药明生物连续第九年斩获“CDMO领军企业奖”

截至2025年，药明生物平台综合项目达945个，拥有全球规模最大的复杂生物药管线之一，其中超过50%为复杂生物药分子，如双特异性/多特异性抗体与抗体药物偶联物（ADC）。依托创新性的技术平台、在分子与工艺开发方面长期积累的深厚经验，以及一流的全球质量体系，药明生物已将DNA到新药临床实验申请（IND）、IND到生物制品上市申请（BLA）的周期分别缩短至6个月和15个月，大幅缩短行业平均10–12个月和24–36个月周期。公司从技术转移到工艺性能确认（PPQ）标准交付周期为6个月，加急交付周期为3.5个月，而行业通常需要12个月以上。

药明生物通过制定并实施系统化的生产战略，构建了规模化、灵活高效的生产解决方案，帮助全球客户应对不断变化的市场需求。该战略包括：应用从2000升、4000升到5000升的更大体积的一次性生物反应器（SUB）；组合多台一次性生物反应器实现大规模生产，单批规模最高达16000升；应用创新强化生物工艺平台提高产量，如WuXiUP™（超高效连续生物工艺平台）和WuXiUI™（超强化分批补料生物工艺平台）；以及应用新一代定点整合CHO细胞株开发平台WuXia™ TrueSite。WuXia™ TrueSite在传60代次后仍保持稳定的蛋白表达，可实现单克隆抗体平均表达量超8.0克/升。

依托创新技术平台，药明生物持续树立生物工艺与生产制造标杆。公司PPQ项目成功率达100%。2017 年至今，公司已为全球合作伙伴交付逾350 批大规模生产项目（单批6000–16000升）。优异的生产成绩，得益于药明生物严格的全球质量管理体系。截至2025年，公司已成功通过46次全球监管机构检查，包括22次FDA和EMA检查，并且在FDA的药品上市批准前检查（PLI）中保持100%通过率。目前，药明生物在全球拥有15个GMP认证的生物药原液及制剂生产厂，厂房许可批准达136次，其国际一流的质量体系与合规能力是赢得全球客户信任的基石。

药明生物同时引领数字化创新，赋能生物药研发与生产变革，将数字技术深度融入研发、生产、运营及客户合作全流程，全面提速项目进展、提升产品质量，并强化与合作伙伴的透明协同。例如，通过电子批记录（EBR）等数字化生产解决方案，公司不仅提升了约40%的生产力，更确保了数据完整性和产品质量。通过使用高效资源计划系统则实现了约20%的效率提升。近期，药明生物还推出行业领先的数字孪生平台 PatroLab™，优化工艺性能、降低工艺风险、缩短开发周期，确保稳定、高质量的生物药生产。

“CDMO领军企业奖”及其颁奖典礼由Life Science Connect策划，并由Outsourced Pharma 主办。2026年奖项评选与塔夫茨大学药物开发研究中心（Tufts CSDD）合作，由其独立负责相关项目的设计、实施及分析。

As of the end of 2025, WuXi Biologics has 945 integrated projects on its platform, making it one of the world's largest portfolios of complex biologics. Among them, more than 50% are complex modalities, such as bi-/multi-specific antibodies and ADCs. Supported by innovative technology platforms, deep accumulated know‑how in molecule and process development, and a leading global quality system, WuXi Biologics' timelines from DNA to IND and from IND to BLA have been shortened to 6 months and 15 months, respectively, compared with industry averages of 10–12 months and 24–36 months. From technology transfer to PPQ, the standard timeline is 6 months, with an accelerated timeline of 3.5 months —compared with industry timelines of over 12 months.

WuXi Biologics has developed a holistic strategy to deliver scalable and agile manufacturing solutions that help global clients address evolving market demand. These include the application of large‑volume single‑use bioreactors (SUBs) ranging from 2,000 L and 4,000 L to 5,000 L; the combination of multiple SUBs to enable large‑scale manufacturing of up to 16,000 L; the implementation of innovative intensified bioprocessing such as WuXiUP™ (continuous bioprocessing platform) and WuXiUI™ (ultra-intensified fed-batch bioprocessing platform) to significantly enhance productivity; and the application of WuXia™ TrueSite, a next‑generation targeted integration (TI)-based CHO cell line platform. WuXia™ TrueSite achieves average mAb titers exceeding 8.0 g/L with outstanding expression stability across 60 generations.

Building on its innovative technology platforms, WuXi Biologics consistently leads the industry in manufacturing and bioprocessing excellence. The company has achieved a 100% success rate in PPQ campaigns. It has delivered more than 350 large‑scale batches (6,000 L – 16,000 L per batch) for global partners since 2017. The strong manufacturing track record is underpinned by WuXi Biologics' rigorous, global quality system. As of the end of 2025, the company had successfully passed 46 regulatory inspections, including 22 inspections conducted by the FDA and EMA. The company also holds an industry-leading record with a 100% pass rate for FDA Pre-License Inspection (PLI). Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network, with 136 facility license approvals and a 100% success in GMP inspections. Its world-class quality and compliance capabilities remain the cornerstone of global clients' trust.

WuXi Biologics is also pioneering digital innovation to transform biologics research, development and manufacturing. It has integrated digital innovation across end-to-end R&D, manufacturing, operations, and customer engagement, driving faster timelines, superior quality, and full partnership transparency. By leveraging digital manufacturing solutions, such as Electronic Batch Record (EBR), the company has driven an approximately 40% productivity gain, consistent data integrity and high product quality, while its advanced planning systems have delivered about a 20% improvement in efficiency. Recently, WuXi Biologics launched the industry-leading digital twin platform PatroLab™ to enhance process performance, minimize process risks, shorten development timelines, and ensure consistent, high-quality biologics manufacturing.

The CDMO Leadership Awards and ceremony are produced by Life Science Connect and hosted by Outsourced Pharma. The awards have partnered with the Tufts Center for the Study of Drug Development (Tufts CSDD) to independently design, field, and analyze the research underlying the 2026 awards program.