藥明康德為何持續(xù)產(chǎn)能建設？從美國米德爾頓基地開放日說起 | 專訪傅小勇博士

6月4日，藥明康德位于美國特拉華州的米德爾頓基地舉辦了一場開放日活動。

來自美國和全球各地的合作伙伴應邀走進仍在進行設備調(diào)試與驗證的制劑生產(chǎn)車間，近距離了解即將投入使用的生產(chǎn)線——從生產(chǎn)到包裝、貼標，每一處環(huán)節(jié)均配備了行業(yè)成熟可靠的設備，并嚴格遵循全球統(tǒng)一的質(zhì)量標準體系。

“這里未來將是藥明康德在美國最大的運營基地。”藥明康德執(zhí)行副總裁傅小勇博士向現(xiàn)場來賓介紹。“米德爾頓基地一期項目預計在2026年底前投入運營，涵蓋口服固體制劑生產(chǎn)、分析、包裝、貼標及臨床藥品配送等關(guān)鍵能力，屆時將為全球客戶提供從臨床到商業(yè)化階段的制劑生產(chǎn)服務。2027年，我們還將投產(chǎn)無菌灌裝生產(chǎn)車間。”

復雜分子趨勢下的產(chǎn)能挑戰(zhàn)

“五年前，客戶問的是‘你們能做嗎？’；兩年前，客戶問的是‘你們還能做得更快嗎？’；現(xiàn)在，客戶問得最多的是‘你們的產(chǎn)能是否足夠，是否能夠隨時啟動項目？’”

傅小勇博士在接受采訪時，用這樣一組對比勾勒出他過去幾年感受到的一個重要的行業(yè)需求變遷。

這種變化并非憑空而來。全球醫(yī)藥研發(fā)的底層邏輯正在經(jīng)歷深刻重塑。

一方面，是分子的復雜性正在顯著增加。科學正在引領行業(yè)將目光投向結(jié)構(gòu)更加復雜、治療更具靶向性的新興分子——創(chuàng)新小分子藥物（例如靶向蛋白降解劑）正變得越來越復雜，多肽、寡核苷酸及各類偶聯(lián)藥物等新型復雜分子不斷涌現(xiàn)，成為研發(fā)的熱點。

這類復雜分子往往涉及新型化學反應、大量單元操作、高度定制化的工藝路徑，以及更高要求的質(zhì)量控制，給整個開發(fā)及上市進程帶來了前所未有的挑戰(zhàn)，更對解決復雜問題的能力和產(chǎn)能規(guī)模提出了更高要求。

以多肽為例，傳統(tǒng)的多肽合成往往停留在公斤級或百公斤級，而隨著多肽藥物在糖尿病、肥胖等代謝性疾病領域的大規(guī)模應用，需求量級已經(jīng)從公斤級躍升至噸級。寡核苷酸藥物同樣如此，隨著更多適應癥的拓展，臨床和商業(yè)化階段的需求量正在快速增長。

創(chuàng)新分子不斷增加的復雜性只是故事的一面。另一面，是行業(yè)對產(chǎn)能的理解和需求正在發(fā)生根本性轉(zhuǎn)變。

“過去幾年，我們觀察到客戶的需求也在發(fā)生變化。”傅小勇博士說，“他們越來越看重并傾向于尋找能快速放大工藝以及保證供應穩(wěn)定的合作伙伴。客戶越來越看重你的產(chǎn)能是否具備靈活性，是否有更具韌性的全球化供應體系。”

這句話背后，是行業(yè)普遍面對的一項現(xiàn)實挑戰(zhàn)。

新藥研發(fā)的旅程漫長而艱難，從靶點發(fā)現(xiàn)到藥物最終上市，往往需要十年以上的時間和數(shù)十億美元的投入。而下游生產(chǎn)作為新藥抵達患者的“最后一公里”，正成為當下行業(yè)被重點關(guān)注和討論的核心議題。

尤其是近年來，隨著研發(fā)生產(chǎn)需求持續(xù)攀升，產(chǎn)能已成為限制新藥成功開發(fā)以及盡早走向臨床的一大瓶頸。如果缺乏足夠的、符合監(jiān)管標準的產(chǎn)能，一些極具潛力的在研藥物的研發(fā)進程可能會被拖延數(shù)月甚至一年以上。

這不僅僅是商業(yè)損失的問題，對于那些正在等待新藥的患者來說，每一天的延誤都可能意味著不可逆的病情進展。

換言之，創(chuàng)新突破必須與生產(chǎn)產(chǎn)能突破同步，否則創(chuàng)新將停留在論文或?qū)嶒炇依铮鵁o法成為臨床可用的藥品。

加快全球產(chǎn)能建設，滿足持續(xù)增長的需求

當前，加強供應鏈韌性與靈活性，已成為全球醫(yī)藥產(chǎn)業(yè)的共識。從監(jiān)管機構(gòu)到生產(chǎn)企業(yè)，各方都在積極應對產(chǎn)能挑戰(zhàn)。例如，歐洲藥品管理局已明確將“靈活性”視為先進生產(chǎn)的核心價值，以提升藥品供應鏈的穩(wěn)定能力。

這樣的產(chǎn)業(yè)環(huán)境，也深刻影響著客戶的關(guān)切與判斷。“當看到一些極具潛力的管線因產(chǎn)能瓶頸而無法盡快抵達需要的患者時，我們就意識到，產(chǎn)能已不僅僅是‘基礎設施’，更是創(chuàng)新藥物能否盡早惠及病患的關(guān)鍵環(huán)節(jié)。”傅小勇博士說，“因此，我們正加快建設能力和產(chǎn)能規(guī)模，以響應客戶最關(guān)切的需求。”

在小分子領域，截至2025年底，藥明康德小分子原料藥反應釜總體積已超過400萬升。在TIDES藥物領域，同樣展現(xiàn)出強勁的增長態(tài)勢。截至2025年底，公司的多肽固相合成反應釜總體積已提前完成超過10萬升的目標，正在進一步擴建至13萬升。寡核苷酸固相合成反應釜的總規(guī)模也已突破8摩爾。基于現(xiàn)有產(chǎn)能與客戶需求，藥明康德WuXi TIDES平臺的全年營收預計將實現(xiàn)約40%的同比增長。

未來兩年，藥明康德計劃在美國、歐洲和亞洲持續(xù)擴建其一體化CRDMO平臺的原料藥及制劑產(chǎn)能。

在美國，特拉華州米德爾頓基地預計于2026年第四季度啟動口服固體制劑生產(chǎn)，并于2027年第四季度開始無菌注射劑生產(chǎn)。

在歐洲，瑞士庫威基地的擴建也在同步推進。該基地的制劑生產(chǎn)及包裝產(chǎn)能都將進一步提升，以滿足不斷增長的商業(yè)化需求。新增的噴霧干燥車間預計于2026年第四季度投產(chǎn)，后續(xù)還將增加無菌注射劑等相關(guān)能力。

在亞洲，產(chǎn)能擴建同樣在加速。中國泰興基地，2026年5月新增1個小分子原料藥車間，另一個生產(chǎn)車間將在2026年內(nèi)啟用，專注于寡核苷酸和多肽生產(chǎn)的兩個新車間也預計在2027年投產(chǎn)。與此同時，公司還計劃提前啟動常州新原料藥生產(chǎn)基地的建設——這背后是客戶需求的緊迫性，以及公司對未來市場增長的堅定信心。

新加坡基地的建設也在加速進行，同樣預計在2027年投入運營。該基地將進一步提升原料藥全球供應鏈的靈活性，更好地支持小分子、寡核苷酸、多肽以及復雜化學偶聯(lián)藥物的商業(yè)化生產(chǎn)需求。目前，泰興基地和新加坡基地有三個全新的TIDES車間正在建設中。

為支持上述擴產(chǎn)計劃，藥明康德預計今年的資本開支將達到65億元至75億元。

這些行動背后，是一個始終未變的出發(fā)點——賦能全球客戶，讓創(chuàng)新療法更快地惠及患者。傅小勇博士在開放日活動期間再次強調(diào)：藥明康德正是在這一目標的指引下，恪守符合全球標準的統(tǒng)一質(zhì)量體系，為客戶提供更多靈活選擇，助力構(gòu)建更穩(wěn)健的供應能力和網(wǎng)絡。“我們所做的一切”，他說道，“最終都是為了助力客戶共同實現(xiàn)這個目標。”

“我們邀請客戶來到這里，不僅是讓他們親眼看見、親身感受藥明康德這一基地的建設進程，更希望傳遞給大家對整個行業(yè)走向的信心和期待。”他補充道。

對于藥明康德來說，這只是又一個新的起點。在全球產(chǎn)能布局的歷程中，還有更多的基地正在建設，更多的技術(shù)正在突破，更多的需求正在被回應。

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 “l(fā)ast 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.

免責聲明：本文僅作信息交流之目的，文中觀點不代表藥明康德立場，亦不代表藥明康德支持或反對文中觀點。本文也不是治療方案推薦。如需獲得治療方案指導，請前往正規(guī)醫(yī)院就診。

版權(quán)說明：歡迎個人轉(zhuǎn)發(fā)至朋友圈，謝絕媒體或機構(gòu)未經(jīng)授權(quán)以任何形式轉(zhuǎn)載至其他平臺。轉(zhuǎn)載授權(quán)請在「藥明康德」微信公眾號回復“轉(zhuǎn)載”，獲取轉(zhuǎn)載須知。