特定对象调研演示材料 凯莱英医药集团（天津）股份有限公司 2025年8月 1 凯莱英（股票代码：002821.SZ/6821.HK） 本文件中若出现总计数与所列数值总和不符，均为四舍五入所致 -2- 免责声明 毛利率 43.5% +1.3pts 收入 31.88亿元 归母净利润 6.17亿元 19.4% 归母净利率 +18.2% +23.7% +0.9pts 10.88亿美元 在手订单 21.4% 经调整净利率* +5.4pts 本文件不得用于公开传播，其中所包含的信息仅供与凯莱英医药集团（天津）股份有限公司（"本公司"，连同其子公司，以下合称"本集团"）有关的人士及其顾问使用。本公司仅向有限 数量的收件人提供本文件。本文件的内容未经任何司法辖区的监管机构审阅。在某些司法辖区派发本文件可能会受到法律限制，持有本文件的任何人都应了解并且遵守该等限制。任何不遵 守该等限制的行为均可能违反美国、加拿大、中国或日本的证券法或其他类似司法辖区的法律。您一旦接收本文件，即代表您同意受到前述限制的约束。 前瞻性陈述 本演示材料本演示材料有若干前瞻性陈述， 该等前瞻性陈述并非历史事实， 乃基于本公司的信念、 管理层所作出的假 ...

Summary of Conference Call Records Industry Overview - The conference call discusses the **clinical CRO (Contract Research Organization)** sector, particularly focusing on the impact of recent order improvements on companies like **Madpace** and **Charles River** [1][2][4]. Key Points and Arguments - **Madpace's Stock Performance**: Madpace's stock price increase reflects improved order conditions, with the net book to bill ratio rising from below 0.9 to above 1, indicating a potential acceleration in future revenue growth [1][2]. - **Global CRO Sector Recovery**: The global clinical CRO sector shows signs of recovery, with Charles River reporting better-than-expected order data and a net book to bill value exceeding 1 for the first time, suggesting a demand-side recovery that may continue [1][4]. - **Importance of CRO Services for Biotech**: Biotech companies, which often lack commercialized products, rely heavily on CRO services to accelerate clinical trials and attract investment. This reliance is crucial for their survival and competitiveness [5][6]. - **Domestic CDMO Landscape**: The domestic pharmaceutical industry is primarily led by export-oriented CDMO companies. After significant expansion from 2020 to 2022, the industry faced a downturn, but is expected to recover in 2024, with leading companies achieving full capacity first [1][8]. - **Geopolitical Impact**: Geopolitical relations affect domestic CXO companies' operations in the U.S. Companies like WuXi Biologics have stable orders due to their production capabilities, while WuXi AppTec's reliance on local raw materials makes it more vulnerable [1][9]. - **Innovation-Driven Market Cycles**: The pharmaceutical industry's development cycles depend on innovation in areas like ADCs, small nucleic acids, and peptides. Breakthroughs in these fields could lead to a new upward market cycle [3][10][11]. - **Market Sentiment and New Drug Categories**: Emerging drug categories, such as weight loss medications, are expected to influence market dynamics and sentiment, indicating a shift in consumer demand [3][10]. Additional Important Insights - **CRO Response to Order Fluctuations**: Companies in the clinical sector may face overcapacity during order declines, leading to potential layoffs. Conversely, when orders exceed a certain level, companies may consider expanding capacity [7]. - **CDMO Pricing Strategies**: In a low-capacity environment, CDMO companies may lower prices to secure orders, but as demand increases, they can achieve both volume and price growth [8]. - **Generational Changes in Pharma**: The pharmaceutical industry has undergone several generational changes, with each new major product category influencing market conditions. For instance, breakthroughs in small nucleic acids have significantly impacted market performance [11][12].

Core Insights - Hanyu Pharmaceutical (300199) has recently conducted investor research, discussing the progress of the HY3003 new drug project, its layout in the innovative drug field, and overseas market expansion [1][2] Group 1: HY3003 New Drug Project - The HY3003 project has completed preclinical candidate compound screening and raw material process development, officially entering the raw material pilot scale-up phase, which validates the producibility of the molecular structure for subsequent IND application and clinical transformation [1] - HY3003 is a GLP-1R/GIPR/GCGR receptor agonist developed using AI peptide chip technology, aimed at weight loss indications [1] - The project employs a multi-formulation parallel development strategy, including weekly, ultra-long-acting monthly, and oral formulations, with the ultra-long-acting formulation designed to reduce dosing frequency and improve medication adherence [1] Group 2: siRNA and Other Drug Developments - The company is also developing siRNA drugs such as Inclisiran and Zilebesiran for treating high cholesterol and hypertension, as well as Pegcetacoplan for treating geographic atrophy [1] Group 3: Overseas Market Expansion - Currently, the company's raw materials are sold to over 20 countries and regions, with formulations licensed in over 90 countries and regions [2] - The company has signed cooperation agreements for the semaglutide injection (weekly formulation) and oral tablets in markets including China, Brazil, Egypt, Mexico, Eurasian Union, GCC member countries, and North Africa [2] - The company has completed the enrollment of all participants in the Phase III clinical trial for semaglutide injection as of January this year, with plans to submit for approval in China by 2026, followed by the US and other global markets [2] Group 4: Future Pipeline - Hanyu Pharmaceutical has a rich pipeline of peptide and small nucleic acid formulations, planning to launch no less than 20 formulations over the next 10 years, including innovative drugs, micro-innovative drugs, and ANDA [2]

Investment Rating - The industry investment rating is positive [1] Core Viewpoints - The report indicates that a turning point has been reached in the CXO sector, suggesting a positive outlook for investment [6][66] - The report highlights that the performance of domestic CXO companies has shown significant improvement, with major players like WuXi AppTec and Kintor Pharmaceutical demonstrating strong order growth [6][66] - The report emphasizes the recovery of revenue growth, with a year-over-year increase of 8.2% in Q1 2025 for CXO companies, indicating a positive trend in the sector [6][26] Financial Analysis - Domestic performance: The medical R&D outsourcing index increased by 0.82% from December 31, 2024, to April 30, 2025, outperforming the pharmaceutical and biotech index by 0.64 percentage points [5][13] - International performance: The report notes a divergence in performance among international CXO companies, with Lonza showing optimistic growth projections for its CDMO business, expecting nearly 20% growth in 2025 [5][18] - Profitability: The average gross margin for Q1 2025 was 30.9%, reflecting a year-over-year increase of 1.1 percentage points, with some companies like Medpace and Boteng showing significant improvements [6][31] - Operational efficiency: Inventory turnover rates have stabilized, with an average of 3.36 in 2024, indicating a positive trend in operational efficiency [6][36] Investment Strategy - The report suggests that the CXO sector is at a turning point, with strong growth potential in small and large molecule CDMO orders, as well as in clinical CRO opportunities driven by domestic innovation policies [6][66] - Recommended companies include WuXi AppTec and Kintor Pharmaceutical for clinical CRO, and WuXi Biologics and Kelun Pharmaceutical for CDMO [6][66] - The report highlights an increase in institutional holdings in CXO companies, indicating growing confidence in the sector [6][60]