上海君实生物医药科技股份有限公司 自愿披露关于 JS001sc 一线治疗非鳞状非小细胞肺癌 的Ⅲ期临床研究达到主要研究终点的公告 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"）产品特瑞 普利单抗注射液（皮下注射）（代号：JS001sc）对比特瑞普利单抗注射液（商 品名：拓益®，产品代号：JS001）联合化疗一线治疗复发或转移性非鳞状非小细 胞肺癌的多中心、开放、随机对照 III 期临床研究（JS001sc-002-III-NSCLC 研究， NCT06505837）达到主要研究终点。公司计划将于近期向监管部门递交该产品的 上市许可申请。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、药品基本情况 证券代码：688180 证券简称：君实生物 公告编号：临 2025-067 JS001sc-002-III-NSCLC 研究是一项多中心、开放、随机对照的 III 期临床研 究，为 ...

Investment Rating - The report maintains a "Buy" rating for several companies including Tian Shi Li, Xin Da Biology, and WuXi AppTec, with a focus on the innovative drug industry and high-end medical devices [3][25]. Core Insights - The small nucleic acid drug sector is experiencing significant advancements, marking the dawn of a new wave of innovative drugs. The industry is entering a golden development period driven by technological breakthroughs and commercial validation, with a recommendation to focus on leading innovative drug companies and those benefiting from the overall industry upturn [1][20][24]. Summary by Sections Market Review - The A-share pharmaceutical and biotechnology index fell by 4.32%, underperforming the CSI 300 index by 0.54 percentage points, while outperforming the ChiNext index by 1.92 percentage points, ranking 30th among 31 sub-industries. The H-share Hang Seng Healthcare Index dropped by 7.5%, underperforming the Hang Seng Index by 2.41 percentage points [1][15][9]. R&D Progress - Recent IND applications have been initiated for Heng Rui Medicine's HRS-1358 and HRS-3738, and clinical applications for SHR-9539 and JS207 have also been newly undertaken. Additionally, Zheng Da Tian Qing's TQB2934 is in Phase I clinical trials, while Gan Li Pharmaceutical's Bo Fan Gu Lu Tai is in Phase III [1][28]. Key Company Recommendations - The report highlights key companies to watch, including Heng Rui Medicine (A+H), Xin Da Biology (H), WuXi AppTec (A+H), Qian Yan Biology, Chengdu Xian Dao, and Jian Kai Technology, focusing on those with leading technology platforms and differentiated pipelines [1][25][24]. Investment Strategy - The report emphasizes the importance of clinical value in the pharmaceutical sector, suggesting that investments should focus on innovative drug chains and medical devices that meet clinical needs. The strategy is based on a three-stage clinical value framework [2][24]. Financial Forecasts - The report provides earnings per share (EPS) forecasts for key companies, with Tian Shi Li projected at 0.64 CNY for 2024, Xin Da Biology at -0.06 CNY, and WuXi AppTec at 3.27 CNY for 2024, indicating a positive outlook for several firms [3].

来源：新浪证券-红岸工作室 11月21日，君实生物跌2.91%，成交额3.10亿元。两融数据显示，当日君实生物获融资买入额1625.62万 元，融资偿还2252.64万元，融资净买入-627.02万元。截至11月21日，君实生物融资融券余额合计13.88 亿元。 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%。 机构持仓方面，截止2025年9月30日，君实生物十大流通股东中，易方达上证科创板50ETF（588080） 位居第七大流通股东，持股1939.29万股，相比上期减少282.03万股。华夏上证科创板50成份ETF （588000）位居第八大流通股东，持股1897.20万股，相比上期减少1074.47万股。 融券方面，君实生物11月21日融券偿还1109.00股，融券卖出4440.00股，按当日收盘价计算，卖出金额 15.87万元；融券余量32.07万股，融券余额1146.45万元，超过近一年90%分位水平， ...

Core Viewpoint - The establishment of the Anhui Gaotou Guotai Haitong Health M&A Equity Investment Fund Partnership (Limited Partnership) with a capital contribution of 500 million yuan indicates a strategic move towards private equity investment in the health sector [1] Group 1 - The newly formed fund will engage in activities such as private equity investment, investment management, and asset management [1] - The fund is co-funded by Junshi Biosciences and Guotai Haitong's wholly-owned subsidiary, Guotai Junan Innovation Investment Co., Ltd. [1]

Core Viewpoint - The establishment of the Anhui Gaotou Guotai Haitong Health M&A Equity Investment Fund marks a significant move in the private equity investment landscape, with a total capital contribution of 500 million RMB [1] Group 1: Fund Details - The fund is a limited partnership, with the managing partner being Junshi Venture Capital (Hainan) Co., Ltd. and Guotai Junan Innovation Investment Co., Ltd. [1] - The fund's operational scope includes private equity investment, investment management, and asset management activities [1] Group 2: Contributors - The fund is jointly funded by Junshi Biological, Anhui Small and Medium Enterprises Development Phase II Fund Co., Ltd., and Guotai Junan Innovation Investment Co., Ltd. [1]

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%。 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 11月18日，君实生物跌1.76%，成交额2.74亿元。两融数据显示，当日君实生物获融资买入额2598.19万 元，融资偿还1861.26万元，融资净买入736.93万元。截至11月18日，君实生物融资融券余额合计14.06 亿元。 融资方面，君实生物当日融资买入2598.19万元。当前融资余额13.94亿元，占流通市值 ...

Core Viewpoint - The company, Junshi Biosciences, is focused on becoming a leading innovative pharmaceutical company with a complete industry chain capability, from drug discovery to commercialization, aiming for global reach [2]. Group 1: Company Overview - Junshi Biosciences has developed a strong portfolio of innovative drugs, including the first domestically approved PD-1 monoclonal antibody, Toripalimab, which has received approval for 11 indications in mainland China and is also approved in multiple countries [2]. - The company is actively involved in the development of vaccines, including monkeypox and Zika vaccines, in collaboration with research institutions and universities [3]. - As of September 30, 2025, Junshi Biosciences reported a revenue of 1.806 billion yuan, a year-on-year increase of 42.06%, while the net profit attributable to shareholders was -596 million yuan, reflecting a growth of 35.72% [8]. Group 2: Market Performance - On November 18, the stock price of Junshi Biosciences fell by 1.76%, with a trading volume of 274 million yuan and a turnover rate of 0.95%, resulting in a total market capitalization of 38.398 billion yuan [1]. - The stock has seen a net outflow of 46.6163 million yuan from major investors, indicating a trend of reduced holdings over the past three days [4][5]. - The average trading cost of the stock is 41.16 yuan, with the current price approaching a resistance level of 37.50 yuan, suggesting potential for a price correction if this level is not surpassed [6].

资金流向方面，主力资金净流出2722.81万元，特大单买入394.77万元，占比2.09%，卖出897.52万元， 占比4.75%；大单买入3021.44万元，占比15.98%，卖出5241.49万元，占比27.73%。 来源：新浪证券-红岸工作室 11月18日，君实生物盘中下跌2.02%，截至13:41，报37.30元/股，成交1.89亿元，换手率0.65%，总市值 382.96亿元。 君实生物今年以来股价涨36.48%，近5个交易日跌2.10%，近20日跌4.33%，近60日跌20.74%。 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：抗癌药物、抗癌治 癌、 ...

智通财经APP获悉，君实生物(01877)涨近3%，截至发稿，涨1.62%，报25.14港元，成交额542.37万港 元。 消息面上，长江证券指出，君实生物的营收增长以特瑞普利单抗(拓益)为核心，2025年前三季度在国内 实现销售收入约14.95亿元，同比增长约40%。2025年第三季度，拓益用于一线治疗HER2表达尿路上皮 癌的新适应症获得国家药品监督管理局受理。截至2025年第三季度，国内已获批12项适应症，其中10项 适应症已纳入国家医保目录。 该行续指，2025年第三季度，君实生物重点管线JS207(PD-1/VEGF双抗)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美国FDA批准，目前还在国内进行结直肠癌、三阴性乳腺癌、肝癌等多 个适应症的II期研究。此外，JS107(Claudin18.2ADC)入选2025年ESMO最新突破摘要(LBA)，将公布治 疗晚期实体瘤的I期临床研究更新数据。 ...

该行续指，2025年第三季度，君实生物重点管线JS207(PD-1/VEGF双抗)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美国FDA批准，目前还在国内进行结直肠癌、三阴性乳腺癌、肝癌等多 个适应症的II期研究。此外，JS107(Claudin18.2ADC)入选2025年ESMO最新突破摘要(LBA)，将公布治 疗晚期实体瘤的I期临床研究更新数据。 消息面上，长江证券指出，君实生物的营收增长以特瑞普利单抗(拓益)为核心，2025年前三季度在国内 实现销售收入约14.95亿元，同比增长约40%。2025年第三季度，拓益用于一线治疗HER2表达尿路上皮 癌的新适应症获得国家药品监督管理局受理。截至2025年第三季度，国内已获批12项适应症，其中10项 适应症已纳入国家医保目录。 君实生物(01877)涨近3%，截至发稿，涨1.62%，报25.14港元，成交额542.37万港元。 ...