媒體聲音 | 藥明康德一體化CRDMO如何讓創新療法更快造福患者 | Bilingual

近年來，新藥研發的復雜程度不斷提升：從多肽和寡核苷酸，到靶向蛋白降解分子以及其他新分子類型，想要推進這些創新療法從概念走向臨床，離不開先進的化學技術、專業的生產能力以及高度協同的研發與生產體系。

為了更好地賦能全球創新者應對這些挑戰，藥明康德通過獨特的一體化CRDMO平臺，將研究、開發與生產能力整合在一個全球化的體系中，幫助新藥研發企業簡化研發流程，并以二十多年來積累的經驗，協助客戶更高效地推進研發項目，讓創新療法加速走向患者。

近日，藥明康德高級副總裁、寡核苷酸和多肽事業部及化學業務平臺商務運營部負責人盧羽女士接受行業媒體Fierce Biotech采訪，分享了藥明康德的一體化能力和全球網絡協同，如何以“藥明速度”，加速推動客戶新一代創新療法的開發。

以下是報道全文，點擊“閱讀原文/Read More”即可訪問原文頁面。

Fierce Biotech：隨著創新分子模式不斷出現，全球生物醫藥產業的合作模式也在發生變化。在您看來，醫藥企業在開展研發與生產合作時，有著哪些變化？

盧羽：一個明顯的變化，是醫藥企業對合作伙伴角色的認識發生了轉變。過去，研發和生產合作更多被視為外包服務，而現在則越來越多地被視為一種戰略協作關系。這一轉變主要由三個關鍵需求所驅動，即創新療法的需要、對于全球質量的要求、以及項目開發的速度。

首先，療法本身正變得更加復雜。隨著新藥研發的邊界拓展至靶向蛋白降解、多肽、寡核苷酸以及復雜偶聯物等新型分子類型，相關的研發項目相比以往，也需要更專業的化學能力、全新的生產技術，以及覆蓋多個研發階段的綜合經驗。在這樣的背景下，合作伙伴不僅需要具備執行能力，還需要提供科學洞察和解決問題的能力。

其次，越來越多的企業從立項開始，就在規劃未來的全球新藥開發計劃。這意味著合作伙伴需要在統一的全球質量體系下開展工作，且能夠滿足不同地區的監管要求，從而確保項目從開發到商業化供應的順利銜接。

第三，速度在當下也變得尤為關鍵。客戶希望在不犧牲質量的前提下，更高效地推進項目進展，因為每一個項目背后，都有等待新治療方案的患者。

舉一個最近的例子。一家開發復雜雙靶點siRNA-GalNAc偶聯藥物的客戶找到我們，希望在8個月內完成支持IND申報所需的完整CMC工作。該項目面臨諸多挑戰，比如，分子的復雜性導致單鏈合成、純化后的產率及純度均較低。雙鏈的雜質譜復雜且不穩定，為分析方法開發帶來不小的挑戰。

針對這些問題，我們與客戶密切合作，共同尋找解決方案。在合成工藝開發環節，我們的團隊憑借豐富的項目經驗，快速確定了適用的固載及合成策略，將正義鏈粗品純度提升了超85%，最終收率提升了超90%。同時，團隊開發出穩健的分析方法，將關鍵雜質與主峰成功分離。此外，多支內部團隊并行推進開發工作，使從原料藥到制劑的工藝開發、分析研究和生產準備能夠同步開展。最終，我們按時交付了IND申報所需的材料，幫助客戶順利達成關鍵里程碑。

在這樣的背景下，一體化平臺的重要性愈發凸顯。通過在統一的全球質量體系中打通化學開發、生產制造與供應環節，各團隊可以并行推進工作，提前預判研發過程中可能存在的挑戰。這樣才能保持高質量的同時，更加高效地推進研發項目。

Fierce Biotech：創新治療模式需要全新的化學和生產技術。藥明康德近年來在這些方面建設了哪些新能力？

盧羽：過去幾年，我們重點建設了一系列關鍵技術平臺，以解決創新藥物開發過程中遇到的技術挑戰。

其中一個重要平臺是流動化學（flow chemistry）技術。它能實現連續化生產，提升化學反應的控制能力、安全性以及規模化生產效率，尤其適用于復雜反應。另一個關鍵平臺則是生物酶催化技術。通過應用新型酶和超高通量篩選技術，我們能夠優化多肽和寡核苷酸這類復雜分子的合成路線。

此外，在多肽和寡核苷酸方面，我們的能力也在不斷演進。在多肽領域，我們開發了多種一體化工藝路徑，通過將固相合成與液相合成相結合（SPPS–LPPS混合策略）來提升效率；在下游環節，我們根據具體多肽分子的特性和開發需求，靈活采用先進的純化及API分離技術，如切向流過濾（TFF）、連續流色譜及噴霧干燥，助力提高收率、工藝穩定性和可擴展性。

在寡核苷酸領域，我們同樣開發了多種創新工藝技術。比如固相與液相合成（SPOS和LPOS），酶促合成等進一步拓展合成復雜序列的效率；在下游純化與分離方面，我們采用薄膜蒸發（TFE）、連續流色譜等創新技術，簡化下游處理流程、減少工藝步驟。

在此基礎上，我們不斷強化制劑（DP）能力，以應對遞送方面的挑戰。在多肽領域，我們支持從臨床前到商業化階段的口服和注射劑開發與生產。截至目前，我們已支持超70個臨床前及10多個臨床階段的口服多肽項目開發。在寡核苷酸方面，我們的脂質納米顆粒（LNP）等遞送技術也能有效提升療效，拓寬藥物治療范圍。此外，我們近期在中國及瑞士的多個基地持續提升噴霧干燥產能，更好地助力合作伙伴解決復雜分子在生物利用度方面的挑戰。

綜合來看，這些能力使我們能夠為新分子項目提供從早期開發到商業化生產的一體化支持，幫助客戶有效應對療法的復雜性，也能更高效地推動項目走向患者。

Fierce Biotech：您提到了泰興和庫威的基地。在您看來，藥明康德的全球化網絡能怎樣更好地推進客戶的研發項目？能否分享一個具體案例？

盧羽：我們的目標是幫助客戶順利實現從研發到生產的轉化，同時保持供應的靈活性和穩健性。而我們的全球化基地，可以通過不同的能力，將新技術轉化為可規模化的解決方案，高效推進客戶的項目。

例如，前面提到的瑞士庫威基地提供口服固體制劑生產以及包裝和標簽服務，使客戶能夠向全球市場供應成品藥。目前，該生產基地正在支持多款商業化產品，供應瑞士、美國、歐盟、英國、日本、澳大利亞、加拿大、新西蘭和中國等市場。同時，全新的PSD-4噴霧干燥生產線預計將于今年第四季度在庫威基地投入運行。

▲藥明康德瑞士庫威基地

在美國，正在建設中的特拉華州米德爾頓（Middletown）基地，預計也將在2026年第四季度投入運營。屆時該基地將具備口服固體制劑生產能力，同時還將提供包裝、貼標、配送服務以及分析開發與質量控制檢測。2027年，米德爾頓基地還將擴展無菌灌裝能力，包括西林瓶、卡式瓶和預充針生產，從而支持寡核苷酸和多肽等創新藥物開發。

美國圣地亞哥基地在全球供應網絡中同樣發揮著重要作用，提供從原料藥到制劑的一體化服務，以滿足臨床供應需求。

與此同時，位于亞洲的生產基地也在持續擴展布局。以泰興基地為例，該基地目前已投產12個生產車間。此外，兩個全新的小分子原料藥生產車間預計將在2026年投入運營，而用于寡核苷酸、多肽和PMO生產的兩個新車間預計在2027年投產。

我們的新加坡基地也在建設中，同樣預計在2027年投入運營，進一步提升原料藥全球供應的靈活性，更好地支持小分子及寡核苷酸、多肽藥物及相關化學偶聯物商業化生產需求。

此外，無錫制劑基地也在持續提升無菌注射劑研發及生產能力。目前該基地配備5條生產線，其中包括1條高活注射劑生產線，年總產能已超過1億支注射劑，支持西林瓶（水針及凍干粉針）、預充針及卡式瓶的無菌灌裝。

這些基地共同構成了一個全球化的一體化平臺，使客戶可以依托全球網絡下的統一質量體系，完成從研發到商業化生產的全流程。通過持續優化全球運營和一體化平臺，我們能夠滿足不斷增長的客戶需求，同時保持高效和可靠性。

借助全球基地賦能新藥開發項目加速推進的故事每天都在發生，這里我想分享一個臨床3期項目從客戶基地成功轉到瑞士庫威基地生產的案例。當時，多個團隊緊密合作，5個月內快速完成了生產工藝轉移和放大。其中，設備產線的兼容性評估、分析方法驗證以及原材料和包裝材料的采購等，均加速提前完成。最終，通過提前協調規劃及無縫平行推進，該項目憑借高效執行得以圓滿完成，這使得客戶能夠按時提交NDA（New Drug Application，新藥上市申請），該藥已經成功獲批上市。

Fierce Biotech：面對如此廣泛的全球生產布局，如何確保不同地區始終保持一致的質量與監管合規標準？

盧羽：質量始終是我們所有工作的基礎。隨著全球業務的不斷拓展，確保不同地區之間保持一致的質量標準，是我們的核心重點之一。

為此，我們建立了名為“One Global Quality System”的全球統一質量體系，在所有基地之間統一質量標準、操作流程和培訓體系。各基地遵循統一的GMP規范和標準化操作程序，從而確保全球范圍內的研發和生產活動都符合一致的質量與監管要求。

這一體系的重要組成部分是全球數字化平臺，用于管理質量文件和相關數據。通過從傳統紙質體系轉向數字化系統，信息能夠在不同基地之間實現一致的共享和解讀，使各團隊在質量要求方面形成統一的理解和執行標準。

這一體系也在實際監管檢查中得到了驗證。僅2025年，藥明康德就接受了741次來自全球客戶、監管機構及第三方的質量審計和檢查，無嚴重發現項。這說明我們的質量夠硬。

Fierce Biotech：感謝您的分享。展望未來，哪些創新領域最讓您感到興奮？

盧羽：未來幾年的藥物創新非常令人期待。我們看到多個領域正在迅速發展，持續重塑新藥的開發方式。

例如，多肽藥物正在改變代謝性疾病的治療模式，而多肽偶聯藥物等新型靶向遞送技術也在不斷拓展精準醫學的應用前景。同時，寡核苷酸療法正從罕見病治療逐步拓展至心血管疾病和神經系統疾病等更廣泛的治療領域。

這些進展為行業帶來了新的機遇，同時也對化學技術、遞送方法、生產模式以及供應體系提出了更高要求。

通過持續強化自身能力、建設全球基地、并與合作伙伴緊密協作，我們希望為客戶同時提供速度、質量和價值優勢，也讓更多創新療法更快惠及全球患者。

How WuXi AppTec’s Integrated Platform Is Helping Therapies Move Faster from Discovery to Patients

Drug discovery is entering a new phase of complexity. From peptides and oligonucleotides to targeted protein degraders and other emerging modalities, many of today’s therapies require advanced chemistry, specialized manufacturing technologies and coordinated execution to move from concept to clinic.

To help innovators address these challenges, WuXi AppTec has built an integrated CRDMO platform that connects discovery, development and manufacturing capabilities across multiple regions. By bringing these functions together within a unified system, the platform enables drug developers to advance programs more efficiently, reduce operational handoffs and move promising therapies toward patients faster.

Recently, Fierce Biotech spoke with Yu Lu, Senior Vice President, Head of WuXi TIDES and WuXi Chemistry Business Operations at WuXi AppTec, about how integrated capabilities, cross-site collaboration and what many clients call “WuXi Speed” are helping advance the next generation of medicines.

Fierce Biotech: As new drug modalities emerge, development and manufacturing partnerships are also evolving. From your perspective, what shifts are you seeing in how pharmaceutical companies approach development and manufacturing collaborations today?

Yu Lu:One of the most significant changes is how pharmaceutical companies view their development and manufacturing partners.What was once treated simply as transactional, outsourcing has increasingly become a strategic collaboration, driven by three key needs: innovation, global quality, and speed.

First, molecules are becoming more complex. As drug discovery expands into modalities such as targeted protein degradation, peptides, oligonucleotides, and complex conjugates, programs require specialized chemistry, new manufacturing technologies, and expertise across multiple stages of development. In this context,partners are expected not only to execute, but also to contribute scientific insight and problem-solving capabilities.Second, more companies are planning for global drug development and launch.This requires partners who can operate under consistent global quality systems and meet regulatory expectations across regions, ensuring a smooth path from development to commercial supply.

Third, speed has become critical.Clients are looking for ways to move programs forward more efficiently, without compromising quality, because behind every program are patients waiting for new treatment options.

Let me share a recent example.A client developing a complex divalent-siRNA-GalNAc conjugate approached us with the need for a complete CMC package to support an IND filing within just 8 months.The complexity of the conjugate led to low yield and purity in single-strand synthesis and purification. Additionally, the impurity profile of the duplex was complicated and unstable, posing significant challenges for analytical method development.

Our approach was to work closely with the client, addressing these challenges collaboratively while leveraging our expertise. Our team, drawing on extensive project experience, quickly identified suitable solid support and synthesis strategies.This increased the purity of the crude sense strand by more than 85% and enhanced the final yield by over 90%.The team also developed a robust analytical method to ensure that key impurities could be separated from the main peak. Simultaneously, multiple in-house teams coordinated development activities from API to drug product, ensuring alignment and progress.As a result, we delivered the necessary materials for the IND filing on schedule, enabling the client to meet their milestones.This is where an integrated platform can make a real difference.By connecting chemistry development, manufacturing, and supply within a unified system, teams can operate in parallel, anticipate challenges, and maintain consistent quality across regions.The result is faster, more reliable progression from discovery to patient access—without compromising the standards required for global development.

Fierce Biotech: To meet the requirement of these new modalities, the underlying chemistry and manufacturing technologies also need to evolve. What are some of the key capabilities WuXi AppTec has been building to support this?

Yu Lu:Over the past several years, we have focused on developing enabling technologies that help address the technical challenges associated with newer drug modalities.

One important area is flow chemistry, which, as you know, enables continuous manufacturing processes that improve reaction control, safety and scalability, particularly for complex or hazardous reactions.Another key capability is biocatalysis.By applying novel enzymes and ultra-high throughput screening technologies, we can streamline synthetic routes for challenging molecules, including small molecules, peptides and oligonucleotides.

Our capabilities in peptides and oligonucleotides also continue to advance alongside the growing complexity of these modalities.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.

These advances are complemented by growing drug product capabilities designed to address delivery challenges.For peptides, we support both oral and parenteral drug product development and manufacturing from preclinical through commercial stages. So far, our team has supported over 70 preclinical and more than 10 clinical phase oral peptide projects. For oligonucleotides, delivery technologies such as lipid nanoparticles (LNPs) play a critical role in improving therapeutic performance.

In addition, we recently expanded spray drying capacity across multiple sites in China and Switzerland, helping address bioavailability challenges for increasingly complex molecules.

Together, these capabilities enable us to support new modality programs from early development through manufacturing, helping clients navigate increasing complexity while advancing their programs more efficiently toward patients.

Fierce Biotech: How does WuXi AppTec’s global site footprint support clients as programs move toward manufacturing and commercialization? Could you share a specific example?

Yu Lu:Infrastructure is essential for translating new technologies into scalable solutions. Our goal is to help clients move smoothly from development into manufacturing while maintaining flexibility and operational resilience.

In Couvet, for example, we provide oral solid dosage manufacturing as well as packaging and labeling capabilities, allowing clients to supply finished drug products to global markets. In recent years we have expanded both manufacturing and packaging capacity there to support larger programs and increasing commercial demand. Today, the facility supplies multiple commercial drug products to Switzerland, the United States, European Union (EU), the United Kingdom, Japan, Australia, Canada, New Zealand, and China. A new PSD-4 spray dryer is expected to become operational in Q4 this year.

▲WuXi AppTec’s site in Couvet, Switzerland

In the U.S., our Middletown, Del., campus, is expected to become operational in Q4 of this year. At that time, it will provide oral solid dosage manufacturing capabilities. The site will also offer packaging, labeling, distribution services and analytical development with quality control testing. Sterile fill-finish manufacturing will be available in 2027, and include vials, cartridges and prefilled syringes. These capabilities will support new modalities such as oligonucleotide and peptide drug products. Our San Diego site acts as another critical hub, enabling a seamless, integrated transition from API to drug product manufacturing for clinical supply.

Meanwhile, we continue to expand API manufacturing capabilities at our sites in Asia. There are 12 manufacturing plants currently operational at our Taixing site. Two new small molecule API plants are expected to become operational this year, and two additional plants dedicated to oligonucleotide, peptide and PMO production are currently under construction and scheduled to be operational in 2027.

Our Singapore site, currently under construction and also will be operational in 2027, will further enhance our global API manufacturing network for both small molecule and TIDES drugs.

Our Wuxi City site has continued to expand its sterile injectable formulation and manufacturing capabilities in recent years. Now featuring five injectable lines, including one dedicated to high potency drugs, the site's total annual capacity exceeds 100 million units. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges.

Together, these locations operate as part of a single integrated platform. Instead of coordinating work across multiple vendors, clients can rely on a unified global network with one global quality system that supports their programs from development through commercialization. Through continuous optimization of our global operations and integrated platform, we are able to accommodate increasing demand while maintaining high efficiency and reliability.

One example that comes to mind involved WuXi AppTec’s successful mobilization of our Couvet site to manufacture a drug in Phase 3 clinical trials that the client had handled at its own site before ramping up production.Multiple teams collaborated closely, completing the manufacturing process transition and scale-up within five months. Detailed planning covered equipment compatibility assessments, analytical method validation, and procurement of raw and packaging materials — all completed well ahead of schedule.Through coordinated planning and parallel execution, this project was flawlessly completed through efficient work that enabled the client to submit the NDA (New Drug Application) on time. The drug was subsequently approved for market launch.

Fierce Biotech: With such a broad manufacturing footprint, how do you ensure consistent quality and regulatory compliance across regions?

Yu Lu:Quality is fundamental to everything we do. As our operations have expanded internationally, maintaining consistent quality standards across regions remains a top priority.

To support this,we implemented “One Global Quality System,” which aligns quality standards, procedures and training across all sites.Instead of each location operating under separate local processes, teams follow a shared framework of GMP practices and standardized procedures. This assures that work performed in different regions meets the same expectations for quality and regulatory compliance.

An important part of this system is the use of global digital platforms to manage documentation and quality data. Moving away from paper-based processes allows information to be shared and interpreted consistently across sites, helping teams operate with a common understanding of quality requirements.

This framework has also been validated through regulatory inspections.In 2025 alone, WuXi AppTec underwent 741 quality audits conducted by global clients, regulatory authorities, and independent third parties, with zero critical findings.

Fierce Biotech: Looking ahead, what areas of innovation are you most excited about?

Yu Lu:The next few years will be very exciting for therapeutic innovation. We are seeing rapid progress in several areas that are reshaping how medicines are developed.

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. At the same time, oligonucleotide therapeutics are moving beyond rare diseases into broader areas including cardiovascular and neurological conditions.

These advances create new opportunities, but they also require new chemistry and drug delivery technologies, manufacturing approaches and supply chain solutions.

Our focus is to continue strengthening our integrated platform so that clients can develop and manufacture these next-generation medicines more efficiently. By combining global infrastructure, new technologies and close collaboration with our partners, we aim to deliver speed, quality and value while helping innovative therapies reach patients around the world.

參考資料：

[1] How WuXi AppTec’s Integrated Platform Is Helping Therapies Move Faster from Discovery to Patients. Retrieved April 20, 2026 from https://www.fiercebiotech.com/sponsored/how-wuxi-apptecs-integrated-platform-helping-therapies-move-faster-discovery-patients

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