Wuxi Biologics Cayman Inc

Wuxi Biologics (Cayman), Inc. is an investment holding company, which provides end-to-end solutions and services for biologics discovery, development, and manufacturing services and manufacturing of biologics products. It operates through the Biologics and XDC segments. The company was founded on February 27, 2014, and is headquartered in Wuxi, China.

CRANBURY, N.J. , Aug. 31, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), today announced the release of its GMP phase I drug substance clinical manufacturing facility, MFG18, in Cranbury, New Jersey.

WuXi Biologics Announces GMP Release of Its First North American Biomanufacturing Facility in Cranbury, New Jersey

Revenue Increased b y 63.5% Y-o-Y to RMB7,206.4 Million Gross Profit Increased b y 48.6% Y-o-Y to RMB3,413.2 Million Net Profit Gre w by 39.2% Y-o-Y to RMB2,621.2 Million Adjusted Net Profit Rose b y 60.9% to RMB2,914.9 Million Total Backlog Reached US$18,467 Million *       *        * Non-COVID Revenue Achieved 72.6% Y-o-Y Growth CRDMO Business Model Led Sustainable Long-Term Growth "Follow and Win the Molecule" Strategies Drove Significant Revenue Increases 534 Total Integrated Projects, Including 59 Additions 29 Phase III Projects & 14 Commercial Manufacturing (CMO) Projects with Potential for Future Growth Late-Phase & Commercial Manufacturing Revenue Increased by  63.5% to RMB3,151.5 Million, A Strong Growth Driver for the Future Business Continuity Plan Implemented During Shanghai COVID Outbreak, Allowed Delivery of Projects Without Disruption Supply Chain Optimized to Safeguard Project Execution and Timelines Premier Quality System Re-verified, Complete d 25 Global Regulatory Inspections Drug Product CDMO Platform Established to Fuel Future Growth Global Presence and Talent Pool Expanded to Support Business Momentum Sufficient Capacity to Start Any Project within 4 Weeks HONG KONG , Aug. 17, 2022 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, is pleased to announce its unaudited interim results for the first half of 2022 ("Reporting Period"). 2022 Interim Financial Highlights Revenue: The Group's revenue increased by 63.5% to RMB7,206.4 million for the six months ended June 30, 2022.

WuXi Biologics Reports Strong 2022 Interim Results

SHANGHAI , Aug. 16, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), announced today that it has once again been selected as a constituent of the FTSE4Good Index Series, and is the only healthcare-sector company among the top 10 constituents in the emerging market category. Created by the global index and data provider FTSE Russell, which is wholly owned by the London Stock Exchange Group, the FTSE4Good Index Series is designed to measure the performance of companies demonstrating strong Environmental, Social, and Governance (ESG) practices.

WuXi Biologics Again Selected as Constituent of FTSE4Good Index Series

This investment will establish a cutting-edge, fully integrated CRDMO center in Singapore, including a research and development service center and large-scale drug substance and drug product manufacturing facilities for biologics The investment strengthens WuXi Biologics' global research, development and manufacturing network with more robust nodes to meet the growing demand from clients worldwide for end-to-end services, and continues to enable its Global Dual Sourcing strategy SINGAPORE , July 19, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), today announced a 10-year USD$1.4 billion (S$2 billion) investment plan to expand the company's research, development, and large-scale drug substance and drug product (DS/DP) manufacturing capacity and capabilities in Singapore. This new site will add 120,000L biomanufacturing capacity to WuXi Biologics' global network by 2026 and is anticipated to employ 1,500 research, development and manufacturing staff when complete.

WuXi Biologics Plans to Build a Comprehensive CRDMO Center in Singapore

WuXi Biologics expands its extensive integrated CRDMO services by offering development and cGMP manufacturing for microbial-derived products. HANGZHOU, China , July 4, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG14 facility in Hangzhou has been released for manufacturing microbial-derived products.

WuXi Biologics Extends Capabilities to Include Development and cGMP Manufacturing for Microbial-Derived Products

WuXi Biologics offers global partners high-efficiency and high-quality manufacturing services for clinical trial and commercial supply by increasing pre-filled syringes (PFS) capacity to 17 million units per year. WuXi Biologics has established a global manufacturing network with 9 drug product facilities for vial and PFS in China and Germany, and is now one of the global leaders in drug product CDMO services.

WuXi Biologics Launches First Commercial Drug Product Facility for Pre-Filled Syringes

-   WuXi Biologics has aligned its ESG strategy with the United Nations Sustainable Development Goals (SDGs), as well as with its stakeholders' interests in sustainable business performance. -   One example of WuXi Biologics' contribution to society is its rapid, robust pandemic response -- enabling nearly 30 Investigational New Drug Applications (INDs) for COVID-19 projects, manufacturing more than 1500kg of COVID-19 neutralizing antibody, and delivering hundreds of millions COVID-19 vaccine doses.

WuXi Biologics' 2021 ESG Report Reveals Company's Strong Commitment to Overall Sustainability

SINGAPORE , April 14, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global Contract Research, Development and Manufacturing Organization (CRDMO) service company, today announced that the company received the award for Bioprocessing Excellence in Viral Clearance and Safety at the Asia-Pacific Bioprocessing Excellence Awards (ABEA) 2022 event. This marks the second consecutive year that WuXi Bio has received this award from IMAPAC, a leading consulting firm in biopharmaceutical industry.

WuXi Biologics Receives Bioprocessing Excellence Award from IMAPAC

Banner Year for Commercial Manufacturing Revenue Increased by 83.3% Y-o-Y to RMB10,290.1 Million Gross Profit Increased by 90.6% Y-o-Y to RMB4,828.9 Million Net Profit Grew by 107.3% Y-o-Y to RMB3,508.6 Million Adjusted Net Profit Rose by 100.3% to RMB3,435.9 Million Total Backlog Grew 20.1% to US$13,597 Million * * * CRDMO Business Model Created Sustainable Long-term Growth Execution of Our Strategies Drove Significant Revenue Increases 156 Integrated Projects Added - Total Number of Projects Reached 480 Commercial Manufacturing (CMO) Projects Increased from 2 to 9 32 Projects in Phase III Including 15 Transferred from External Late-phase & Commercial Manufacturing Revenue Increased to RMB4,930.5 Million Accounting for 47.9% of Total Revenue Non-COVID-19 Business Accelerated with Much Potential for the Future Premier Quality System Re-verified, Completed 22 Global Regulatory Inspections Optimized Supply Chain to Safeguard Project Execution and Timelines Expanded Capacity to 150 INDs and 12 BLAs per Year with Capacity of Starting Any Project within 4 Weeks Increased Global Presence and Grew Talent Pool to Nearly 10,000 with 93.7% of Key Talent Retention Rate HONG KONG, March 22, 2022 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group," stock code: 2269.HK), a global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, announced its audited annual results for the year ended December 31, 2021. 2021 Financial Highlights Revenue : The Group's revenue increased to RMB10,290.1 million with an increase of 83.3% y-o-y.

WuXi Biologics Achieved Record Growth and Profitability in 2021

SHANGHAI, March 14, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global CRDMO service company, has been recognized as the Industry Top-Rated Company in 2022 by Sustainalytics, a global provider of Environmental, Social and Governance (ESG) related research, ratings and data. This is the second year in a row that WuXi Biologics has received this recognition.

WuXi Biologics Recognized as 2022 Top-Rated ESG Company by Sustainalytics

SHANGHAI, March 1, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global CRDMO service company, today announced that the company has won the 2022 CMO Leadership Awards in all six core categories (i.e., capabilities, compatibility, expertise, reliability, quality and service).

WuXi Biologics Wins CMO Leadership Awards in All Six Core Categories for Fifth Consecutive Year

SHANGHAI, Feb. 7, 2022 /PRNewswire/ -- We have been made aware of a recent U.S. Commerce Department announcement that two WuXi Biologics (Cayman) subsidiaries in Shanghai and Wuxi will be added to the department's "Unverified List" (UVL) on February 8, 2022. We understand that the reason for this action is because U.S. government agencies have not been able to undertake required end-use verifications in order for certain equipment to be exported from U.S. suppliers.

WuXi Biologics Statement

WuXi Biologics said in a statement on Tuesday on WeChat that two of its subsidiaries being put on the U.S. Commerce Department's "unverified list" will have no impact on its business or services to partners.

WuXi Biologics sees no impact from addition to unverified list for U.S. exports

WuXi Biologics completes the first GMP inspection in 2022, demonstrating the company's premier quality system is in full compliance with global regulatory requirements. WUXI, China, Jan. 17, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by South Korea's Ministry of Food and Drug Safety for its drug substance facility (MFG2) in Wuxi city.

WuXi Biologics Completes GMP Inspection by South Korea's Ministry of Food and Drug Safety for Drug Substance Facility

SHANGHAI and SEOUL, South Korea, Dec. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, and ImmuneOncia Therapeutics, Inc., a clinical-stage, immuno-oncology company in South Korea, today announced that a Memorandum of Understanding (MOU) was signed to form a strategic partnership in the development and manufacturing of IOH-001, ImmuneOncia's therapeutic bispecific antibody targeting PD-L1 and CD47. Within the partnership, ImmuneOncia will have access to WuXi Biologics' integrated services in cell line development, cell culture development, biologics manufacturing and bioassay development.

WuXi Biologics and ImmuneOncia Sign MOU for Development and Manufacturing of Anti-PD-L1/CD47 Bispecific Antibody

BeiGene

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WUXI, China, Nov. 22, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has successfully completed the first GMP production at the new 24,000L line of its drug substance facility MFG5. This follows the initial GMP operations of the 36,000L biomanufacturing line of MFG5 this February.

First GMP Production at 24,000L Line of MFG5 Facility Successfully Completed at WuXi Biologics

Enhances drug product services for projects at various stages, with an emphasis on late and commercial stage production Increases up to 60 million vials for commercial drug production per year Consolidates WuXi Biologics' pioneering the application of innovative technologies such as single-use and automation WUXI, China, Oct. 31, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics. The 12,000m² drug product facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of wide size range – from 2R to 50R of liquid and 20m 2/40m 2 of lyophilization.

WuXi Biologics Launches a New GMP Commercial Drug Product Facility

- Successfully completed nearly 20 regulatory inspections in total, including 13 regulatory inspections since the start of 2021 WUXI, China, Oct. 27, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by Health Canada for its drug substance facility (MFG2) in Wuxi city. There were no observations during the inspection, demonstrating that the company's premier quality system is in full compliance with global regulatory requirements.

WuXi Biologics Completes GMP Inspection by Health Canada for Drug Substance Facility

Successfully completed 12 regulatory inspections so far this year WUXI, China, Sept. 1, 2021 /PRNewswire/ -- WuXi Biologics (WuXi Bio) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has received the Manufacturing License from Japan's Minister of Health, Labor and Welfare (MHLW) for its drug substance facility (MFG2) at Wuxi city, China after a 2-day remote GMP inspection.

WuXi Biologics Received First Manufacturing License from Japan and Completed 12 Global Regulatory Inspections in 2021 Year to Date

Revenue Increases by 126.7% Y-o-Y to RMB4,406.8 Million Gross Profit Grows by 191.7% Y-o-Y to RMB2,296.8 Million Adjusted Net Profit Attributable to Owners of the Company Increases by 163.0% Y-o-Y to RMB1,768.7 Million Gross and Net Profit Margins Reach 52.1% and 42.7%, Respectively Diluted EPS Reaches RMB0.42 with 133.3% Growth Y-o-Y "Follow & Win the Molecule" Strategies Expand Global Market Share to 408 Total Integrated Projects Including 79 New Additions   A Banner Year of Commercial Manufacturing: Four Commercial Manufacturing Projects and 32 Phase-III Projects Commercial Manufacturing Revenue Reaches RMB888.9 Million Late Phase and Commercial Manufacturing Revenue Grows 366% Y-o-Y Backlog within Three Years Increases by 143% Y-o-Y to US$2,249 Million Three Acquisitions Successfully Integrated and Generate Revenue Nine Regulatory Inspections Passed, Demonstrating Global Premier Quality WuXi Vaccines Progresses Rapidly with Nine Contracts Signed Including Three COVID-19 Vaccines Projects WuXi XDC Established as Few Global CDMOs Dedicated to Enable Discovery, Development and Manufacturing of Bioconjugates Expanded Development Capacity to 120 Integrated Projects per Year to Enable Growing Global Partners Global Manufacturing Capacity Expansion on Schedule to Support Sustainable High Growth HONG KONG, Aug. 23, 2021 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Company", together with its subsidiaries "the Group", stock code: 2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, is pleased to announce its unaudited interim results for the six months, ending on June 30, 2021. 2021 Interim Financial Highlights Revenue: The Group's revenue grew rapidly to RMB4,406.8 million with an increase of 126.7% Y-o-Y.

WuXi Biologics Reports Strong 2021 Interim Results

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Harnessing Growth: Navigating China's Regulatory Puzzle

SUZHOU, China, Aug. 2, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, it has once again received a European Medicines Agency (EMA) GMP certificate for the Biosafety Testing facility in Suzhou. This certificate demonstrates WuXi Biologics' compliance to global cGMP biosafety testing standards and regulatory guidelines.

WuXi Biologics Biosafety Testing Facility Received Second EMA GMP Certificate

First GMP manufacturing authorization outside of China, validating WuXi Biologics' world-class quality system Only 12 months from facility qualification to licensure demonstrating global adoption of "WuXi Biologics Speed" LEVERKUSEN, Germany, July 26, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that Premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries.

WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility

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