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可同时以高亲和力结合于PD-1与VEGFA，有效阻断PD-1与PD-L1和PD-L2的结合，并抑制VEGF与 其受体的结合。JS207具有免疫治疗药物和抗血管生成药物的疗效特性，通过中和VEGF可抑制血管内 皮细胞增殖，改善肿瘤微环境，增加细胞毒性T淋巴细胞在肿瘤微环境中的浸润，从而达到更好的抗肿 瘤活性。 格隆汇10月16日丨君实生物(688180.SH)公布，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（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。 ...

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】智通财经10 月16日电，君实生物(688180.SH)公告称，公司产品重组人源化抗PD-1和VEGF双特异性抗体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临 床试验申请获FDA批准。JS207具有免疫治疗药物和抗血管生成药物的疗效特性，可同时阻断PD-1与 PD-L1和PD-L2的结合，并抑制VEGF与其受体的结合。该研究为PD-1/VEGF双靶点药物首次在可手术 人群中获批开展确证性研究。 转自：智通财经 ...

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]

Core Insights - The "2025 Shanghai International Biopharmaceutical Industry Week" forum successfully held the Shanghai Biopharmaceutical Investment and Financing Summit, focusing on "Diverse Capital Empowering Ecological Strengthening" to explore better combinations for the innovation ecosystem in the biopharmaceutical industry [1][3] Group 1: Event Overview - The summit gathered over 200 professionals from academia, industry, investment, and finance, featuring keynote speeches and roundtable discussions on biopharmaceutical investment and financing [3] - The event was hosted by Shanghai Guotou Company, aiming to enhance source innovation and industry aggregation in the biopharmaceutical sector [1] Group 2: Investment Strategies - Shanghai Guotou Company has invested approximately 6.6 billion yuan in biopharmaceutical sub-funds, focusing on innovative drugs, self-controllable industrial chains, brain-computer interfaces, cell and gene therapies, and synthetic biology [5] - The company emphasizes collaboration with ecological partners to explore innovative models and integrate innovation chains, industry chains, capital chains, and talent chains [5] Group 3: Industry Insights - Professor Hong Bo from Tsinghua University discussed the future of brain-computer interfaces, highlighting advancements and clinical trials involving 32 patients, with plans to submit a clinical trial report by the end of the year [7] - CEO Zou Jianjun of Junshi Biosciences emphasized the need for innovation-driven drug companies to focus on unmet clinical needs and build global capabilities from R&D to commercialization [9] Group 4: Market Trends - Guo Qiushan, President of the Shanghai Biopharmaceutical Innovation Transformation Fund, noted a strong recovery in China's capital market and the increasing importance of domestic pharmaceutical companies and M&A funds in driving innovation [11] - Liang Yijian from Shiyao Group highlighted the significance of early-stage projects and the unique advantages of corporate venture capital (CVC) in enhancing clinical, registration, and market capabilities [13] Group 5: Research and Development - The summit featured the release of the latest research results, including the "Stem Cell Industry Development Blue Book" and "AI Pharmaceutical Industry Development Blue Book," providing insights into technological evolution and industry trends [15] - The event underscored the importance of a supportive regulatory environment and the need for diverse capital to interact positively with innovative enterprises [16]

Core Viewpoint - The "2025 Shanghai International Biopharmaceutical Industry Week" forum focused on "Diverse Capital Empowering Ecological Strengthening" to explore better combinations for the innovation ecosystem in the biopharmaceutical industry, aiming to enhance source innovation and industrial aggregation in Shanghai [1] Group 1: Investment and Funding - Shanghai Guotou Company has committed approximately 6.6 billion yuan to biopharmaceutical sub-funds, with a market selection and investment in 22 sub-funds, achieving a leverage ratio of about 5.5 times [4] - The investment strategy emphasizes innovative drugs and devices, self-controllable industrial chains, brain-computer interfaces, cell and gene therapies, and synthetic biology [4] - The company aims to foster collaboration among ecological partners to integrate innovation, industry, finance, and talent chains [4] Group 2: Technological Innovations - Professor Hong Bo from Tsinghua University discussed the development of brain-computer interface technology, highlighting its evolution and future directions, including expanding indications and enhancing precision [6] - The team behind the brain-computer interface has successfully conducted surgeries on 32 patients, with plans to submit clinical trial reports for the first class III medical device by the end of the year [6] Group 3: Industry Trends and Challenges - CEO Zou Jianjun of Junshi Biosciences emphasized the shift from valuation-driven to value-driven approaches in the innovative pharmaceutical sector, focusing on unmet clinical needs and building global capabilities [8] - The resilience and value reconstruction of the biopharmaceutical industry in China were discussed, noting a strong recovery in the capital market and the increasing importance of domestic pharmaceutical companies in mergers and acquisitions [10] Group 4: Collaborative Ecosystem - Liang Yijian from CSPC shared insights on the value creation journey of corporate venture capital (CVC), emphasizing the importance of clinical value and early-stage project innovation [12] - The latest research results on stem cell and AI pharmaceutical industries were released, providing a comprehensive overview of technological evolution and industry trends [14] Group 5: Future Directions - The roundtable discussion highlighted the need for diverse capital to empower industrial innovation, with a focus on regulatory support and the interaction between capital and innovative enterprises [16] - Shanghai Guotou Company plans to build an innovation ecosystem through a comprehensive fund matrix and collaborative partnerships to support the development of a world-class biopharmaceutical industry [16]

Group 1 - The innovative drug sector is leading the market, with Kangfang Biotech and 3SBio both rising over 8%, contributing to a 3.5% increase in the Hang Seng Innovative Drug ETF (159316) [1] - The Hang Seng Innovative Drug ETF has attracted a total of 849 million in capital over the past 20 days, bringing its latest scale to 2.961 billion [1] - The ETF is the only one tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Index, which has recently been updated to exclude CXO, achieving a "100% purity" in innovative drug representation [1] Group 2 - The innovative drug sector is experiencing a significant upward trend, with attention on domestic innovative drug companies participating in the upcoming ESMO conference in Berlin from October 17 to 21, 2025 [1] - Companies to watch include Kangfang Biotech, Kelun-Biotech, Hengrui Medicine, Rongchang Biotech, Junshi Biosciences, and Jinfang Medicine, particularly for new data releases in dual antibodies and ADC technologies [1] - Huafu Securities expresses optimism about the innovative drug industry, predicting a transformative growth over the next 5-10 years driven by overseas business development, continuous data catalysts, and new product sales expansion [1]

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 主席 中國，上海，2025年10月15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。 * 僅供識別之用 （股份代號：1877） 董事會召開日期 上海君實生物醫藥科技股份有限公司（「本公司」及其附屬公司「本集團」）董事會 （「董事會」）茲通告謹定於二零二五年十月二十八日（星期二）舉行董事會會議，以 考慮及通過本集團截至二零二五年九月三十日止九個月未經審核的財務業績。 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 （於中華人民共和國註冊成立的股份有限公司） ...

格隆汇10月15日丨君实生物(01877.HK)宣布，谨定于2025年10月28日（星期二）举行董事会会议，以考 虑及通过本集团截至2025年9月30日止九个月未经审核的财务业绩。 ...

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） 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 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。 主席 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 董事會召開日期 上海君實生物醫藥科技股份有限公司（「本公司」及其附屬公司「本集團」）董事會 （「董事會」）茲通告謹定於二零二五年十月二十八日（星期二）舉行董事會會議，以 考慮及通過本集團截至二零二五年九月三十日止九個月未經審核的財務業績。 * 僅供識別之用 中國，上海，2025年10月15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。 ...