药明生物发布H1 2026增长新闻稿但当前正文未提供完整财务预期差

We offer customized antibody discovery platforms for monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), multispecific antibodies (msAbs), immunocytokines, and other therapeutic modalities, to accelerate biology-driven lead identification.
At WuXi Biologics, we specialize in the production and engineering of monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and novel biologics. With industry-leading expertise, state-of-the-art facilities and proprietary technologies, we offer our customers high-quality protein engineering and production services for research use.
At WuXi Biologics, we provide comprehensive protein characterization testing to help you triage and optimize your lead candidates. Our integrated protein characterization and analytics platform includes purity/impurity testing, structure characterization assessment, including MS-based protein ID and post-translational modification analysis, and function testing (e.g., SPR/ELISA/cell-based activity assays).
Leveraging advanced in vitro assay technologies such as cellular, biochemical, molecular, immune, and Fc effector function assays, we deliver reproducible, high-quality results with data interpretation to support biologics discovery and development.
Our multi-species in vivo pharmacology services provide science-driven solutions for preclinical studies, including pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, efficacy models, toxicology studies, and immunohistology.
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Process characterization supports drug substance production within a data-driven framework that streamlines PPQ and meets global compliance requirements.
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
Bispecific and Multispecific Antibodies - WuXiBody™
The WuXiBody platform for the generation of bispecific and multispecific antibodies speeds up drug development by 6‒18 months and cuts production costs. Assembly of mAb sequence pairs into various formats with different valency optimizes flexibility.
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
We offer customized antibody discovery platforms for monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), multispecific antibodies (msAbs), immunocytokines, and other therapeutic modalities, to accelerate biology-driven lead identification.
At WuXi Biologics, we specialize in the production and engineering of monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and novel biologics. With industry-leading expertise, state-of-the-art facilities and proprietary technologies, we offer our customers high-quality protein engineering and production services for research use.
At WuXi Biologics, we provide comprehensive protein characterization testing to help you triage and optimize your lead candidates. Our integrated protein characterization and analytics platform includes purity/impurity testing, structure characterization assessment, including MS-based protein ID and post-translational modification analysis, and function testing (e.g., SPR/ELISA/cell-based activity assays).
Leveraging advanced in vitro assay technologies such as cellular, biochemical, molecular, immune, and Fc effector function assays, we deliver reproducible, high-quality results with data interpretation to support biologics discovery and development.
Our multi-species in vivo pharmacology services provide science-driven solutions for preclinical studies, including pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, efficacy models, toxicology studies, and immunohistology.
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Process characterization supports drug substance production within a data-driven framework that streamlines PPQ and meets global compliance requirements.
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
Bispecific and Multispecific Antibodies - WuXiBody™
The WuXiBody platform for the generation of bispecific and multispecific antibodies speeds up drug development by 6‒18 months and cuts production costs. Assembly of mAb sequence pairs into various formats with different valency optimizes flexibility.
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.