智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，公司自主研发的程序性死亡配体1(PD-L1)/血管内 皮生长因子受体2(VEGFR2)双特异性抗体偶联药物(ADC(s))JSKN027新药临床试验(IND)申请，已获国 家药品监督管理局(NMPA)药品审评中心(CDE)正式受理。本公司计划开展JSKN027用于治疗晚期恶性 实体瘤的I期临床研究，旨在评估其在该等患者人群中的安全性、耐受性、药代动力学、药效学特征以 及初步抗肿瘤活性，并确定最大耐受剂量及/或推荐II期剂量。 目前，全球范围内尚无单独靶向VEGFR2或者同时靶向PD-L1与VEGFR双通路的ADC进入临床研究。 JSKN027是全球首款进入临床研究阶段的PD-L1/VEGFR2双抗ADC药物。临床前数据显示，JSKN027在 体外及体内模型中均表现出显著的肿瘤抑制活性。GLP毒理学研究显示，该药物在最高剂量下耐受性良 好。基于其细胞毒杀伤、抗血管生成及免疫调节等多重作用机制，JSKN027有望为多种实体瘤治疗提供 新的治疗选择。 ...

一、药品相关情况 JS212是重组人源化抗表皮生长因子受体（以下简称"EGFR"）和人表皮生长因子受体3（以下简 称"HER3"）双特异性抗体偶联药物（以下简称"ADC"），主要用于晚期恶性实体瘤的治疗。EGFR和 HER3在多种肿瘤细胞表面存在高表达，如肺癌、结直肠癌、头颈部肿瘤等。EGFR和HER3之间存在信 号通路的相互作用，共同参与促进肿瘤细胞的增殖、存活、迁移和血管生成等过程。此外，HER3参与 多种抗肿瘤药物（包括EGFR靶向药物和化疗等）的耐药性机制。与单一靶点ADC药物相比，JS212能 够通过与EGFR或HER3结合发挥肿瘤抑制作用，有望对更广泛的肿瘤有效，同时有望克服耐药性问 题。临床前研究显示，JS212与EGFR和HER3具有高亲和力、特异性结合作用，在多个动物模型中展示 了显著的抑瘤作用。同时，JS212具备良好、可接受的安全性。 2025年1月，JS212的临床试验申请获得国家药品监督管理局（以下简称"国家药监局"）受理，并于2025 年3月获得国家药监局批准。截至本公告披露日，JS212正在中国内地开展一项开放标签、剂量递增和剂 量扩展的I/II期临床试验，旨在晚期实体瘤患者中评 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688180 证券简称：君实生物 公告编号：临2025-074 自愿披露关于JS212临床试验申请获得FDA批准的公告 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"）收到美国食品药品监督管理局（以下简 称"FDA"）的通知，EGFR/HER3双特异性抗体偶联药物（代号：JS212）用于治疗晚期实体瘤的临床试 验申请获得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： 上海君实生物医药科技股份有限公司 2025年1月，JS212的临床试验申请获得国家药品监督管理局（以下简称"国家药监局"）受理，并于2025 年3月获得国家药监局批准。截至本公告披露日，JS212正在中国内地开展一项开放标签、剂量递增和剂 量扩展的I/II期临床试验，旨在晚期实体瘤患者中评估JS212的安全性、耐受性、药代动力学和初步疗 效。此外， ...

2025年1月，JS212的临床试验申请获得国家药品监督管理局(国家药监局)受理，并于2025年3月获得国 家药监局批准。截至本公告日期，JS212正在中国内地开展一项开放标签、剂量递增和剂量扩展的I/II期 临床试验，旨在晚期实体瘤患者中评估JS212的安全性、耐受性、药代动力学和初步疗效。此外，JS212 多队列联合用药的临床试验申请已于2025年11月获得国家药监局批准，计划于近期开展相关临床研究。 君实生物(01877)发布公告，本公司收到美国食品药品监督管理局(FDA)的通知，EGFR/HER3双特异性 抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批准。 JS212是重组人源化抗表皮生长因子受体(EGFR)和人表皮生长因子受体3(HER3)双特异性抗体偶联药物 (ADC)，主要用于晚期恶性实体瘤的治疗。EGFR和HER3在多种肿瘤细胞表面存在高表达，如肺癌、结 直肠癌、头颈部肿瘤等。EGFR和HER3之间存在信号通路的相互作用，共同参与促进肿瘤细胞的增 殖、存活、迁移和血管生成等过程。此外，HER3参与多种抗肿瘤药物(包括EGFR靶向药物和化疗等)的 耐药性机制。与单一 ...

2025年1月，JS212的临床试验申请获得国家药品监督管理局(国家药监局)受理，并于2025年3月获得国 家药监局批准。截至本公告日期，JS212正在中国内地开展一项开放标签、剂量递增和剂量扩展的I/II期 临床试验，旨在晚期实体瘤患者中评估JS212的安全性、耐受性、药代动力学和初步疗效。此外，JS212 多队列联合用药的临床试验申请已于2025年11月获得国家药监局批准，计划于近期开展相关临床研究。 JS212是重组人源化抗表皮生长因子受体(EGFR)和人表皮生长因子受体3 (HER3)双特异性抗体偶联药物 (ADC)，主要用于晚期恶性实体瘤的治疗。 EGFR和HER3在多种肿瘤细胞表面存在高表达，如肺癌、 结直肠癌、头颈部肿瘤等。EGFR和HER3之间存在信号通路的相互作用，共同参与促进肿瘤细胞的增 殖、存活、迁移和血管生成等过程。此外，HER3参与多种抗肿瘤药物(包括 EGFR靶向药物和化疗等)的 耐药性机制。与单一靶点ADC药物相比，JS212能够通过与EGFR或HER3结合发挥肿瘤抑制作用，有望 对更广泛的肿瘤有效，同时有望克服耐药性问题。临床前研究显示，JS212与EGFR和HER3具有高亲和 ...

人民财讯12月14日电，君实生物(688180)12月14日公告，公司收到美国食品药品监督管理局(FDA)的通 知，EGFR/HER3双特异性抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批 准。JS212是重组人源化抗表皮生长因子受体和人表皮生长因子受体3双特异性抗体偶联药物，主要用于 晚期恶性实体瘤的治疗。 ...

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, received written notification from the FDA approving the clinical trial application for GenSci143, allowing trials to be conducted in the United States [1] Group 1: Product Development - GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, indicated for advanced solid tumors, with potential dual therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug has already been approved for clinical trials in advanced solid tumors in China, and the FDA approval will help the company expand its business structure and optimize its product portfolio [1] Group 2: Strategic Implications - The approval from the FDA enriches the product line layout in strategic areas for the company, indicating a positive step towards enhancing its market presence and competitiveness [1]

Policy Developments - The National Medical Insurance Administration announced that as of November 12, 2025, 24 provinces and regions in China have completed the deployment of the medical imaging cloud software, with 140 million indexed data uploaded to the national center [2] Drug and Device Approvals - Changchun High-tech's subsidiary received FDA approval for the clinical trial of GenSci143, a dual-specific antibody drug targeting B7-H3 and PSMA for treating advanced solid tumors [4] - Zai Lab announced that its ZG006 injection, in combination with etoposide and cisplatin, received clinical trial approval for advanced neuroendocrine carcinoma [5] - Heng Rui Medicine received approval for the clinical trial of Rivegromab tablets for prostate cancer [6] - Haisco announced that its HSK39297 tablets for age-related macular degeneration received clinical trial approval, showing promising preclinical results [7] Capital Market Activities - Kintor Pharmaceutical reported the repurchase of approximately 3.31 million shares since October 2025, with plans to repurchase up to 25.46 million shares over the next 50 trading days [9] - Changlian Co. signed an agreement to establish a joint venture with Shanghai Waigaoqiao Biopharmaceutical, contributing 30 million yuan for a 60% stake [10] Financial Reports - In the third quarter report, Nocera Biopharma reported a net loss of 64.41 million yuan for the first three quarters of 2025, despite a revenue increase of 59.85% to 1.115 billion yuan, driven by sales of its core product [12] Industry Events - The first China-Africa Joint Medical Center was established in Guinea, aiming to enhance healthcare collaboration and address cardiovascular diseases in West Africa [14] Shareholder Actions - Renhe Pharmaceutical's controlling shareholder plans to reduce its stake by up to 0.21% through public trading or block transactions [16]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received FDA approval for the clinical trial application of GenSci143, a dual-target antibody-drug conjugate for treating advanced solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci143 - Application: Clinical trial in the United States - Acceptance Number: 177763 - Applicant: Changchun Jinsai Pharmaceutical Co., Ltd. - Approval Conclusion: Clinical trial permitted in the U.S. - Indication: Advanced solid tumors [1]. Group 2: Drug Mechanism and Innovation - GenSci143 targets B7-H3 and PSMA, internalizing into lysosomes to release TOPO-I inhibitor toxins, effectively killing B7-H3 positive, PSMA positive, and dual-positive tumor cells [2]. - The dual-target mechanism helps overcome tumor heterogeneity and resistance due to reduced expression of single targets, potentially benefiting a broader patient population [2]. Group 3: Company Impact - Successful progress in clinical trials could enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness [3]. - The company is committed to advancing the research project and will fulfill its information disclosure obligations regarding subsequent developments [4].

Core Viewpoint - Changchun High New Technology Industry Group Co., Ltd. (000661.SZ) announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (referred to as "JinSai Pharmaceutical"), received written notification from the U.S. Food and Drug Administration (FDA) that the clinical trial application for GenSci143 has been approved, marking a significant milestone for the company in the biopharmaceutical sector [1]. Group 1 - JinSai Pharmaceutical's GenSci143 is a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA, which has potential therapeutic effects in both targeted chemotherapy and tumor immunotherapy [1]. - GenSci143 is classified as a Class 1 therapeutic biological product and is intended for the treatment of advanced solid tumors, including prostate cancer and lung cancer [1].