RAS靶向疗法

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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
Zhi Tong Cai Jing· 2025-09-29 12:46
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].
劲方医药-B(02595)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
智通财经网· 2025-09-29 12:44
GFH276可靶向抑制多数活化状态的野生╱突变型RAS蛋白。根据2025年AACR 年会壁报数据:GFH276 在多种RAS突变肿瘤模型中,显示了相较于海外同类产品的更低起效剂量和更佳药代动力学特征,并在 激酶选择性和安全相关靶点测试中展现良好的安全性及靶向特异性;此外在多种机理诱导的KRAS抑制剂 耐药细胞系中,均保持强效活性、显示多重抗耐药潜力。 劲方首席医学官汪裕博士表示:"通过氟泽雷塞和GFH375的成功开发,我们已经积累了丰富的RAS靶向 疗法研发经验。GFH276是劲方管线中首个进入临床研究的分子胶产品,公司自研的EGFR-Pan RAS ADC也进入临床申报阶段。多靶点、多元化分子形态的创新产品展现了公司RAS疗法矩阵的深度。我 们也期待GFH276在临床研究中展现良好疗效、造福全球患者。" 智通财经APP讯,劲方医药-B(02595)发布公告,GFH276治疗RAS突变型晚期实体瘤的I/II期试验首例患 者近日已完成入组。国家药品监督管理局已于9月初批准GFH276进入一项开放标签及多中心研究的临床 试验申请,该产品为劲方自主开发的分子胶Pan RAS(ON) 抑制剂、拥有全球权益。 弗若斯特 ...
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
Ge Long Hui· 2025-09-29 12:42
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) - 自愿公告 分子胶Pan RAS(ON)抑制剂GFH276治疗RAS突...
2025-09-29 12:34
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容引致的任何損失承擔任何責任。 GenFleet Therapeutics (Shanghai) Inc. 勁方醫藥科技(上海)股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2595) 勁方首席醫學官汪裕博士表示:「通過氟澤雷塞和GFH375的成功開發,我們已 經積累了豐富的RAS靶向療法研發經驗。GFH276是勁方管線中首個進入臨床研 究的分子膠產品,公司自研的EGFR-Pan RAS ADC也進入臨床申報階段。多靶 點、多元化分子形態的創新產品展現了公司RAS療法矩陣的深度。我們也期待 GFH276在臨床研究中展現良好療效、造福全球患者。」 關於RAS蛋白及GFH276 RAS蛋白為二元分子開關,在與GDP(二磷酸鳥苷)結合的失活狀態和與GTP(三 磷酸鳥苷)結合的活化狀態之間切換,以此調控RAF-MEK-ERK、PI3K-AKT- mTOR等通路。RAS的致癌突變導致其GTP水解酶活性被破壞,從而令RAS蛋白 ...
港股异动 | 劲方医药-B(02595)涨超11% 公司研究数据亮相AACR年会 目前已形成R...
Xin Lang Cai Jing· 2025-09-24 03:29
Group 1 - The stock of Jinfang Pharmaceutical-B (02595) increased by over 11%, currently up 10.67% at HKD 43.78, with a trading volume of HKD 78.4735 million [1] - At the recent American Association for Cancer Research (AACR) annual meeting, numerous Chinese new drug research companies had their product research abstracts selected, with RAS-targeted therapies and antibody/antibody-drug conjugates being popular areas for small and large molecules [1] - Jinfang Pharmaceutical's pipeline includes three innovative products (GFH276, GFS202A, GFH375) that were featured in the poster session of the AACR meeting, indicating their leading position in the domestic targeted therapy landscape and targeting multiple broad indications [1] Group 2 - Guotou Securities noted that Jinfang Pharmaceutical is a globally positioned innovative drug development company focusing on unmet clinical needs in oncology and immune-related diseases [2] - The company has established an integrated matrix for RAS-targeted therapies and is actively expanding its pipeline to include other "global new" targeted drugs and novel therapies [2] - The most noteworthy product in the pipeline is the core KRAS G12D inhibitor GFH375, which has shown positive data in pancreatic cancer and non-small cell lung cancer (NSCLC), with future clinical progress being closely monitored [2]
劲方医药-B涨超11% 公司研究数据亮相AACR年会 目前已形成RAS靶向疗法矩阵
Zhi Tong Cai Jing· 2025-09-24 03:28
Group 1 - The core viewpoint is that Jingfang Pharmaceutical-B (02595) has seen a significant stock increase of over 11%, currently trading at 43.78 HKD with a transaction volume of 78.47 million HKD, driven by positive developments in its drug pipeline presented at the AACR annual meeting [1] - The AACR annual meeting highlighted the advancements in RAS-targeted therapies and antibody-drug conjugates, with Jingfang's three products (GFH276, GFS202A, GFH375) being recognized in the poster session, showcasing their leading position in the domestic market for targeted therapies [1] - The company’s pipeline demonstrates innovation and diversity, targeting multiple broad indications, which reflects its strong research capabilities in the oncology sector [1] Group 2 - Guotou Securities notes that Jingfang Pharmaceutical is a globally positioned innovative drug development company focusing on unmet clinical needs in oncology and immune-related diseases [2] - The company has established an integrated matrix for RAS-targeted therapies and is actively expanding its pipeline to include other global new targeted drugs and novel therapeutic types [2] - The core product of interest is the KRAS G12D inhibitor GFH375, which has shown positive data in pancreatic cancer and NSCLC, indicating promising future clinical developments [2]
港股异动 | 劲方医药-B(02595)涨超11% 公司研究数据亮相AACR年会 目前已形成RAS靶向疗法矩阵
智通财经网· 2025-09-24 03:27
Group 1 - The stock price of Jinfang Pharmaceutical-B (02595) increased by over 11%, reaching 43.78 HKD with a trading volume of 78.47 million HKD [1] - At the recent American Association for Cancer Research (AACR) annual meeting, numerous Chinese new drug research enterprises had their product research abstracts selected, with RAS-targeted therapies and antibody/antibody conjugate drugs being prominent areas of focus [1] - Jinfang Pharmaceutical's pipeline includes three innovative products (GFH276, GFS202A, GFH375) that were featured in the poster session of the AACR meeting, indicating their leading position in the domestic targeted therapy landscape [1] Group 2 - Guotou Securities highlighted that Jinfang Pharmaceutical is a globally positioned innovative drug development company focusing on unmet clinical needs in oncology and immune-related diseases [2] - The company has established an integrated matrix for RAS-targeted therapies and is actively expanding its pipeline to include other global new targeted drugs and novel therapy types [2] - The core product of interest in the pipeline is the KRAS G12D inhibitor GFH375, which has shown positive data in pancreatic cancer and non-small cell lung cancer (NSCLC) [2]