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劲方医药-B分子胶Pan RAS(ON)抑制剂GFH276治疗RAS突变型癌症患者的I/II期临床试验首位患者完成入组

Core Viewpoint - The announcement highlights the initiation of the clinical trial for GFH276, a novel Pan RAS(ON) inhibitor developed by the company, targeting RAS mutation-driven advanced solid tumors, with significant market potential as no similar drugs are currently approved globally [1][2]. Group 1: Clinical Development - GFH276 has entered the I/II phase clinical trial, with the first patient enrolled recently, following approval from the National Medical Products Administration [1]. - The trial will be conducted at approximately 10 research centers, including Sun Yat-sen University Cancer Center and Fudan University Shanghai Cancer Center, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy [1]. - GFH276 is the third RAS-targeted therapy from the company's pipeline to enter clinical research, following the successful launch of GFH925 and the development of GFH375 [1]. Group 2: Market Potential - According to Frost & Sullivan, the global cancer incidence is expected to reach nearly 22 million by 2025, with approximately 30% (over 6.5 million) of patients having tumors with various RAS gene mutations [1]. - GFH276 is positioned among the top three global candidates in the Pan RAS(ON) inhibitor space, indicating a strong competitive advantage [1]. Group 3: Mechanism of Action - GFH276 is a unique oral molecular glue that employs a three-complex mechanism (CypA-GFH276-RAS) to effectively inhibit both wild-type and mutant RAS proteins, including common KRAS mutations [3]. - Preclinical studies demonstrate dose-dependent anti-tumor activity of GFH276, promoting tumor regression in various KRAS-mutant tumor models, and it is expected to overcome limitations of existing therapies related to adaptive and acquired resistance [3]. Group 4: Company Insights - The Chief Medical Officer of the company emphasized the accumulated experience in RAS-targeted therapy development through the successful launches of GFH925 and GFH375, highlighting the innovative product matrix in RAS therapies [2].