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胃癌围手术期免疫单药治疗
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复宏汉霖开创胃癌围手术期免疫单药治疗新时代 市场潜力超60亿美元H药独占先机
Xin Lang Zheng Quan· 2025-10-14 07:24
Core Insights - Fuhong Hanlin's PD-1 inhibitor H drug (Surulitinib) has achieved primary endpoints in the ASTRUM-006 clinical trial for perioperative gastric cancer, marking it as the first immunotherapy to replace postoperative chemotherapy in this context [1][4] - The study demonstrated significant improvements in event-free survival (EFS) and a pathological complete response (pCR) rate over three times that of the control group, while also reducing recurrence risk [1][3] Group 1: Clinical Significance - Gastric cancer poses a major public health challenge, with approximately 969,000 new cases and 660,000 deaths globally in 2022, making it the fifth highest in incidence and mortality among all cancers [2] - Current standard treatment for perioperative gastric cancer is chemotherapy, but recurrence rates remain high at 40%-70%, with five-year survival rates below 50% [2] - The ASTRUM-006 trial is a randomized, double-blind, multi-center Phase III study aimed at evaluating the clinical efficacy and safety of H drug in early gastric cancer patients [2] Group 2: Innovative Treatment Strategy - The ASTRUM-006 study features an innovative treatment strategy, utilizing H drug in combination with chemotherapy during the neoadjuvant phase and transitioning to monotherapy in the adjuvant phase, replacing traditional postoperative chemotherapy [2][3] - The independent data monitoring committee confirmed that the study met pre-set superiority standards, showing significant improvements in EFS and pCR rates compared to the control group [3] Group 3: Market Potential - The global market for gastric cancer drugs is projected to grow from $22.1 billion in 2024 to $36.4 billion by 2030, with the perioperative gastric cancer market potential estimated at $6-7 billion [5] - H drug, already approved in nearly 40 countries for small cell lung cancer, is now the first to secure approval for perioperative gastric cancer treatment, indicating a long market exclusivity period [5]