Core Viewpoint - Multiple pharmaceutical companies announced positive developments, including FDA approvals and clinical trial advancements, indicating a favorable environment for the sector. Group 1: FDA Approvals and Clinical Trials - Ji'an Medical announced that its U.S. subsidiary received pre-market notification from the FDA for its quadrivalent home test kits for influenza A, influenza B, COVID-19, and RSV, allowing for normal sales in the U.S. market [1] - Junshi Biosciences reported that its EGFR/HER3 bispecific antibody-drug conjugate for treating advanced solid tumors received FDA approval for clinical trial application [1] - Innovent Biologics disclosed that its self-developed BTK inhibitor, Orelabrutinib, achieved the primary endpoint in a Phase II study for systemic lupus erythematosus and has been approved for Phase III registration clinical trials [1] Group 2: Strategic Partnerships and Product Developments - Yipinhong announced that its Qinxing Qingjie oral solution was approved as a national second-level protected traditional Chinese medicine. Additionally, the company secured a deal with Swedish pharmaceutical giant Sobi for $950 million (approximately 6.713 billion RMB) upfront and up to $550 million (approximately 3.887 billion RMB) in additional payments for a new URAT1 inhibitor, which has shown strong efficacy in dissolving gout stones and has received FDA fast track designation, with key Phase III clinical trials completed [1]

每经AI快讯，君实生物(01877.HK)涨超4%，截至发稿涨4.33%，报25港元，成交额3483.03万港元。 ...

智通财经APP获悉，君实生物(01877)涨超4%，截至发稿，涨4.33%，报25港元，成交额3483.03万港 元。 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。 消息面上，12月14日，君实生物发布公告，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。 ...

资料显示，上海君实生物医药科技股份有限公司位于上海市浦东新区平家桥路100弄6号7幢16层,香港铜 锣湾希慎道33号利园1期19楼1918室，成立日期2012年12月27日，上市日期2020年7月15日，公司主营业 务涉及单克隆抗体药物和其他治疗型蛋白药物的研发与产业化,单克隆抗体药物研发的技术服务与技术 转让等。主营业务收入构成为：药品销售90.67%，技术许可及特许权使用收入8.74%，技术服务及其他 0.59%。 君实生物所属申万行业为：医药生物-生物制品-其他生物制品。所属概念板块包括：精准医疗、创新 药、猴痘概念、生物医药、抗癌治癌等。 截至9月30日，君实生物股东户数3.59万，较上期增加15.17%；人均流通股21361股，较上期减少 12.96%。2025年1月-9月，君实生物实现营业收入18.06亿元，同比增长42.06%；归母净利润-5.96亿元， 同比增长35.72%。 来源：新浪证券-红岸工作室 12月15日，君实生物盘中上涨2.05%，截至09:45，报37.33元/股，成交6195.19万元，换手率0.22%，总 市值383.26亿元。 资金流向方面，主力资金净流入339.33万元 ...

君实生物(01877)涨超4%，截至发稿，涨4.33%，报25港元，成交额3483.03万港元。 消息面上，12月14日，君实生物发布公告，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。 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。 ...

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 ...

Group 1 - Multiple pharmaceutical stocks announced positive news, including Jiuan Medical's FDA pre-market notification for home test kits for influenza and COVID-19, allowing normal sales in the U.S. market [1] - Junshi Bioscience received FDA approval for clinical trials of its EGFR/HER3 bispecific antibody drug for treating advanced solid tumors [1] - Innovent Biologics' BTK inhibitor, Orelabrutinib, reached primary endpoints in a Phase II trial for systemic lupus erythematosus and has been approved for Phase III trials [2] Group 2 - The Chinese innovative drug industry is at a critical turning point, with over $100 billion in licensing deals in the first three quarters of 2025, indicating significant potential for domestic innovative drugs [3] - Major collaborations between Chinese companies and multinational corporations include a $12 billion deal between Hengrui and GSK, and a $114 billion potential deal between Innovent and Takeda [3] - The Chinese innovative drug sector is expected to show a compound annual growth rate of 20.2% from 2024 to 2028, with the market size projected to reach 26.9 billion yuan by 2028 [1][4] Group 3 - The pharmaceutical industry is anticipated to thrive by 2025, with the Hang Seng Index expected to double in value [4] - The innovative drug sector's listed companies achieved a total revenue of 48.83 billion yuan in the first three quarters of 2025, a 22% year-on-year increase, marking the first quarterly profit since inception [4] - The investment landscape is shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on companies' tangible strengths and product quality [4]

Core Insights - Multiple pharmaceutical companies have recently announced positive developments, indicating a potential growth phase in the industry [1][2][4]. Group 1: Company Announcements - Jiuan Medical's U.S. subsidiary received pre-market notification from the FDA for its home testing kits for multiple viruses, including COVID-19, allowing for normal sales in the U.S. market [1]. - Junshi Bioscience's dual-specific antibody drug for treating advanced solid tumors has received FDA approval for clinical trials [1]. - Innovent Biologics announced that its BTK inhibitor, Orelabrutinib, has met primary endpoints in a Phase II study for systemic lupus erythematosus and has been approved for Phase III trials [1]. - Yipinhong's Qinxiang Qingjie oral solution has been approved as a national secondary protected traditional Chinese medicine, and the company is set to receive up to $15 billion (approximately 67.13 billion RMB) from Sobi for a new URAT1 inhibitor [2]. Group 2: Market Trends - The Chinese innovative drug sector is experiencing a significant turnaround after a challenging period from 2021 to 2024, with total external licensing amounts surpassing $100 billion in the first three quarters of 2025 [4]. - Major collaborations between Chinese innovative drug companies and multinational corporations (MNCs) are on the rise, exemplified by significant deals such as the $12 billion partnership between Hengrui Medicine and GSK [4]. - The speed and cost-effectiveness of Chinese drug development are becoming competitive advantages, with drug discovery processes being 2-3 times faster than international counterparts [4]. Group 3: Financial Performance - The innovative drug sector in China reported a total revenue of 48.83 billion RMB in the first three quarters of 2025, reflecting a year-on-year growth of 22% [5]. - The sector achieved its first quarterly profit since its inception, with a net profit of 1.1 billion RMB in the third quarter [5]. Group 4: Investment Landscape - The capital market for Chinese innovative drugs is undergoing a transformation, shifting from a focus on academic backgrounds and preclinical data to a stronger emphasis on tangible product capabilities [6].

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， ...

Core Viewpoint - Multiple pharmaceutical companies have announced positive developments, including FDA approvals and significant clinical trial milestones, indicating a robust growth trajectory in the pharmaceutical sector. Group 1: Company Announcements - Jiuan Medical announced that its U.S. subsidiary received FDA pre-market notifications for its four-in-one and three-in-one home testing kits for influenza and COVID-19, enhancing its product line in the IVD field [1][3]. - Junshi Biosciences reported that its dual-specificity antibody-drug conjugate (JS212) for treating advanced solid tumors received FDA approval for clinical trials [4]. - Innovent Biologics disclosed that its BTK inhibitor, Obutinib, achieved primary endpoints in a Phase II clinical trial for systemic lupus erythematosus and received approval for Phase III trials [4]. - Yipinhong announced that its Qinxing Qingjie oral solution was approved as a national secondary protected traditional Chinese medicine, which will strengthen its market position [5]. Group 2: Market Trends and Insights - The Chinese innovative drug industry is expected to experience rapid growth, with over $92 billion in outbound BD transactions in the first three quarters of 2025, indicating a significant opportunity for Chinese companies in the global market [7]. - The first version of the commercial health insurance innovative drug directory was released, highlighting the competitive landscape and the inclusion of several high-efficacy domestic drugs, which signals a positive trend for innovative drug development [8]. - Analysts suggest that the integration of innovative drugs into both medical insurance and commercial insurance will lead to rapid revenue growth for these products, benefiting patients and companies alike [8].