股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 FF301 公司名稱: WuXi Biologics (Cayman) Inc. 藥明生物技術有限公司*（於開曼群島註冊成立的有限公司）*僅供識別 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02269 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 6,000,000,000 | USD | 0.000008333333 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 6,000,000, ...

Group 1 - Jefferies reports that after President Trump's threat of a 200% drug tariff, he announced a 100% tariff on brand-name or patented drugs to promote domestic manufacturing [1] - The impact on Chinese pharmaceutical companies is expected to be limited due to their minimal direct sales in the U.S. market and the ability to collaborate with multinational pharmaceutical companies to avoid tariff effects [1] - For CDMO companies, it is anticipated that the increased production costs in the U.S. will be borne by multinational pharmaceutical clients [1] Group 2 - WuXi Biologics has established production capacity in the U.S., currently having 4,000 liters in New Jersey and plans to add 36,000 liters by 2027 [1] - In contrast, Samsung Biologics has not yet established a facility in the U.S., suggesting a potential investment opportunity in WuXi Biologics during stock price adjustments [1]

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry [2] Core Insights - The CXO industry is experiencing a recovery in market conditions, driven by improvements in supply-demand dynamics and a rebound in financing activities for innovative drugs [3][4] - The CDMO sector continues to show high growth potential, with leading companies improving their performance and expanding into emerging markets [5][6] - The CRO sector is approaching a turning point, with signs of demand recovery and improved order conditions [6][7] Summary by Sections CXO Industry Overview - The CXO industry operates on a "water seller" business model, closely tied to the financing of the biopharmaceutical sector. In the first eight months of 2025, overseas innovative drug financing reached $22.6 billion, a year-on-year decline of approximately 36%, while domestic innovative drug financing amounted to $7.75 billion, a year-on-year increase of about 89% [3][31] - The leading companies in the CXO sector are expected to enter an expansion phase as demand recovers, while smaller companies may face increased competition and exit the market [4][44] CDMO Sector - CDMO leading companies have begun to see marginal improvements in performance since Q4 2024, attributed to high overseas revenue and a unique business model that supports project pipeline growth [5][46] - The order situation for CDMO companies has improved significantly, with notable increases in backlogged orders for major players like WuXi AppTec and WuXi Biologics [49][50] - The CDMO business model is characterized by strong customer retention and project scalability, allowing for sustained growth despite challenges in new project signings [52] CRO Sector - The CRO sector is witnessing a divergence in performance among leading companies, with some starting to recover. The overall order situation has shown improvement, indicating a potential demand revival [6][22] - The price increase of experimental monkeys suggests a forthcoming recovery in preclinical CRO demand, highlighting the importance of resource availability for leading CRO companies [6][24] - The integration of AI in drug development processes is expected to enhance efficiency and reduce costs, with many domestic CRO leaders already adopting AI technologies [7][18] Recommended Companies - The report suggests focusing on key players in the CXO sector, including WuXi AppTec, WuXi Biologics, WuXi AppTec, and others, which are positioned well for growth based on their business characteristics and market trends [8][10]

Summary of the Conference Call on China's CRO Industry Industry Overview - The conference call focuses on the **China CRO (Contract Research Organization) industry** and its global competitiveness from short-term, medium-term, and long-term perspectives [1][2]. Key Insights and Arguments - **Strong Performance in 2024-2025**: The Chinese CRO industry is expected to perform strongly in 2024-2025, driven by policy support, AI technology applications, and robust performance from companies like WuXi AppTec, which has seen significant stock price increases [1]. - **Geopolitical Risks**: Despite challenges from geopolitical factors such as India's PLI scheme and the US Biodefense Act, the risks are considered manageable due to China's comprehensive advantages in chemical capabilities, compliance capacity, and intellectual property protection [1][5]. - **Supply and Demand Dynamics**: The small molecule supply peak has passed, while the large molecule sector remains in a high investment phase. The global pharmaceutical pipeline and R&D investments continue to grow, with a strong demand side indicated by the increasing number of clinical trial registrations in China [1][6]. - **Investment Trends**: Overall R&D investment is on the rise, although growth rates may slow. In the large molecule CDMO sector, WuXi Biologics' revenue growth is slower than that of Samsung Biologics, with guidance for 2025 set at 14%-16% for WuXi and 25%-30% for Samsung [7]. - **Order Growth**: In the large molecule CDMO sector, WuXi Biologics has $4.2 billion in unfulfilled orders, a 15.3% year-on-year increase, while Samsung has $18.7 billion, up 43.8%. WuXi AppTec's new contract amounts have also shown significant growth [8]. Additional Important Content - **Emerging Business Layouts**: Several CRO companies are venturing into emerging fields such as peptides and oligonucleotides. Investment recommendations suggest favoring companies with strong valuations and competitive positions in the small molecule sector, with WuXi AppTec highlighted as a key player [12][13]. - **Capital Expenditure**: Capital expenditures remain high in the large molecule sector, with companies like Samsung and WuXi maintaining significant investments. WuXi AppTec plans to invest at least 7-8 billion yuan in 2025, reflecting confidence in future growth [11]. - **Clinical CRO Performance**: Clinical CROs are currently experiencing performance fluctuations, but order growth indicates potential recovery. Companies like Tigermed and PPD have reported double-digit order growth, suggesting a positive outlook for future performance [9][10]. This summary encapsulates the key points discussed in the conference call regarding the current state and future outlook of the Chinese CRO industry, highlighting both opportunities and challenges.

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Core Viewpoint - The Chinese pharmaceutical industry is experiencing a significant transformation driven by technological breakthroughs and demographic changes, leading to a shift from a reliance on license-in to license-out strategies, positioning Chinese companies as key players in the global market [2][4][11]. Group 1: Industry Trends - The Hong Kong pharmaceutical sector is witnessing a surge, with ETFs tracking the Hang Seng Biotechnology Index showing strong performance, indicating a structural change in the industry [1][3]. - Innovation drugs are becoming a major investment theme for 2025, with significant year-to-date gains in related indices, highlighting the leading role of companies like WuXi Biologics and BeiGene [4][5]. - The Chinese pharmaceutical industry now ranks second globally, with approximately 30% of innovative drugs under development worldwide, and a notable increase in the approval rate of new drugs [8][9]. Group 2: Technological Advancements - The advent of CRISPR gene editing and AI technologies is revolutionizing drug development, significantly reducing research and development cycles and enhancing the capabilities of Chinese pharmaceutical companies [2][7]. - The emergence of platform technologies such as ADCs, bispecific antibodies, and cell therapies is opening new avenues for drug development, contributing to the increased competitiveness of domestic biotech products [7]. Group 3: Market Dynamics - The market is currently experiencing a revaluation of innovative drug companies, with many leading firms turning profitable and their valuations being reassessed positively [7][11]. - The increase in license-out transactions indicates a shift in the global innovation chain, with Chinese companies now accounting for over 51% of the total transaction value in the BD market [11]. Group 4: Policy and Financial Environment - Supportive policies, including stable medical insurance negotiations and expedited drug approval processes, are fostering an environment conducive to innovation [8]. - The easing of monetary policy, including interest rate cuts by the Federal Reserve, is providing a favorable financing environment for biotech companies, further enhancing their growth prospects [8]. Group 5: Investment Opportunities - The Hang Seng Medical ETF and the Hong Kong Stock Connect Medical ETF are emerging as attractive investment vehicles, providing exposure to core assets in the Hong Kong pharmaceutical sector [3][15]. - The recent restructuring of the Hang Seng Biotechnology Index has improved its focus on leading companies in the biotech field, enhancing its investment appeal [14][15].

Key Points - The top three companies with net inflows of southbound funds are Shandong High Holdings (22.20 billion), Yingfu Fund (21.69 billion), and Alibaba-W (17.13 billion) [1][2] - The top three companies with net outflows of southbound funds are Tencent Holdings (-6.24 billion), Xiaomi Group-W (-4.00 billion), and Xpeng Motors-W (-2.89 billion) [1][2] - In terms of net inflow ratio, Yanzhou Coal Mining (47.47%), Shenwei Pharmaceutical (44.33%), and Xinhua Wencuan (42.23%) lead the market [1][2] - The companies with the highest net outflow ratios are Zhenjiu Lidu (-59.14%), China National Heavy Duty Truck Group (-51.32%), and Yancoal Australia (-46.95%) [1][2] Net Inflow Rankings - Shandong High Holdings (22.20 billion, 37.22% increase) [2][3] - Yingfu Fund (21.69 billion, 9.52% increase) [2][3] - Alibaba-W (17.13 billion, 7.73% increase) [2][3] - Other notable inflows include Pop Mart (9.73 billion, 19.07% increase) and Meituan-W (8.48 billion, 12.33% increase) [2] Net Outflow Rankings - Tencent Holdings (-6.24 billion, -4.66% decrease) [2][3] - Xiaomi Group-W (-4.00 billion, -4.06% decrease) [2][3] - Xpeng Motors-W (-2.89 billion, -17.08% decrease) [2][3] - Other significant outflows include WuXi Biologics (-2.33 billion, -12.08% decrease) and Ping An Insurance (-2.14 billion, -10.00% decrease) [2]

Core Insights - WuXi Biologics has been recognized as a constituent company of the FTSE4Good Index Series for the fifth consecutive year, highlighting its commitment to sustainability [1] Company Performance - The recognition by FTSE Russell reflects WuXi Biologics' outstanding sustainability performance, reinforcing its position as a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) [1]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 1.50% on September 22, with a trading volume of 1.263 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of September 19, 2024, the fund's latest share count was 8.17 billion shares, with a total size of 7.676 billion yuan, reflecting a year-to-date increase of 1966.38% in shares and 1931.78% in size compared to December 31, 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 87.92% during the management period [2] - The top holdings of the fund include Innovent Biologics (9.52%), WuXi Biologics (9.47%), BeiGene (8.73%), and others, with their respective market values and share counts detailed [2] - The cumulative trading amount over the last 20 trading days reached 37.235 billion yuan, with an average daily trading amount of 1.862 billion yuan [1][2]

2025 中期報告 2025 INTERIM REPORT INTERIM REPORT 2025 中期報告 目錄 | 公司資料 | 2 | | --- | --- | | 財務摘要 | 4 | | 公司簡介 | 5 | | 管理層討論及分析 | 6 | | 其他資料 | 35 | | 簡明綜合財務報表的審閱報告 | 58 | | 簡明綜合損益及其他全面收益表 | 59 | | 簡明綜合財務狀況表 | 61 | | 簡明綜合權益變動表 | 63 | | 簡明綜合現金流量表 | 65 | | 簡明綜合財務報表附註 | 66 | | 釋義 | 110 | 公司資料 董事會 執行董事 陳智勝博士 （首席執行官） Sherry Xuejun Gu博士 （首席技術官） （於二零二五年六月六日獲委任） 非執行董事 李革博士 （董事長） 周偉昌博士 （於二零二五年六月六日退任） 曹彥凌先生 繆靜雯女士 薪酬委員會 獨立非執行董事 William Robert Keller先生 Kenneth Walton Hitchner III先生 戴國良先生 陳珏博士 審核委員會 戴國良先生 （主席） William Robert K ...