华泰研究 中报点评 2025 年 8 月 26 日│中国内地/中国香港 医疗服务 公司 1H25 实现收入/归母净利/扣非归母净利 31.88/6.17/5.66 亿元 （yoy+18.2%/+23.7%/+26.3%），其中 2Q25 实现收入/归母净利/扣非归母 净利 16.47/2.91/2.61 亿元（yoy+26.9%/+33.9%/+34.3%），医药行业筑底 回暖背景下，公司业绩持续提速。截至中报披露日，公司在手订单总额 10.88 亿美元，为实现全年业绩的稳健增长奠定基础。考虑行业需求持续回暖，公 司技术工艺行业领先，看好公司 25 年延续向好发展势头。公司 A、H 股均 维持"买入"。 毛利率积极提升，三大费用率同比下降 证券研究报告 凯莱英 (6821 HK/002821 CH) 业绩持续提速，新兴业务亮眼 小分子 CDMO：板块收入稳健增长，海外产能建设积极推进 小分子 CDMO 1H25 收入 24.29 亿元（yoy+10.6%），毛利率 47.8% （yoy+0.6pct），板块发展稳步向前。公司核心业务项目交付能力扎实，1H25 小分子交付项目数共 329 个，其中商业化、临床 ...

药明生物 20250821 摘要 药明生物 2025 年上半年收益接近 100 亿元，同比增长 16.1%，新增 项目和订单管线创新高，预示加速增长。研发和早期开发板块增长 35%，占总收入 40%以上，为公司最强劲增长点。 商业化生产（M 端）项目增至 24 个，收入增长 24.9%，预计未来五至 六年内将有 40 至 50 个新商业化生产项目，到 2030 年或超 70 个，M 端加速发展。 公司拥有强大的 backlog，R 端里程碑合同金额增至 90 亿美元，服务 backlog 达 113 亿美元，表明未来订单充足稳定。北美市场收入占比 60%，增长 20%，仍为最大市场。 药明生物在全球最具潜力的双抗和 ADC 赛道占据重要地位，分别拥有 168 个双抗/多抗和 225 个 ADC 项目，市场份额远超传统抗体，显示强 大国际影响力。 公司通过实施 follow and win molecule 战略，提高研发效率和流程， 扩大全球产能，压缩 DNA 到 IND 转换周期至 6-9 个月，有效应对全球 融资环境不确定性。 Q&A 药明生物在 2025 年上半年的业绩表现如何？ 2025 年上半年，药 ...

Financial Data and Key Metrics Changes - Revenue reached nearly RMB 10 billion, representing a 16.1% increase year-over-year [28] - Adjusted EBITDA increased by 20.6% to RMB 4.3 billion, with an adjusted EBITDA margin of 43.3% [35][36] - Adjusted net profit exceeded RMB 2.8 billion, reflecting an 11.6% year-over-year increase [36] - Gross profit margin improved from 39.1% to 42.7%, with adjusted gross profit margin at 45.6% [7][40] Business Line Data and Key Metrics Changes - Research and Development (R&D) revenue grew over 35% year-over-year, driven by a strong pipeline of projects [30] - Late-phase and commercial manufacturing revenue grew close to 25%, representing over 43% of the total portfolio [30] - Early-phase revenue saw a decline due to timing issues with large-scale clinical manufacturing projects transitioning from phase two to phase three [30][31] Market Data and Key Metrics Changes - North America accounted for nearly 60% of revenue, with a growth rate of 20% [23] - Europe contributed close to 20% of revenue, showing modest growth as the company shifts focus from CMO projects to early-phase programs [24] - China represented 13% of revenue, experiencing a single-digit decline primarily due to out-licensing of programs to global partners [25] - Asia, particularly Japan, Korea, and Singapore, showed significant growth, now accounting for nearly 7% of revenue with more than double the growth rate [26] Company Strategy and Development Direction - The company emphasizes a unique CRDMO model, focusing on both service-based and IP-driven revenue streams [50][57] - The strategy includes expanding capacity globally, with significant investments in facilities in the US, Ireland, and Singapore [47][79] - The company aims to leverage its strong portfolio in ADCs and bispecifics, which now account for over 40% of its project portfolio [22] Management's Comments on Operating Environment and Future Outlook - Management noted that the company has absorbed post-COVID industry adjustments and is positioned for accelerated growth [28] - The backlog has shown significant growth, with milestone backlog increasing from RMB 7 billion to RMB 9 billion and service backlog from RMB 10 billion to RMB 11.3 billion [16][17] - The company expects to continue benefiting from global biotech trends, including M&A activities and out-licensing of Chinese assets to global partners [63][64] Other Important Information - The company achieved a 100% success rate in regulatory inspections, hosting 44 inspections [6] - Employee retention rate remains high at 98.8%, with no increase in total employee numbers over the past 18 months [42] - The company has a strong cash position with RMB 12.5 billion on hand and a conservative debt level of RMB 2.7 billion [43][47] Q&A Session Summary Question: What are the key drivers for revenue growth in the upcoming quarters? - Management highlighted the successful execution of the follow and win molecule strategies, with a strong pipeline of late-phase projects expected to ramp up [29] Question: How does the company plan to address the decline in early-phase revenue? - The decline is attributed to timing issues with large-scale projects transitioning to manufacturing, which is expected to be replenished by new projects in the pre-IND space [30][31] Question: What is the company's outlook on the global market trends? - Management expressed confidence in continued growth driven by M&A activities and the out-licensing of Chinese biotech programs to global partners, which typically results in significant revenue amplification [63][64]

Financial Data and Key Metrics Changes - Revenue reached nearly RMB 10 billion, representing a 16.1% increase year-over-year [27] - Adjusted EBITDA increased by 20.6% to RMB 4.3 billion, with an adjusted EBITDA margin of 43.3% [34] - Adjusted net profit exceeded RMB 2.8 billion, an 11.6% increase year-over-year [35] - Gross profit margin improved from 39.1% to 42.7%, with a gross profit increase of RMB 900 million [32][38] Business Line Data and Key Metrics Changes - Early phase R&D revenue grew over 35%, while late phase manufacturing revenue increased by nearly 25% [28][29] - The company added a record 86 new projects in the first half of the year, continuing strong momentum from the previous year [4][28] - The backlog grew significantly, with milestone backlog increasing from RMB 7 billion to RMB 9 billion and service backlog from RMB 10 billion to RMB 11.3 billion [16][17] Market Data and Key Metrics Changes - North America accounted for nearly 60% of revenue, with a growth rate of 20% [22] - Europe contributed close to 20% of revenue with modest growth, while China accounted for 13% with a single-digit decline [24] - Asia, particularly Japan, Korea, and Singapore, saw revenue growth exceeding 100% [25] Company Strategy and Development Direction - The company emphasizes its unique CRDMO model, which integrates R&D, development, and manufacturing [50][58] - Focus on expanding capabilities in ADCs and bispecifics, with over 300 projects in the pipeline [19][21] - Plans to enhance global capacity, with significant expansions in the US, Ireland, and Singapore [76][80] Management's Comments on Operating Environment and Future Outlook - Management noted that the company has absorbed post-COVID industry adjustments and is positioned for accelerated growth [27][28] - The company expects to continue benefiting from the increasing number of projects moving through its golden funnel [28] - Management expressed confidence in achieving positive free cash flow for the fourth consecutive year [48] Other Important Information - The company maintained a high employee retention rate of 98.8% and stable employee numbers despite revenue growth [6] - The company has a strong balance sheet with RMB 12.5 billion in cash and a conservative debt level of RMB 2.7 billion [42][47] - The company achieved a 100% success rate in regulatory inspections, reinforcing its quality assurance [6][81] Q&A Session Summary Question: What are the key drivers of revenue growth? - Revenue growth was primarily driven by successful execution of the follow and win the molecule strategies, with late phase and commercial manufacturing revenue growing close to 25% [28][29] Question: How is the company addressing the decline in early phase revenue? - The decline in early phase revenue is attributed to timing issues as several large-scale projects progressed from phase two to phase three, which is expected to be replenished by new projects [29] Question: What is the company's strategy for expanding its market presence? - The company aims to leverage its strong market share in China and capitalize on global licensing trends, expecting revenue to grow significantly as projects are out-licensed to global partners [64][65]

Core Insights - The company, WuXi Biologics, reported a revenue of 9.95 billion RMB for the first half of 2025, representing a year-on-year growth of 16.1%, with net profit increasing by 54.8% to 2.76 billion RMB [1] - Key drivers for revenue growth include the successful execution of the "Follow and Win" strategy, expansion of service offerings in the biopharmaceutical industry, and improved utilization of existing and new capacities [1][2] - The company added 86 integrated development projects in the first half of 2025, solidifying its position as a leader in complex biologics with a product line that includes 168 bispecific/multispecific antibodies and 225 antibody-drug conjugates (ADCs) [1][2] Revenue Growth and Project Development - Preclinical revenue increased by 35.2% year-on-year, driven by the development and transition of R&D service projects [2] - The company supports 67 Phase III clinical projects and 24 commercial production projects, with a 24.9% increase in revenue from these areas, reflecting the maturation of early projects [3] - The total unfulfilled order backlog reached 20.34 billion USD, with unfulfilled service orders and potential milestone payments amounting to 11.35 billion USD and 9 billion USD, respectively [4] Strategic Initiatives - The company is advancing its "Global Dual Factory" strategy to enhance capacity and capabilities in response to growing commercialization demands [3] - Recent strategic transactions include the asset transfer of a vaccine facility in Ireland and a biomanufacturing plant in Germany, aimed at optimizing global operations and focusing on large-scale biomanufacturing in Singapore [3] - The company has empowered over 50 molecular projects and is set to receive potential milestone payments and sales royalties, contributing to long-term profit growth [2]

Core Viewpoint - The article discusses the rising trend of business development (BD) in the Chinese innovative pharmaceutical sector, highlighting significant transactions and the evolving landscape of BD strategies among companies and investors [5][11]. BD Trends - Many fund teams are researching the next BD trends and adjusting their investments accordingly, with a notable increase in BD transaction amounts in China, exceeding $48.4 billion in the first half of 2025, including over $2 billion in upfront payments [5][6]. - The impact of BD news on companies' short-term strategies is significant, especially in a resource-constrained environment where pipeline prioritization is critical [5][6]. Major BD Events - Significant transactions this year include a $60.5 billion collaboration between 3SBio and Pfizer, setting a record for domestic dual antibodies, and a $53.3 billion deal between CSPC and AstraZeneca [8][9]. - The trend is shifting towards "packaged" BD deals, which help build trust between companies, as MNCs remain cautious about the long-term delivery capabilities of Chinese biotech firms [9][10]. Changes in Perception of Going Global - The perception of Chinese innovative drugs going global has evolved, with a shift from high barriers to entry to recognizing numerous opportunities as MNCs actively seek partnerships [12][13]. - The focus has shifted to products that can be standardized and have a proven track record in China, indicating that BD opportunities are increasingly competitive [12][13]. High-Value BD Opportunities - The PD-1/VEGF dual antibody market is highlighted as a high-value area, with multiple Chinese biotech firms entering clinical stages and generating significant BD events [13][14]. - The TCE (T-cell engagers) sector is also emerging as a promising area for BD, with substantial transaction amounts already recorded [15]. Future Considerations - The BD landscape is expected to evolve, with uncertainties about the long-term sustainability of current successes and the potential impact of future clinical data on the reputation of Chinese biotech [17][18]. - Concerns exist regarding the sustainability of companies focusing solely on BD, as excessive reliance on selling core pipelines may hinder future growth and exit strategies [18][19].

Group 1 - The company has entered into a global exclusive licensing agreement with Madrigal Pharmaceuticals, Inc. for SYH2086, covering development, production, and commercialization, with potential total payments of up to $2.075 billion, including an upfront payment of $120 million and milestone payments based on annual net sales [1] - SYH2086 is in the preclinical stage and has complete intellectual property rights, with expectations for significant growth in the weight loss and MASH fields following the licensing agreement [1] - The management anticipates potential upfront and milestone payments from ongoing negotiations for three other projects, including SYS6010 (EGFR-ADC), could total around $5 billion [1] Group 2 - The company continues to increase its R&D investment, with 2024 R&D expenses projected to reach ¥5.191 billion (up 7.5% year-over-year), accounting for 21.9% of its revenue from prescription drugs, which is industry-leading [2] - As of the end of Q1 2025, the company has 24 projects in critical II/III clinical phases and 9 projects under review for market approval, indicating a robust pipeline [2] - The company is expected to achieve multiple new drug approvals and data readouts throughout the year, maintaining a strong position in business development [2] Group 3 - The company is recognized as a leading domestic pharmaceutical firm with ample cash reserves, transitioning from traditional pharmaceuticals to innovation [2] - The net profit forecasts for 2025 and 2026 have been revised down to ¥4.92 billion and ¥5.25 billion, respectively, reflecting a decrease of 24.9% and 23.9% from previous estimates [2] - The current valuation is considered attractive due to the expected orderly market entry of significant products, maintaining a "buy" rating [2]

Core Viewpoint - The report from Guojin Securities highlights the rise of innovative drugs in China, indicating that the industry is in the early stages of realizing innovation outcomes, with significant opportunities for independent development and large-scale licensing transactions in the future [1] Group 1: Industry Trends - The global oncology immunotherapy landscape is entering a new era characterized by the combination of PD-1 and TAA (tumor-associated antigens) with cytokines [2] - Multinational pharmaceutical companies are facing patent cliffs for their blockbuster drugs while new innovative drug assets are rapidly emerging globally, including in China, leading to a trend of licensing agreements to fill pipeline gaps [2] - The global innovative drug business development (BD) upfront payments have reached the billion-dollar level, with China accounting for 40% of the total upfront payments [2] Group 2: Drug Development Focus - The evolution from single antibodies to dual and multi-target molecules is ongoing, with a focus on enhancing efficacy and reducing toxicity [3] - The exploration of new molecular constructs has progressed from combinations of immune checkpoint inhibitors (ICIs) and TAAs to combinations with cytokines like IL-2, aiming for better therapeutic outcomes [3][4] - The next wave of innovation in the post-PD-1 era is just beginning, with numerous companies exploring combinations of PD-1 with IL-2 and other structural innovations [4] Group 3: Potential Investment Targets - The report suggests that promising new products may emerge from segments such as TCE (T-cell engagers), other dual/multi-antibodies, and innovative ADCs (antibody-drug conjugates), with a focus on leading clinical enterprises [5] - Recommended companies to watch include Innovent Biologics (01801), Kintor Pharmaceutical (09926), and Kelun-Biotech (06990) [5]

Core Viewpoint - The National Healthcare Security Administration (NHSA) has announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, with 534 drugs passing the initial review, indicating a significant step towards a dual catalog mechanism that promotes both basic insurance and innovative commercial insurance [1][2]. Group 1: Drug Catalog Overview - A total of 534 drugs were reviewed, with 310 drugs excluded from the catalog and 224 drugs included. The commercial insurance innovative drug catalog includes 121 drugs, with 12 drugs under non-exclusive agreements still in negotiation [2]. - The NHSA will continue to advance the basic catalog adjustments and the commercial insurance innovative drug catalog, including expert reviews in August-September, price negotiations in September-October, and results announcement in October-November [2]. Group 2: Dual Catalog Mechanism - The dual catalog mechanism establishes a clear division of responsibilities, where the basic medical insurance catalog covers essential clinical drugs, while the commercial insurance innovative catalog focuses on high-value drugs not covered by basic insurance but with significant clinical value [3]. - The framework encourages commercial insurance companies to invest in innovative drug development through various means, such as investment funds, to provide stable long-term funding for innovative drug research [3]. Group 3: Implications for Drug Development - The commercial insurance innovative drug catalog is a crucial step in developing a multi-tiered medication security system, addressing diverse medication needs of the population. It is believed that supplementing commercial insurance on top of basic insurance will facilitate the introduction of high-priced innovative drugs [4]. - Innovative drugs can accumulate real-world data and enhance clinical penetration through commercial insurance applications, thereby increasing their potential market value [4]. Group 4: Investment Recommendations - Companies to watch include BeiGene, Kelun-Biotech, CanSino Biologics, Innovent Biologics, and Zai Lab, along with other relevant companies such as CSPC Pharmaceutical Group, China National Pharmaceutical Group, and Hengrui Medicine [5].

Core Insights - The company announced a rapid growth in orders for TPD, ADC, and peptide-related molecular building blocks, indicating a sustained demand in the new drug market [1] - In the TPD field, the company has built a large linker library with over 1,000 novel CRBN ligand structures, attracting inquiries from clients [1] - Due to space limitations, the current number of personnel in related business areas is limited, but new facilities will be operational by early next year, adding 300-400 fume hoods to enhance ADC and TPD-related operations [1] - The company aims to continuously enhance its influence in PROTAC, ADC, peptides, and non-natural amino acids [1]