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WuXi Biologics Achieves "CDMO of the Year" Among Three Prestigious IMAPAC Awards
Prnewswire· 2025-09-12 01:30
Core Insights - WuXi Biologics has been awarded "CDMO of the Year – Asia Pacific", "Best Biologics CDMO Award: Bioprocessing", and "Best Biologics CDMO in Greater China Region" at the APBCEA 2025 [1][2] - The company has received multiple awards since 2017, highlighting its consistent excellence in the biomanufacturing sector [1][2] Company Achievements - WuXi Biologics has a portfolio of 864 integrated projects, including 168 bispecific and multispecific antibodies and 225 antibody-drug conjugates (ADCs) [3] - The development cycle for monoclonal antibody projects has been reduced to 6 months from DNA to Investigational New Drug (IND) application [3] - The company has achieved a 100% success rate in Pre-License Inspections (PLI) and has passed 44 inspections by global regulatory authorities, including 22 by the FDA and EMA [3] Leadership and Vision - Dr. Chris Chen, CEO of WuXi Biologics, emphasized the recognition received from clients and the industry, attributing it to the company's commitment to excellence and world-class quality standards [4] - The company aims to empower partners to accelerate the delivery of groundbreaking therapies to patients globally [4] Workforce and Global Presence - WuXi Biologics employs over 12,000 skilled professionals across China, the United States, Ireland, Germany, and Singapore [6] - The company supports 864 integrated client projects, with 24 currently in commercial manufacturing as of June 30, 2025 [6] Sustainability Commitment - WuXi Biologics prioritizes sustainability as a cornerstone for long-term growth, focusing on green technology innovations and responsible practices [7] - The company collaborates with stakeholders to create positive social and environmental impacts while promoting excellence in Environment, Social, and Governance (ESG) [7]
WuXi Biologics' WuXiUP™ Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale
Prnewswire· 2025-08-12 09:00
Core Insights - WuXi Biologics has achieved fully automated continuous drug substance production at pilot scale using its WuXiUP™ platform, enhancing efficiency and flexibility for clients [1][4][6] Production Efficiency - The WuXiUP™ platform allows for non-stop 24/7 operation, minimizing manual intervention and reducing quality risks, leading to enhanced manufacturing efficiency [2] - In upstream processes, WuXiUP™ has demonstrated a total output exceeding 110 g/L over 24 days of continuous cell culture, with a peak daily yield of 7.6 g/L [2] - The downstream purification process utilizes a two-step, high-efficiency membrane chromatography system, resulting in a 5- to 10-fold increase in productivity compared to traditional methods [2][6] Quality Control - WuXiUP™ employs advanced Process Analytical Technology (PAT) for real-time monitoring of critical parameters, significantly improving manufacturing procedure control [3] - The integration of automated closed-loop control systems with PAT allows for intelligent diversion of out-of-spec samples, enhancing overall quality control [3] Technological Advancements - The platform is designed to manufacture a variety of pharmaceutical proteins, achieving 5–20 times higher productivity compared to traditional processes [5] - Notably, when scaling to 1,000–2,000 L using single-use bioreactors, WuXiUP™ achieves productivity levels comparable to traditional 10,000–20,000 L stainless steel bioreactors [6] Regulatory Success - The WuXiUP™ platform has facilitated one molecule to receive Biologics License Application (BLA) approval and 11 others to receive Investigational New Drug (IND) approvals [6]
WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293 Stable for Development and Manufacturing of Difficult-to-Express Molecules
Prnewswire· 2025-08-11 08:30
Core Viewpoint - WuXi Biologics has launched the WuXia293Stable platform, enhancing the development and manufacturing of complex biologics with high titers, stability, and quality [1][6]. Group 1: Platform Features - WuXia293Stable is designed for innovative, difficult-to-express molecules, demonstrating high titers of up to 5.0 g/L for monoclonal antibodies while improving purity [4][10]. - The platform maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L for fed-batch and 1000L for perfusion [4][10]. - It offers a comprehensive suite of services, including cell bank testing and viral clearance validation, as part of its one-stop CMC solution [4]. Group 2: Comparison with CHO Cells - Traditionally, CHO cells have been used for recombinant protein expression but may face challenges with complex modalities, leading to low titer levels and truncation issues [2]. - HEK293 cells, utilized in WuXia293Stable, can alleviate truncation issues while maintaining high titer levels, making them more suitable for complex molecules [2]. Group 3: Company Commitment and Vision - The launch of WuXia293Stable reinforces WuXi Biologics' commitment to technological innovation and the vision that every biologic can be made [6]. - The WuXia™ platform family, which includes WuXia293Stable, has generated over 1000 cell lines for various therapeutic applications, showcasing its proven track record [7][8].
Sai Life Sciences Limited Reports Revenue growth of 77% YoY
Globenewswire· 2025-08-08 06:50
Core Insights - Sai Life Sciences Limited reported strong financial performance for Q1FY26, with revenue reaching ₹496 crore, a 77% increase year-over-year, driven by growth in the CDMO segment [1][2][8] - The company achieved an EBITDA of ₹125 crore, reflecting a 305% increase compared to the same quarter last year, with an EBITDA margin of 25% [2][6][8] - Net profit for the quarter was ₹60 crore, a significant turnaround from a loss of ₹13 crore in Q1FY25, resulting in a PAT margin of 12% [2][6][8] Financial Performance - Revenue from Operations: ₹496 crore in Q1FY26 compared to ₹280 crore in Q1FY25, a 77% increase [2][6] - EBITDA: ₹125 crore in Q1FY26, up from ₹31 crore in Q1FY25, a 303% increase [2][6] - EBITDA Margin: Expanded to 25% in Q1FY26 from 11% in Q1FY25 [2][6] - Profit Before Tax (PBT): ₹81 crore in Q1FY26, compared to a loss of ₹18 crore in Q1FY25 [2][6] - Profit After Tax (PAT): ₹60 crore in Q1FY26, compared to a loss of ₹13 crore in Q1FY25 [2][6] Business Highlights - The company inaugurated new Biology Labs and a Peptide Research Center, enhancing its Integrated Discovery platform [6][9] - Commenced commercial operations at Bidar Unit IV, increasing total manufacturing capacity to approximately 700 KL [6][9] - Invested ₹134 crore in capital expenditure during Q1FY26, focusing on R&D infrastructure and process development capabilities [6][9] - Onboarded 253 scientists and technical staff to support scaling operations [6][9] Strategic Focus - The company is committed to advancing innovation in complex science and enhancing client partnerships [5][7] - Plans to build additional production capacity at Unit IV, Bidar, expected to be ready by Q3FY27 [6][9] - Ongoing construction of a new Medicinal Chemistry block to support early-phase peptide development and clinical formulations [6][9]
Unaudited Interim Results
Globenewswire· 2025-06-19 06:00
Core Viewpoint - The Company reported a decline in net asset value (NAV) and total return for the six months ending March 31, 2025, reflecting challenging market conditions and investment performance [3][4][13]. Financial Highlights - NAV per share decreased from 40.55p to 34.48p, representing a total return of -8.19% [4][13]. - Market capitalization fell from £150.60 million to £124.25 million [4]. - Share price also declined from 42.20p to 33.80p, with a share price discount to NAV per share of 1.97% [4]. - Dividends paid per share increased from 1.50p to 2.75p during the period [4][6]. Investment Activity - The Company invested £3.6 million in qualifying companies during the period, maintaining 92.29% of its portfolio in qualifying investments [6][30]. - An offer for subscription launched on October 9, 2024, aimed to raise up to £20 million, with £5.4 million raised by issuing 14 million shares [6][31]. Performance of Qualifying Investments - Positive contributors included Aquis Exchange (+95.8%, +£1.71 million) and Cohort (+26.1%, +£1.12 million) due to increased defense spending [15][16]. - Negative contributors included Kidly (-100.00%, -£1.26 million) which went into administration, and Zoo Digital (-74.3%, -£1.14 million) which issued a disappointing trading update [20][21]. Non-Qualifying Investments - The non-qualifying portfolio saw a decline of £1.27 million, with notable losses in WH Smith and Hollywood Bowl due to a weaker economic outlook [27][28]. - The fixed income portfolio returned +£0.35 million, offsetting some losses from direct equities [29]. Market Outlook - The UK economy is expected to see a modest GDP growth of +1.0% in 2025, supported by increased public spending despite inflation concerns [10][39]. - The AIM index has shown resilience post 'Liberation Day', indicating potential growth opportunities despite ongoing market volatility [12][40]. Portfolio Structure - The Company maintained a strong liquidity position with net cash of £11.7 million and a focus on recurring revenue, which represented 82% of total revenue [26][29]. - The portfolio's weighting to qualifying investments increased to 58.4%, while cash weighting decreased to 7.6% [36].