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, ...

Core Insights - WuXi Biologics has launched TrueSite TI™, a targeted integration-based CHO cell line platform aimed at enhancing biologics development by improving timelines, product quality, and scalability for antibody and complex protein therapies [1][4]. Technology Overview - Targeted integration is a precise cellular engineering technique that allows for the delivery of expression units to specific locations in host cells, streamlining development and reducing the number of clones needed for screening [2]. - TrueSite TI™ is the fourth generation of the WuXia™ cell line platform, which has been validated in over 1000 molecules over the past decade, achieving an average monoclonal antibody (mAb) titer exceeding 8.0 g/L and maintaining over 99% of clonal cell lines' stability after 60 generations [3][5]. Development Efficiency - The platform enables a 6-month IND timeline, significantly accelerating the development of innovative therapies and their path to commercial launch [6][7]. - TrueSite TI™ is particularly effective for mAb development and has shown strong applicability for complex biologics, including bispecific antibodies, Fc-fusion proteins, and Fab fragments, ensuring consistent quality and stability [3][6]. Company Vision - The CEO of WuXi Biologics emphasized the importance of cell line development in delivering high-quality therapies faster, highlighting the advancements made with the TrueSite TI™ platform in both quality and efficiency [4].

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]

Financial Performance - Revenue for the first half of 2025 reached RMB 9,953,216 thousand, a 16.1% increase from RMB 8,574,214 thousand in 2024[11] - Gross profit increased by 27.0% to RMB 4,252,852 thousand, compared to RMB 3,349,951 thousand in the previous year[11] - Adjusted net profit rose by 11.6% to RMB 2,839,986 thousand, up from RMB 2,544,800 thousand in 2024[11] - Revenue for the six months ended June 30, 2025, increased by 16.1% year-on-year to RMB 9,953.2 million[17] - Gross profit rose by 27.0% year-on-year to RMB 4,252.9 million, with a gross margin improvement of approximately 3.6%[17] - Net profit attributable to the company increased by 54.8% year-on-year to RMB 2,756.6 million, while net profit attributable to shareholders rose by 56.0% to RMB 2,339.3 million[17] - Total revenue for the six months ended June 30, 2025, was approximately RMB 9,953.2 million, up from RMB 8,574.2 million in the previous year[60] - Gross profit increased by 27.0% to approximately RMB 4,252.9 million, with a gross margin rising from 39.1% to 42.7%[62] - The group's net profit increased by 54.8% from approximately RMB 1,780.3 million for the six months ended June 30, 2024, to approximately RMB 2,756.6 million for the six months ended June 30, 2025[72] - The net profit margin rose from 20.8% to 27.7% during the same period, primarily due to increased gross profit and investment income from the group's investment portfolio[72] Project and Operational Growth - The total number of ongoing integrated projects reached 864, with 86 new projects added in the reporting period[14] - The number of preclinical projects increased to 429, while early clinical projects rose to 344, indicating sustainable growth[14] - The company successfully secured 9 external projects during the reporting period, including 2 late-stage clinical projects[14] - The total amount of uncompleted orders as of June 30, 2025, increased to USD 20.3 billion, including USD 11.4 billion in service orders and USD 9.0 billion in potential milestone payment orders[17] - The company has empowered over 660 IND submission projects, reducing the development cycle from DNA to IND to just nine months[25] - The proprietary WuXiaTM platform has delivered over 1,000 cell lines and can empower 150 comprehensive CMC projects annually, making it one of the largest platforms in the industry[25] - The WuXiUPTM platform has been applied to develop over 170 processes for more than 60 molecules, achieving production capacities of 20 to 120 g/L[26] - The number of late-stage clinical and commercial production projects reached 67 and 24, respectively, by the end of the reporting period, with two new late-stage projects acquired[31] Financial Position and Assets - Total assets increased by 6.1% to RMB 60,437,387 thousand, compared to RMB 56,977,435 thousand at the end of 2024[11] - Total liabilities decreased by 1.1% to RMB 11,372,316 thousand, down from RMB 11,499,866 thousand[11] - Cash and cash equivalents stood at RMB 8,439,058 thousand, reflecting a 1.9% increase from RMB 8,279,182 thousand[11] - The company's property, plant, and equipment balance grew by 6.7% from approximately RMB 26,070.5 million to approximately RMB 27,815.9 million, driven by ongoing construction in Singapore and currency appreciation in Europe[74] - Inventory increased by 8.8% from approximately RMB 1,521.7 million to approximately RMB 1,655.0 million, attributed to stockpiling for business expansion in Europe[82] - Trade and other receivables rose by 23.7% from approximately RMB 6,240.7 million to approximately RMB 7,721.2 million, reflecting business expansion and revenue growth[84] Regulatory and Compliance - The company successfully passed 44 regulatory inspections since 2017, including 22 from the EU EMA and US FDA, with no major issues found[37] - The company is actively monitoring global regulatory changes to adapt to evolving compliance requirements in the biopharmaceutical industry[120] - Data compliance has become a critical issue, with the company monitoring risks associated with data protection and compliance plans[127] - The company has received ISO 22301 certification for business continuity management, covering all business functions[129] Shareholder and Equity Information - The total number of issued shares as of June 30, 2025, is 4,068,902,309[132] - Dr. Li Ge holds 509,962,633 shares, representing 12.53% of the total equity[138] - Life Science Holdings, Life Science Limited, and WuXi PharmaTech collectively hold 501,251,133 shares, accounting for 12.32% of the total equity[138] - BlackRock, Inc. holds 208,273,538 shares, which is 5.12% of the total equity[138] - The company has a pre-IPO share option plan with a total of 121,477,019 shares available for issuance, approximately 2.98% of the total issued shares[141] - The board decided not to declare any interim dividend for the six months ended June 30, 2025[110] Employee and Talent Management - Employee costs for the six months ended June 30, 2025, were approximately RMB 2,586.6 million, an increase from RMB 2,295.2 million in the same period of 2024, reflecting a growth of 12.7%[107] - The company maintained a key talent retention rate of approximately 98.8%[107] - The company has implemented various employee incentive plans to reward contributions from eligible participants[107] Investment and Capital Management - The company raised approximately RMB 10,899.0 million from the fourth placement, with 40% allocated for acquiring additional DS/DP production capacity and another 40% for establishing large-scale production capabilities for various technology platforms[170] - The company invested RMB 1,035.8 million in mRNA-related technologies, which accounts for 10% of the total raised funds[170] - The company repurchased a total of 60,539,500 shares during the reporting period, with a total purchase price of approximately HKD 1,110.62 million[172] - The repurchase was conducted to demonstrate confidence in the company's business outlook, as the current trading price did not reflect its intrinsic value[172] Risk Management - The company faces interest rate risks related to fixed and floating rate bank borrowings and deposits, which are managed through regular assessments of potential impacts[123] - The group generates most of its revenue from sales denominated in USD, while procurement costs are settled in RMB, USD, and EUR, exposing it to foreign exchange risk[126] - The group has established forward contracts to manage foreign exchange risk and has adopted hedge accounting for derivatives[126] - The group faces maximum credit risk from financial assets listed at their carrying value on the consolidated balance sheet[124]

Summary of WuXi Biologics Cayman Inc Conference Call Company Overview - **Company**: WuXi Biologics Cayman Inc - **Ticker**: 2269.HK - **Industry**: China Healthcare - **Market Cap**: HK$164,437 million - **Current Price**: HK$38.90 (as of September 18, 2025) - **Price Target**: HK$35.00, indicating a downside of 10% from the current price [8][8] Key Industry Insights - **Fastest Growing Modality**: In the first half of 2025, WuXi's 864 integrated projects included 168 bi-/multi-specific antibody projects, representing 19% of total projects. Revenue from these contracts increased by over 200% year-over-year [2][2] - **Comparison with Other Modalities**: Antibody-drug conjugates (ADCs) also showed significant growth, with a 50% year-over-year increase in revenue [2][2] - **Proprietary Platforms**: WuXi's CD3 T-cell engager platform has engineered various bi-/multi-specific antibodies, including CD3xCD19 and CD3xPSMA [2][2] Clinical Development Highlights - **TQB2825 Trials**: The bi-specific antibody TQB2825 is currently in Phase 3 clinical trials, having previously undergone Phase 2 trials in combination with immunochemotherapy and chemotherapy alone. The primary endpoints include dose and toxicity, with response rates and survival as secondary endpoints [3][3][11] - **Significance of TQB2825**: This is the first antibody enabled by the WuXiBody technology platform to enter a pivotal study, marking a significant milestone for the company [11][11] Financial Projections - **Revenue Growth**: Projected revenue for the fiscal year ending December 2025 is Rmb 21,157 million, with an expected increase to Rmb 24,092 million in 2026 [8][8] - **Earnings Per Share (EPS)**: Expected EPS for 2025 is Rmb 0.93, increasing to Rmb 1.15 in 2026 [8][8] - **Valuation Metrics**: The company has a P/E ratio of 38.2 for 2025, which is expected to decrease to 30.8 by 2026 [8][8] Risks and Opportunities - **Upside Risks**: Faster pharmaceutical market growth, increased outsourcing of R&D, and stronger biotech funding could enhance WuXi's performance [14][14] - **Downside Risks**: Potential slowdown in biologics programs, lower outsourcing intensity, and geopolitical risks could negatively impact the company [14][14] Competitive Landscape - **Bi-specific Antibodies**: The conference highlighted several approved bi-specific antibodies as of March 2025, including those developed by major players like Merus Biopharm and Regeneron, indicating a competitive market landscape [6][6] Conclusion WuXi Biologics is positioned for significant growth in the biopharmaceutical sector, particularly in bi-specific antibodies, with promising clinical developments and robust financial projections. However, the company must navigate various risks that could impact its growth trajectory.

Group 1 - WuXi Biologics announced that its biologics drug substance manufacturing facilities MFG1 and MFG2, along with the DP5 drug product facility, received GMP certification from the Turkish Medicines and Medical Devices Agency [1]

Core Viewpoint - WuXi Biologics has successfully obtained GMP certification from the Turkish Medicines and Medical Devices Agency (TITCK) for its manufacturing facilities in Wuxi, marking the company's first successful audit by TITCK [1] Group 1 - The facilities that received GMP certification include the Biologics Drug Substance Plant 1 (MFG1), Biologics Drug Substance Plant 2 (MFG2), and Biologics Drug Product Plant 5 (DP5) [1]

Group 1 - The innovative drug sector has become a focal point in the secondary market this year, raising questions about whether this enthusiasm is translating to the primary market and if there is a shift in capital investment attitudes towards innovative drugs [1] - WuXi Biologics held its first "M Powering Global Success" CRDMO+ Open Day, where executives discussed trends in biopharmaceutical innovation, international expansion, and quality system development [1] - The CEO of WuXi Biologics noted that while the Chinese biopharmaceutical investment market has not fully recovered, there are signs of improvement in cutting-edge fields such as ADC and bispecific antibodies [1] Group 2 - More companies are willing to invest in First-in-Class projects, indicating a shift from fast follow strategies to genuine source innovation [2] - WuXi Biologics is focusing on high-potential areas such as monoclonal antibodies, bispecific/multispecific antibodies, and ADCs, with expectations that 10 products in the monoclonal antibody sector could exceed $5 billion in sales, and 5 of those could surpass $10 billion [2] - The company demonstrates significant production efficiency, completing technology transfer to PPQ in just 6 months, which is 3-6 months faster than the industry average, and can reduce this to 3.5 months with an accelerated process [2]

Summary of WuXi Biologics Cayman Inc Conference Call Company Overview - **Company**: WuXi Biologics Cayman Inc - **Industry**: Biologics and Biopharmaceuticals - **Market Cap**: HK$159,195 million - **Stock Rating**: Overweight - **Price Target**: HK$35.00 - **Current Price**: HK$37.66 - **52-Week Range**: HK$39.38 - HK$10.36 - **Fiscal Year Ending**: December 2024 Key Industry Insights - **Project Modalities**: As of mid-2025, WuXi has 864 integrated projects, with the following distribution: - **mAbs (Monoclonal Antibodies)**: 38% of total projects - **Bi-/Multi-specifics**: 19% of total projects, with a 37% year-over-year growth - **ADCs (Antibody-Drug Conjugates)**: 26% of total projects, with a 35% year-over-year growth - **Revenue Growth**: - **Bi-/Multi-specifics**: 1H25 revenue increased by 200% YoY on over 160 programs - **ADCs**: 1H25 revenue increased by 50% YoY on over 220 programs - **R&D Activity**: Strong performance in ADCs noted, with raised guidance from subsidiary WuXi XDC Financial Performance - **Revenue Projections**: - **2024**: Rmb 18,675 million - **2025**: Rmb 21,157 million - **2026**: Rmb 24,092 million - **2027**: Rmb 27,626 million - **Earnings Per Share (EPS)**: - **2024**: Rmb 0.79 - **2025**: Rmb 0.93 - **2026**: Rmb 1.15 - **2027**: Rmb 1.40 - **EBITDA**: - **2024**: Rmb 6,380 million - **2025**: Rmb 7,552 million - **2026**: Rmb 8,657 million - **2027**: Rmb 10,061 million Licensing and Contracts - **Biopharma Licensing**: Major driver of new contracts, contributing approximately 24% of cumulative revenue of US$11.7 billion from 2018 to 1H25 - **Contract Value**: Total contract value signed post-licensing amounted to US$2.8 billion from 2018 to 1H25 Geopolitical Context - **Tariffs**: US pharmaceutical tariffs on Singapore, EU, and China are at 10%, 15%, and 20% respectively - **Supply Chain**: WuXi's supply chain spans multiple regions, including the US, with a capacity roadmap of ~500,000L of bioreactor capacity Risks and Opportunities - **Upside Risks**: - Faster pharmaceutical market growth - Increased outsourcing of R&D globally - Stronger-than-expected biotech funding turnaround - **Downside Risks**: - Slowdown in biologics programs from pharma and biotech companies - Lower intensity of outsourcing R&D services - Geopolitical risks Conclusion - **Overall Outlook**: The biologics industry remains attractive, with WuXi positioned for growth through innovative project modalities and strong licensing activity. The company is navigating geopolitical challenges while maintaining robust financial projections and market presence.

SHANGHAI, Sept. 9, 2025 /PRNewswire/ --Â WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), recently launched the "WuXi Biologics Green CRDMO White Paper" at its first CRDMO Open Day event, sharing the end-to-end Green CRDMO solution for biologics and driving the sustainable development of the global biologics industry supply chain. Last November, the company's Green CRDMO solution was also featured in the "20 Case Examples for 20 Years" report ...