君实生物(688180.SH)发布公告，公司全资子公司苏州众合生物医药科技有限公司(简称"苏州众合")于 2025年6月16日至2025年6月24日期间接受了美国食品药品监督管理局(简称"FDA")的CGMP(现行药品生 产质量管理规范)飞行检查。近日，苏州众合收到FDA签发的现场检查报告(EIR)，该报告表明苏州众合 已通过本次CGMP现场检查。 此次是苏州众合继2023年首次通过FDA现场检查以来，第二次通过FDA现场检查，表明公司高质量生产 制造体系持续获得国际认可。 ...

此次是苏州众合继2023年首次通过FDA现场检查以来，第二次通过FDA现场检查，表明公司高质量生产 制造体系持续获得国际认可。 君实生物(688180.SH)发布公告，公司全资子公司苏州众合生物医药科技有限公司(简称"苏州众合")于 2025年6月16日至2025年6月24日期间接受了美国食品药品监督管理局(简称"FDA")的CGMP(现行药品生 产质量管理规范)飞行检查。近日，苏州众合收到FDA签发的现场检查报告(EIR)，该报告表明苏州众合 已通过本次CGMP现场检查。 ...

证券代码：688180 证券简称：君实生物 公告编号：临2025-063 上海君实生物医药科技股份有限公司 关于召开2025年第三季度业绩说明会的公告 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。 重要内容提示： ● 投资者可于2025年10月22日（星期三）至2025年10月28日（星期二）16:00前登录上证路演中心网站 首页点击"提问预征集"栏目或通过上海君实生物医药科技股份有限公司（以下简称"公司"）邮箱 info@junshipharma.com进行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 公司将于2025年10月29日在上海证券交易所网站（www.sse.com.cn）披露公司2025年第三季度报告，为 便于广大投资者更全面深入地了解公司2025年第三季度的经营成果、财务状况，公司计划于2025年10月 29日11：00-12：00召开2025年第三季度业绩说明会，就投资者关心的问题进行交流。 登录新浪财经APP 搜索【信披】查看更多考评等级 （一）投资者可在2025年10月29日（星期三）上午 ...

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 （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關於召開2025年第三季度業績說明會的公告》， 僅供參閱。 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10月21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 证券代码：688180 证券简称：君实生物 公告 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2025-063 上海君实生物医药科技股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 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。 重要内容提示： 会议召开时间：2025 年 10 月 29 日（星期三）11：00-12：00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2025 年 10 月 22 日（星期三）至 2025 年 10 月 28 日（星期 二）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过上海君 实生物医药科技股份有限公司（以下简称"公司"）邮箱 info@junshipharma.com 进行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 公司将于 2025 年 10 月 29 日在上海证券交易所网站（www.sse.com.cn）披 露公司 2 ...

Group 1 - The core point of the news is that Junshi Biosciences experienced a slight decline in stock price and significant trading activity, with notable financing and margin trading figures indicating high levels of investor engagement [1][2][3] Group 2 - On October 20, Junshi Biosciences' stock fell by 0.34%, with a trading volume of 351 million yuan. The financing buy-in amount was 28.92 million yuan, while the financing repayment was 33.51 million yuan, resulting in a net financing outflow of 4.59 million yuan [1] - As of October 20, the total financing and margin trading balance for Junshi Biosciences was 1.401 billion yuan, with the financing balance at 1.39 billion yuan, accounting for 4.69% of the circulating market value, which is above the 90th percentile of the past year [1] - In terms of margin trading, on October 20, Junshi Biosciences had 3,815 shares repaid and 2,550 shares sold short, with a short selling amount of 98,600 yuan. The remaining short selling volume was 284,500 shares, with a margin balance of 11 million yuan, also above the 90th percentile of the past year [1] Group 3 - Junshi Biosciences, established on December 27, 2012, and listed on July 15, 2020, focuses on the research and commercialization of monoclonal antibody drugs and other therapeutic protein drugs. The main revenue sources are 90.67% from drug sales, 8.74% from technology licensing, and 0.59% from technical services [2] - As of June 30, 2025, Junshi Biosciences reported a revenue of 1.168 billion yuan, representing a year-on-year growth of 48.64%, while the net profit attributable to shareholders was -413 million yuan, showing a year-on-year increase of 36.01% [2] Group 4 - As of June 30, 2025, among the top ten circulating shareholders of Junshi Biosciences, the Huaxia SSE STAR 50 ETF held 29.7167 million shares, a decrease of 536,700 shares from the previous period. The E Fund SSE STAR 50 ETF increased its holdings by 630,000 shares to 22.2132 million shares [3] - Hong Kong Central Clearing Limited was the tenth largest circulating shareholder, holding 13.1291 million shares, a decrease of 186,650 shares from the previous period [3]

Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.48% from October 13 to October 17, underperforming the broader market index, the CSI 300, which fell by 2.22% [3][8] - There is a sustained enthusiasm for business development (BD) transactions in innovative drugs, with several companies entering agreements with international pharmaceutical firms [3][12] - The ESMO conference held from October 17 to 21 showcased positive advancements in multiple studies, particularly in immunotherapy and antibody-drug conjugates (ADCs), highlighting the potential of domestic biotech companies [3][11] Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly decline of 2.48%, with offline pharmacies and traditional Chinese medicine showing slight gains of 0.59% and 0.38%, respectively [8] - Medical research outsourcing, medical devices, and other biological products faced significant declines, with drops of 6.46%, 5.37%, and 3.6% respectively [8][9] - Notable stock performances included Asia-Pacific Pharmaceutical with a rise of 36.7%, while Betta Pharmaceuticals saw a decline of 17.0% [11] Industry News and Key Company Announcements Important Industry Events - On October 18, Kangfang Biologics presented data on a PD-1/VEGF dual antibody in non-small cell lung cancer at the ESMO conference, showing significant improvement in progression-free survival (PFS) [11] - On October 16, Hansa Biopharma announced a licensing agreement with Roche for the global exclusive rights to develop and commercialize HS-20110, with an upfront payment of $80 million [12] - On October 16, Prigen Biologics entered a collaboration with Gilead's Kite Pharma, receiving an upfront payment of $120 million [12][13] Company Announcements - Huayuan Biologics reported a slight decrease in total revenue for the third quarter, amounting to 936 million yuan, a 0.2% year-on-year decline [14] - Shanghai Pharmaceuticals received FDA approval for Doxycycline capsules, with projected sales of approximately $130 million in the U.S. for 2024 [14][16]

Core Insights - The biotechnology sector in the Hong Kong stock market has shown strong performance, with several stocks experiencing significant gains today, particularly药捷安康-B which surged over 30% [1] Stock Performance Summary - 药捷安康-B: Increased by 31.25%, latest price at 218.000, total market value of 86.524 billion, year-to-date increase of 1557.79% [2] - 康宁杰瑞制药-B: Increased by 7.15%, latest price at 14.680, total market value of 14.245 billion, year-to-date increase of 319.43% [2] - 帝王国际投资: Increased by 5.50%, latest price at 0.115, total market value of 0.0213 billion, year-to-date increase of 155.56% [2] - 映恩生物-B: Increased by 5.00%, latest price at 336.000, total market value of 29.58 billion, year-to-date increase of 255.18% [2] - 基石药业-B: Increased by 4.66%, latest price at 7.190, total market value of 10.612 billion, year-to-date increase of 212.61% [2] - 三叶草生物-B: Increased by 4.39%, latest price at 2.140, total market value of 2.776 billion, year-to-date increase of 787.97% [2] - 百奥塞图-B: Increased by 3.86%, latest price at 24.220, total market value of 9.673 billion, year-to-date increase of 184.94% [2] - 来凯医药-B: Increased by 3.71%, latest price at 14.540, total market value of 6.49217 billion, year-to-date increase of 55.18% [2] - 君实生物: Increased by 3.29%, latest price at 27.600, total market value of 28.337 billion, year-to-date increase of 138.34% [2] - MIRXES-B: Increased by 3.26%, latest price at 72.900, total market value of 20.145 billion, year-to-date increase of 212.88% [2]

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application for JS207, a dual-specific antibody targeting PD-1 and VEGF, aimed at treating non-small cell lung cancer patients [1][2]. Group 1 - Junshi Biosciences' stock opened nearly 5% higher and is currently trading at 28.04 HKD with a transaction volume of 6.41 million HKD [1]. - The clinical trial for JS207 is a Phase II/III study comparing it to Nivolumab in patients with resectable, AGA-negative non-small cell lung cancer [1]. - JS207 is a recombinant humanized dual-specific antibody that binds with high affinity to both PD-1 and VEGFA, effectively blocking their interactions and exhibiting properties of both immunotherapy and anti-angiogenic drugs [1]. Group 2 - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with additional Phase II studies ongoing in various cancers including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]. - The ongoing studies are exploring combinations of JS207 with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) [2].

Core Viewpoint - Junshi Biosciences (01877) experienced a nearly 5% increase in stock price following the announcement of FDA approval for its clinical trial application for JS207, a dual-specific antibody targeting PD-1 and VEGF for the treatment of non-small cell lung cancer [1][2]. Group 1: Product Development - JS207 is a recombinant humanized dual-specific antibody targeting PD-1 and VEGF, developed by the company for the treatment of advanced malignancies [1]. - The antibody effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenesis properties [1]. - The drug aims to improve the tumor microenvironment by inhibiting endothelial cell proliferation and increasing the infiltration of cytotoxic T lymphocytes, thereby enhancing anti-tumor activity [1]. Group 2: Clinical Research - As of the announcement date, JS207 has been approved to enter the Phase II/III clinical research stage, with multiple ongoing Phase II studies exploring its use in various cancers, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]. - The ongoing studies are investigating combinations of JS207 with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) [2].