公司近期获悉，康龙绍兴已收到美国FDA出具的现场检查报告(Establishment Inspection Report)。该检查 报告确认，康龙绍兴的生产设施顺利通过美国FDA的现场质量检查。根据该检查报告，康龙绍兴符合美 国药品cGMP质量标准，通过了美国FDA认证。这是公司绍兴原料药(API)商业化生产基地首次通过美国 FDA新药批准前检查，也是继2025年4月公司宁波原料药生产车间通过美国FDA现场检查后，公司在中 国的原料药生产车间再次通过美国FDA检查。这标志着公司质量体系已经与国际接轨，具备持续为美国 及全球市场供应商业化创新药原料药(API)的资质。现时，公司位于中、英、美三地的4个原料药商业化 生产基地均已通过美国FDA检查，可以为全球客户提供针对不同市场的创新药原料药商业化生产解决方 案。 公司始终坚持成为值得客户信赖、可靠、负责任的高品质合作伙伴，为客户在全球医药市场取得成功作 出有意义的贡献。本次顺利通过美国FDA现场检查是公司始终坚持严格贯彻执行最高级别的国际质量标 准的成果，亦是对公司质量管理体系有效运行的高度肯定，对公司继续深耕并不断拓展全球创新药 CDMO领域具有积极的深远影响 ...

Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's pre-approval inspection, confirming its compliance with cGMP standards, which enhances its capability to supply commercialized innovative drug APIs globally [1][2]. Group 1 - 康龙化成(绍兴) underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering various quality and production systems [1]. - The establishment inspection report confirmed that 康龙化成(绍兴) met the cGMP quality standards set by the FDA, marking the first successful pre-approval inspection for its API production base [2]. - This achievement indicates that 康龙化成's quality systems are aligned with international standards, enabling it to supply commercialized innovative drug APIs to the US and global markets [2]. Group 2 - 康龙化成 aims to be a trusted and responsible high-quality partner in the global pharmaceutical market, contributing meaningfully to clients' success [3]. - The successful FDA inspection reflects the company's commitment to adhering to the highest international quality standards and validates the effective operation of its quality management system [3]. - This milestone is expected to have a positive and far-reaching impact on 康龙化成's continued expansion in the global innovative drug CDMO sector [3].

Core Viewpoint - 康龙化成's wholly-owned subsidiary, 康龙化成（绍兴）药业有限公司, successfully passed the cGMP pre-market inspection by the FDA, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - The inspection took place from May 29 to June 4, 2025, covering various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] - 康龙绍兴 has received the FDA's on-site inspection report, affirming that its production facilities meet U.S. cGMP quality standards [1] Group 2: Significance of the Approval - This marks the first time 康龙化成's Shaoxing API commercial production base has passed the FDA's pre-approval inspection [1] - This follows the successful FDA inspection of 康龙化成's Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]

Core Viewpoint - 康龙化成's subsidiary 康龙绍兴 successfully passed the FDA's pre-approval inspection, confirming its compliance with cGMP standards, which enhances its capability to supply commercialized innovative drug APIs to the US and global markets [1][2]. Group 1 - 康龙绍兴 underwent a pre-approval inspection by the FDA from May 29 to June 4, 2025, covering various GMP systems including quality, material management, production, equipment, packaging, labeling, and laboratory control [1]. - The FDA's Establishment Inspection Report confirmed that 康龙绍兴's production facility passed the quality inspection, meeting the cGMP quality standards required for drug production [2]. - This marks the first time 康龙绍兴's API commercial production base has passed the FDA's pre-approval inspection, following the successful inspection of the 宁波 facility in April 2025 [2]. Group 2 - 康龙化成 now has four commercial API production bases located in China, the UK, and the US that have all passed FDA inspections, enabling the company to provide innovative drug API production solutions tailored to different markets [2].

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，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致之任何損失承擔任何責任。 本公司全資附屬公司康龍化成（紹興）藥業有限公司（以下簡稱「康龍紹興」）於 2025年5月29日至2025年6月4日接受了美國食品藥品監督管理局（以下簡稱「美國 FDA」）的cGMP（現行藥品生產質量管理規範）上市批准前檢查(PAI)。本次檢查範 圍涵蓋質量體系、物料管理體系、生產管理體系、設備設施體系、包裝和標籤體 系、實驗室控制體系等各GMP系統。 本公司近期獲悉，康龍紹興已收到美國FDA出具的現場檢查報告(Establishment Inspection Report)。該檢查報告確認，康龍紹興的生產設施順利通過美國FDA的 現場質量檢查。根據該檢查報告，康龍紹興符合美國藥品cGMP質量標準，通過 了美國FDA認證。這是本公司紹興原料藥(API)商業化生產基地首次通過美國FDA 新藥批准前檢查，也是繼2025年4月本公司寧波原料藥生產車間通過美國FDA現 場檢查後，本公司在中國的原料藥生產車間再次通過 ...

Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: Company Overview - 康龙化成's subsidiary, 康龙化成(绍兴), underwent a cGMP pre-approval inspection by the FDA from May 29 to June 4, 2025 [1] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control [1] - 康龙绍兴 received a positive on-site inspection report from the FDA, confirming that its production facilities met the required quality standards [1]

Core Insights - 康龙化成's subsidiary 康龙化成（绍兴）药业有限公司 successfully passed the cGMP pre-approval inspection by the FDA, confirming compliance with U.S. drug quality standards [1][2] - This marks the first successful FDA pre-approval inspection for the company's raw material drug commercialization production base in Shaoxing, following the successful inspection of the Ningbo facility in April 2025 [2] - With all four of the company's raw material drug production bases in China, the UK, and the US now FDA-approved, 康龙化成 is positioned to provide commercialized innovative drug active pharmaceutical ingredients (APIs) for global markets [2] Summary by Sections FDA Inspection - 康龙绍兴 received an Establishment Inspection Report from the FDA, confirming that its production facility passed the quality inspection [2] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] Market Position - The successful FDA inspection indicates that 康龙化成's quality systems are aligned with international standards, enabling the company to continuously supply commercialized innovative APIs to the U.S. and global markets [2] - The company now has the capability to offer commercialized production solutions for innovative drug APIs tailored to different markets [2]

Core Viewpoint - Kanglong Chemical (300759.SZ) has successfully passed the FDA's pre-approval inspection for its subsidiary's production facility, marking a significant milestone in its compliance with international quality standards [1] Group 1: Company Achievements - The company’s subsidiary, Kanglong Chemical (Shaoxing) Pharmaceutical Co., Ltd., underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering multiple GMP systems [1] - The Shaoxing facility has received a favorable on-site inspection report from the FDA, confirming its compliance with cGMP quality standards for pharmaceuticals [1] - This marks the first time the Shaoxing API production base has passed the FDA's pre-approval inspection, following the successful inspection of the Ningbo API production facility [1] Group 2: Market Positioning - The successful FDA inspection indicates that the company's quality system is aligned with international standards, enabling it to continuously supply commercial innovative drug APIs to the U.S. and global markets [1] - Currently, the company has four commercial API production bases located in China, the UK, and the U.S., all of which have passed FDA inspections [1]

Core Viewpoint - 康龙化成's subsidiary successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - 康龙化成 (Shaoxing) Pharmaceutical Co., Ltd. underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering quality systems, material management systems, and production management systems [1] - The inspection report from the FDA confirmed that the production facility met the necessary standards and received FDA certification [1] Group 2: Significance of the Approval - This marks the first time the Shaoxing API commercial production base has passed the FDA's new drug pre-approval inspection [1] - This follows the successful inspection of the Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]

证券代码：300759 证券简称：康龙化成 公告编号：2025-051 康龙化成（北京）新药技术股份有限公司 康龙化成（北京）新药技术股份有限公司董事会 2025 年 9 月 15 日 由于医药行业特点，药品生产、销售受到政策、市场环境、用药需求等影响， 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。 特此公告。 关于全资子公司顺利通过美国 FDA 现场检查的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 康龙化成（北京）新药技术股份有限公司（以下简称"公司"）的全资子公 司康龙化成（绍兴）药业有限公司（以下简称"康龙绍兴"）于 2025 年 5 月 29 日至2025年6月4日接受了来自美国食品药品监督管理局（以下简称"美国FDA"） 的 cGMP（现行药品生产质量管理规范）上市批准前检查（PAI），检查范围涵 盖质量体系、物料管理体系、生产管理体系、设备设施体系、包装和标签体系、 实验室控制体系等各 GMP 系统。 近日，康龙绍兴收到美国 FDA 出具的现场检查报告（Establishment Inspection Report）。该检查报 ...