劲方首席医学官汪裕博士表示："这是全球首个口服RAS抑制剂治疗胰腺癌的注册性临床研究，这一重 要里程碑体现了劲方临床团队的临床研发和执行能力、以及公司深耕于RAS疗法矩阵的一体化新药开发 实力。GFH375在去年进入临床试验，今年就已获得优秀的单药I/II期研究数据，并在近期进入多项单 药、联合疗法试验，我们期待该产品在这项注册性研究(GFH375X1301)中取得积极结果、早日造福患 者。我们也期待以GFH375为代表的劲方RAS靶向药物在未来实现更多突破，并与公司的恶病质双抗疗 法形成靶向胰腺癌的协同性治疗矩阵。" 智通财经APP讯，劲方医药-B(02595)发布公告，口服KRAS G12D (ON/OFF)抑制剂GFH375治疗经治 KRAS G12D突变型转移性胰腺癌患者的注册性III期试验(GFH375X1301)已在北京大学肿瘤医院启动。 目前GFH375开发进度位于全球口服KRAS G12D抑制剂第一梯队，多项GFH375(于中国境外称VS-7375) 单药和联合疗法正在中国(由劲方主导)及海外(由劲方合作伙伴Verastem Oncology主导)进行临床探索， 包括 GFH375联合化疗(白 ...

这项多中心、开放标签、随机对照的III期试验(GFH375X1301)将在约40家中心开展，计划入组约320例 既往接受至少一种标准系统性治疗的转移性胰腺癌患者。沙利文资料显示2037年全球胰腺癌新发病例将 超过77万人，胰腺癌恶性程度高、预后极差，5年生存率不足10%；目前胰腺癌治疗仍以化疗药物为 主，二线至三线客观缓解率(ORR)仅为10-20%，三线及以上治疗尚无标准治疗方案。科研文献显示近 40%胰腺癌患者存在KRAS G12D突变，而全球尚无相关靶向药获批上市；KRAS G12D突变是晚期 PDAC应答率及总生存期不佳的独立预后标志物，且KRAS G12D突变在调节性T细胞转化过程中发挥关 键作用，可促进形成免疫抑制性肿瘤微环境、并导致患者对免疫检查点抑制剂应答不佳。 格隆汇12月5日丨劲方医药-B(02595.HK)宣布，口服KRAS G12D (ON/OFF)抑制剂GFH375治疗经治 KRAS G12D突变型转移性胰腺癌患者的注册性III期试验(GFH375X1301)已在北京大学肿瘤医院启动。 目前GFH375开发进度位于全球口服KRAS G12D抑制剂第一梯队，多项GFH375(于中国境外 ...

Core Viewpoint - Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, achieving a significant increase in share price and setting a new fundraising record for the Hong Kong 18A sector since 2022 [1][4] Company Overview - Jinfang Pharmaceutical was established in 2017, focusing on innovative and effective treatments for oncology, autoimmune, and inflammatory diseases. The company has not yet achieved profitability [2] - The company has a unique advantage in its forward-looking layout and deep cultivation of RAS therapy, which is a common mutation gene family driving about one-third of tumor occurrences [2] Product Pipeline - The core of Jinfang Pharmaceutical's research and development pipeline is RAS-targeted drugs, with eight candidate drugs in total. GFH925 is the first KRAS G12C selective inhibitor approved in China, and GFH375 targets KRAS G12D mutations, filling a treatment gap [3] - The company has established a highly integrated R&D platform covering target discovery, molecular design and evaluation, translational science, and global clinical development, with a research efficiency higher than industry peers [3] Financial Performance - Due to significant investment in innovative drug development, Jinfang Pharmaceutical faces substantial debt pressure. R&D expenses from 2022 to 2024 are projected to exceed revenues, with losses increasing each year [4] - The company's debt-to-asset ratio is projected to reach 422.38% by 2024, indicating a challenging financial landscape [4] Strategic Vision - The chairman of Jinfang Pharmaceutical emphasized the creation of a "compound" pipeline, focusing on major unmet clinical needs in global markets such as pancreatic cancer, lung cancer, and colorectal cancer [4] - The CEO stated that the listing marks an important milestone for the company, aiming to build closer and more trusting relationships with investors while continuing to create value for shareholders and society [4]

Core Viewpoint - The article highlights the successful IPO of Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd., marking it as the first biotech company in the Hong Kong IPO phase to hold both a listed new drug and multiple BD (business development) revenue streams [3][5]. Group 1: IPO Details - Jinfang Pharmaceutical officially listed on the Hong Kong Stock Exchange on September 19, 2025, under the stock code "2595" [3]. - The IPO raised a total of $268 million, setting a record for the Hong Kong 18A biotech sector since 2022 [3]. - The cornerstone investment of $100 million also marked a new high for Hong Kong 18A biotech companies since 2022 [3]. Group 2: Company Overview - Founded in 2017, Jinfang focuses on innovative and effective treatment solutions for oncology, autoimmune, and inflammatory diseases, targeting unverified innovative targets and indications with global intellectual property rights [6]. - The company has established a comprehensive and differentiated RAS product matrix, with eight candidate drugs, five of which are in clinical stages, addressing treatment needs for various advanced solid tumors [6]. Group 3: Key Products - The core product GFH925 (Fluorazepine Tablets) is the first KRAS-targeted drug approved in China for treating KRAS G12C mutation non-small cell lung cancer (NSCLC) [6]. - GFH375 (oral KRAS G12D inhibitor) shows promising treatment potential for advanced solid tumors, with ongoing clinical trials and FDA fast track designation for specific indications [7][8]. Group 4: Strategic Partnerships and Revenue - Jinfang has recorded revenue through external collaborations, including a domestic licensing agreement with Innovent Biologics for GFH925 in 2021 [8]. - The company has also secured overseas licensing agreements for GFH009 and GFH375, indicating a robust business development strategy [8]. Group 5: Investor Support - Notable investors include Dinghui Investment and Huagai Capital, both holding over 5% of the company’s shares prior to the IPO [9][10]. - Investors express confidence in Jinfang's potential for sustainable growth and its ability to create value for shareholders and society [10][12].