Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its self-developed innovative anti-PD-1 monoclonal antibody, Hansizhuang® (Sruvilizumab), has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) for use in neoadjuvant therapy combined with platinum-based chemotherapy for PD-L1 positive, resectable gastric cancer patients, and has been included in the priority review process [1] Group 1 - The acceptance of the NDA and inclusion in the priority review process will significantly shorten the review timeline to 130 working days, accelerating the market entry process for Hansizhuang in the perioperative treatment of gastric cancer [1] - Hansizhuang is expected to become the world's first approved anti-PD-1 monoclonal antibody for this indication, marking a significant milestone in the treatment of gastric cancer [1] - The CEO of Junshi Biosciences, Dr. Jun Zhu, stated that this acceptance signifies the formal entry of Hansizhuang into the "fast track" for market approval, highlighting the potential for improved patient quality of life and survival benefits [1] Group 2 - Previously, Hansizhuang was included in the breakthrough therapy designation list by the Center for Drug Evaluation (CDE), being the first drug recognized in the perioperative treatment field for gastric cancer [1] - The CDE agreed to include Hansizhuang in the priority review process due to its alignment with the criteria for expedited evaluation [1]
创新突破！复宏汉霖H药胃癌围手术适应症申报上市并被纳入优先审评 有望加速上市 引领癌症治疗“免化疗”新时代”