treatment stages of esophageal cancer and in neoadjuvant treatment of colorectal cancer. At the same time, the H drug has also achieved positive data in the exploration of extrapulmonary neuroendocrine carcinoma and renal cancer, released respectively in the form of a rapid oral presentation and a poster.
As the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer, the H drug has currently been approved for marketing in more than 50 countries and regions worldwide, covering nearly half of the global population, and has been included in local medical insurance payment systems in more than ten countries. Relying on the positive data of this U.S. bridging study, the internationalization process of the H drug is expected to accelerate, bringing more immunotherapy options to patients with solid tumors worldwide.
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