Core Viewpoint - The company Fuhong Hanlin (2696.HK) announced that its innovative PD-1 inhibitor, H drug (Han's Zhuang®), has been officially included in the National Medical Products Administration (NMPA) breakthrough therapy list for use in combination with chemotherapy for new adjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized by the NMPA for perioperative treatment of gastric cancer [1] Group 1 - The H drug has achieved significant clinical milestones, including reaching the primary endpoint in its Phase III clinical study, which demonstrated a significant reduction in recurrence risk and an increase in cure opportunities for gastric cancer patients [1] - This therapy is the first in the world to replace postoperative adjuvant chemotherapy with a single-agent immunotherapy for perioperative treatment of gastric cancer, potentially offering dual benefits of survival improvement and enhanced quality of life for patients [1] - The inclusion in the breakthrough therapy program allows the company to apply for conditional approval and priority review during the drug listing application process, which could accelerate the review and market launch of the H drug [1] Group 2 - Currently, there are no approved immunotherapies for perioperative treatment of gastric cancer globally, highlighting the potential market opportunity for the H drug [1] - The recognition of the H drug as a breakthrough therapy underscores its clinical value and potential in the field of gastric cancer treatment, filling a significant gap in immunotherapy options [1] - Following the announcement, the company's stock rose by 4.89% to HKD 67.6, marking a 185% increase year-to-date and a rebound of over 3.4 times from its year-to-date low on January 23 [1]
全球首个胃癌围术期“免化疗”方案！复宏汉霖(2696.HK)连续两日逆势上涨 旗下H药获中国药监局突破性疗法认定