筑城以創(chuàng)新，聯(lián)結(jié)為健康——藥明康德的全球足跡 | Bilingual

每一座城市都能成為創(chuàng)新的土壤。從長江之濱到萊茵河畔，從太平洋岸到日內(nèi)瓦湖邊——藥明康德的足跡，正與世界的城市一同成長。

在10月31日世界城市日這一天，我們不僅慶祝城市的繁榮與多樣，更希望講述一段關(guān)于“全球連接”的故事。2000年，藥明康德從一間實驗室起步，如今在亞洲、歐洲和北美擁有20多個研發(fā)和生產(chǎn)基地，覆蓋新藥研究（R）、開發(fā)（D）和生產(chǎn)（M）的各個環(huán)節(jié)。我們?yōu)楫數(shù)睾腿蚩蛻籼峁╈`活、高效和高質(zhì)量的服務(wù)，賦能每個創(chuàng)新夢想轉(zhuǎn)化為切實有效的療法。

25年來，藥明康德的發(fā)展跨越國界，跨越時區(qū)與文化，卻始終恪守同樣的高質(zhì)量標準；如今的我們，仍在以CRDMO業(yè)務(wù)模式和極致運營，驅(qū)動自身的長期發(fā)展，也不斷為客戶、為創(chuàng)新生態(tài)圈、為全球患者創(chuàng)造價值。

從亞洲、北美、到歐洲，夯實CRDMO全球網(wǎng)絡(luò)

在全球生命科學產(chǎn)業(yè)合作日益緊密的今天，創(chuàng)新的腳步從未停歇，藥明康德也步履不停。

中國泰興基地——藥明康德5個原料藥生產(chǎn)基地中最新及最大的基地，覆蓋了所有合成分子類型，包括小分子、多肽、寡核苷酸及相關(guān)偶聯(lián)藥物。今年3月，泰興原料藥基地順利通過美國FDA針對1款多肽創(chuàng)新藥商業(yè)化生產(chǎn)進行的上市前檢查（Pre-Approval Inspection），檢查過程中未發(fā)現(xiàn)任何不符合項，標志著泰興基地已具備面向全球市場提供原料藥商業(yè)化供應(yīng)的能力。

正在建設(shè)中的美國米德爾頓基地，于2022年破土動工，目前已完成建筑主體，進入內(nèi)部安裝階段，預(yù)計將于2026年底前投入運營。

米德爾頓基地占地77萬平方米，旨在為全球客戶提供從臨床前到商業(yè)化階段的制劑開發(fā)與生產(chǎn)服務(wù)。一期工程將具有口服和注射制劑的研發(fā)、生產(chǎn)、包裝、貼標和分發(fā)在內(nèi)的能力，能夠更好地賦能美國及全球客戶。

位于瑞士庫威的生產(chǎn)基地也在持續(xù)擴建，其中口服劑型包裝產(chǎn)能已于2024年翻倍，噴霧干燥車間正在建設(shè)中，預(yù)計將于2026年四季度竣工，后續(xù)還將增加腸外制劑等方面的能力建設(shè)。

與此同時，在新加坡，面向未來的原料藥生產(chǎn)基地正在加速建設(shè)，以高效與可持續(xù)為核心理念，連接亞洲與世界，為區(qū)域產(chǎn)業(yè)生態(tài)注入新動能。該基地于2024年初正式開工建設(shè)，計劃于2027年起陸續(xù)投入運營，為小分子、寡核苷酸、多肽及復(fù)雜偶聯(lián)藥物提供服務(wù)。

足跡的每一次延伸，都是藥明康德與城市共生共長的新篇章。近日，公司與沙特新未來城（NEOM）及沙特衛(wèi)生部分別簽署戰(zhàn)略合作備忘錄。藥明康德將與NEOM攜手合作，探索在沙特開展新藥研發(fā)與生產(chǎn)服務(wù)的本地化進程。

此次合作為公司未來在NEOM的先進、清潔制造城市Oxagon或沙特其他地區(qū)建立世界一流的CRDMO研發(fā)及生產(chǎn)基地奠定了基礎(chǔ)。藥明康德將憑借其獨特的專業(yè)能力與全球網(wǎng)絡(luò)，持續(xù)推動醫(yī)藥創(chuàng)新，助力當?shù)厣锛夹g(shù)產(chǎn)業(yè)的加速發(fā)展。

此次合作匯聚了藥明康德服務(wù)全球生物醫(yī)藥行業(yè)二十多年的深厚經(jīng)驗，以及NEOM在創(chuàng)新與可持續(xù)領(lǐng)域的宏偉愿景。雙方將共同推動醫(yī)藥創(chuàng)新生態(tài)在中東地區(qū)的成長，并助力當?shù)厣锛夹g(shù)產(chǎn)業(yè)的加速發(fā)展。

同時，藥明康德與沙特衛(wèi)生部的合作將重點聚焦醫(yī)藥產(chǎn)業(yè)價值鏈本地化、醫(yī)藥人才培養(yǎng)及吸引外商直接投資，為區(qū)域醫(yī)療健康體系注入新動能。

精益運營，質(zhì)量為基

值得一提的是，歷經(jīng)多年，藥明康德一直承接著大量客戶需求，建能力、擴規(guī)模的效率也在不斷提升。

在不久前的投資者開放日活動上，公司披露，常州基地從2016年第一個車間投入使用，一期和二期共計9個車間，耗時5年完成全部建設(shè)，并投入使用。而到了三期，6個車間僅用兩年時間，便投入使用。在一江之隔的泰興基地，一期的6個車間、二期的4個車間，分別都只用了一年時間就投入使用，產(chǎn)能爬坡的速度越來越快。

2017年，藥明康德從投入使用一個新車間，到達到滿產(chǎn)，大約需要2年時間，而在2024年，這一數(shù)字已經(jīng)縮短為兩個月。“藥明速度”的背后，有規(guī)模效應(yīng)帶來的資源調(diào)配便利、標準化培訓的機制方法，也體現(xiàn)出藥明康德文化中對極致的追求。

今年9月，泰興基地已經(jīng)提前完成多肽產(chǎn)能建設(shè)。公司多肽固相合成反應(yīng)釜總體積目前已提升至超過10萬升。

而不可忽視的是，快速建設(shè)和投產(chǎn)離不開以完善的質(zhì)量體系作為基石。堅實的質(zhì)量才能承托起卓越的運營。

今年3月，美國FDA對藥明康德常州原料藥基地開展了未預(yù)先通知的GMP符合性檢查（又稱“飛行檢查”），涵蓋六大GMP系統(tǒng)和21款已獲FDA批準的產(chǎn)品。其結(jié)果是，F(xiàn)DA檢查官提前一天完成所有核查，未發(fā)現(xiàn)任何不符合項，證明了藥明康德所恪守的高質(zhì)量體系，經(jīng)得起隨時隨地的檢驗。

2009年以來，僅前述基地所在的藥明康德化學業(yè)務(wù)平臺，就成功通過了全球監(jiān)管機構(gòu)的審計超過140次，所支持的創(chuàng)新藥在全球105個國家獲批。得益于出色的質(zhì)量記錄，化學業(yè)務(wù)平臺已有25次新藥審批前審計得到美國FDA和歐洲EMA的豁免。

結(jié)束語

不同城市承載了藥明康德不同的成長印記，他們也都是公司全球發(fā)展的縮影。廣泛的布局讓藥明康德更貼近全球各地的客戶，也讓創(chuàng)新成果更快抵達患者。通過統(tǒng)一的質(zhì)量體系、精益運營與極致執(zhí)行，藥明康德正在讓科學的力量跨越地理與語言的邊界，讓創(chuàng)新真正“無界”。

從城市網(wǎng)絡(luò)到實驗室里的每一個細節(jié)，從新藥發(fā)現(xiàn)、開發(fā)、生產(chǎn)，到真正惠及患者，25年來，我們不斷推動創(chuàng)新成果快速轉(zhuǎn)化，為全球客戶提供全方位支持。未來，藥明康德將繼續(xù)聚焦一體化CRDMO業(yè)務(wù)模式，以開放合作的姿態(tài)，與城市共生，與產(chǎn)業(yè)共進，與各方攜手，共同實現(xiàn)“讓天下沒有難做的藥，難治的病”的愿景。

Connected by Science, United for Health — WuXi AppTec’s Global Footprint

Innovation thrives wherever people and ideas connect.

From the banks of the Yangtze to the shores of the Rhine, from the Pacific Coast to Lake Geneva, WuXi AppTec has grown alongside the world’s most vibrant cities — linking science, talent, and opportunity across continents.

On World Cities Day, October 31, we not only celebrate the prosperity and diversity of cities but also share a story about global connection. Founded in 2000 with a single laboratory, WuXi AppTec now operates more than 20 R&D and manufacturing sites across Asia, Europe, and North America, covering the full spectrum of new drug Research (R), Development (D) and Manufacturing (M). Our global network enables us to provide flexible, efficient, and high-quality services to customers worldwide — helping every innovative idea transform into effective therapies.

Over the past 25 years, WuXi AppTec’s growth has crossed borders, time zones, and cultures — yet we have always adhered to the same high-quality standards. Today, through our CRDMO business model and relentless operational excellence, we continue to drive sustainable growth and create value for customers, the innovation ecosystem, and patients around the world.

From Asia to North America and Europe — Strengthening Our Global CRDMO Network

In an era where global collaboration in life sciences grows ever closer, the pace of innovation never stops — and neither do we.

At ourTaixing sitein China, the newest and largest among WuXi AppTec’s five API manufacturing facilities, we cover all types of synthetic molecules, including small molecules, peptides, oligonucleotides, and related conjugates. In March 2024, the site successfully passed a U.S. FDA Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic — with no observations — marking Taixing’s readiness to support commercial API supply for global markets.

Across the Pacific, construction of ourMiddletonsite in the United States — launched in 2022 — is progressing rapidly. The main structure has been completed, and interior installation is underway. Scheduled to start operation by the end of 2026, the 770,000 m2 facility will provide formulation development and manufacturing services from preclinical to commercial stages. Phase I is designed for the development and manufacturing of oral and parenteral drug products, including packaging, labeling, and distribution — empowering customers in the U.S. and worldwide.

InCouvet, Switzerland, expansion continues apace. Oral dosage packaging capacity has doubled in 2024, and a new spray drying workshop is under construction, expected to be completed in Q4 2026. Further investments are planned to add parenteral formulation capabilities in the future.

Meanwhile, inSingapore, a next-generation API manufacturing site is taking shape — built on the principles of efficiency and sustainability to connect Asia with the world. Officially breaking ground in early 2024, the facility is expected to begin phased operations from 2027, serving small molecules, oligonucleotides, peptides, and complex conjugates.

A new chapter unfolds in WuXi AppTec’s global journey of enabling innovation. Recently, WuXi AppTec has signed two strategic memoranda of understanding (MoUs) with NEOM, the sustainable region under development in northwestSaudi Arabiaand the Ministry of Health of the Kingdom of Saudi Arabia (MOH). WuXi AppTec and NEOM have agreed to collaborate to explore the localization of pharmaceutical research, development and manufacturing in Saudi Arabia.

The agreement lays the groundwork for establishing world-class CRDMO facilities at Oxagon, NEOM’s advanced and clean manufacturing city, or other locations in Saudi Arabia. By leveraging WuXi AppTec’s unique expertise and global network, the initiative aims to drive innovation and accelerate the growth of the biotechnology sector in Saudi Arabia.

This partnership brings together WuXi AppTec’s decades of experience as a trusted partner to the global biopharmaceutical industry with NEOM’s commitment to fostering innovation and building a future-focused ecosystem.

The MoU offers a compelling opportunity to extend WuXi AppTec’s integrated capabilities into a market with ambitious national biotechnology goals. It also capitalizes on NEOM’s visionary approach to sustainability, innovation, and talent development.

Lean Operations, Quality as the Foundation

Over the years, WuXi AppTec has continuously enhanced its capability-building and expansion efficiency — meeting a growing number of customer needs with speed and precision.

At our recent Investor Day, we shared that construction of ourChangzhousite has accelerated remarkably. Phase I and II — totaling nine workshops — were completed and put into operation in five years after the first plant launched in 2016. By Phase III, six plants were built and operational in just two years. Across the river at the Taixing site, Phase I (six plants) and Phase II (four plants) each took only one year to complete. In 2017, it took approximately two years for a new workshop to reach full capacity after startup; by 2024, this period has shortened to just two months.

Behind this “WuXi Speed” are economies of scale, efficient resource allocation, standardized training, and a corporate culture that pursues excellence in every detail.

In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule. WuXi AppTec's total reactor volume of Solid Phase Peptide Synthesizers has been increased to over 100,000L.

But speed means little without quality. Robust quality systems remain the cornerstone of our world-class operations.

In March 2024, the U.S. FDA conducted an unannounced GMP inspection at our Changzhou API site, following the FDA’s six-system inspection model while covering 21 FDA-approved products. The inspection concluded a day ahead of schedule, with no observations, demonstrating that WuXi AppTec’s rigorous quality system stands the test of any audit — anytime, anywhere.

Since 2009, WuXi AppTec’s Chemical Business Platform alone has passed over 140 global regulatory inspections, supporting innovative drugs approved in 105 countries. Owing to this exceptional compliance record, the platform has received 25 FDA and EMA PAI waivers for new drug approvals.

Conclusion

Every city bears a unique mark of WuXi AppTec’s growth — each a reflection of our global journey. Our worldwide network brings us closer to customers and accelerates the delivery of innovation to patients. Through unified quality systems, lean operations, and excellent execution, WuXi AppTec is breaking the boundaries of geography and language — making innovation truly borderless.

From our city network to every detail within our laboratories, from drug discovery and development to delivery to patients, we have spent 25 years enabling the fast translation of scientific breakthroughs into real-world therapies. Looking ahead, WuXi AppTec will continue to focus on our integrated CRDMO model, embracing open collaboration — co-growing with cities, advancing with industries, and working hand in hand with partners around the world to fulfill our vision:“ every drug can be made and every disease can be treated.”

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(dǎo)，請前往正規(guī)醫(yī)院就診。

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