Core Viewpoint - GFH276, a novel Pan RAS(ON) inhibitor developed by the company, has entered clinical trials for treating RAS-mutated advanced solid tumors, marking a significant advancement in the company's oncology pipeline [1][2] Group 1: Clinical Development - The first patient has been enrolled in the Phase I/II trial of GFH276, which was approved by the National Medical Products Administration in early September [1] - The Phase I 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] Group 2: Market Context - According to Frost & Sullivan, the global cancer incidence is expected to reach nearly 22 million by 2025, with about 30% (over 6.5 million) of patients having tumors with various RAS gene mutations [1] - Currently, there are no approved pan-RAS targeted therapies globally, positioning GFH276 among the top three in the development of Pan RAS(ON) inhibitors [1] Group 3: Competitive Advantage - GFH276 demonstrates lower effective doses and better pharmacokinetic properties compared to similar overseas products, along with good safety and specificity in kinase selectivity tests [2] - The drug maintains strong efficacy against multiple KRAS inhibitor-resistant cell lines, indicating potential for overcoming drug resistance [2] Group 4: Company Strategy - The company has gained substantial experience in RAS-targeted therapy development through the successful launch of the KRASG12C inhibitor, Furazadore (GFH925), and is advancing GFH375, an oral KRASG12D inhibitor [1][2] - GFH276 is the first molecular glue product to enter clinical research in the company's pipeline, reflecting a diversified approach to RAS therapies [2]
劲方医药-B(02595.HK)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