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TrueSite TI™是第四代WuXia™细胞株平台, 凭借定点整合技术，大幅简化细胞克隆筛选流程，同时确保表达的高稳定性
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该平台可实现单克隆抗体平均表达量超8.0克/升，超99%的克隆细胞在传60代次后仍保持稳定的蛋白表达，可有效降低超20000升规模放大生产中的表达量下降风险
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平台支持6个月内完成新药临床试验申请（IND）准备，加速创新疗法研发与商业化进程
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TrueSite TI™不仅是单克隆抗体开发的理想选择，更在双特异性抗体、Fc融合蛋白、Fab片段等复杂生物药开发中展现出优异的适用性
上海，
2025年9月25日
全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）今日宣布推出行业领先的定点整合CHO细胞株开发平台TrueSite TI™。平台凭借对抗体及复杂药物分子细胞株质量的显著优化、工艺放大的卓越稳定性，以及研发周期的大幅缩短，为创新生物药研发提供更具竞争优势的全新解决方案。
定点整合是一种以精准化为核心的细胞工程技术，能够将目的蛋白导入宿主细胞中预先确定且经过严格验证的位点。与传统的随机整合或转座酶介导整合技术不同，该技术大幅简化了开发流程，仅需筛选数十个细胞克隆即可锁定高性能候选细胞株，不仅确保了目的蛋白长期表达的稳定性，更能显著缩短新药临床试验申请（IND）的准备周期。
TrueSite TI™是药明生物WuXia™第四代细胞株开发平台。过去十年间，WuXia™平台不断升级迭代，已在超1000个分子中得到验证，能稳定构建高表达、高稳定性的细胞株。TrueSite TI™通过技术创新进一步大幅提升开发效率和质量，可实现单克隆抗体平均表达量超8.0克/升，为商业化生产的高产量需求提供支撑。与此同时，TrueSite TI™能显著提升细胞池与细胞克隆质量的一致性，并且超99%的克隆细胞在传60代次后仍保持稳定的蛋白表达，可降低20000升以上规模放大生产中表达量下降的风险。
TrueSite TI™不仅是单克隆抗体开发的理想选择，更在双特异性抗体、Fc融合蛋白、Fab片段等复杂生物药开发中展现出优异的适用性。该平台所构建的细胞株兼具卓越稳定性、一致且可预测的生长特性，以及细胞池与克隆间高度匹配的质量表现。通过优化工艺开发流程，TrueSite TI™能赋能客户实现6个月IND准备周期，为极具创新的治疗药物开辟驶入临床研发的快车道。
陈智胜
博士
药明生物首席执行官
当前，全球生物制药企业都在全力推动让高品质创新疗法更快惠及患者，而细胞株开发正是实现这场使命的关键起点。药明生物持续迭代WuXia™细胞株平台，不断突破细胞株开发的创新边界。作为WuXia™4.0平台，TrueSite TI™实现细胞株‘质量’与‘效率’的双重突破，赋能客户领跑创新研发前沿。作为专业的CRDMO合作伙伴，我们不仅具备全链条的产业服务实力，更拥有对前沿技术的持续创新能力，助力客户在飞速发展的生物药时代取得成功，最终造福广大患者。
关于WuXia™细胞株构建系列平台
WuXia™是药明生物开发的高产哺乳动物细胞株构建系列平台，产量最高可达11克/升。该系列平台已获得全球药品监管机构的认可，截至2024年已开发超过1000个表达单克隆抗体、双特异性抗体、融合蛋白、酶和其他重组蛋白的细胞株，用于临床和商业化生产。WuXia™平台历经技术迭代，TrueSite TI™是最新推出的WuXia™4.0平台，通过行业领先的定点整合技术，显著增强细胞株表达量和稳定性，大幅提升细胞株开发效率。
WuXia™系列平台目前还包括：WuXiaADCCPlus™，用于开发和生产无岩藻糖基化抗体，以增强抗体依赖性细胞介导的细胞毒性（ADCC）效应；WuXia RidGS™，用于非抗生素筛选的细胞株开发；WuXia293Stable ™，基于HEK293细胞系，赋能复杂药物分子研发与生产。WuXia™系列平台持续拓展，以满足全球客户的多元化需求。
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关于药明生物
药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。
药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2025年6月底，药明生物帮助客户研发和生产的综合项目高达864个，其中包括24个商业化生产项目。
药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。更多信息，请访问：www.wuxibiologics.com
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WuXi Biologics Launches WuXia™4.0, Targeted Integration Cell Line Platform TrueSite TI™，to Accelerate Biologics Development with High Titer and Superior Stability
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TrueSite TI™, the fourth generation of WuXia™ cell line platform, leverages targeted integration technique to streamline clone screening and guarantees expression stability
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The platform has achieved an average mAb titer exceeding 8.0 g/L with over 99% of clonal cell lines maintaining stable protein expression after passaging for 60 generations, which effectively mitigates the risk of titer drop during scale-up manufacturing to over 20,000 L
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It enables a 6-month IND timeline, accelerating development of innovative therapies and their path to commercial launch
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TrueSite TI™ has proved to be ideal for mAb development and demonstrated strong applicability to complex biologics, including bispecific antibodies (BsAb), Fc-fusion proteins, and Fab fragments
Shanghai,
September 25, 2025
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of TrueSite TI™, an industry-leading targeted integration (TI)-based CHO cell line platform designed to reshape biologics development by accelerating timelines, enhancing product quality, and ensuring consistent scalability for antibody and complex protein therapies.
Targeted integration is a precision-driven cellular engineering technique that enables the delivery of target expression units to predefined and rigorously validated locations in the host cells. Unlike conventional random integration or transposase methods, it streamlines development by limiting clone screening to just dozens of candidates, ensuring long-term expression stability, and significantly shortening IND timelines.
TrueSite TI™ is the fourth generation of WuXi Biologics' proprietary WuXia™ cell line platform, an established system for generating high-titer, stable cell lines that has been technologically evolved and validated in over 1000 molecules over the past decade. TrueSite TI™ drives greater efficiency and quality with cutting-edge innovations. It has achieved an average monoclonal antibody (mAb) titer exceeding 8.0 g/L, supporting high-yield commercial manufacturing. It also significantly improves pool and clone quality consistency. Over 99% of the platform's clonal cell lines have maintained stable protein stability after passaging for 60 generations, mitigating the risk of titer drop during scale-up manufacturing to over 20,000 L.
While TrueSite TI™ has proved to be ideal for mAb development, it has also demonstrated strong applicability to complex biologics, including bispecific antibodies (BsAb), Fc-fusion proteins, and Fab fragments, delivering outstanding cell line stability, a reliable and predictable growth profile, and seamlessly consistent pool-to-clone quality. By streamlining process development workflows, TrueSite TI™ provides clients with an industry-leading 6-month IND timeline, enabling fast clinical trials for breakthrough therapeutics.
Dr. Chris Chen
Chief Executive Officer
WuXi Biologics
With biopharmaceutical companies striving to bring high-quality, life-saving therapies to patients faster, cell line development stands as the critical point in achieving this mission. WuXi Biologics continues to advance its WuXia™ platform, pushing the boundaries of cell line development. As the fourth generation of the platform, TrueSite TI™ has achieved dual breakthroughs in both 'quality' and 'efficiency' of cell lines, enabling our clients to lead the forefront of innovative therapeutics R&D. As a CRDMO partner, we are fully equipped with both cutting-edge technologies and a comprehensive suite of services to address the diverse needs of our clients, enabling them to succeed in the rapidly evolving era of biologics and ultimately to benefit patients worldwide.
About the WuXia™ Cell Line Development Platform Family
WuXia™ is a proven, high-yield (up to about 11 g/L) mammalian cell line platform family developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform family have generated over 1,000 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing as of 2024. The WuXia™ platform has seen continuous technical advancements, and TrueSite TI™ is its fourth-generation version. It leverages industry-leading targeted integration technology to significantly enhance cell line titer and stability, greatly boost cell line development efficiency, and ultimately enable faster biologics development.
The WuXia™ platform family also include WuXiaADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, WuXia293Stable ™ for expressing difficult-to-express molecules built on HEK293 cell lines. The WuXia™ cell line development platform family continue to expand to cater to the diverse needs of global customers.
About
WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2025, WuXi Biologics is supporting 864 integrated client projects, including 24 in commercial manufacturing.
WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
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