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君实生物JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准
Bei Jing Shang Bao· 2025-10-16 12:55
Core Viewpoint - Junshi Biosciences (君实生物) announced that its product JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody, has received FDA approval for a clinical trial in patients with resectable, AGA-negative non-small cell lung cancer [1] Group 1: Product Information - JS207 is a self-developed bispecific antibody targeting PD-1 and VEGFA, primarily used for the treatment of advanced malignancies [1] - The drug binds with high affinity to both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and PD-L1/PD-L2, as well as inhibiting the binding of VEGF to its receptors [1] - JS207 exhibits both immunotherapeutic and anti-angiogenic properties, neutralizing VEGF to inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, leading to better anti-tumor activity [1] Group 2: Clinical Trial Details - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study comparing JS207 to Nivolumab for neoadjuvant treatment [1] - The study focuses on patients with resectable, AGA-negative non-small cell lung cancer [1]
君实生物(01877) - 自愿性公告-JS207用於非小细胞肺癌患者新辅助治疗的II/III期临床...
2025-10-16 12:49
本公告由上海君實生物醫藥科技股份有限公司(「本公司」)自願作出。請亦參見本 公司於2025年10月16日刊發的海外監管公告。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司產品重組人源化抗PD-1和 VEGF雙特異性抗體(代號:JS207)對比納武利尤單抗用於II/III期、可切除、可改 變驅動基因(AGA)陰性非小細胞肺癌患者新輔助治療的開放標籤、雙臂、隨機、 陽性對照II/III期臨床研究(「本次研究」)的臨床試驗申請獲得美國食品藥品監督管 理局(FDA)批准。 關於JS207 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,概不對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。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 自願性公告- JS207用於非小細胞肺癌患者新輔助治療的 II/III期臨床試驗申請獲得FDA批准 JS207為本公司自主研發的重組人源化 ...
10月16日晚间公告 | 兆丰股份与纽鼐机器人签订战略合作框架协议;智光电气拟购买控股子公司智光储能股权
Xuan Gu Bao· 2025-10-16 12:07
Resumption of Trading - Zhiguang Electric plans to issue new shares to purchase all or part of the minority equity of Guangzhou Zhiguang Energy Technology, leading to the resumption of its stock trading [1] Mergers and Acquisitions - Guotou Fengle's acquirer, Guotou Seed Industry, intends to subscribe for no more than 184 million shares at a price of 5.91 yuan per share [2] Share Buybacks and Equity Transfers - Zhijiang Biology plans to repurchase shares worth between 60 million to 120 million yuan [3] - YTO Express, for strategic and financial planning reasons, intends to transfer no more than 2% of its shares through block trading by Hangzhou Haoyue [4] Daily Operations and External Investments - Zhaofeng Co. signed a strategic cooperation framework agreement with NiuNai Robotics, focusing on cognitive and humanoid robot development [5] - Huayu Automotive completed the acquisition of a 49% stake in Shanghai SAIC Qingtao Energy Technology Co., Ltd. [6] - Dingjide's high-end new material project for petrochemical technology, POE industrialization device, has been put into production [7] - Chiplink Integration plans to increase capital by 1.8 billion yuan to ensure the ongoing implementation of its 12-inch integrated circuit analog mixed-signal chip manufacturing project [7] - Shanghai Xiba has obtained the IATF16949 automotive quality management system certification for the design and production of silicon-carbon anode materials for new energy batteries [7] - Zhongtian Technology won multiple marine series projects in deep-sea technology, totaling approximately 1.788 billion yuan [8] - TBEA's subsidiary plans to acquire 74.19% of Shuguang Cable for 946 million yuan, specializing in 1E-level K1 and K3 cables for nuclear power plants [8] - Junshi Biosciences received FDA approval for the clinical trial application of JS207 for neoadjuvant therapy in non-small cell lung cancer patients [9] - Longbai Group's subsidiary intends to acquire assets related to Venator UK's titanium dioxide business [10] - Yunnan Energy Investment is investing 1.872 billion yuan to construct a 350MW compressed air energy storage demonstration project in Kunming Anning [11] Performance Changes - Shijia Photon reported a net profit of 299 million yuan for the first three quarters, a year-on-year increase of 728%, with orders for optical chips and devices increasing [12] - Guangku Technology expects a net profit of 110 million yuan for the first three quarters, a year-on-year increase of 97.00%-117.00%, driven by technological innovation and new product launches [12] - Rongzhi Rixin anticipates a net profit of 26.4 million to 27.4 million yuan for the first three quarters, a year-on-year increase of 871.30%-908.09% [13] - Guangsheng Nonferrous expects a net profit of 100 million to 130 million yuan for the first three quarters, a year-on-year increase of 136.29% to 147.18%, due to rising rare earth market prices [14] - Aobi Zhongguang expects to achieve a net profit of approximately 108 million yuan for the first three quarters, returning to profitability with rapid growth in various business areas [15] - Cangge Mining reported a net profit of 951 million yuan in the third quarter, a year-on-year increase of 66.49% [15]
君实生物(01877):JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准
智通财经网· 2025-10-16 11:07
Core Viewpoint - The company has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable, AGA-negative non-small cell lung cancer (NSCLC) patients in a Phase II/III study [1][2]. Company Summary - JS207 is a recombinant humanized bispecific antibody designed to target PD-1 and VEGF, developed independently by the company, primarily for the treatment of advanced malignancies [1]. - The antibody has high affinity for both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and its ligands, as well as inhibiting VEGF from binding to its receptors [1]. - JS207 combines the therapeutic effects of immunotherapy and anti-angiogenic therapy, improving the tumor microenvironment and enhancing the infiltration of cytotoxic T lymphocytes, thereby achieving better anti-tumor activity [1][2]. Clinical Research Summary - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study comparing the efficacy and safety of JS207 with Nivolumab in NSCLC patients [3]. - This study marks the first confirmatory research for a PD-1/VEGF dual-target drug in a surgical population, led by Professor Wu Yilong from Guangdong Provincial People's Hospital [3]. - The company is also conducting multiple Phase II clinical studies exploring JS207 in various cancers, including NSCLC, colorectal cancer, triple-negative breast cancer, and liver cancer, in combination with chemotherapy and other therapies [2]. Industry Context - Lung cancer remains the leading cause of cancer incidence and mortality globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [3]. - Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancer cases, with 20% to 25% of patients being eligible for surgical resection at diagnosis [3]. - Despite advancements in treatment, there remains an unmet clinical need for improved survival rates and cure rates in resectable NSCLC patients [3].
君实生物(01877.HK):JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准
Ge Long Hui· 2025-10-16 11:04
Core Viewpoint - The company, Junshi Biosciences, has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, for use in neoadjuvant therapy for AGA-negative non-small cell lung cancer patients in a Phase II/III study [1][2] Group 1: Product Overview - JS207 is a recombinant humanized bispecific antibody designed to target both PD-1 and VEGF, primarily for the treatment of advanced malignancies [1] - The drug effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenic properties [1] - By neutralizing VEGF, JS207 can inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes, leading to better anti-tumor activity [1] Group 2: Clinical Development - JS207 is designed based on the clinically validated anti-PD-1 drug, Toripalimab, with a Fab structure to maintain high affinity for PD-1 [2] - The VEGF-targeting component of JS207 has binding affinity comparable to Bevacizumab [2] - Non-clinical in vitro studies indicate that the bispecific antibody shows significantly enhanced PD-1 antigen binding and internalization, as well as synergistic activation of immune cells in the tumor microenvironment compared to the combination of PD-1/PD-L1 and VEGF monoclonal antibodies [2] - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with multiple ongoing Phase II studies exploring combinations with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) across various cancer types including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]
君实生物(01877) - 海外监管公告 - 上海君实生物医药科技股份有限公司自愿披露关於JS207...
2025-10-16 10:59
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,概不對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。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於JS207用於非小細胞肺癌患者新輔 助治療的II/III期臨床試驗申請獲得FDA批准的公告》,僅供參閱。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國,上海,2025年10月16日 於本公告日期,本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士;非執行董事湯毅先 生;以及獨立非執行董事張淳先生、馮曉源博士、酈仲賢先生、魯琨女士及楊勁 博士。 * 僅供 ...
君实生物(688180.SH):JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准
Ge Long Hui A P P· 2025-10-16 10:26
Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody, has received FDA approval for a clinical trial application to compare its efficacy against Nivolumab in a Phase II/III study for patients with resectable, AGA-negative non-small cell lung cancer [1] Group 1 - JS207 is developed by the company and is primarily used for the treatment of advanced malignant tumors [1] - The drug can bind with high affinity to both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and PD-L1/PD-L2, as well as inhibiting the binding of VEGF to its receptors [1] - JS207 exhibits characteristics of both immunotherapy and anti-angiogenic drugs, neutralizing VEGF to inhibit endothelial cell proliferation, improve the tumor microenvironment, and increase the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-tumor activity [1]
君实生物(688180) - 君实生物自愿披露关于JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准的公告
2025-10-16 10:15
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 近日,上海君实生物医药科技股份有限公司(以下简称"公司")产品重组 人源化抗 PD-1 和 VEGF 双特异性抗体(代号:JS207)对比纳武利尤单抗用于 II/III 期、可切除、可改变驱动基因(AGA)阴性非小细胞肺癌患者新辅助治疗 的开放标签、双臂、随机、阳性对照 II/III 期临床研究(以下简称"本次研究") 的临床试验申请获得美国食品药品监督管理局(FDA)批准。由于药品的研发周 期长、审批环节多,容易受到一些不确定性因素的影响,敬请广大投资者谨慎决 策,注意防范投资风险。现将相关情况公告如下: 证券代码:688180 证券简称:君实生物 公告编号:临 2025-062 上海君实生物医药科技股份有限公司 自愿披露关于 JS207 用于非小细胞肺癌患者新辅助 治疗的 II/III 期临床试验申请获得 FDA 批准的公告 一、药品基本情况 JS207 为公司自主研发的重组人源化抗 PD-1 和 VEGF 双特异性抗体,主要 用于晚期恶性肿瘤的治疗。JS207 可同时以 ...
君实生物:JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获FDA批准
Xin Lang Cai Jing· 2025-10-16 10:13
Core Viewpoint - Junshi Biosciences' application for a Phase II/III clinical trial of JS207 for neoadjuvant treatment in patients with non-small cell lung cancer has been approved by the FDA [1] Group 1: Company Information - Junshi Biosciences (688180.SH) announced the FDA approval for its clinical trial application of JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody [1] - JS207 is designed to block the binding of PD-1 to PD-L1 and PD-L2, as well as inhibit the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenesis properties [1] Group 2: Industry Context - This study marks the first time a PD-1/VEGF dual-target drug has been approved for confirmatory research in a surgically resectable population [1]
君实生物:JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准
Ge Long Hui· 2025-10-16 10:10
Core Viewpoint - The company announced that its product, JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody, has received FDA approval for a clinical trial application to compare it with Nivolumab in a Phase II/III study for neoadjuvant treatment in patients with resectable, genetically altered negative non-small cell lung cancer [1] Group 1 - JS207 is developed by the company and is primarily used for the treatment of advanced malignant tumors [1] - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study [1] - The study focuses on patients with resectable, genetically altered negative non-small cell lung cancer [1]