劲方首席医学官汪裕博士表示："从去年临床获批以来，GFH375研究展现了快速的临床进展和优秀疗 效。KRAS G12D突变患者存在巨大的未满足临床需求，我们期待通过规划后线治疗的关键性研究和前 线治疗的联合治疗研究，在GFH375临床开发中取得进一步突破。" 劲方医药-B(02595)发布公告，GFH375单药治疗KRAS G12D突变型胰腺导管腺癌(PDAC)患者数据于德 国当地时间10月19日登陆2025年欧洲肿瘤内科学会(ESMO)年会的突破性研究摘要(LBA)和口头报告。 此次口头报告由中国医学科学院肿瘤医院周爱萍教授完成，该报告标题为"GFH375治疗经治晚期KRAS G12D突变型PDAC患者的疗效及安全性"(摘要编号：LBA84)。报告聚焦该试验600mg QD(RP2D)剂量组 PDAC患者的研究数据，显示GFH375治疗PDAC患者的疗效突出且安全性可控。 GFH375为口服高活性、高选择性小分子KRAS G12D(ON/OFF)抑制剂，通过非共价形式结合KRAS G12D蛋白，抑制其与下游效应蛋白结合，从而在细胞中破坏KRAS G12D对下游通路的持续活化，最终 高效抑制肿瘤细胞增殖。临床 ...

GFH375单药疗法于2024年6月获国家药监局批准进入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。 劲方首席医学官汪裕博士表示："从去年临床获批以来，GFH375研究展现了快速的临床进展和优秀疗 效。KRAS G12D突变患者存在巨大的未满足临床需求，我们期待通过规划后线治疗的关键性研究和前 线治疗的联合治疗研究，在GFH375临床开发中取得进一步突破。" 智通财经APP讯，劲方医药-B(02595)发布公告，GFH375单药治疗KRAS G12D突变型胰腺导管腺癌 (PDAC)患者数据于德国当地时间10月19日登陆2025年欧洲肿瘤内科学会(ESMO) 年会的突破性研究摘 要(LBA)和口头报告。此次口头报告由中国医学科学院肿瘤医院周爱萍教授完成，该报告标题 为"GFH375治疗经治晚期KRAS G12D突变型PDAC患者的疗效及安全性"(摘要编号：LBA84)。报告聚 焦该试验60 ...

Group 1: Core Insights - The recent approval of Jinfang Pharmaceutical's IPO marks a significant milestone for the Hong Kong innovative drug market, indicating an expansion of the 18A gate for new listings [1] - Jinfang Pharmaceutical focuses on KRAS mutations, particularly the KRAS G12C inhibitor, Fulzerasib, which is gaining attention in the market [1][5] - The global KRAS G12C inhibitor market is projected to grow from $489 million in 2024 to $3.491 billion by 2033, with a compound annual growth rate (CAGR) of 24.4% [3] Group 2: KRAS Market Dynamics - KRAS mutations account for approximately 14% of all cancer cases, with pancreatic cancer (88%), colorectal adenocarcinoma (50%), and lung adenocarcinoma (32%) being the most affected types [1] - The first KRAS G12C inhibitor, Sotorasib, had disappointing sales of $350 million in 2024, indicating challenges in market penetration [2][3] - Mirati Therapeutics' Adagrasib, another KRAS G12C inhibitor, is also underperforming with projected sales of $118 million in 2024 [3] Group 3: Fulzerasib's Potential - Fulzerasib has shown promising results in clinical trials for non-small cell lung cancer (NSCLC), achieving a confirmed overall response rate (cORR) of 49.1% [5][11] - The drug is positioned as a strong competitor in the KRAS G12C inhibitor market, potentially surpassing the first-in-class Sotorasib [11] - Fulzerasib is also expanding its indications to colorectal cancer, where it has demonstrated a cORR of 44.6% in early trials [9][11] Group 4: Business Development and Financials - Jinfang Pharmaceutical has secured significant partnerships, including a global exclusive licensing agreement with Innovent Biologics for Fulzerasib, which included upfront payments totaling $8.5 million [12] - The company has also engaged in collaborations for other pipelines, such as the KRAS G12D inhibitor GFH375, which has shown promising early clinical data [13][14] - Despite the potential of its lead product, the overall market for KRAS inhibitors remains underwhelming, necessitating further development and market strategies [11][15]

Core Viewpoint - Heng Rui Medicine (01276) has received approval from the National Medical Products Administration for clinical trials of HRS-6093, a novel oral KRAS G12D inhibitor, which is expected to have significant anti-tumor effects [1] Group 1 - The clinical trial approval for HRS-6093 indicates a strategic advancement in the company's oncology pipeline [1] - HRS-6093 is a selective and efficient oral inhibitor specifically targeting the KRAS G12D mutation, which is crucial for certain cancer treatments [1] - Currently, there are no similar products approved for market in both domestic and international markets, highlighting a potential competitive advantage for the company [1] Group 2 - The total research and development investment for the HRS-6093 project has reached approximately 29.84 million yuan [1]