Core Insights - The company has initiated the clinical trial of GFH375 in combination therapies for treating KRAS G12D mutant advanced solid tumors, marking a significant step in its clinical development [1][2] Group 1: Clinical Trials and Research - GFH375 has received approval for clinical trials from the National Medical Products Administration, with the first patient enrolled at Peking University Cancer Hospital [1] - The trial (GFH375X1202) will evaluate the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in combination with cetuximab or chemotherapy in approximately 15 centers [1] - The Ib phase will focus on assessing the combination of GFH375 with chemotherapy as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1] Group 2: Product Development and Efficacy - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - Clinical data for GFH375 as a monotherapy for PDAC and non-small cell lung cancer (NSCLC) has shown promising efficacy, with recent presentations at ESMO and WCLC [2] - The drug has been granted FDA Fast Track designation for use in treating locally advanced and metastatic KRAS G12D mutant PDAC patients [2] Group 3: Strategic Partnerships - The company has entered into a licensing and early collaboration agreement with Verastem for three products related to RAS/MAPK-driven cancers [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights for development and commercialization outside Greater China, while the company retains rights within China [3]
劲方医药-B(02595)：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药