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。 2025年1月，JS212的臨床試驗申請獲得國家藥品監督管理局（「國家藥監局」）受 理，並於2025年3月獲得國家藥監局批准。截至本公告日期，JS212正在中國內地 開展一項開放標籤、劑量遞增和劑量擴展的I/II期臨床試驗，旨在晚期實體瘤患者 中評估JS212的安全性、耐受性、藥代動力學和初步療效。此外，JS212多隊列聯 合用藥的臨床試驗申請已於2025年11月獲得國家藥監局批准，計劃於近期開展相 關臨床研究。 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－ JS212臨床試驗申請獲得FDA批准 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12月14日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」） ...

Core Viewpoint - Junshi Biosciences (stock code: 688180) announced that its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA) [1] Group 1 - JS212 is a recombinant humanized bispecific antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The primary indication for JS212 is the treatment of advanced malignant solid tumors [1]

智通财经APP讯，君实生物(688180.SH)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。 ...

格隆汇12月14日丨君实生物(688180.SH)发布公告，近日，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。 ...

君实生物(688180.SH)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。 ...

君实生物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 - Junshi Biosciences (688180) announced on December 14 that it has received approval from the U.S. Food and Drug Administration (FDA) for its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code: JS212) for the treatment of advanced solid tumors [1] Group 1 - The FDA approval allows Junshi Biosciences to proceed with clinical trials for JS212, which is designed to treat advanced malignant solid tumors [1] - JS212 is a recombinant humanized bispecific antibody targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) [1] - The drug aims to address the treatment needs for patients with advanced solid tumors, indicating a potential advancement in cancer therapy [1]

每经AI快讯，12月14日，君实生物(688180.SH)公告称，公司收到FDA通知，EGFR/HER3双特异性抗体 偶联药物JS212用于治疗晚期实体瘤的临床试验申请获得FDA批准。JS212主要用于晚期恶性实体瘤的治 疗，与单一靶点ADC药物相比，有望对更广泛的肿瘤有效，同时有望克服耐药性问题。 ...

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。 证券代码：688180 证券简称：君实生物 公告编号：临 2025-074 上海君实生物医药科技股份有限公司 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： 一、药品 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The 2025 National Medical Insurance Negotiation results were announced, with 114 new drugs added to the medical insurance directory, achieving an overall success rate of 88%, the highest in nearly seven years, with a maximum price reduction of 94 [4][19] - The newly added drugs include monoclonal antibodies, bispecific antibodies, ADCs, siRNA, and small molecules, indicating a strong focus on innovative therapies [19][32] - The commercial insurance directory has added 19 innovative drugs, which, while not reimbursed by medical insurance, receive support for innovative drug applications, enhancing patient access and benefiting the innovative drug industry [5][24] Summary by Sections 1. National Medical Insurance Negotiation Results - The 2025 medical insurance directory added 114 new drugs, with a success rate of 88% and a maximum price reduction of 94% [4][13] - The total number of drugs in the national medical insurance directory reached 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [16][17] - The directory reflects a significant increase in the inclusion of innovative drugs, with 50 of the new additions classified as category 1 innovative drugs [19][21] 2. Commercial Insurance Directory - The commercial insurance directory added 19 innovative drugs, highlighting their clinical value and innovation [24][28] - The directory includes treatments for diseases such as Alzheimer's, rare diseases in children, and other critical conditions, showcasing a focus on addressing unmet medical needs [24][28] - The support for innovative drugs in the commercial insurance directory aims to fill gaps in patient coverage and enhance the overall healthcare system [25][28] 3. Market Performance - In the second week of December, the pharmaceutical and biotechnology sector declined by 1.04%, underperforming the CSI 300 index by 0.96 percentage points [6][34] - The medical research outsourcing sector showed the highest increase, up by 3.69%, while offline pharmacy and medical circulation sectors experienced the largest declines [6][36] 4. Recommended Companies - The report continues to favor innovative drugs and their supply chain, recommending companies such as Sanofi, Innovent Biologics, and others for investment [7][32]