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 ...

每经AI快讯，9月15日，港股CRO概念股早盘走高，截至发稿，康龙化成(03759.HK)涨8.11%，报25.58 港元；昭衍新药(06127.HK)涨6.27%，报24.76港元；药明生物(02269.HK)涨4.88%，报38.26港元；凯莱 英(06821.HK)涨4.33%，报101.3港元。 ...

Group 1 - CRO concept stocks experienced a rise in early trading, with notable increases in share prices for companies such as 康龙化成 (up 8.11% to HKD 25.58), 昭衍新药 (up 6.27% to HKD 24.76), 药明生物 (up 4.88% to HKD 38.26), and 凯莱英 (up 4.33% to HKD 101.3) [1] - On September 12, the National Medical Products Administration of China announced a new policy to complete the review and approval of clinical trial applications for innovative drugs within 30 working days, effective immediately [1] - The new policy applies to clinical trial applications for innovative drugs that meet one of three specified criteria, further accelerating the approval process for certain applications [1] Group 2 - Concerns have arisen in the market regarding the U.S. administrative draft, with 华福证券 noting that the "Biological Safety Act" has undergone 10 changes since the end of 2023 [2] - The stock price response of representative CXO companies to the progress of the "Biological Safety Act" has shown a trend of desensitization, with current stock prices recovering and reaching new highs [2] - The ongoing BD wave in China's innovative drug sector reflects the advantages of talent resources, research efficiency, and cost, indicating that U.S. policies will not significantly impact the competitiveness of China's innovative drug industry [2]

Group 1 - CRO concept stocks experienced a significant rise, with 康龙化成 (03759) up 8.11% to HKD 25.58, 昭衍新药 (06127) up 6.27% to HKD 24.76, 药明生物 (02269) up 4.88% to HKD 38.26, and 凯莱英 (06821) up 4.33% to HKD 101.3 [1] - On September 12, the National Medical Products Administration announced a new policy to complete the review and approval of clinical trial applications for innovative drugs within 30 working days after acceptance, effective immediately [1] - The new policy applies to innovative drug clinical trials that meet one of three criteria: traditional Chinese medicine, chemical drugs, and biological products of Class 1 [1] Group 2 - Concerns have arisen in the market regarding the U.S. administrative draft, with 华福证券 noting that the "Biosafety Act" has undergone 10 changes since the end of 2023 [2] - The stock price response of representative CXO companies to the progress of the "Biosafety Act" has become desensitized, with current stock prices recovering and reaching new highs [2] - The ongoing BD wave in China's innovative drug sector reflects the advantages of talent resources, research efficiency, and research costs, indicating that U.S. policies will not significantly impact the globally competitive Chinese innovative drug industry [2]

Company Overview - Kanglong Chemical (Beijing) New Drug Technology Co., Ltd. was established on July 1, 2004, and went public on January 28, 2019. The company is located in Beijing Economic and Technological Development Zone [1] - The main business areas include drug research, development, and production services, with revenue composition as follows: laboratory services 60.43%, CMC (small molecule CDMO) services 21.58%, clinical research services 14.58%, macromolecule and cell & gene therapy services 3.28%, and others 0.12% [1] Stock Performance - On September 15, Kanglong Chemical's stock rose by 5.07%, reaching a price of 35.46 CNY per share, with a trading volume of 1.122 billion CNY and a turnover rate of 2.27%. The total market capitalization is 63.055 billion CNY [1] Fund Holdings - Southern Fund has a significant holding in Kanglong Chemical, with the Southern Growth Enterprise Board 2-Year Open Mixed Fund (160143) increasing its position by 85,200 shares in the second quarter, bringing the total to 318,000 shares, which accounts for 3.15% of the fund's net value, making it the fourth-largest holding [2] - The fund has a current size of 248 million CNY and has achieved a year-to-date return of 40.91%, ranking 1426 out of 8246 in its category. Over the past year, the return is 73.43%, ranking 1375 out of 8054 [2]