Core Viewpoint - The company, Junshi Biosciences, has received acceptance for its New Drug Application (NDA) for the innovative anti-PD-1 monoclonal antibody, Hanshuo® (Surufilumab), for use in perioperative treatment of PD-L1 positive, resectable gastric cancer, which has been included in the priority review process by the National Medical Products Administration (NMPA) [1][2] Group 1 - The acceptance into the priority review process means that the review timeline will be significantly shortened to 130 working days, accelerating the market entry process for Hanshuo in the perioperative treatment indication [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][2] Group 2 - The NDA is primarily based on the positive results from the key study ASTRUM-006, which showed that Hanshuo 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] - Hanshuo has demonstrated unique advantages in treating various solid tumors due to its differentiated mechanism, including stronger PD-1 internalization and enhanced T cell activation [2] - Currently, Hanshuo is approved for multiple indications, including squamous non-small cell lung cancer, and has been approved 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(02696)H药胃癌围手术适应症申报上市获优先审评