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]

Group 1 - The CRO concept sector rose by 1.44%, ranking 8th among concept sectors, with 42 stocks increasing in value, including notable gainers such as Dezheng Health, Zhaoyan New Drug, and ST Weiming, which hit the daily limit, while Boteng Co., Haofan Bio, and Kanglong Chemical saw significant increases of 9.21%, 9.10%, and 6.37% respectively [1][2] - The sector experienced a net inflow of 778 million yuan from main funds, with 35 stocks receiving net inflows, and 7 stocks attracting over 50 million yuan, led by Kanglong Chemical with a net inflow of 172 million yuan, followed by Kailaiying, WuXi AppTec, and Dezheng Health with net inflows of 159 million yuan, 148 million yuan, and 148 million yuan respectively [2][3] Group 2 - In terms of fund inflow ratios, Dezheng Health, Haoyuan Pharmaceutical, and New World had the highest net inflow ratios at 30.08%, 12.93%, and 11.07% respectively [3] - The CRO concept fund inflow rankings showed that Kanglong Chemical had a daily increase of 6.37% with a turnover rate of 6.31%, while Kailaiying and WuXi AppTec also performed well with increases of 4.11% and 1.45% respectively [4][5] - The overall performance of the CRO sector was mixed, with some stocks like ST Weiming and *ST Shuangcheng experiencing declines of 2.19% and 1.92% respectively, indicating volatility within the sector [1][6]

Core Points - The Bioeconomy Index (970038) closed at 2418.21 points on September 15, with a gain of 0.91% and a trading volume of 34.584 billion yuan, resulting in a turnover rate of 2.15% [1] - Among the index constituents, 21 stocks rose while 29 fell, with Furuide (福瑞股份) leading the gainers at 20.01% and BGI Genomics (华大基因) leading the decliners at 3.11% [1] Index Constituents Summary - The top ten constituents of the Bioeconomy Index include: - Mindray Medical (迈瑞医疗) with a weight of 13.82%, latest price at 239.60 yuan, and a market cap of 290.501 billion yuan [1] - Shijia History (十肖史上) with a weight of 4.71%, latest price at 6.84 yuan, and a market cap of 45.404 billion yuan [1] - Tigermed (泰格医药) with a weight of 4.69%, latest price at 61.77 yuan, and a market cap of 53.186 billion yuan [1] - Changchun High-tech (长春高新) with a weight of 4.34%, latest price at 126.81 yuan, and a market cap of 51.731 billion yuan [1] - Kanglong Chemical (康龙化成) with a weight of 3.99%, latest price at 35.90 yuan, and a market cap of 63.837 billion yuan [1] - Muyuan Foods (牧原股份) with a weight of 3.85%, latest price at 58.77 yuan, and a market cap of 321.047 billion yuan [1] - Aimeike (爱美客) with a weight of 3.73%, latest price at 194.07 yuan, and a market cap of 58.724 billion yuan [1] - Lepu Medical (乐普医疗) with a weight of 3.25%, latest price at 18.53 yuan, and a market cap of 34.848 billion yuan [1] - Shenzhen Technology (深科技) with a weight of 3.24%, latest price at 21.88 yuan, and a market cap of 34.292 billion yuan [1] - Jiao Yue Medical (角跃医疗) with a weight of 3.10%, latest price at 38.75 yuan, and a market cap of 38.846 billion yuan [1] Capital Flow Summary - The Bioeconomy Index constituents experienced a net inflow of 645 million yuan from main funds, while retail investors saw a net outflow of 5.51 billion yuan [3] - Notable capital flows include: - Furuide (福瑞股份) with a net inflow of 356 million yuan from main funds [3] - Wens Foodstuffs (温氏股份) with a net inflow of 209 million yuan from main funds [3] - Kanglong Chemical (康龙化成) with a net inflow of 184 million yuan from main funds [3] - Mindray Medical (迈瑞医疗) with a net inflow of 82 million yuan from main funds [3] - Changchun High-tech (长春高新) with a net inflow of 59 million yuan from main funds [3]

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 ...

Market Overview - On September 15, the medical services sector rose by 1.58%, led by Zhaoyan New Drug, while the Shanghai Composite Index closed at 3860.5, down 0.26% [1] - The Shenzhen Component Index closed at 13005.77, up 0.63% [1] Top Performers - Zhaoyan New Drug (603127) closed at 41.65, with a gain of 10.01% and a trading volume of 597,900 shares, amounting to a transaction value of 2.418 billion [1] - Boteng Co., Ltd. (300363) closed at 28.59, up 9.21%, with a trading volume of 571,200 shares, totaling 1.633 billion [1] - Kanglong Chemical (300759) closed at 35.90, increasing by 6.37%, with a trading volume of 895,600 shares, amounting to 3.178 billion [1] Underperformers - Jukang Life (300143) closed at 12.19, down 5.21%, with a trading volume of 245,900 shares, totaling 306 million [2] - Digital Human (835670) closed at 17.13, down 3.22%, with a trading volume of 55,800 shares, amounting to 9.562 million [2] - BGI Genomics (300676) closed at 53.20, down 3.11%, with a trading volume of 152,700 shares, totaling 81.5 million [2] Capital Flow - The medical services sector saw a net inflow of 502 million from institutional investors, while retail investors experienced a net outflow of 423 million [2] - The sector's overall capital flow indicates a mixed sentiment, with institutional buying contrasting with retail selling [2] Individual Stock Capital Flow - Kailaiying (002821) had a net inflow of 1.90 billion from institutional investors, while retail investors saw a net outflow of 1.87 billion [3] - Kanglong Chemical (300759) experienced a net inflow of 184 million from institutional investors, with retail investors seeing a net outflow of 1.51 billion [3] - Jiuzhou Pharmaceutical (603456) had a net inflow of 47.19 million from institutional investors, while retail investors experienced a net outflow of 81.89 million [3]

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]