Core Viewpoint - Junshi Biosciences announced that its wholly-owned subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed a CGMP inspection by the FDA, indicating compliance with current good manufacturing practices [1] Group 1 - The FDA conducted an unannounced CGMP inspection from June 16 to June 24, 2025 [1] - Suzhou Zhonghe received a report from the FDA confirming the successful completion of the CGMP inspection [1]

Core Points - Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, successfully passed an unannounced CGMP inspection by the FDA from June 16 to June 24, 2025, marking the second successful inspection since 2023 [1] - The successful inspection indicates that the company's high-quality manufacturing system continues to receive international recognition [1] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, primarily for the commercialization supply of Toripalimab in overseas markets [1] Business Impact - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, providing solid assurance for the continued expansion into the US market [2] - This achievement is expected to have a positive impact on the company's production and operations [2]

Group 1 - Tianpu Co., Ltd. warns that its stock price has significantly deviated from its fundamentals, with a potential for rapid decline after a 246.02% increase from August 22 to October 22 [3] - Shenzhen Sanda A plans to sell stakes in several subsidiaries to focus on its core business, including 80% of Zhongdian Intercontinental Environmental Technology [4] - Zhongchong Co., Ltd. received an administrative regulatory measure from the Shandong Securities Regulatory Bureau for failing to announce a significant change in shareholding [5] Group 2 - Construction Machinery has reported a net loss for three consecutive years, with a net profit of -447 million yuan for the first half of 2025 [6] - Junshi Biosciences' subsidiary passed a CGMP inspection by the FDA, indicating compliance with manufacturing standards [7] - Xinguang Optoelectronics announced the lifting of detention measures against its chairman, indicating normal operations [8] Group 3 - Jiangsu New Energy's controlling shareholder plans to invest in offshore wind power projects and will manage the project companies through the listed company [10] - Duofluorid's net profit for the first three quarters increased by 407.74%, with a revenue of 6.729 billion yuan [12] - Weihuaxin Materials reported a 250.04% increase in net profit for the third quarter, with revenue of 223 million yuan [13] Group 4 - Xianggang Technology's net profit for the first three quarters increased by 186.19%, with a revenue of 742 million yuan [14] - Defu Technology's net profit increased by 132.63% in the first three quarters, with a revenue of 8.5 billion yuan [15] - Taishan Petroleum reported a 112.32% increase in net profit for the first three quarters, with a revenue of 2.395 billion yuan [16] Group 5 - Kaisheng New Materials reported a 121.56% increase in net profit for the first three quarters, with a revenue of 774 million yuan [17] - Guangku Technology's net profit increased by 106.61% in the first three quarters, with a revenue of 998 million yuan [18] - Xinong Co., Ltd. reported a 105.68% increase in net profit for the third quarter, with a revenue of 837 million yuan [19] Group 6 - Mairande's net profit increased by 36.71% in the third quarter, with a revenue of 103 million yuan [20] - ST Nuotai reported a 26.92% increase in net profit for the first three quarters, with a revenue of 1.527 billion yuan [21] - Anke Rui's net profit increased by 21.31% in the first three quarters, with a revenue of 837 million yuan [22] Group 7 - Weisheng Information reported a 12.24% increase in net profit for the first three quarters, with a revenue of 2.112 billion yuan [23] - Action Education plans to distribute a cash dividend of 5 yuan per 10 shares, with a net profit increase of 10.39% [24] - Henghui Security reported a 12.85% decrease in net profit for the first three quarters, with a revenue of 880 million yuan [25] Group 8 - China Shipbuilding Han Guang reported a 9.44% decrease in net profit for the first three quarters, with a revenue of 875 million yuan [26] - Sichuan Chengyu's subsidiary signed a sand and gravel supply contract worth up to 100 million yuan [28][29] - Yuegui Co., Ltd.'s subsidiary signed a mining rights transfer contract for a quartz rock mine with a reserve of 18.163 million cubic meters [30]

Core Viewpoint - Junshi Biosciences (01877) announced that its wholly-owned subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced CGMP inspection by the FDA, indicating the company's high-quality manufacturing system continues to gain international recognition [1] Group 1: FDA Inspection - Suzhou Zhonghe underwent an unannounced CGMP inspection from June 16 to June 24, 2025, and received a favorable Establishment Inspection Report (EIR) from the FDA [1] - This marks the second successful FDA inspection for Suzhou Zhonghe since its first in 2023, reinforcing the company's commitment to quality [1] Group 2: Production Capacity and Certifications - As of the announcement date, the Suzhou Wujiang production facility has a fermentation capacity of 4,500 liters (9 x 500 liters) [1] - The facility has obtained GMP certifications and approvals from multiple countries and regions, including mainland China, Hong Kong, the USA, EU, UK, Australia, Singapore, India, Jordan, UAE, Kuwait, and Pakistan [1] Group 3: Market Implications - The successful FDA inspection is crucial for the company's strategy to expand in the US market, providing a solid foundation for ongoing commercial supply of Toripalimab [1] - This development is expected to have a positive impact on the company's production and operations [1]

Core Points - Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, successfully passed an unannounced CGMP inspection by the FDA from June 16 to June 24, 2025, marking the second successful inspection since 2023 [1] - The successful inspection indicates that the company's high-quality manufacturing system continues to receive international recognition [1] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, primarily for the commercialization supply of Toripalimab in overseas markets [1] Business Impact - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, providing solid assurance for the continued expansion into the US market [2] - This development is expected to have a positive impact on the company's production and operations [2]

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。截至本公告披露日，苏州吴江生产基地拥有4500升(9*500升)发酵能力， 已获得中国内地、中国香港、美国、欧盟、英国、澳大利亚、新加坡、印度、约旦、阿联酋、科威特、 巴基斯坦等多个国家和地区的GMP认证和批准，主要负责特瑞普利单抗海外市场的商业化供应。美国 市场是公司海外商业化战略的重要构成部分，本次通过FDA现场检查，为公司持续拓展美国市场提供了 坚实的保障，将对公司生产经营产生积极影响。 智通财经APP讯，君实生物(01877)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(以下简 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(以下简称"FDA") 的CGMP(现行药品生产质量管理规范)飞行检查(UnannouncedInspection，指在日常期间不事先通知的检 查)。近日，苏州众合收到FDA签发的现场检查报告(EIR，EstablishmentInspectionReport)，该报告表明 苏州众合已通过本次CGMP现场 ...

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 * 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全資子公司通過FDA現場檢查的公 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22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。 上海君实生物医药科技股份有限公司 自愿披露关 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2025-064 上海君实生物医药科技股份有限公司 自愿披露关于全资子公司通过 FDA 现场检查的公告 二、对公司的影响 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。截至本公告披露日， 苏州吴江生产基地拥有 4,500 升（9*500 升）发酵能力，已获得中国内地、中国 香港、美国、欧盟、英国、澳大利亚、新加坡、印度、约旦、阿联酋、科威特、 巴基斯坦等多个国家和地区的 GMP 认证和批准，主要负责特瑞普利单抗海外市 场的商业化供应。 美国市场是公司海外商业化战略的重要构成部分，本次通过 FDA 现场检查， 为公司持续拓展美国市场提供了坚实的保障，将对公司生产经营产生积极影响。 三、风险提示 公司预计本次检查短期内不会对公司业绩产生重大影响。由于药品的生产和 销售容易受市场环境变化等因素影响，存在不确定性，敬请广大投资者谨慎决策， 注意防范投资风险。 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 ...

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。 ...