宗艾替尼在华获批 用于非小细胞肺癌治疗

Core Insights - The National Medical Products Administration of China has conditionally approved Zongaitini tablets for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy [1][2] Group 1: Market Context - Lung cancer is the leading cause of cancer-related deaths globally, with an estimated incidence exceeding 3 million cases by 2040. Non-small cell lung cancer is the most common pathological type, and patients typically present at an advanced stage, with a 5-year survival rate of less than 30% [1] - There is a significant unmet medical need for advanced NSCLC patients, particularly those with HER2 mutations, which lead to uncontrolled cell proliferation and tumor growth [1] Group 2: Product Overview - Zongaitini is the first and only oral HER2 tyrosine kinase inhibitor approved globally, previously receiving "breakthrough therapy designation" and "priority review" status in China. It is co-promoted by Boehringer Ingelheim and China National Pharmaceutical Group [2] - The conditional approval is based on positive results from the Beamion-LUNG 1 study, which demonstrated an objective response rate (ORR) of 71% in treated patients, with 7% achieving complete response. The disease control rate (DCR) was 96%, with a median duration of response (DoR) of 14.1 months and a median progression-free survival (PFS) of 12.4 months [2] - The safety profile of Zongaitini is manageable, with a treatment interruption rate of only 2.9% reported in the study [2] Group 3: Expert Commentary - Professor Wu Yilong, Chairman of the Chinese Society of Thoracic Oncology, emphasized that the approval of Zongaitini addresses a critical challenge in NSCLC treatment, providing a new benchmark for HER2-mutated advanced NSCLC patients. This innovative drug offers an efficient, targeted, and oral treatment option for a patient group with poor prognosis and limited treatment choices [3] - Zongaitini's selective design effectively avoids severe skin or gastrointestinal adverse reactions associated with traditional treatments that inhibit EGFR, significantly improving patient tolerance and quality of life [3]