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]

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 ...

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]

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]

Core Insights - The biopharmaceutical sector experienced a slight increase of 0.13% on October 16, with Sanofi leading the gains [1] - The Shanghai Composite Index closed at 3916.23, up 0.1%, while the Shenzhen Component Index closed at 13086.41, down 0.25% [1] Biopharmaceutical Sector Performance - Sanofi (688336) saw a significant rise of 13.02%, closing at 59.90 with a trading volume of 177,400 shares and a transaction value of 1.063 billion [1] - Other notable gainers included: - Nossland (920047) up 4.09% to 25.46 with a transaction value of 125 million [1] - Rongchang Bio (688331) up 3.28% to 99.20 with a transaction value of 684 million [1] - Conversely, several companies experienced declines, including: - Anke Bio (300009) down 2.48% to 10.23 with a transaction value of 315 million [2] - Kain Technology (688687) down 1.92% to 28.62 with a transaction value of 169 million [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 2.7582 million from institutional investors, while retail investors experienced a net outflow of 140 million [2] - Notable capital inflows included: - Junshi Biosciences (688180) with a net inflow of 71.7936 million from institutional investors [3] - Sanofi (688336) with a net inflow of 67.508 million from institutional investors [3] - Conversely, significant outflows were observed in: - Sanofi (688336) with a retail net outflow of 540,300 [3] - Rongchang Bio (688331) with a retail net outflow of 4.41034 million [3]

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]

Core Viewpoint - The innovation drug sector in China is experiencing significant growth, driven by increased investment, favorable policies, and a strong pipeline of new drugs entering clinical trials, positioning it for a robust future in both domestic and international markets [6][8][10]. Group 1: Market Performance - As of October 16, the Science and Technology Innovation Drug ETF (Huitianfu, 589120) saw a notable increase of 3.31%, maintaining a rise of over 2% despite a slight pullback [1]. - The ETF has attracted over 40 million yuan in net inflows over the past five days, indicating strong investor interest [1]. - Key constituent stocks such as Sangfor Technology and Yifang Bio have shown significant gains, with Sangfor hitting the daily limit up and Yifang Bio rising by 8.61% [2][3]. Group 2: Industry Trends - The number of License-out transactions in China reached 72 in the first half of 2025, surpassing half of the total for 2024, with a total transaction value 16% higher than the previous year [5]. - The innovation drug sector is primarily driven by business development (BD) expectations, with a significant portion of annual BD activity occurring in the fourth quarter [6]. - The Chinese innovation drug market is expected to see a recovery in confidence as more BD deals materialize, particularly as companies prepare for the upcoming European Society for Medical Oncology (ESMO) conference [6][7]. Group 3: R&D and Financial Outlook - Since 2015, Chinese innovation drug companies have significantly increased R&D investments, leading to a rise in the number of original innovative drugs entering clinical trials, with 704 drugs expected to enter Phase I trials in 2024 [8]. - The revenue of innovation drug companies has been steadily increasing, with projections indicating that one-third of these companies will achieve profitability by 2025, and 70% will reach breakeven by 2026 [8]. - The Chinese government's support for innovation drugs through favorable policies and increased funding is expected to enhance the sector's growth, with healthcare spending on innovation drugs projected to rise from 50 billion yuan in 2022 to 120 billion yuan in 2024 [9]. Group 4: Competitive Landscape - The impending patent cliff for multinational corporations (MNCs) is expected to create a demand for new products, with 190 drugs losing patent protection by 2030, including 69 with annual sales exceeding 1 billion dollars [10]. - Chinese innovation drug companies are well-positioned to fill this gap due to their high R&D efficiency and rich technological outcomes, making them attractive partners for MNCs [10].

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） ...