Core Viewpoint - The company, Fuhong Hanlin, has received acceptance for its New Drug Application (NDA) for the innovative anti-PD-1 monoclonal antibody, Hanshuozhuang (Slulizumab), for use in combination with platinum-based chemotherapy in the neoadjuvant and postoperative adjuvant treatment of PD-L1 positive, resectable gastric cancer patients, which has been prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The acceptance of the NDA and its inclusion in the priority review process will significantly shorten the review timeline to 130 working days, accelerating the market entry of Hanshuozhuang for perioperative treatment of gastric cancer [1] - Gastric cancer is a highly prevalent malignancy globally, with high incidence and mortality rates, and there is an urgent clinical need for effective therapies in the perioperative setting, as no immunotherapy has been approved in China for this phase [1] Group 2 - The NDA is primarily based on the positive results from the key study ASTRUM-006, which showed that Hanshuozhuang combined with chemotherapy significantly improved event-free survival (EFS) and pathological complete response (pCR) rates compared to the control group, with a notable reduction in recurrence risk and manageable overall safety [2] - Hanshuozhuang, as a core anti-tumor drug for the company, demonstrates unique advantages in treating various solid tumors due to its differentiated mechanism, which enhances T cell activation and preserves CD28 signaling [2] - Currently, Hanshuozhuang has been approved for multiple indications, including squamous non-small cell lung cancer, and is available in over 40 countries, covering nearly half of the global population [2]
锁定胃癌重大适应症！复宏汉霖H药胃癌围手术适应症申报上市获优先审评