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 ...

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） 自願公告 KRAS G12D抑制劑GFH375治療晚期胰腺導管腺癌研究數據 呈列於2025年ESMO年會口頭報告及突破性研究摘要 本公告由勁方醫藥科技（上海）股份有限公司（「本公司」或「勁方」，連同其附屬公 司統稱「本集團」）自願刊發，以知會本公司股東及潛在投資者有關本集團最新業 務動態。 本公司董事會欣然宣佈，GFH375單藥治療KRAS G12D突變型胰腺導管腺癌 (PDAC)患者數據於德國當地時間10月19日登陸2025年歐洲腫瘤內科學會(ESMO) 年會的突破性研究摘要(LBA)和口頭報告。此次口頭報告由中國醫學科學院腫 瘤醫院周愛萍教授完成，該報告標題為「GFH375治療經治晚期KRAS G12D突 變型PDAC患者的療效 ...

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].

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 ...

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 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5][36]. Core Viewpoints - The pharmaceutical sector has shown weaker performance compared to the overall market, with a decline of 2.07% in the biotechnology sector [1][27]. - The report emphasizes the importance of focusing on innovative drug companies with differentiated capabilities and global commercialization potential [3][36]. - The report highlights the potential for valuation recovery in the medical device sector due to policy optimization and performance recovery [3]. Summary by Sections Market Performance - The overall A-share market declined by 0.65%, while the biotechnology sector fell by 2.07% [1][27]. - Specific declines were noted in chemical pharmaceuticals (down 2.43%), biological products (down 3.47%), and medical devices (down 2.04%) [1][27]. Company Focus: Jinfang Pharmaceutical - Jinfang Pharmaceutical, listed on the Hong Kong Stock Exchange, focuses on RAS-targeted molecular research and has successfully launched its first innovative drug [2][10]. - The core product GFH925 is a selective inhibitor for KRAS G12C mutations, approved for use in NSCLC and expected to enter the market in August 2024 [2][20]. - The company has a robust pipeline, including GFH312 for PAD and PBC indications, and GFH375 for KRAS G12D mutations, with ongoing clinical trials [2][22]. Investment Strategy - The report suggests investing in innovative drug companies with strong growth in new orders and backlogs, as well as leading CDMO companies [3][36]. - Recommended companies include Mindray Medical, WuXi AppTec, and Aier Eye Hospital, all rated as "Outperform" [4][36]. Valuation Metrics - The TTM P/E ratio for the pharmaceutical and biotechnology sector is 39.77x, significantly higher than the overall A-share market P/E of 20.32x [32][36]. - Specific sector P/E ratios include chemical pharmaceuticals at 49.53x and biological products at 48.34x [32]. Recommended Stocks - Mindray Medical is highlighted for its strong R&D and sales capabilities, benefiting from domestic medical infrastructure and international expansion [36]. - WuXi AppTec is noted for its comprehensive new drug development service platform, poised to benefit from the global outsourcing market [36]. - Aier Eye Hospital is recognized for its leading position in the private eye care sector and ongoing expansion efforts [36].

Group 1 - The core viewpoint of the article highlights the significant market activity surrounding Jinfang Pharmaceutical-B (02595), including a stock transfer valued at HKD 437 million, representing 3.42% of the company [1] - On September 19, Jinfang Pharmaceutical-B was listed on the Hong Kong Stock Exchange, with its stock price reaching a peak of HKD 50.20, an increase of 146.20% from the issue price, and closing with a gain of 106.47%, bringing its market capitalization close to HKD 15 billion [1] - Jinfang Pharmaceutical focuses on developing new treatment solutions for oncology, autoimmune, and inflammatory diseases, with a product pipeline that includes eight candidate products, five of which are in clinical development, including two core products GFH925 and GFH375 [1]

Core Viewpoint - The successful IPO of Jinfang Pharmaceutical on the Hong Kong Stock Exchange marks a significant milestone in the innovative drug sector, with a first-day increase of nearly 110% and a market capitalization approaching 15 billion [1][2]. Group 1: Company Overview - Jinfang Pharmaceutical, founded in 2017 by returning scientist Lü Qiang, focuses on the research and development of oncology and autoimmune drugs [1][2]. - The company has completed seven rounds of financing totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [1]. - The company has a strong foundation of cornerstone investors, including RTW Fund and OrbiMed, with over half being professional pharmaceutical investment institutions [1][2]. Group 2: Product Pipeline and Market Position - Jinfang's core product, Fluzelezib, is set to be launched in August 2024, making it the first KRAS G12C inhibitor approved in China and the third globally [2][3]. - The KRAS target is still in its early stages, with the overall market not yet fully developed, but Jinfang is positioned to be among the first to market with its product [2][3]. - The company has established multiple business development (BD) collaborations, contributing significantly to its revenue stream [7][8]. Group 3: Financial Performance and Revenue Sources - Jinfang's revenue for 2023, 2024, and the first four months of 2025 were reported at 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses of 508 million, 678 million, and 6.6 million [8]. - The company has relied on BD transactions for income, which has become a core revenue source, although this dependence poses potential risks [8][9]. - The termination of the overseas rights for Fluzelezib with Innovent Biologics raised concerns about the future market prospects of this core product [9].