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 ...

Group 1 - The company, Zhejiang Jiuzhou Pharmaceutical Co., Ltd., announced that its subsidiary, Rebo (Suzhou) Pharmaceutical Co., Ltd., successfully passed the FDA's cGMP inspection conducted from May 19 to May 22, 2025 [1] - The inspection covered six major systems: quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls [1] - The inspection result was classified as NAI (No Action Indicated), indicating compliance with FDA standards [1] Group 2 - The successful FDA inspection provides a solid foundation for the company to expand its international market presence and positively impacts its ability to enter global regulated markets [1] - The company has established a tiered cGMP quality management system that meets global industry-leading standards, which enhances its overall competitiveness and future development [1]

Group 1 - The company has received the CBPF-GMP certificate from Brazil's National Health Surveillance Agency (ANVISA), confirming compliance with international production quality management standards [1][2] - The cGMP inspection covered the company's production line for active pharmaceutical ingredients Semaglutide and Liraglutide, marking the third successful overseas compliance check after the FDA and MFDS [2][6] - This certification is expected to enhance the company's ability to promote and sell its products in international markets [2][6] Group 2 - The cGMP inspection took place from April 28 to May 2, 2025, at the company's facility located in Lianyungang Economic and Technological Development Zone [6] - The inspection concluded that the company's production practices are in accordance with cGMP regulations, which is crucial for exporting pharmaceutical products [6]