9月11日下午，在天津辖区上市公司2025年投资者网上集体接待日活动中，凯莱英（002821）执行董 事、首席运营官兼首席财务官张达就多肽产能、海外政策影响及订单情况等投资者关注问题作出集中回 应。 针对投资者关心的多肽产能问题，张达表示，公司多肽CDMO业务主要来源于快速增长的减重领域，目 前已参与该领域十几个分子合作，预计明年将有项目进入PPQ（验证批）阶段。随着国内重要客户在减 重领域的首个多肽项目商业化获批上市，多肽产能利用率正呈逐步上升趋势。公司产能扩展计划不仅基 于当前利用率，更着重考量未来客户项目商业化需求。 对于美国可能对中国药品实施严格限制的担忧，张达回应称，制药行业全球专业化分工趋势难以被实质 性撼动，目前相关政策对公司全球业务市场拓展影响非常有限。公司将持续提升自身综合竞争力，密切 评估外界政策影响。 凯莱英作为医药外包服务企业，正通过加速全球市场拓展和新兴业务布局，巩固其在化学小分子和多肽 CDMO领域的竞争优势。本次说明会展现了公司在减重等热门靶点领域的深度参与及全球化战略的积极 推进，为投资者研判公司发展前景提供了重要参考。 在全球订单方面，张达透露，截至2025年半年报披露日，公 ...

Core Insights - The trend of outbound licensing transactions for innovative drugs is expected to continue, providing financing and revenue sources for innovative pharmaceutical companies while potentially increasing order amounts for contract development and manufacturing organizations (CDMOs) [1][3] Company Insights - WuXi Biologics' CEO, Chen Zhisheng, stated that approximately 70% of the Chinese assets involved in overseas CDMO collaborations are participated by the company, with over 90% of projects continuing collaboration post-transaction, and 60% of buyers being large multinational pharmaceutical companies [1] - The company provides end-to-end solutions for the discovery, development, and production of biopharmaceuticals, and has seen increased collaboration from overseas pharmaceutical companies after acquiring Chinese projects [1][4] - Chen highlighted that projects initially targeting the Chinese market could see order values increase significantly when shifted to the U.S. market, with examples showing potential orders rising from 10 million yuan to 10 million or even 20 million USD [1] Industry Insights - The Chinese innovative drug market has seen explosive growth in outbound licensing transactions, with the market size ranking second globally, and the total amount for innovative drug licensing nearing 66 billion USD in the first half of 2025 [3] - The complexity of innovative drug development creates opportunities for CDMOs, as domestic companies pursue speed and quality, facilitating the transition from laboratory to commercialization [3] - CMC (Chemistry, Manufacturing, and Controls) capabilities are crucial for successful international projects, impacting regulatory approval processes and production stability, thereby reducing buyer risks and enhancing transaction value [4] - The outbound trend is expected to persist, with multinational companies increasingly recognizing the value of Chinese innovative drugs, contrasting with previous skepticism [4]

Core Insights - The company reported a revenue of 3.188 billion yuan for the first half of 2025, representing an 18.20% year-on-year growth, and a net profit attributable to shareholders of 617 million yuan, up 23.71% year-on-year [1] - The company is focusing on expanding its market presence, particularly in peptide, oligonucleotide, and ADC segments, which are expected to support sustained growth in the future [1] Small Molecule CDMO Business - The small molecule CDMO service, the core business segment, achieved a revenue of 2.429 billion yuan, a 10.64% increase year-on-year, with a gross margin of 47.79%, up 0.6 percentage points [2] - The company delivered 44 commercial projects and 285 clinical projects, including 52 in Phase III [2] - There are 11 small molecule validation batch projects expected in the second half of 2025, indicating a solid order reserve for long-term growth [2] Emerging Business Growth - The emerging business segment saw rapid growth, generating 756 million yuan in revenue, a 51.22% increase year-on-year, with a gross margin of 29.79%, up 9.5 percentage points [3] - The chemical macromolecule CDMO segment achieved over 130% revenue growth, delivering 88 projects and acquiring 38 new clients [3] - The company has over 10 clinical mid-to-late stage projects in peptide and small nucleic acid areas, indicating strong commercial order reserves [3] Formulation CDMO and Clinical CRO - The formulation CDMO segment reported a revenue of 118 million yuan, a 7.81% increase, delivering 171 projects and completing 31 clinical mid-to-late stage projects [4] - The clinical CRO segment generated 139 million yuan, up 44.84%, assisting 13 projects in obtaining domestic clinical trial approvals [4] Biologics CDMO Performance - The biologics CDMO segment achieved a revenue of 90 million yuan, a 70.74% increase, delivering 53 batches and completing 3 IND submissions [5] - The order amount in hand increased by over 60%, with expectations of doubling revenue in 2025 [5] Technology Output and Synthetic Biology - The technology output segment is advancing in fine chemical projects, with 20 ongoing orders and plans to expand dedicated facilities in 2025 [6] - The synthetic biology segment maintained stable revenue, delivering 41 projects and acquiring 19 new clients [6] R&D and Talent Development - The company invested 286 million yuan in R&D, accounting for 8.96% of revenue, with significant achievements in continuous reaction and biosynthesis [7] - The workforce exceeds 9,000, with 78% holding a bachelor's degree or higher, and 37% of R&D personnel being advanced degree holders [7]

Core Viewpoint - The company reported a significant turnaround in its financial performance for the first half of 2025, achieving a revenue of 1.621 billion yuan, a year-on-year increase of 19.88%, and a net profit of 27.0595 million yuan, compared to a loss of 170 million yuan in the same period last year [1] Group 1: Financial Performance - The company achieved a basic earnings per share of 0.05 yuan [1] - Revenue growth was primarily driven by strong performances in small molecule APIs, gene cell therapy, and new molecular businesses, with respective year-on-year growth rates of approximately 20%, 71%, and 128% [1] - The European market saw a revenue increase of about 35%, while the North American market grew by approximately 33% [1] Group 2: Client and Project Engagement - The company provided small molecule API services to over 320 global clients, acquiring 40 new clients during the reporting period [2] - The gene cell therapy business achieved a reduction in losses, serving 51 clients and signing new orders worth 52.55 million yuan [2] - The new molecular business signed orders worth 41.86 million yuan, providing services for 38 clients across 67 projects [2] Group 3: Market and Operational Insights - The company has a cumulative service record of over 1,300 clients and more than 4,600 successful project deliveries, covering major disease treatment areas such as antiviral, oncology, and rare diseases [3] - The company has optimized its internal operations to effectively respond to challenges in the domestic generic drug CDMO market [2]

Hong Kong Market Overview - The Hang Seng Index closed at 24,072, down 0.87% for the day but up 20% year-to-date[3] - The Hang Seng China Enterprises Index fell 0.96% to 8,678, with a year-to-date increase of 19.05%[3] - The Hang Seng Tech Index decreased by 0.72% to 5,303, showing an 18.68% rise for the year[3] - In June, the Hang Seng Index, China Enterprises Index, and Tech Index rose by 3.36%, 2.92%, and 2.56% respectively[10] US Market Performance - The Dow Jones Industrial Average increased by 0.91% to 44,495, with a year-to-date gain of 4.59%[3] - The S&P 500 Index fell by 0.11% to 6,198, up 5.38% year-to-date[3] - The Nasdaq Composite dropped 0.82% to 20,203, with a year-to-date increase of 4.62%[3] - Major tech stocks showed mixed results, with Nvidia down 2.97% and Apple up 1.29%[10] Sector Trends - In the US, all sectors except Technology, Communications, and Semiconductors saw gains, with Materials up 2.59% and Healthcare up 1.42%[10] - In Hong Kong, new consumption and stablecoin concepts gained traction, while gold and precious metal stocks faced declines[10] Notable Stock Movements - Xiaomi and NetEase rose over 1%, while Meituan and Alibaba fell over 2%[10] - In the US, Tesla dropped 5.34%, while Amazon and Berkshire Hathaway saw slight increases[10] - Chinese electric vehicle manufacturers showed varied performance, with Li Auto down 1.03% and XPeng up 2.13%[11]

Market Overview - The Hong Kong stock market experienced a collective decline on June 12, with the Hang Seng Index falling by 1.36%, the Hang Seng China Enterprises Index down by 1.53%, and the Hang Seng Tech Index decreasing by 2.2% [1] - Various sectors, including short video, cloud computing, and tech stocks, saw significant drops, with Kuaishou-W down 5.87% and Alibaba-W down 3.21% [1] Sector Performance - The consumer sector faced pressure, with notable declines in beer, sports goods, and airline stocks. Budweiser APAC dropped 6.39%, while Meituan-W fell by 1.95% [1] - The automotive industry, including lithium batteries and smart driving concepts, also saw a downturn, with China Graphite down 12.36% and Xpeng Motors-W down 6.66% [2] - Chip and robotics stocks experienced declines, with Horizon Robotics-W down 3.9% and SMIC down 2.04% [2] Gainers - Pharmaceutical stocks showed resilience, with China Biologic Products rising by 19.29% due to anticipated significant business developments [3] - Other biopharmaceutical companies like Junshi Biosciences and Zai Lab also saw substantial gains, with increases of 12.35% and 8.65% respectively [3] Gold and Precious Metals - Gold and precious metals stocks rose, driven by global gold purchasing trends and rising gold prices. Zijin Mining increased by 4.93% [4] - The global demand for gold as a reserve asset has surged, with central banks increasing their gold holdings amid geopolitical tensions [4] Notable Stocks - Cloudfin Financial, associated with Ant Group, surged by 54.24% following reports of plans to apply for stablecoin licenses in Singapore and Hong Kong [4] - Jiuyuan Gene saw a remarkable increase of 43.73%, marking its fourth consecutive day of gains [5]

Core Insights - The CRO (Contract Research Organization) and CDMO (Contract Development and Manufacturing Organization) sectors are crucial in advancing innovative drugs from laboratory to clinical application and large-scale production, with Chinese companies gaining significant market share due to enhanced technical capabilities and cost advantages [1][2]. Group 1: Strategic Opportunities in CXO - The CXO sector in China has experienced rapid growth over the past decade, evolving through four development stages, with a significant acceleration post-2015 due to increased demand for innovative drug development and the transfer of overseas industrial chains [2][3]. - The COVID-19 pandemic in 2020 catalyzed the upgrade of China's CXO industry, leading to a surge in participation in the global innovative drug supply chain [3]. Group 2: Growing Demand for Outsourcing in the Pharmaceutical Industry - The number of new drug registration clinical trials in China has been increasing annually, with a compound annual growth rate (CAGR) of 15% from 2019 to 2024, rising from 2,385 trials in 2019 to 4,884 in 2024 [4]. - The number of first-class new drugs listed in China has grown from 18 in 2020 to 49 in 2024, reflecting a CAGR of 28.4%, indicating a sustained upward trend in innovation capabilities [6]. Group 3: MAH System and Business Opportunities - The implementation of the MAH (Marketing Authorization Holder) system has separated drug production and marketing licenses, significantly boosting the CDMO market, with the number of B certificate enterprises increasing from 140 in 2021 to 1,349 by the end of 2024, a growth rate of 23% [10]. Group 4: Market Growth Rates - China's CRO market is projected to grow at a CAGR of 20.4%, increasing from 388 billion RMB in 2018 to 1,183 billion RMB in 2024, with expectations to reach 1,923 billion RMB by 2027 [12][14]. - The CDMO market in China is expected to grow at a CAGR of 37.8%, from 132 billion RMB in 2017 to 1,246 billion RMB in 2024, with projections to reach 3,559 billion RMB by 2030 [16][18]. Group 5: Rankings of CRO and CDMO Companies - The 2024 rankings of Chinese CRO companies include top-tier firms such as WuXi Biologics, Kanglong Chemical, and Tigermed, while the second tier features companies like Yino Science and Kingsray Biotech [22]. - The leading CDMO companies in 2024 include WuXi AppTec, Kelun Pharmaceutical, and WuXi Biologics, with a second tier comprising companies like Notch Biotech and Haier Pharmaceutical [24]. Group 6: Conclusion - Chinese CRO and CDMO companies have established comprehensive service capabilities across the pharmaceutical industry chain, transitioning from "Chinese service providers" to "global innovation partners," with a focus on technological innovation and compliance [26][27].