药明康德为何持续产能建设？从美国米德尔顿基地开放日说起 | 专访傅小勇博士

6月4日，药明康德位于美国特拉华州的米德尔顿基地举办了一场开放日活动。

来自美国和全球各地的合作伙伴应邀走进仍在进行设备调试与验证的制剂生产车间，近距离了解即将投入使用的生产线——从生产到包装、贴标，每一处环节均配备了行业成熟可靠的设备，并严格遵循全球统一的质量标准体系。

“这里未来将是药明康德在美国最大的运营基地。”药明康德执行副总裁傅小勇博士向现场来宾介绍。“米德尔顿基地一期项目预计在2026年底前投入运营，涵盖口服固体制剂生产、分析、包装、贴标及临床药品配送等关键能力，届时将为全球客户提供从临床到商业化阶段的制剂生产服务。2027年，我们还将投产无菌灌装生产车间。”

复杂分子趋势下的产能挑战

“五年前，客户问的是‘你们能做吗？’；两年前，客户问的是‘你们还能做得更快吗？’；现在，客户问得最多的是‘你们的产能是否足够，是否能够随时启动项目？’”

傅小勇博士在接受采访时，用这样一组对比勾勒出他过去几年感受到的一个重要的行业需求变迁。

这种变化并非凭空而来。全球医药研发的底层逻辑正在经历深刻重塑。

一方面，是分子的复杂性正在显著增加。科学正在引领行业将目光投向结构更加复杂、治疗更具靶向性的新兴分子——创新小分子药物（例如靶向蛋白降解剂）正变得越来越复杂，多肽、寡核苷酸及各类偶联药物等新型复杂分子不断涌现，成为研发的热点。

这类复杂分子往往涉及新型化学反应、大量单元操作、高度定制化的工艺路径，以及更高要求的质量控制，给整个开发及上市进程带来了前所未有的挑战，更对解决复杂问题的能力和产能规模提出了更高要求。

以多肽为例，传统的多肽合成往往停留在公斤级或百公斤级，而随着多肽药物在糖尿病、肥胖等代谢性疾病领域的大规模应用，需求量级已经从公斤级跃升至吨级。寡核苷酸药物同样如此，随着更多适应症的拓展，临床和商业化阶段的需求量正在快速增长。

创新分子不断增加的复杂性只是故事的一面。另一面，是行业对产能的理解和需求正在发生根本性转变。

“过去几年，我们观察到客户的需求也在发生变化。”傅小勇博士说，“他们越来越看重并倾向于寻找能快速放大工艺以及保证供应稳定的合作伙伴。客户越来越看重你的产能是否具备灵活性，是否有更具韧性的全球化供应体系。”

这句话背后，是行业普遍面对的一项现实挑战。

新药研发的旅程漫长而艰难，从靶点发现到药物最终上市，往往需要十年以上的时间和数十亿美元的投入。而下游生产作为新药抵达患者的“最后一公里”，正成为当下行业被重点关注和讨论的核心议题。

尤其是近年来，随着研发生产需求持续攀升，产能已成为限制新药成功开发以及尽早走向临床的一大瓶颈。如果缺乏足够的、符合监管标准的产能，一些极具潜力的在研药物的研发进程可能会被拖延数月甚至一年以上。

这不仅仅是商业损失的问题，对于那些正在等待新药的患者来说，每一天的延误都可能意味着不可逆的病情进展。

换言之，创新突破必须与生产产能突破同步，否则创新将停留在论文或实验室里，而无法成为临床可用的药品。

加快全球产能建设，满足持续增长的需求

当前，加强供应链韧性与灵活性，已成为全球医药产业的共识。从监管机构到生产企业，各方都在积极应对产能挑战。例如，欧洲药品管理局已明确将“灵活性”视为先进生产的核心价值，以提升药品供应链的稳定能力。

这样的产业环境，也深刻影响着客户的关切与判断。“当看到一些极具潜力的管线因产能瓶颈而无法尽快抵达需要的患者时，我们就意识到，产能已不仅仅是‘基础设施’，更是创新药物能否尽早惠及病患的关键环节。”傅小勇博士说，“因此，我们正加快建设能力和产能规模，以响应客户最关切的需求。”

在小分子领域，截至2025年底，药明康德小分子原料药反应釜总体积已超过400万升。在TIDES药物领域，同样展现出强劲的增长态势。截至2025年底，公司的多肽固相合成反应釜总体积已提前完成超过10万升的目标，正在进一步扩建至13万升。寡核苷酸固相合成反应釜的总规模也已突破8摩尔。基于现有产能与客户需求，药明康德WuXi TIDES平台的全年营收预计将实现约40%的同比增长。

未来两年，药明康德计划在美国、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。

在美国，特拉华州米德尔顿基地预计于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，瑞士库威基地的扩建也在同步推进。该基地的制剂生产及包装产能都将进一步提升，以满足不断增长的商业化需求。新增的喷雾干燥车间预计于2026年第四季度投产，后续还将增加无菌注射剂等相关能力。

在亚洲，产能扩建同样在加速。中国泰兴基地，2026年5月新增1个小分子原料药车间，另一个生产车间将在2026年内启用，专注于寡核苷酸和多肽生产的两个新车间也预计在2027年投产。与此同时，公司还计划提前启动常州新原料药生产基地的建设——这背后是客户需求的紧迫性，以及公司对未来市场增长的坚定信心。

新加坡基地的建设也在加速进行，同样预计在2027年投入运营。该基地将进一步提升原料药全球供应链的灵活性，更好地支持小分子、寡核苷酸、多肽以及复杂化学偶联药物的商业化生产需求。目前，泰兴基地和新加坡基地有三个全新的TIDES车间正在建设中。

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。

这些行动背后，是一个始终未变的出发点——赋能全球客户，让创新疗法更快地惠及患者。傅小勇博士在开放日活动期间再次强调：药明康德正是在这一目标的指引下，恪守符合全球标准的统一质量体系，为客户提供更多灵活选择，助力构建更稳健的供应能力和网络。“我们所做的一切”，他说道，“最终都是为了助力客户共同实现这个目标。”

“我们邀请客户来到这里，不仅是让他们亲眼看见、亲身感受药明康德这一基地的建设进程，更希望传递给大家对整个行业走向的信心和期待。”他补充道。

对于药明康德来说，这只是又一个新的起点。在全球产能布局的历程中，还有更多的基地正在建设，更多的技术正在突破，更多的需求正在被回应。

Build Locally, Impact Globally: WuXi AppTec Continues to Increase Capacity Amid Demand Growth

On June 4, 2026, WuXi AppTec’s drug product manufacturing site in Middletown, Del., hosted an Open House preview event. Customers and partners from around the world were invited into the site, where equipment commissioning and validation are still underway. Visitors had the opportunity to observe the oral solid dosage (OSD) plants up close, covering every step from manufacturing to packaging and labeling. Each operation is equipped with industry-proven and reliable machinery, and strictly adheres to a globally consistent quality management system.

The OSD manufacturing facilities are expected to be available in Q4 of this year; the sterile filling manufacturing will come online in 2027.

“This will be WuXi AppTec’s largest U.S. facility,” said Dr. Xiaoyong Fu, Executive Vice President of WuXi AppTec. “We expect to be operational by the end of 2026, providing global clients with oral solid dosage manufacturing services ranging from early-stage to commercial.”

Capacity Challenges Amid the Trend Toward Complex Molecules

“Five years ago, clients asked, ‘Can you do it?’ Two years ago, they asked, ‘Can you do it faster?’ Now, the most common question is, ‘Do you have enough capacity to launch a project at any time?’”

In a recent interview, Dr. Fu used this contrast to illustrate a major shift in industry demand that he has observed over the past several years.

This shift reflects deeper trends in the industry. The fundamental logic of global pharmaceutical innovation is undergoing meaningful change.

On one hand, the complexity of molecules is increasing significantly. Science is leading the industry to focus on novel molecules with more intricate structures and greater targeting specificity—innovative small molecule drugs (e.g., targeted protein degraders) are becoming more complex, while new complex modalities such as peptides, oligonucleotides, and various conjugates are emerging as industry hotspots.

These complex molecules often involve novel chemical reactions, numerous unit operations, highly customized process routes, and stricter quality control requirements. These factors pose significant challenges to the entire process-from research to development to manufacturing, while also demanding greater problem-solving capabilities and larger manufacturing capacity.

Take peptides as an example. Traditional peptide synthesis often remained at the kilogram or hundred‑kilogram scale. However, with the prevalent use of peptide drugs to treat metabolic diseases such as diabetes and obesity, demand has surged from kilograms to metric tons. The same is true for oligonucleotide drugs: as more indications are pursued, late-stage and commercial demand is growing rapidly.

The increasing complexity of innovative molecules is only part of the story. The other side is a fundamental shift in how the industry understands and demands capacity.

“In the past few years, we have seen client needs change as well,” said Dr. Fu. “Clients increasingly value—and seek out—partners who can quickly scale up processes and ensure supply stability. They care more and more about whether your capacity is flexible and resilient.”

Behind these words lies a practical challenge widely shared across the industry.

The journey of new drug development is long and complex. From target discovery to final market approval often takes more than a decade and billions of dollars in investment. Downstream manufacturing—the “last mile” in bringing new drugs to patients—has become a central topic of discussion and concern in the industry.

Capacity has become an important consideration limiting successful development and timely late-stage progress. Without sufficient, regulatory‑compliant capacity, the development of promising drug candidates could be delayed by months or even more than a year.

This is not merely a matter of commercial loss. For patients awaiting new treatments, every day of delay may mean irreversible disease progression.

In other words, innovation increasingly depends on corresponding advances in manufacturing capabilities; otherwise, innovation remains confined to academic papers or laboratory benches and never becomes a clinically available medicine.

Building Global Capacity to Meet Growing Demand

Strengthening the resilience and flexibility of the global supply chain is a key priority for the pharmaceutical industry. From regulators to manufacturers, all parties are actively responding to capacity challenges. The European Medicines Agency, for example, has explicitly identified “flexibility” as a core value of advanced manufacturing to enhance the stability of medicine supply.

This industrial environment is also deeply influencing client priorities and decisions. “When we see that promising pipelines cannot reach patients as quickly as possible because of capacity constraints, capacity is no longer just ‘infrastructure’—it is an important link to patients,” said Dr. Fu. “That is why we are accelerating the build‑out of our capabilities and capacity scale to respond to our clients’ needs.”

In the small molecule field, as of the end of 2025, the total volume of WuXi AppTec’s small molecule active pharmaceutical ingredient (API) reactor capacity exceeded 4,000 kL.

In the TIDES sector, a similar upward trend can be seen. At the end of 2025, the total solid phase peptide synthesis (SPPS) reactor volume exceeded 100,000 liters, completed ahead of schedule, and is now expanding to 130,000 liters. The total solid phase oligonucleotide synthesis (SPOS) reactor scale also exceeded 8 mol. Based on existing capacity and client demand, the WuXi TIDES platform, an integral part of WuXi AppTec, expects full-year growth of about 40% year-over-year.

Over the next two years, WuXi AppTec plans to gradually increase its drug substance and drug product manufacturing capacity across its integrated CRDMO platform in the United States, Europe, and Asia.

In the U.S., the Middletown, Del., site is expected to begin oral solid dosage manufacturing in the fourth quarter of 2026, followed by sterile/injectable production in the fourth quarter of 2027.

In Europe, expansion at the Couvet site in Switzerland is advancing in parallel. Drug product manufacturing and packaging capacity at the site will be further increased to meet growing commercial demand. A new spray-drying facility (PSD-4) is expected to become operational in the fourth quarter of 2026, with the subsequent addition of sterile injectable capabilities.

In Asia, capacity development is also progressing. At the Taixing site in China, one new small‑molecule API plant began operation in May 2026, and another small‑molecule plant will come online later in 2026. Two additional plants focused on oligonucleotides, peptides, and PMO production are currently under construction and expected to be operational in 2027. At the same time, the company has also advanced plans to begin construction of a new API manufacturing site in Changzhou—in response to client demand and industry trends.

Construction at the Singapore site is also accelerating, with operations similarly expected to begin in 2027. This site will further enhance the global flexibility of API supply and better support commercial manufacturing of small molecules, oligonucleotides, peptides, and related synthetic conjugates. Currently, three new TIDES plants are under construction in Taixing and Singapore.

To meet growing customer demand globally, WuXi AppTec is increasing its capital expenditure by at least 17% in 2026 to between USD 0.96 billion and USD 1.11 billion.

Behind these actions lies an unchanged commitment: enabling global clients to bring innovative therapies to patients faster. During the Open House event, Dr. Fu reiterated that, guided by this goal,WuXi AppTec adheres to a globally consistent quality system, offers clients more flexible options, and helps build more robust supply capabilities and networks.“Everything we do,” he said, “is ultimately to help our clients achieve this goal together.”

“By inviting clients here, we want them not only to see and experience firsthand the progress of this site, but also to share with them our confidence and expectations for the future of the entire industry,” he added.

For WuXi AppTec, this is just another new beginning. In its journey of global capability development, more sites are being built, more technologies are being advanced, and more needs are being met.

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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