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奥赛康创新药战略再添核心拼图 利厄替尼片一线适应症获批上市

Core Viewpoint - The approval of Liratinib tablets for first-line treatment marks a significant breakthrough for the company in the field of targeted therapy for lung cancer, expanding its innovative drug strategy [1][2][8] Company Developments - The company’s subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for Liratinib tablets, which are indicated for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2] - Liratinib is a third-generation EGFR TKI developed collaboratively with the Chinese Academy of Sciences, featuring independent intellectual property rights and significant efficacy [1][2] Clinical Data and Efficacy - Clinical trials for Liratinib showed an objective response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%, with a median duration of response (DoR) of 11.1 months and a median progression-free survival (PFS) of 11.0 months [4] - The drug demonstrated good efficacy in patients with central nervous system (CNS) metastases, with an ORR of 65.9% and a median PFS of 10.6 months [4] Market Potential and Commercialization - The domestic EGFR TKI market exceeds 20 billion yuan, and with the exclusive commercialization partnership with Innovent Biologics, Liratinib is expected to accelerate market penetration due to its efficacy and pricing advantages [5] - The company reported a net profit of 160 million yuan in 2024, indicating a turnaround and potential for stock price recovery and value reassessment [5] Research and Development Focus - The company has a robust pipeline with 42 ongoing projects, including 10 key innovative drugs in clinical research, and continues to invest heavily in R&D, with 354 million yuan allocated in 2024 [6][7] - The company aims to enhance its competitive edge by focusing on the development of small molecule targeted innovative drugs and tumor immunobiological innovative drugs [7][8]