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劲方医药-B尾盘涨超8% GFH375片启动III期临床 适应症为转移性胰腺癌
Zhi Tong Cai Jing· 2025-11-13 08:01
Core Viewpoint - Jinfang Pharmaceutical-B (02595) experienced a significant stock price increase, rising over 8% towards the end of trading, with a current price of 31.1 HKD and a trading volume of 28.08 million HKD [1] Group 1: Clinical Trial Announcement - On November 11, Jinfang Pharmaceutical announced the initiation of a Phase III clinical trial comparing the efficacy and safety/tolerability of GFH375 monotherapy versus investigator-selected chemotherapy for patients with KRAS G12D mutated metastatic pancreatic cancer [1] - The company’s prospectus indicates that GFH375 is being developed as a first-in-class oral G12D inhibitor, with plans for the monotherapy to enter Phase I/II trials by June 2024 [1] - GFH375/VS-7375 has received FDA Fast Track designation this year, allowing it to be used for first-line and subsequent treatment of locally advanced and metastatic KRAS G12D mutated PDAC patients [1] Group 2: Previous Data Presentation - Early data on GFH375 monotherapy for solid tumors was presented at prestigious international academic conferences such as ASCO and WCLC this year, through late-breaking abstracts and oral presentations [1]
港股异动 | 劲方医药-B(02595)尾盘涨超8% GFH375片启动III期临床 适应症为转移性胰腺癌
智通财经网· 2025-11-13 07:58
智通财经APP获悉,劲方医药-B(02595)尾盘涨超8%,截至发稿,涨7.46%,报31.1港元,成交额2808.49 万港元。 消息面上,11月11日,药物临床试验登记与信息公示平台显示,劲方医药开启了一项比较GFH375单药 与研究者选择化疗治疗KRAS G12D突变型经治转移性胰腺癌患者的有效性及安全性/耐受性的多中心、 开放标签、随机对照的III期临床研究。 据该公司招股书显示,GFH375开发为口服G12D抑制剂第一梯队,该产品单药疗法于2024年6月获批进 入I/II期试验,GFH375/VS-7375今年已获得FDA快速通道资格认定,可用于一线及后线治疗局部晚期、 转移性KRAS G12D突变型PDAC患者;此前GFH375单药治疗实体瘤早期数据在今年ASCO、WCLC等 权威国际学术会议中以LBA及口头报告等形式披露。 ...