Core Viewpoint - The approval of the innovative ALK inhibitor, Dirocitinib (formerly known as "Dahitinib"), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Xuan Bamboo Biotechnology and provides a breakthrough treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Approval and Significance - Dirocitinib is the third innovative drug approved for Xuan Bamboo Biotechnology and the second innovative oncology drug, showcasing the company's continuous advancement in targeted therapies from breast cancer to lung cancer [1] - The approval represents an important research and development milestone for Xuan Bamboo's innovative drug pipeline, contributing to the acceleration of cancer prevention and treatment goals under the "Healthy China 2030" initiative [2] Group 2: Drug Advantages - Dirocitinib has four core advantages: rapid onset of action, superior tumor suppression, prolonged relief for patients, and significant survival benefits, achieving the goal of chronic disease management [1] - The drug effectively penetrates the blood-brain barrier, addressing existing therapies' shortcomings in central nervous system protection, while demonstrating a favorable safety profile with manageable side effects [2] Group 3: Clinical Impact - In pivotal Phase III clinical trials, Dirocitinib showed significant efficacy compared to existing first- and second-generation ALK inhibitors, particularly against resistant mutations such as G1202R and I1171N [1] - The drug's safety profile includes primarily mild gastrointestinal reactions, with reduced risks of pleural effusion and hepatotoxicity, enhancing long-term medication adherence among patients [2]
四环医药(00460.HK)：轩竹生物自研创新药地罗阿克片获国家药监局上市批准