HENLIUS (02696) announced that Hansizhuang® (Serplulimab Injection) combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer has been officially included in the Breakthrough Therapy Designation Program by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Hansizhuang®, an innovative anti-PD-1 monoclonal antibody independently developed by the company, has already received approval in mainland China for indications including first-line treatment of squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) in combination with chemotherapy. Additionally, Hansizhuang® has been approved for marketing in the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea. The company is also advancing multiple global clinical trials for Hansizhuang® and related combination therapies, covering indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer.