Workflow
复星医药子公司斯鲁利单抗注射液纳入突破性治疗药物程序
Bei Jing Shang Bao·2025-11-20 12:01

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received inclusion in the breakthrough therapy designation for its independently developed drug, Surulitinib injection, for the treatment of gastric cancer, which is a significant milestone as no PD-1 targeted monoclonal antibody has been approved for this indication globally [1] Group 1 - The drug Surulitinib (marketed as Hanshuang in China) is intended for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - The inclusion in the breakthrough therapy program is expected to expedite the review and market launch process for this indication in China [1] - As of the announcement date, there are no approved PD-1 targeted monoclonal antibodies for neoadjuvant/adjuvant treatment of gastric cancer worldwide [1]