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]

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 ...