HENLIUS (02696) H-Drug ESMO 2026 Preview: U.S. Bridging Study to Be Presented Orally, Adding New Evidence for the World's First Anti-PD-1 Monoclonal Antibody in First-Line Lung Cancer Treatment

On October 19, 2026 local time, the European Society for Medical Oncology (ESMO) Annual Congress published research abstracts. A total of 10 studies on HENLIUS (02696)'s core product, the innovative anti-PD-1 monoclonal antibody H-drug Hansizhuang (serplulimab, European trade name Hetronifly), were selected for this year's congress, among which the U.S. bridging ASTRIDE study will be presented as an oral report, supplementing key clinical evidence in the U.S. native population for this world's first anti-PD-1 monoclonal antibody 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 ES-SCLC clinical trial in terms of U.S. enrollment among those that have completed enrollment, and was independently executed by a local team. Abstract data showed that at a median follow-up of 14.1 months, the median overall survival (OS) in the serplulimab group was 12.4 months, superior to 10.2 months in the atezolizumab group; the 24-month OS rates in 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 extrapolation of the conclusions of the global multicenter Phase III ASTRUM-005 study to the U.S. patient population. In addition, H-drug has also made positive progress in the field of quality of life in lung cancer. Quality-of-life analysis results from the ASTRUM-002 and ASTRUM-004 studies showed that serplulimab combined with chemotherapy can prolong the time to deterioration in overall health status/quality of life in patients with non-small cell lung cancer and is associated with improvements in multiple symptoms such as cough, dyspnea, and hemoptysis. In the field of gastrointestinal tumors, quality-of-life analysis from the ASTRUM-007 study indicated that serplulimab combined with chemotherapy did not adversely affect patients' quality of life; multiple investigator-initiated clinical studies explored the value of H-drug in different treatment stages of esophageal cancer and in neoadjuvant treatment of colorectal cancer. Meanwhile, H-drug has also achieved positive data in the exploration of extrapulmonary neuroendocrine carcinoma and renal cancer, published as a rapid oral presentation and a poster, respectively. As the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer, H-drug has currently been approved and marketed 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. Supported by the positive data from this U.S. bridging study, the internationalization process of H-drug is expected to accelerate, bringing more immunotherapy options to patients with solid tumors worldwide.