WUXI BIO(WXXWY)

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WuXi Biologics Kicks off Construction of Microbial Manufacturing Site for Commercial Production in Chengdu
Prnewswire· 2025-06-09 10:10
Core Insights - WuXi Biologics has commenced construction of a new microbial manufacturing site in Chengdu, China, aimed at enhancing its commercial production capabilities in the pharmaceutical sector [1][4]. Group 1: Facility Details - The new site will cover an area of 95,000 square meters and will include both drug substance (DS) and drug product (DP) facilities, capable of producing a variety of modalities such as peptides, antibody fragments, plasmid DNA, enzymes, cytokines, and virus-like particles (VLPs) [2][6]. - The facility is expected to complete GMP release for production by the end of 2026 and will feature a 15,000L fermenter, allowing for an annual production capacity of 80 to 110 DS batches, with future expansion potential to 60,000L [2][6]. - It will also house China's first dual-chamber lyophilization production line and a vial filling line, with an overall DP manufacturing capacity exceeding 10 million vials annually [2][6]. Group 2: Technological Advancements - The site will utilize WuXi Biologics' EffiXTM microbial expression platform, designed for the development and manufacturing of biologics with high yield, consistent quality, and superior stability and scalability, achieving titers exceeding 15 g/L for non-mAb recombinant proteins [3][6]. - Advanced automated systems will be implemented to ensure regulatory compliance, operational efficiency, and high-quality standards, with a focus on energy conservation and sustainability through optimized processes and carbon tracking mechanisms [3]. Group 3: Strategic Partnerships - WuXi Biologics will produce VISEN Pharmaceuticals' first commercial product, Lonapegsomatropin, at the new site, which is a long-acting growth hormone for treating pediatric growth hormone deficiency [4]. - The company has also formed a strategic partnership with Virogen Biotechnology, highlighting its expanding portfolio of collaborations aimed at meeting the growing demand for advanced biologic therapies [4][5]. Group 4: Market Positioning - The CEO of WuXi Biologics emphasized that the new Chengdu site is strategically positioned to capitalize on the booming global market for microbial products, which presents significant potential for next-generation therapies [5].
花旗:药明生物- 有望成为 GLP - 1 项目的主要受益方
花旗· 2025-06-02 15:44
Investment Rating - The investment rating for WuXi AppTec is "Buy" with a target price of HK$95.00, indicating an expected share price return of 43.2% and an expected total return of 46.0% [5]. Core Insights - WuXi AppTec's CFO maintained the 2025 revenue guidance of Rmb41.5-43.0 billion, reflecting a year-over-year growth of 10-15% for continuing business, with faster bottom line growth than topline [1]. - The company expects TIDES revenue to grow over 60% year-over-year in 2025, with involvement in key GLP-1 projects such as tirzepatide, orforglipron, and retatrutide [2]. - WuXi AppTec currently has the world's largest peptide capacity of 41,000L, aiming to expand to 100,000L by the end of 2025 [2]. - The Testing and Biology businesses are anticipated to recover in the second half of 2025, with management noting that over 50% of Testing revenue comes from Chinese clients [3]. - The CDMO business is viewed as a cornerstone, with over 90% retention of projects in the Chemistry business for Phase 2/3/CMO projects [4]. Summary by Sections Financial Performance - Revenue guidance for 2025 is set at Rmb41.5-43.0 billion, with a projected growth rate of 10-15% year-over-year for continuing business [1]. - The expected share price return is 43.2%, with a total expected return of 46.0% [5]. Business Segments - TIDES revenue is expected to grow over 60% year-over-year in 2025, with significant involvement in GLP-1 projects [2]. - The company is confident in adding approximately 10 commercial projects to its pipeline annually [4]. - The Testing and Biology segments are expected to show double-digit growth in volume, with a recovery anticipated in the second half of 2025 [3]. Capacity and Expansion - WuXi AppTec currently operates with a peptide capacity of 41,000L, the largest globally, and aims to increase this to 100,000L by the end of 2025 [2]. - The company retains over 90% of projects in the Chemistry business for Phase 2/3/CMO projects, indicating strong project management capabilities [4].
WuXi Biologics Congratulates Partner CANbridge Pharmaceuticals on the Approval of Innovative Velaglucerase-beta for Injection (Gaurunning) for Gaucher Disease by China NMPA
Prnewswire· 2025-05-17 01:42
Core Insights - WuXi Biologics congratulates CANbridge Pharmaceuticals on the approval of velaglucerase-beta for injection, marking it as China's first locally developed enzyme replacement therapy for Gaucher disease [1][5] Company Overview - WuXi Biologics is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics [10][11] - The company has over 12,000 employees across multiple countries and supports 817 integrated client projects, including 21 in commercial manufacturing [11] Product Development - Velaglucerase-beta for injection is the first collaboration project between CANbridge and WuXi Biologics, utilizing WuXi's integrated technology platform to enhance yield and quality [3][5] - The project achieved over 110 times increase in overall yield and over 50% increase in specific enzyme activity, ensuring affordability for patients [3] Clinical Significance - The pivotal clinical trial for velaglucerase-beta demonstrated significant efficacy, with a statistically significant reduction in spleen volume for Gaucher disease patients [8] - Gaucher disease affects approximately 0.7 to 1.75 per 100,000 people globally, with around 3,000 patients reported in China as of 2020 [2][9] Market Impact - The approval of velaglucerase-beta represents a significant milestone in rare disease drug innovation in China, reflecting CANbridge's commitment to addressing unmet clinical needs [4][5] - CANbridge has a differentiated drug portfolio with three approved drugs and a pipeline of eight assets targeting rare diseases [15]
Driving Impact Through Responsibility: WuXi Biologics Releases 2024 Sustainability Report
Prnewswire· 2025-04-29 10:47
Contributing to United Nations Sustainable Development Goals Enhancing transparency and effectiveness for corporate governance Empowering employees and delivering positive impact to communities Accelerating actions for tackling climate change and promoting environmental stewardship Providing Green CRDMO solutions to empower global clients on their sustainability journeysHONG KONG, April 29, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manu ...
WuXi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site
Prnewswire· 2025-04-18 06:30
Core Insights - WuXi Biologics has successfully completed Asia's first commercial-scale Process Performance Qualification (PPQ) campaign for 5,000L single-use bioreactors, marking a significant advancement in biomanufacturing capabilities [1][3] - The company achieved a nearly 70% reduction in protein production costs per gram and a 20% increase in protein yield per batch through innovative process technologies [2][7] - The MFG20 facility's total capacity has increased from 8,000L to 23,000L by integrating three 5,000L single-use bioreactors with existing production lines [2][3] Company Achievements - WuXi Biologics has maintained a 99% production success rate over the past three years across over 300 batches of scaled production, demonstrating its leadership in commercial biomanufacturing [3] - The MFG20 facility has achieved a 100% PPQ success rate and holds ISO 14001 and ISO 45001 certifications, underscoring its operational excellence [3] - The company supports 817 integrated client projects, including 21 in commercial manufacturing, showcasing its extensive engagement in the biopharmaceutical sector [5] Sustainability and Innovation - WuXi Biologics emphasizes sustainability as a cornerstone of its long-term growth strategy, driving green technology innovations to provide advanced end-to-end Green CRDMO solutions [6] - The company is committed to fostering positive social and environmental impacts through responsible practices and collaboration with stakeholders [6]
药明生物20250326
2025-04-15 14:30
图名先生第三位是SVP以及Head of IR,Lina,Lina Fan女士然后以及整个药物生物的IR团队那么without further delay那我把这个时间交给公司非常感谢谢谢John非常高兴给大家机会跟大家来分享我们2024年的业绩我们总体来说对2024年非常满意而且2025年是加速增长 如果熟悉我们的投资人,我非常喜欢用这一个slide来总结我们2024年的业绩。左边是我们的业务的数据,右边更多的是financial的数据。 如果看项目数,我们过去一年项目数增长17%,在这么大的一个Portfolio,近700个项目,现在增加到817个项目,相当的了不起,尤其是去年,大家也都知道,噪音还是非常大的,就是生物技术的投融资不一定那么稳健,还有别的噪音也非常大。 即使这样的情况下我们最终我们是非新冠业务的增速我们达到了13%我们管理层对这个非常满意我觉得对我们最开心的还是说我这边已经切过了你们在第几页我在第五页我们看到还是第一页样目比较我这边看到第五页怎么那么奇怪呢 好了现在第五页对现在回到第五页是吗所有人都在第五页吗对对对我这边看到第五页的OK好对我觉得去年2024年我觉得在这个大环境非常复杂的情 ...
WuXi Biologics Wins Five Asia-Pacific Biopharma Excellence Awards
Prnewswire· 2025-04-14 13:07
SHANGHAI, April 14, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has received five awards at the 2025 Asia-Pacific Biopharma Excellence Awards (ABEA) ceremony. This also marks the seventh time that the company has been recognized by the organizer. Best Contract Development and Manufacturing Organization Award Best Aseptic Fill-Finish & Packaging CMO of the Year Best Aseptic Fill-Finish & ...
药明生物-盈利回顾_2024 年下半年盈利略高于高盛预期;预计 2025 财年收入增长 12 - 15% 且利润率改善
Goldman Sachs· 2025-04-01 04:17
27 March 2025 | 12:00AM HKT WuXi Biologics (2269.HK) Earnings Review: 2H24 earnings slightly higher than GSe; guided 12-15% revenue growth for FY25 and improving margin | 2269.HK | | --- | | 12m Price Target: HK$23.40 | | Price: HK$26.20 | | Downside: 10.7% | 2H24 revenue reached Rmb10.1bn (vs GSe Rmb9.70bn or VA consensus Rmb9.43bn), +18.3% y/y, that came at higher end of the previous guidance (FY24 +9.6% y/y, vs guidance of +5%-10% y/y), mainly attributable to the robust growth from WuXi XDC (+111% in 2H) ...
WuXi Biologics Reports Solid 2024 Annual Results and Expects Accelerated Growth in 2025
Prnewswire· 2025-03-25 10:30
Revenue grew 9.6% YoY to RMB 18,675.4 million, with non-COVID revenue up 13.1% YoY Adjusted EBITDA grew 14.4% YoY to RMB7,999.3 million and Adjusted Net Profit increased 9.0% YoY to RMB5,396.9 million Added 151 new integrated projects, including 13 in late-stage and commercial stage Total integrated projects reached 817, one of the largest portfolios of complex biologics Research Services enabled 7 global programs for molecule discovery, eligible to receive ~$140 million in near-term payments Completed 16 ...
WuXi Biologics Again Passed GMP Inspection by Japan PMDA
Prnewswire· 2025-02-27 04:30
Core Insights - WuXi Biologics has successfully passed the GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities, MFG2 and MFG5, in Wuxi city, indicating strong compliance with global regulatory standards [1][2] - The company has a proven track record, having passed 42 regulatory inspections and received 97 license approvals from various drug administration agencies across multiple regions, including the U.S., Europe, China, Singapore, Japan, and Canada [3] - WuXi Biologics employs over 12,000 skilled employees globally and is currently supporting 817 integrated client projects, with 21 in commercial manufacturing, excluding COVID-related projects [5] Company Overview - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that provides end-to-end solutions for the discovery, development, and manufacturing of biologics [4] - The company emphasizes Environmental, Social, and Governance (ESG) responsibilities as a core part of its business strategy, aiming to become a leader in ESG within the biologics CRDMO sector [6]