编者按:为满足全球客户日益增长的需求,药明康德正积极加速全球产能布局与能力建设。未来两年,公司计划在美国、欧洲和亚洲持续扩建其一体化CRDMO平台的原料药及制剂产能。
其中,位于美国特拉华州的米德尔顿基地将于2026年底前投入运营,届时将成为药明康德在美国最大的运营基地。该基地预计于2026年第四季度启动口服固体制剂生产,并于2027年第四季度开始无菌注射剂生产。
在欧洲,药明康德正持续扩建瑞士库威基地的制剂生产及包装产能,以满足不断增长的商业化需求。该基地新增的PSD-4喷雾干燥车间预计于2026年第四季度投入运营。
位于亚洲的生产基地也在持续扩展布局。在中国泰兴基地,两个全新的小分子原料药生产车间预计将在今年投入运营,而用于寡核苷酸、多肽和PMO生产的两个新车间预计在2027年投产。此外,公司还计划提前启动常州新原料药生产基地的建设。
新加坡基地也在加速建设中,同样预计在2027年投入运营,进一步提升原料药全球供应的灵活性,更好地支持小分子,以及寡核苷酸、多肽药物及相关化学偶联物(TIDES药物)商业化生产需求。目前,泰兴基地和新加坡基地仍有三个全新的TIDES车间建设正在推进中。
为支持上述扩产计划,药明康德预计今年的资本开支将达到65亿元至75亿元。通过持续优化全球运营网络和一体化平台能力建设,药明康德始终致力于更好地满足客户需求,加速赋能全球医药创新,助力更多创新疗法更快惠及患者。
日前,行业媒体Pharma Manufacturing的主编Greg Slabodkin采访了公司联席首席执行官陈民章博士,围绕全球产能建设、新分子能力布局及未来发展战略等话题展开深入交流。
以下为专访内容精编,点击“阅读原文/Read More”即可访问原文页面。
Greg Slabodkin:全球宏观政策等外部不确定因素,是否会影响药明康德扩建全球产能的决策?
陈民章博士:我们全球产能扩张的核心驱动力始终只有一个:客户需求。客户需要更多产能,而我们正在全力建设以满足这些需求。当前,尤其是在多肽及前沿小分子领域,客户对我们服务的需求显著增长,扩大产能规模是客户与我们共同的期望。这才是驱动我们投资决策的根本原因。
当然,我们也密切关注全球宏观政策的变化,但这并不是驱动公司增长战略的核心因素。客户选择药明康德,源于我们一体化CRDMO模式在质量、速度和效率方面的综合优势。我们持续扩大全球布局,是为了能够更好地赋能客户:无论客户在哪里推进项目,我们都能满足他们的需求。
Greg Slabodkin:药明康德正在美国、欧洲和亚洲同步扩建产能,公司多地扩产战略的目标是什么?
陈民章博士:我们的目标,是在符合全球标准的统一质量体系下,为客户提供更多灵活选择,助力构建更加安全、稳健的药品供应链。客户对我们在欧洲和美国的平台能力在广度与深度上都提出了更高要求,因此我们持续在这些地区加大投资。
例如,我们位于美国特拉华州米德尔顿的新基地,将首次在美国大规模开展制剂生产业务。同时,我们也正在持续扩建瑞士库威基地能力,计划于2026年新增喷雾干燥能力,后续还将增加无菌注射剂等相关能力。在亚洲,新加坡基地也将新增小分子、寡核苷酸、多肽及复杂偶联物的原料药生产能力,其一期项目预计于2027年开始投入运营。
Greg Slabodkin:在扩建原料药和制剂产能方面,目前客户需求增长主要集中在哪些特定领域?WuXi TIDES是否是公司增长最快的业务之一?
陈民章博士:目前需求来自多个治疗领域,包括肿瘤、心血管及代谢疾病、传染病、中枢神经系统疾病以及罕见病等。随着产能的不断提升,WuXi TIDES确实已成为我们在全球增长最快的业务之一,预计全年营收将实现约40%的同比增长。
WuXi TIDES能够为客户提供全方位的CRDMO能力,涵盖复杂化学偶联物、新型单体、连接子和配体的发现合成、工艺开发与任何规模的生产服务,实现从毫克级到商业化规模的全流程支持。
Greg Slabodkin:随着药物分子日益庞大且复杂,特别是寡核苷酸、多肽、靶向蛋白降解剂(TPD)和抗体偶联药物(ADC)等新分子的涌现,这是否直接驱动了药明康德全球产能的扩张?支持这些新分子需要哪些核心能力?
陈民章博士:科学正在引领我们将目光投向结构更加复杂、治疗更具靶向性的前沿分子。因此,寡核苷酸、多肽、TPD等新分子能力建设,是药明康德重点投资方向之一。
在多肽领域,我们开发了多种一体化工艺路径,通过将固相合成与液相合成相结合(SPPS–LPPS混合策略)来提升效率;在下游环节,我们根据具体多肽分子的特性和开发需求,灵活采用先进的纯化及API分离技术,如切向流过滤(TFF)、连续流色谱及喷雾干燥,助力提高收率、工艺稳定性和可扩展性。
在寡核苷酸领域,我们同样开发了多种创新工艺技术。比如固相与液相合成(SPOS和LPOS)、酶促合成等,进一步拓展合成复杂序列的效率;在下游纯化与分离方面,我们采用薄膜蒸发(TFE)、连续流色谱等创新技术,简化下游处理流程、减少工艺步骤。
与此同时,我们还在全球范围内持续扩建相关产能。在中国泰兴基地,两个用于寡核苷酸、多肽和PMO生产的新车间正在建设中,预计于2027年投产;新加坡首个TIDES车间也将于2028年投入运营。
TPD和ADC领域也正在快速发展,但其面临的核心挑战之一,仍然是研发成果的可转化性。我们经常会看到,一些在体外实验中表现非常优异的化合物,进入细胞或动物体内之后,往往难以复制同样的效果。这种情况在降解剂或ADC等复杂分子类型中更加明显。与此同时,随着检测体系越来越复杂,如何高效解析大规模的数据,也逐渐成为新的挑战。
针对这些问题,药明康德的做法是尽可能在药物发现早期,就把化学、生物学以及测试能力整合在一起。例如,构建更高质量的化合物库,在关注活性的同时推进多参数优化,并加快化合物系列的筛选与迭代。
通过实时的数据整合,以及高效的一体化工作流程,我们可以帮助客户在研发项目中,更早决定是继续推进,还是及时终止。这在降低后期研发风险的同时,也能提升整体的研发效率。
我们在这些方面都进行了投资。例如,截至2025年底,我们的多肽固相合成反应釜(SPPS)总体积已提前完成超过10万升目标,正在进一步扩建至13万升,目前仍有三个全新的TIDES车间正在建设中。而寡核苷酸固相合成反应釜(SPOS)的总规模也已突破8摩尔。此外,截至2025年底,小分子原料药反应釜也已经超过400万升。
我们之所以进行这样有针对性的产能与能力扩建,是基于深思熟虑的战略决策,即前瞻性布局产能,从而确保客户项目推进过程中不会面临产能上的掣肘。
Greg Slabodkin:为什么药明康德要“双管齐下”,同时扩大小分子原料药反应釜和多肽固相合成反应釜总体积?
陈民章博士:因为在这两大领域,我们都看到了强劲的市场需求。根据弗若斯特沙利文(Frost & Sullivan)数据,全球研发管线正在快速扩张,无论是新分子类型还是活跃项目数量都在不断增加。其中,小分子、多肽及寡核苷酸等合成类分子仍占据主导地位,在2024年的研发管线中占比达54.3%。
截至今年3月底,我们的小分子项目管线已达到3,550个,仅2026年第一季度就新增了328个。这一增长既得益于小分子口服GLP-1药物的热潮,也离不开其他强劲的项目管线的支撑。
值得注意的是,由于具备成本优势、物流便利性以及患者依从性高等特点,小分子药物依然是现代药物的重要基石,每年FDA批准的新药中,超过一半为小分子药物。与此同时,PROTAC及分子胶等技术突破,使此前“不可成药”的细胞内靶点成为可能,也正在进一步推动小分子领域需求增长。
药明康德的CRDMO模式具备充分优势,能够把握这一不断扩大的需求,并持续为客户创造价值。随着CRDMO项目不断向后期临床及商业化阶段推进,客户对生产规模的需求也会显著提升。
这解释了为何我们持续扩建常州和泰兴基地的小分子原料药产能。这两个基地已于2025年3月以零缺陷顺利通过FDA现场检查。2026年第一季度,公司小分子D&M业务收入同比增长80.1%至69.3亿元,也反映了项目管线持续向后期推进。
对于多肽领域而言,未来几年同样值得期待。多肽药物正在深刻改变代谢疾病治疗模式,更复杂的多肽偶联技术和精准递送方式,也正在不断拓展精准医疗的边界。
2026年第一季度,WuXi TIDES D&M客户数量同比增长28%,项目数量同比增长59%,进一步体现了市场需求的持续增长,以及一体化CRDMO模式的价值受到认可。到2026年底,WuXi TIDES收入预计将实现约40%的同比增长,而这一增长与我们持续扩建产能密切相关。
Interview with Co-CEO Dr. Minzhang Chen: WuXi AppTec Expands Global Manufacturing Capacity as Customer Demand Accelerates
To meet growing customer demand globally, WuXi AppTec is increasing its capital expenditure at least 17% in 2026 to between RMB 6.5 billion and RMB 7.5 billion, as the company looks to add new drug substance and drug product manufacturing capacity over the next two years in Asia, Europe, and the United States.
Among its infrastructure investments, the contract research, development, and manufacturing organization (CRDMO) will begin operations later this year at a new 1.74 million-square-foot plant in Middletown, Delaware, which will be WuXi AppTec’s largest U.S. facility.
The Delaware drug product site, which will serve the CRDMO’s North American market, is scheduled to start operations in the fourth quarter of 2026 for oral solid dosage manufacturing — with plans to expand into sterile/injectable production in the fourth quarter of 2027.
In Europe, WuXi AppTec is boosting its drug product manufacturing and packaging capacity in Couvet, Switzerland — which the company contends is designed to support growing commercial demand, with a new PSD-4 spray dryer slated to become operational in the fourth quarter of 2026.
In China, two new small molecule active pharmaceutical ingredient (API) plants at WuXi AppTec’s Taixing site are planned to become operational this year, and two additional plants focused on oligonucleotides, peptides, and phosphorodiamidate morpholino oligomer (PMO) production are currently under construction and expected to be operational in 2027. WuXi AppTec also plans to build a new API production site in Changzhou ahead of schedule, according to the company.
A Singapore site, which is currently under construction, will be operational next year augmenting the CRDMO’s global API manufacturing network for both small molecules and oligonucleotides, peptides and related synthetic conjugates (TIDES drugs). Three new TIDES plants are under accelerated construction in Taixing and in Singapore.
In a Q&A with Pharma Manufacturing Editor-in-Chief Greg Slabodkin, WuXi AppTec Co-CEO Dr. Minzhang Chen discusses the company’s business strategy and planned investments.
How have tariffs and trade policy considerations influenced WuXi AppTec’s decision to expand global manufacturing capacity?
Chen:Our global manufacturing growth is driven by one dynamic: our customers need more capacity, and we are building it. Demand for our services — particularly in peptides and advanced small molecule modalities — has grown significantly, and our customers are asking us to scale with them. That’s what is driving our investment decisions. We monitor trade policy and tariffs closely, but they are not the engine of our growth strategy. Our customers choose WuXi AppTec because of the competitive advantages of our integrated CRDMO model — our quality, speed, and efficiency — and we are growing to ensure we can continue meeting their needs wherever they operate.
WuXi AppTec is expanding its manufacturing capacity in the U.S., Europe, and Asia. What is the goal of the company’s regionalization of manufacturing strategy?
Chen:The goal is to deliver a secure and robust drug product supply chain under a single quality system meeting global standards. Our customers are asking for more and broader capabilities in Europe and the U.S., so we have been making investments in those regions aim to meet this demand. Our Middletown, Delaware facility will bring our drug product manufacturing to the U.S. for the first time at this scale.
At the same time, we’re expanding the capabilities of our Couvet site in Switzerland, adding spray drying in 2026, followed by parenteral manufacturing and LNP capabilities. We’re growing in Asia, too: our Singapore site will add API manufacturing for small molecules, oligonucleotides, peptides and conjugates, with Phase I operations expected in 2027.
When it comes to adding new drug substance and drug product manufacturing capacity, are there certain areas of customer demand that are growing for WuXi AppTec? Is WuXi TIDES one of your fastest-growing businesses?
Chen:The demand is coming from a broad range of therapeutic areas including oncology, cardiovascular and metabolic diseases, infectious diseases, central nervous system disorders, and rare diseases. WuXi TIDES is one of our fastest-growing businesses globally, with full-year growth expected to be about 40% year-over-year as we continue to increase manufacturing capacity.
We can meet customers’ demands by offering a full range of CRDMO capabilities at any scale — from discovery synthesis and process development to the manufacturing of complex synthetic conjugates, novel monomers, linkers, and ligands. This is what WuXi TIDES offers, from milligram-scale synthesis all the way through to commercial supply.
Are the increasing size and complexity of drug molecules, especially new modalities like oligonucleotides, peptides, targeted protein degraders (TPDs), and antibody-drug conjugates (ADCs), driving WuXi AppTec’s global manufacturing expansion? What capabilities are needed to support these new modalities?
Chen:The science is moving toward molecules that are structurally more complex and therapeutically more targeted. For this reason, a key focus of WuXi AppTec’s investments is on increasing capabilities related to new modalities like oligonucleotides, peptides, and TPDs. For example, for peptides, we have developed integrated process approaches such as combining solid-phase and liquid-phase synthesis (SPPS–LPPS hybrid), enabling greater efficiency and scalability for longer and more complex sequences.
Downstream, we apply advanced purification and API isolation technologies such as tangential flow filtration, continuous flow chromatography and spray drying to help improve yield, process robustness, and scalability.
In oligonucleotides, we bring a similarly flexible and integrated approach. Innovations such as thin film evaporation (TFE), continuous flow chromatography help streamline downstream handling and reduce processing steps, while biocatalytic fragment ligation expands the toolkit for constructing more complex sequences. Meanwhile, we continue to expand manufacturing capacity and capabilities across the globe.
At our Taixing site in China, two additional plants dedicated to oligonucleotide, peptide and PMO production are currently under construction and scheduled to be operational in 2027, and the first TIDES plant in Singapore will be operational in 2028.
TPDs and ADCs are advancing rapidly as well, but translatability remains one of the key challenges. Compounds that perform well in vitro often fail in cellular or in vivo systems, especially with complex modalities like degraders or ADC payloads. At the same time, increasing assay complexity generates large datasets that are difficult to interpret efficiently. We address this by integrating chemistry, biology, and testing early in the discovery process. This includes designing higher-quality libraries, applying multi-parameter optimization beyond potency, and enabling rapid triage of chemical series.
By combining real-time data integration with iterative workflows, we can enable our customers to make earlier, more informed go or no-go decisions, thereby reducing downstream risk and improving overall efficiency. We have invested in all of these. For example, at the end of 2025, our total solid phase peptide synthesis (SPPS) reactor volume exceeded 100,000 liters, completed ahead of schedule. We are now expanding that to 130,000 liters, with three new production units under construction.
The total solid phase oligo synthesis (SPOS) reactor scale also exceeded 8 mol. Our total small molecule API reactor volume exceeded 4,000 kL at the end of 2025. This targeted expansion of our capacities and capabilities reflects a deliberate decision to build manufacturing infrastructure ahead of demand, so that customers do not face constraints as their programs advance.
Why is WuXi AppTec growing both total reactor volume of small molecule APIs and total reactor volume of solid phase peptide synthesizers?
Chen:Because there is proven demand for both segments. According to Frost & Sullivan, the global R&D pipeline has expanded significantly, both in the diversity of new modalities and the number of active programs. Synthetic molecules — specifically small molecules, peptides, and oligonucleotides — continue to dominate, representing 54.3% of the pipeline in 2024.
Our small molecule pipeline reached 3,550 molecules at the end of March this year. We added 328 new molecules in Q1 2026 alone. The growth is driven by both small molecule oral GLP-1 drugs, and other robust project pipelines. Notably, due to their economic affordability, logistical convenience, and high patient compliance, small molecules remain the cornerstone of modern medicines, accounting for over 50% drugs approved by FDA each year.
Recent scientific breakthroughs in technologies like PROTACs and molecular glues are further driving this demand by successfully targeting previously “undruggable” pathways inside the cell. WuXi AppTec’s CRDMO model is well positioned to capitalize on this expanding demand and deliver continued value to customers. As these programs in our CRDMO funnel advance through clinical stages into commercial manufacturing, the volume requirements increase substantially — which is why we have been expanding API reactor capacity in Changzhou and Taixing, both of which passed FDA on-site inspections in March 2025 with no observations. Q1 2026 small molecule D&M revenue rose 80.1% year over year to RMB 6.93 billion, reflecting that pipeline progression.
For peptides, the next few years will be very exciting for innovation. We are seeing peptide-based medicines are transforming treatment approaches in metabolic diseases, while increasingly sophisticated peptide conjugates and other targeted delivery technologies are expanding the possibilities for precision medicine.
In Q1 2026, the number of WuXi TIDES D&M customers increased 28% year-over-year, while that of molecules rose 59% year-over-year — reflecting both the increasing customer demand and the effectiveness of our CRDMO model. By the end of 2026, we expect TIDES revenue to grow by approximately 40% year-over-year. This capacity expansion and the revenue trajectory are directly connected.
免责声明:本文仅作信息交流之目的,文中观点不代表药明康德立场,亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导,请前往正规医院就诊。
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