股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 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, 「本公司」） 呈交日期: 2025年11月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02595 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 324,643,020 | RMB | | 0.1 RMB | | 32,464,302 | | 增加 / 減少 (-) | | | 13,386,000 | | | RMB | | 1,338,600 | | 本月底結存 | | | 338,029,020 | RMB | | ...

Core Viewpoint - The innovative drug concept stocks experienced a significant rally on October 31, with multiple stocks reaching their daily limit up or showing substantial gains, indicating a strong market sentiment towards the pharmaceutical sector [1]. Group 1: Stock Performance - Sangfor Health (三生国健) surged by 20% to a price of 72.96 [2] - Shuyou Shen (舒泰神) increased by 14.29% to 36.47 [2] - Tuo Jing Life (透景生命) rose by 11.97% to 24.78 [2] - Maiwei Biotechnology (迈威生物-U) gained 11.69% to 47.23 [2] - Zejing Pharmaceutical (泽璟制药-U) climbed 11.06% to 99.18 [2] - Rongchang Biopharmaceutical (荣昌生物) went up by 10.87% to 98.30 [2] - Other notable gainers included Haitai Biotechnology (海特生物) at +10.33% and Weiguan Biotechnology (微感生物) at +10.19% [2]. Group 2: Hong Kong Market Performance - Fosen Pharmaceutical (福森药业) saw a remarkable increase of 53.62% to 1.060 [3] - Yingtou Biotechnology (映图生物-B) rose by 12.44% to 318.200 [3] - Yaojie Jiankang (药捷家康-B) increased by 9.45% to 190.000 [3] - Other stocks such as Innovent Biologics (信达生物) and Jinfang Pharmaceutical (劲方医药) also experienced gains of 8.18% and 8.05% respectively [3].

Summary of Key Points Group 1: 52-Week Highs - A total of 45 stocks reached their 52-week highs as of October 23, with notable performers including Base Champion Group (08460) at 234.56%, Tianjin Chuangye Environmental Protection Co., Ltd. (01065) at 136.88%, and Liji Engineering Holdings (01690) at 80.26% [1] - The closing prices and peak prices for the top three stocks are as follows: Base Champion Group closed at 0.250 with a peak of 0.455, Tianjin Chuangye at 4.880 with a peak of 10.020, and Liji Engineering at 0.105 with a peak of 0.137 [1] Group 2: 52-Week Lows - The report also highlighted stocks that reached their 52-week lows, with Huaxi Holdings (01689) showing a decline of 16.67%, China New Economy Equity (02958) down by 14.17%, and Agile Holdings (00186) down by 13.16% [2] - The closing prices and lowest prices for the top three declining stocks are: Huaxi Holdings at 0.400 with a low of 0.350, China New Economy at 0.123 with a low of 0.103, and Agile Holdings at 0.165 with a low of 0.165 [2]

每经AI快讯，劲方医药-B(02595.HK)午后一度跌超8%，临近尾盘拉升转涨逾9%。截至发稿，涨 6.71%，报28.3港元，成交额4451.83万港元。 （文章来源：每日经济新闻） ...

消息面上，劲方医药宣布，旗下口服高活性及高选择性小分子KRAS G12D(ON/OFF)抑制剂GFH375， 联合疗法用于治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究，首例患者已在北京大学肿瘤医院完成 入组。该项研究今年9月获得国家药监局临床试验批准，涉及联合西妥昔单抗或化疗两项联合疗法，其 中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。 值得注意的是，GFH375单药治疗KRAS G12D突变型胰腺导管腺癌(PDAC)患者数据于10月19日登陆 2025 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"。报告 聚焦该试验600 mgQD(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。 智通财经APP获悉，劲方医药-B(02595)午后一度跌超8%，临近尾盘拉升转涨逾9%。截至发稿，涨 6.71%，报28.3港元，成交额4451.83万港元。 ...

消息面上，劲方医药宣布，旗下口服高活性及高选择性小分子KRAS G12D(ON/OFF)抑制剂GFH375， 联合疗法用于治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究，首例患者已在北京大学肿瘤医院完成 入组。该项研究今年9月获得国家药监局临床试验批准，涉及联合西妥昔单抗或化疗两项联合疗法，其 中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。 值得注意的是，GFH375单药治疗KRAS G12D突变型胰腺导管腺癌(PDAC)患者数据于10月19日登陆 2025ESMO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"。报告 聚焦该试验600mgQD(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。 劲方医药-B(02595)午后一度跌超8%，临近尾盘拉升转涨逾9%。截至发稿，涨6.71%，报28.3港元，成 交额4451.83万港元。 ...

Core Insights - The company has initiated the clinical trial of GFH375, a KRAS G12D inhibitor, for treating advanced solid tumors, marking a significant step in its clinical development [1][2] - The trial, approved by the National Medical Products Administration, aims to evaluate the safety, efficacy, and pharmacokinetics of GFH375 in combination with chemotherapy and cetuximab [1] - GFH375 has shown promising results in preclinical studies and has received fast track designation from the FDA for treating advanced KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [2] Group 1 - GFH375's clinical trial (GFH375X1202) has commenced with the first patient enrolled at Peking University Cancer Hospital [1] - The trial will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with either cetuximab or chemotherapy [1] - The Phase II trial will specifically target first-line treatment for advanced PDAC and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer, expressed optimism about advancing GFH375 into frontline PDAC treatment, highlighting its potential across multiple tumor types [2] - The single-agent study of GFH375 is set to begin in June 2024, with promising data already presented at major oncology conferences [2] - GFH375 is a highly selective oral small molecule that inhibits KRAS G12D, effectively disrupting downstream signaling pathways and tumor cell proliferation [2] Group 3 - The company has entered into a licensing and early collaboration agreement with Verastem for three RAS/MAPK-driven cancer products [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights outside Greater China upon achieving specific clinical milestones [3] - The licensing agreement allows Verastem to develop and commercialize GFH375 outside of China, while the company retains rights within the country [3]

劲方首席医学官汪裕博士表示："很高兴GFH375两项联合疗法方案进入临床阶段，尤其是一线PDAC治 疗将把GFH375临床开发从后线推向前线。GFH375单药治疗PDAC及非小细胞肺癌(NSCLC)的研究数 据，近期分别在ESMO和WCLC以突破性研究摘要、口头报告形式展示，优秀疗效提示了该产品治疗多 个瘤种的前景。我们期待基于该产品的多项国内外研究能够快速推进，早日造福患者。" Ib期试验将首先在北京大学肿瘤医院等约15家中心开展，整体试验的主要研究目的为评估GFH375联合 西妥昔单抗或化疗两项联合疗法在实体瘤患者中的安全性╱耐受性、疗效和药代动力学特征。II期试验 中，GFH375联合化疗（白蛋白紫杉醇和吉西他滨）方案将治疗一线晚期PDAC患者，GFH375联合西妥 昔单抗（EGFR单抗）方案将治疗晚期PDAC和结直肠癌(CRC)患者。 格隆汇10月22日丨劲方医药-B(02595.HK)宣布，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的 Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督 管理局临床试验批准，该研究包含GFH37 ...

智通财经APP讯，劲方医药-B(02595)发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的 Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督 管理局临床试验批准，该研究包含GFH375(口服KRAS G12D抑制剂)联合西妥昔单抗或化疗两项联合疗 法;其中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。 Ib期试验将首先在北京大学肿瘤医院等约15家中心开展，整体试验的主要研究目的为评估GFH375联合 西妥昔单抗或化疗两项联合疗法在实体瘤患者中的安全性╱耐受性、疗效和药代动力学特征。II期试验 中，GFH375联合化疗(白蛋白紫杉醇和吉西他滨)方案将治疗一线晚期PDAC患者，GFH375联合西妥昔 单抗(EGFR单抗)方案将治疗晚期PDAC和结直肠癌(CRC)患者。 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。 GFH375为口服高活性、高选择性 ...

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） 勁方與Verastem就勁方開發的三款有關RAS/MAPK驅動癌症的產品達成了授權及 早期合作開發協議。該合作賦予Verastem獨家選擇權，以就該等三款產品在成功 達成I期臨床試驗預先設定的里程碑後獲得各自許可。於2023年12月，Verastem 選擇GFH375/VS-7375（一款口服KRAS G12D(ON/OFF)抑制劑）作為其合作的 領頭項目，就GFH375獲得的許可乃該合作誕生的第一個許可。該等許可將賦予 Verastem在大中華區外的開發和商業化權利，而勁方保留中國境內的該等權利。 自願公告 KRAS G12D抑制劑GFH375聯合西妥昔單抗或化療治療 晚期實體瘤的Ib/II期研究完成首例患者給藥， 適應症涵蓋一線 ...