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劲方医药-B由跌转涨逾9% GFH375联合疗法治疗晚期实体瘤研究完成首例入组
Zhi Tong Cai Jing· 2025-10-23 07:22
Core Viewpoint - The stock of Jinfang Pharmaceutical-B (02595) experienced significant volatility, initially dropping over 8% before recovering to a gain of 6.71%, trading at 28.3 HKD with a transaction volume of 44.52 million HKD. This fluctuation is linked to the announcement of a clinical trial for their KRAS G12D inhibitor GFH375, which has garnered attention due to its potential in treating advanced solid tumors [1]. Group 1 - Jinfang Pharmaceutical announced the initiation of an Ib/II phase clinical trial for GFH375, a small molecule KRAS G12D inhibitor, in combination therapies for KRAS G12D mutant advanced solid tumors [1]. - The trial received approval from the National Medical Products Administration in September 2023 and involves combination therapies with cetuximab or chemotherapy, with GFH375 being part of the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1]. - Data from GFH375's monotherapy for KRAS G12D mutant PDAC patients was presented at the 2025 ESMO annual meeting, highlighting its efficacy and safety [1]. Group 2 - The oral presentation at the ESMO meeting was conducted by Professor Zhou Aiping from the Chinese Academy of Medical Sciences, focusing on the efficacy and safety of GFH375 in a specific dosage group of PDAC patients [1]. - The study emphasized the promising results of GFH375 treatment, showcasing its potential as a significant therapeutic option for patients with advanced KRAS G12D mutant PDAC [1].
劲方医药-B:KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药
Zhi Tong Cai Jing· 2025-10-22 00:14
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]
劲方医药-B(02595.HK):KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药,适应症涵盖一线胰腺导管腺癌(PDAC)
Ge Long Hui· 2025-10-21 23:40
Core Insights - GFH375, a KRAS G12D inhibitor, has entered clinical trials for treating advanced solid tumors, marking a significant step in its development [1][2] - The study, GFH375X1202, received approval from the National Medical Products Administration in September and involves combination therapies with cetuximab or chemotherapy [1] - The primary objective of the trial is to assess the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in patients with solid tumors [1] Group 1 - The first patient has been enrolled in the Ib/II phase study at Peking University Cancer Hospital [1] - The Ib phase will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with cetuximab or chemotherapy [1] - The II phase will specifically target first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer of the company, expressed optimism about advancing GFH375's clinical development from later lines to first-line treatment for PDAC [2] - Recent data on GFH375's monotherapy for PDAC and non-small cell lung cancer (NSCLC) were presented at ESMO and WCLC, indicating promising efficacy across multiple tumor types [2] - The company anticipates rapid progress in both domestic and international studies based on GFH375, aiming to benefit patients soon [2]
劲方医药-B(02595):KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药
智通财经网· 2025-10-21 23:36
Core Insights - The company has initiated the clinical trial of GFH375 in combination therapies for treating KRAS G12D mutant advanced solid tumors, marking a significant step in its clinical development [1][2] Group 1: Clinical Trials and Research - GFH375 has received approval for clinical trials from the National Medical Products Administration, with the first patient enrolled at Peking University Cancer Hospital [1] - The trial (GFH375X1202) will evaluate the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in combination with cetuximab or chemotherapy in approximately 15 centers [1] - The Ib phase will focus on assessing the combination of GFH375 with chemotherapy as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [1] Group 2: Product Development and Efficacy - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - Clinical data for GFH375 as a monotherapy for PDAC and non-small cell lung cancer (NSCLC) has shown promising efficacy, with recent presentations at ESMO and WCLC [2] - The drug has been granted FDA Fast Track designation for use in treating locally advanced and metastatic KRAS G12D mutant PDAC patients [2] Group 3: Strategic Partnerships - The company has entered into a licensing and early collaboration agreement with Verastem for three products related to RAS/MAPK-driven cancers [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights for development and commercialization outside Greater China, while the company retains rights within China [3]
劲方医药-B(02595) - 自愿公告KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗...
2025-10-21 23:30
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 ...
劲方医药-B(02595) - 章程
2025-10-21 14:06
勁方醫藥科技(上海)股份有限公司 章程 (該章程自2025年10月21日起生效) 1 | 目錄 | | --- | | 第一章 | 總則 | 3 | | --- | --- | --- | | 第二章 | 經營宗旨和範圍 | 4 | | 第三章 | 股份 | 4 | | 第一節 | 股份發行 | 4 | | 第二節 | 股份增減和回購 | 8 | | 第三節 | 股份轉讓 | 9 | | 第四章 | 股東和股東會 | 10 | | 第一節 | 股東 | 10 | | 第二節 | 股東會的一般規定 | 16 | | 第三節 | 股東會的召集 | 18 | | 第四節 | 股東會的提案與通知 | 19 | | 第五節 | 股東會的召開 | 21 | | 第六節 | 股東會的表決和決議 | 24 | | 第五章 | 董事會 | 29 | | 第一節 | 董事 | 29 | | 第二節 | 董事會 | 32 | | 第六章 | 高級管理人員 | 36 | | 第七章 | 監事會 | 37 | | 第一節 | 監事 | 37 | | 第二節 | 監事會 | 38 | | 第八章 | 財務會計制度、利潤分配和審計 | 4 ...
劲方医药-B(02595) - 修订组织章程细则
2025-10-21 13:57
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。 根據於2024年12月3日舉行的股東大會授予的授權以及本公司董事會(「董事會」) 授予的進一步授權,獲董事會授權的人士已批准根據全球發售完成,對組織章程 細則作出相應調整及修訂,包括但不限於本公司註冊股本及股權結構的內容。 組織章程細則的修訂詳情如下: 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) 修訂組織章程細則 本公告乃根據香港聯合交易所有限公司(「聯交所」)證券上市規則第13.51(1)條作 出。 茲提述勁方醫藥科技(上海)股份有限公司(「本公司」)日期為2025年10月16日的 公告(「該公告」),內容有關悉數行使超額配股權,涉及合共13,386,000股H股, 佔全球發售項下於任何超額配股權獲行使前初步可供認購發售股份總數約15%(經 計及發售量調整權獲悉數行使)。除 ...
劲方医药-B(02595)10月21日因超额配股权获行使而发行1338.6万股
Zhi Tong Cai Jing· 2025-10-21 08:48
Core Viewpoint - The company,劲方医药-B (02595), announced the issuance and allocation of 13.386 million H-shares due to the full exercise of the over-allotment option on October 21, 2025 [1] Group 1 - The total number of H-shares issued is 13.386 million [1]
劲方医药-B10月21日因超额配股权获行使而发行1338.6万股
Zhi Tong Cai Jing· 2025-10-21 08:42
劲方医药-B(02595)发布公告,于2025年10月21日因超额配股权获悉数行使而发行及配发1338.6万股H 股。 ...
劲方医药-B(02595) - 翌日披露报表
2025-10-21 08:30
FF305 備註: 有關股份發行前的已發行股份數目為356,980,630股 (包括324,643,020股H股及32,337,610股未上市股份)。 第 2 頁 共 6 頁 v 1.3.0 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 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10月21日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 普通股 | 股份類別 | H | | 於香港聯交所上市 | | 是 | | | | 證券代號 (如上 ...