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]

Group 1 - The core point of the news is that Kailaiying's stock price dropped by 5.86% to 104.50 CNY per share, with a trading volume of 282 million CNY and a turnover rate of 0.86%, resulting in a total market capitalization of 37.682 billion CNY [1] - Kailaiying Pharmaceutical Group (Tianjin) Co., Ltd. is located in Tianjin Economic and Technological Development Zone and was established on October 7, 1998, with its listing date on November 18, 2016 [1] - The company's main business involves providing CMO pharmaceutical outsourcing services, with revenue composition being 76.19% from small molecule CDMO solutions, 23.71% from emerging services, and 0.10% from other sources [1] Group 2 - From the perspective of Kailaiying's top ten circulating shareholders, Huabao Fund's ETF reduced its holdings by 1.0921 million shares in the second quarter, now holding 6.6467 million shares, which accounts for 1.93% of circulating shares [2] - The estimated floating loss for Huabao Zhongzheng Medical ETF today is approximately 43.2035 million CNY [2] - Huabao Zhongzheng Medical ETF was established on May 20, 2019, with a latest scale of 26.147 billion CNY, and has achieved a year-to-date return of 19.93% [2]

Core Viewpoint - The company is actively expanding its capabilities in the peptide CDMO sector, particularly in the weight loss area, and is well-positioned for future growth despite potential regulatory challenges in the U.S. market [1][2] Group 1: Peptide Capacity and Market Demand - The company's peptide CDMO business is primarily driven by the rapidly growing weight loss sector, with participation in over ten molecular collaborations [1] - Projects in the weight loss field are expected to enter the PPQ (Process Performance Qualification) stage next year, indicating a positive trajectory for capacity utilization [1] - The company’s capacity expansion plans are based not only on current utilization rates but also on anticipated future commercialization needs from clients [1] Group 2: Order Backlog and Revenue Growth - As of the disclosure date of the 2025 semi-annual report, the company has a total order backlog of nearly $1.1 billion, providing a solid foundation for annual performance growth [1] - The European market has shown exceptional performance, with revenue reaching 548 million yuan in the first half of the year, representing a year-on-year growth of over 200% [1] Group 3: Global Market Strategy and Regulatory Concerns - The company is focused on accelerating global market expansion and emerging business layouts to strengthen its competitive advantage in the chemical small molecule and peptide CDMO sectors [2] - Concerns regarding potential strict regulations on Chinese pharmaceuticals by the U.S. are deemed to have limited impact on the company's global business expansion [1] - The company aims to continuously enhance its overall competitiveness while closely monitoring external policy impacts [1]

证券研究报告 | 2025年09月11日 凯莱英（002821.SZ） 小分子CDMO行业引领，新兴业务扬帆起航 公司研究 · 深度报告 医药生物 · 医药研发外包 投资评级：优于大市（首次覆盖） 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 证券分析师：陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师：彭思宇 联系人：凌珑 021-60375401 linglong@guosen.com.cn 请务必阅读正文之后的免责声明及其项下所有内容 1 投资建议 n 凯莱英：全球领先、技术驱动型的一站式CDMO综合服务商 凯莱英成立于1998年，是中国第二大化学药物CDMO企业。公司以化学小分子CDMO业务为基石，逐步拓展业务边界，技术创新能力行业领先， 研发费用率长期居于行业领先水平，服务辉瑞、默沙东等全球超1100家客户。 n 小分子业务：基石业务稳健 小分子CDMO作为公司的业务根基，依托连续流化学(CFCT)、酶催化等核心技术，持续攻克高难度分子合成壁垒，巩固在抗肿瘤、抗病毒 ...

Market Overview - The A-share market opened with mixed results, with the Shanghai Composite Index down by 0.16%, the Shenzhen Component Index up by 0.11%, and the ChiNext Index up by 0.46% [3][4] - The Hang Seng Index opened down by 0.81%, and the Hang Seng Tech Index fell by 0.97% [6][7] Pharmaceutical Sector Performance - The innovative drug concept stocks experienced significant declines, with BeiGene falling over 10%, WuXi AppTec and Tigermed down over 7%, and several other companies like Hengrui Medicine, Junshi Biosciences, and Kelun Pharmaceutical dropping over 5% [2][6] - The pharmaceutical sector as a whole saw a downturn, with various sub-sectors such as medical services, weight loss drugs, and CRO concepts all reporting negative performance, with declines ranging from -1.13% to -1.99% [5] Notable Stock Movements - Specific stocks such as Hansoh Pharmaceutical and WuXi Biologics dropped over 10%, while Jiangsu Hengrui Medicine and Junshi Biosciences also faced significant losses [6] - Conversely, some stocks like Jiujiuwang Pharmaceutical saw a rise of 5% despite the overall market trend [6]

Market Overview - The innovative drug concept stocks opened significantly lower, with BeiGene dropping over 10%, WuXi AppTec and Tigermed down over 7%, and several other companies like HengRui Medicine, Junshi Biosciences, and Kelun Pharmaceutical falling over 5% [3][4]. - The A-share market showed mixed results, with the Shanghai Composite Index down 0.16%, while the Shenzhen Component Index rose 0.11% and the ChiNext Index increased by 0.46% [4][5]. Sector Performance - The healthcare sector experienced a decline, with various sub-sectors such as medical services, CRO concepts, and innovative drugs all showing negative performance, with declines ranging from -1.99% to -1.44% [6]. - The Hong Kong market also opened lower, with the Hang Seng Index down 0.81% and the Hang Seng Tech Index falling 0.97%. Pharmaceutical stocks in Hong Kong saw significant drops, with companies like Hansoh Pharmaceutical and WuXi Biologics declining over 10% [6][7]. Notable Stocks - Specific stocks highlighted include BeiGene, WuXi AppTec, and Tigermed, which are part of the innovative drug sector and faced substantial declines in their stock prices [3][4]. - In the Hong Kong market, Hansoh Pharmaceutical and WuXi Biologics were noted for their significant drops, while a few stocks like Jiujiuwang Technology showed resilience with a 5% increase [6][7].

Market Overview - The pharmaceutical sector experienced significant declines, with WuXi AppTec and Tigermed opening down over 7% [1][2] - Innovative drug concept stocks also saw substantial drops, with BeiGene falling over 10% and several other companies, including WuXi AppTec and Tigermed, dropping more than 7% [1][2] Index Performance - The Shanghai Composite Index decreased by 0.16%, while the Shenzhen Component Index increased by 0.11%, and the ChiNext Index rose by 0.46% [2][3] - The healthcare services sector fell by 1.99%, with various sub-sectors such as weight loss drugs and CRO concepts also declining [3] Hong Kong Market - The Hang Seng Index opened down 0.81%, and the Hang Seng Tech Index fell by 0.97% [4][5] - Pharmaceutical stocks in Hong Kong saw widespread declines, with Hansoh Pharmaceutical and WuXi Biologics dropping over 10% [4] Currency and Monetary Policy - The People's Bank of China conducted a 7-day reverse repurchase operation of 292 billion yuan at a steady rate of 1.40% [5] - The RMB to USD central parity rate was reported at 7.1034, an increase of 28 basis points from the previous trading day [6]

| 股份代號: | 06821 | | --- | --- | | 上市法國名稱: | 訓萊英醫藥集團(天津)股份有限公司 - H | | 日期 (日 / 月 / 年): | 11/08/2025 - 11/09/2025 | 格隆汇9月11日丨根据联交所最新权益披露资料显示，2025年9月5日，凯莱英(06821.HK)获JPMorgan Chase & Co.以每股均价92.6442港元增持好仓8.4万股， 涉资约778.21万港元。 增持后，JPMorgan Chase & Co.最新持好仓数目为1,669,746股，持好仓比例由5.75%上升至6.06%。 | 家福家 | 大船車/華車/最高行政人員名 作出披露的 貫入/ 朝出或法及的 每船的平均價 | | | | | | 持有權益的股份數目 佔已發行的 有關事件的日期 * | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | 四十三十二 | | | 語學生 | 有技景裡版(日/月/年) | | | | | | | | | 位自分网 | | | | | | | | | 90 | | CS ...