Core Viewpoint - Junshi Biosciences (01877) announced that its product JS001sc (subcutaneous injection of Toripalimab) has achieved the primary endpoint in a Phase III clinical study for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer, paving the way for a forthcoming market application submission [1]. Group 1 - The clinical study (JS001sc-002-III-NSCLC) is a multicenter, open-label, randomized controlled trial comparing JS001sc with Toripalimab injection (JS001) in combination with chemotherapy [1]. - JS001sc is the first domestically developed subcutaneous PD-1 monoclonal antibody to enter Phase III clinical trials, potentially offering patients greater convenience in medication administration [1]. - The company plans to submit a marketing authorization application to regulatory authorities in the near future [1].

Core Viewpoint - The company announced that its product, JS001sc (subcutaneous injection of Tislelizumab), has achieved the primary endpoint in a Phase III clinical trial for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer, and plans to submit a marketing authorization application soon [1] Group 1: Clinical Trial Results - The Phase III clinical study (JS001sc-002-III-NSCLC) comparing JS001sc with Tislelizumab injection (brand name: Tuoyi®) in combination with chemotherapy has reached its primary endpoint [1] - JS001sc is the first domestically developed subcutaneous PD-1 monoclonal antibody to enter Phase III clinical trials, potentially offering convenience for patients [1] Group 2: Regulatory Plans - The company intends to submit a marketing authorization application to regulatory authorities in the near future [1] Group 3: Product Development - JS001sc is developed based on the already marketed Tislelizumab injection, indicating a strategic expansion of the company's product line [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之內容概不負責，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 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 主席 中國，上海，2025年11月24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 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於JS001sc一線治療非鱗狀非小細胞肺 癌的III期臨床研究達到主要研究終點的公告》，僅供參閱。 ...

Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product JS001sc, a subcutaneous injection of Toripalimab, has met the primary endpoint in a Phase III clinical trial for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer, and plans to submit a marketing authorization application soon [1] Group 1 - The clinical trial (JS001sc-002-III-NSCLC) is a multicenter, open-label, randomized controlled study comparing JS001sc with Toripalimab injection (trade name: Tuoyi®) in combination with chemotherapy [1] - JS001sc is developed based on the already marketed Toripalimab injection and is the first domestic PD-1 monoclonal antibody subcutaneous formulation to enter Phase III clinical trials [1] - The new formulation is expected to provide convenience for patients in terms of medication administration [1]

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 ...