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港股异动 | 康宁杰瑞制药-B(09966)涨超4% 新药JSKN027临床试验申请获受理
智通财经网· 2025-12-18 02:38
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 4%, currently trading at 10.68 HKD with a transaction volume of 2.7829 million HKD, following the acceptance of its IND application for the dual-targeting ADC JSKN027 by the NMPA [1] Group 1: Company Developments - Corning Jereh has announced that its self-developed PD-L1/VEGFR2 dual-specific antibody conjugate drug (ADC) JSKN027 has received formal acceptance for clinical trial (IND) application by the National Medical Products Administration (NMPA) [1] - The company is set to initiate Phase I clinical research for JSKN027, aimed at treating advanced malignant solid tumors [1] - JSKN027 is the first ADC globally to enter clinical research that targets VEGFR2 alone or simultaneously targets both PD-L1 and VEGFR pathways [1] Group 2: Clinical Data - Preclinical data indicates that JSKN027 demonstrates significant tumor suppression activity in both in vitro and in vivo models [1]
康宁杰瑞制药-B:JSKN027 IND申请获CDE正式受理
Zhi Tong Cai Jing· 2025-12-17 10:23
Core Viewpoint - The company has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-targeting antibody-drug conjugate (ADC) aimed at treating advanced malignant solid tumors [1] Group 1: Drug Development - JSKN027 targets both Programmed Death Ligand 1 (PD-L1) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2), making it the first ADC to enter clinical research that specifically targets these pathways [1] - The planned Phase I clinical study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of JSKN027, as well as determine the maximum tolerated dose and/or recommended dose for Phase II [1] Group 2: Market Position - Currently, there are no ADCs targeting VEGFR2 alone or simultaneously targeting both PD-L1 and VEGFR2 in clinical research globally [1] - Preclinical data indicates that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] Group 3: Safety and Efficacy - Good tolerability was observed in GLP toxicology studies at the highest dose [1] - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]
康宁杰瑞制药-B(09966):JSKN027 IND申请获CDE正式受理
智通财经网· 2025-12-17 10:17
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a dual-specific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Details - The company plans to conduct a Phase I clinical study of JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - The study will also determine the maximum tolerated dose and/or recommended dose for Phase II trials [1] Group 2: Unique Positioning and Preclinical Data - JSKN027 is the first PD-L1/VEGFR2 dual-targeting ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both pathways simultaneously currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models [1] - GLP toxicology studies indicate good tolerability of the drug at the highest doses [1] Group 3: Mechanism of Action and Potential Impact - JSKN027 is expected to provide new treatment options for various solid tumors due to its multiple mechanisms of action, including cytotoxicity, anti-angiogenesis, and immune modulation [1]
康宁杰瑞制药-B(09966.HK):“JSKN027”IND申请获CDE正式受理
Ge Long Hui· 2025-12-17 10:08
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has received formal acceptance from the National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for JSKN027, a bispecific antibody-drug conjugate (ADC) targeting PD-L1 and VEGFR2, aimed at treating advanced malignant solid tumors [1] Group 1 - The company plans to conduct Phase I clinical research for JSKN027 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced malignant solid tumors [1] - JSKN027 is the first PD-L1/VEGFR2 bispecific ADC to enter clinical research globally, with no other ADCs targeting VEGFR2 alone or both PD-L1 and VEGFR pathways currently in clinical studies [1] - Preclinical data shows that JSKN027 exhibits significant tumor suppression activity in both in vitro and in vivo models, and GLP toxicology studies indicate good tolerability at the highest doses [1] Group 2 - The multiple mechanisms of action of JSKN027, including cytotoxicity, anti-angiogenesis, and immune modulation, suggest it may provide new treatment options for various solid tumors [1]
康宁杰瑞制药(09966) - 自愿公告 - JSKN027 IND申请获CDE正式受理
2025-12-17 10:03
康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 自願公告 JSKN027 IND申請獲CDE正式受理 本公告乃由康寧傑瑞生物製藥(「本公司」,連同其附屬公司,統稱「本集團」)自願 作出,以知會本集團股東(「股東」)及潛在投資者有關本集團之最新業務進展。 本公司董事(「董事」)會(「董事會」)欣然宣佈,公司自主研發的程序性死亡配 體1(「PD-L1」)╱ 血管內皮生長因子受體2(「VEGFR2」)雙特異性抗體偶聯藥 物(「ADC(s)」)JSKN027新藥臨床試驗(「IND」)申請,已獲國家藥品監督管理局 (「NMPA」)藥品審評中心(「CDE」)正式受理。本公司計劃開展JSKN027用於治 療晚期惡性實體瘤的I期臨床研究,旨在評估其在該等患者人群中的安全性、耐受 性、藥代動力學、藥效學特徵以及初步抗腫瘤活性,並確定最大耐受劑量及╱或 推薦II期劑量。 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之內容概不負責,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倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONC ...
大行评级丨交银国际:上调康宁杰瑞制药-B目标价至13港元 看好ADC产品矩阵的巨大全球市场潜力
Ge Long Hui· 2025-12-11 02:49
交银国际发表报告指,看好康宁杰瑞制药-B ADC产品矩阵的巨大全球市场潜力,上调2025至2027年收 入预测3%至8%,上调目标价至13港元,上调评级至"买入"。报告指,公司已成功搭建多个生物大分子 药物研发技术平台,持续产出差异化竞争优势显著的早期候选药物、并快速推进临床开发。 ...
交银国际:升康宁杰瑞制药(09966)目标价至13港元 升评级至“买入”
智通财经网· 2025-12-11 02:34
交银国际发布研报称,看好康宁杰瑞制药(09966)ADC产品矩阵的巨大全球市场潜力,上调2025-27年收 入预测3-8%,上调目标价至13港元,评级升至"买入"。该行认为,凭借KN026及JSKN003,公司有望实 现在乳腺癌的全线、多亚型覆盖,并拓展其他HER2表达实体瘤的使用,借助差异化布局在HER2赛道拥 有一席之地。 ...
交银国际:升康宁杰瑞制药目标价至13港元 升评级至“买入”
Zhi Tong Cai Jing· 2025-12-11 02:28
交银国际发布研报称,看好康宁杰瑞制药(09966)ADC产品矩阵的巨大全球市场潜力,上调2025-27年收 入预测3-8%,上调目标价至13港元,评级升至"买入"。该行认为,凭借KN026及JSKN003,公司有望实 现在乳腺癌的全线、多亚型覆盖,并拓展其他HER2表达实体瘤的使用,借助差异化布局在HER2赛道拥 有一席之地。 ...
康宁杰瑞制药(09966) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-04 09:00
截至月份: 2025年11月30日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2025年12月4日 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 II. 已發行股份及/或庫存股份變動 FF301 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50,200 | | 增加 / 減少 (-) | | | | 0 | | USD | | 0 | | 本月底結存 | | | 25,100,000,000 | USD | | 0.000002 USD | | 50 ...
康宁杰瑞制药-B(09966)12月1日斥资245.7万港元回购23.6万股
Zhi Tong Cai Jing· 2025-12-01 12:40
Group 1 - The company, Corning Jereh Pharmaceutical-B (09966), announced a share buyback plan [1] - The company will spend HKD 2.457 million to repurchase 236,000 shares [1]