編者按

瑞士，是全球生物醫(yī)藥創(chuàng)新的重要高地。憑借卓越的科研能力與高度國際化的合作環(huán)境，這片土地既吸引了大型跨國藥企，也培育了眾多生物科技新銳。

作為創(chuàng)新賦能者，藥明康德已深度融入這一充滿活力的生態(tài)圈。我們的瑞士庫威（Couvet）基地正依托一體化CRDMO業(yè)務(wù)模式，賦能全球藥企加速研發(fā)進程。

近期，藥明康德高級副總裁，制劑研發(fā)和生產(chǎn)業(yè)務(wù)部負(fù)責(zé)人陳金玲博士接受了德國媒體VC Magazin專訪。作為深耕行業(yè)二十余年的資深專家，陳博士深入解讀了CRDMO模式的價值，并分享了瑞士庫威基地如何構(gòu)建穩(wěn)健的能力體系，以高效應(yīng)對復(fù)雜研發(fā)挑戰(zhàn)。

無論是在歐洲、北美還是亞洲，藥明康德正持續(xù)賦能全球合作伙伴，加速創(chuàng)新轉(zhuǎn)化，讓更多突破性療法更快惠及患者。

以下是報道節(jié)選的編譯。點擊“閱讀原文/Read More”即可訪問原文頁面。

01

CRDMO模式的獨特價值

VC Magazin：在生命科學(xué)領(lǐng)域，初創(chuàng)企業(yè)往往面臨高昂的實驗室建設(shè)和運營成本。專注于開發(fā)和生產(chǎn)的CDMO，以及專注于研究的CRO，通常是其常見的合作伙伴。而藥明康德的CRDMO模式集成了兩者，這一模式能為客戶帶來哪些價值？

陳金玲博士：藥物開發(fā)與生產(chǎn)密不可分。商業(yè)化生產(chǎn)的成功與否，在很大程度上取決于前端開發(fā)工藝的穩(wěn)健性。藥明康德的CRDMO模式將研究（R）、開發(fā)（D）和生產(chǎn)（M）深度整合。這種“一體化”的優(yōu)勢在于，我們在藥物發(fā)現(xiàn)階段進行篩選時，就已經(jīng)充分評估了后續(xù)開發(fā)的可行性；同樣，在開發(fā)階段，我們也前瞻性地納入了對生產(chǎn)制造的考量。這不僅有助于提高新藥注冊申報的成功率，也能打磨出穩(wěn)健的生產(chǎn)工藝，從而實現(xiàn)從研發(fā)到生產(chǎn)的平穩(wěn)過渡與穩(wěn)定的商業(yè)化供應(yīng)。

歸根結(jié)底，CRDMO模式通過開發(fā)與生產(chǎn)環(huán)節(jié)的“無縫銜接”，幫助客戶顯著節(jié)約時間、降低成本并有效規(guī)避風(fēng)險。

VC Magazin：與其他服務(wù)提供商相比，藥明康德的CRDMO模式有何獨特之處？為何對中小型公司特別有吸引力？

陳金玲博士：我們的優(yōu)勢在于真正的“一體化”能力，將藥物發(fā)現(xiàn)、開發(fā)和生產(chǎn)整合于同一個平臺，能顯著減少不同環(huán)節(jié)間的轉(zhuǎn)移摩擦，同時確保質(zhì)量始終如一。

行業(yè)內(nèi)常見的是“先有D再補M”或“拼湊式”能力擴展，而我們的能力是伴隨業(yè)務(wù)自然延伸并高度協(xié)同形成的。這意味著我們能提供真正“端到端”的服務(wù)——覆蓋原料藥、制劑生產(chǎn)以及分析測試，分子類型從傳統(tǒng)小分子延伸到寡核苷酸、多肽及偶聯(lián)藥物等各類新分子。

此外，橫跨亞洲、歐洲和北美的全球運營網(wǎng)絡(luò)，使我們能為全球客戶提供高效且高品質(zhì)的服務(wù)。

對于中小型公司而言，我們獨特的“一體化”平臺顯著降低了管理復(fù)雜性，節(jié)約了時間與成本，使他們能更專注于自身的科學(xué)創(chuàng)新。

VC Magazin：在您看來，CRDMO模式為患者帶來了什么價值？

陳金玲博士：CRDMO模式的核心價值在于，以高質(zhì)量標(biāo)準(zhǔn)加速創(chuàng)新藥物惠及患者，為他們提供更優(yōu)質(zhì)、更及時的治療選擇。這既是CRDMO模式的使命，也契合藥明康德“讓天下沒有難做的藥，難治的病”的愿景。

02

賦能歐洲生態(tài)，服務(wù)全球客戶

VC Magazin：作為藥明康德全球CRDMO網(wǎng)絡(luò)中的關(guān)鍵節(jié)點，瑞士庫威基地主要服務(wù)哪些客戶？這一選址有何獨特優(yōu)勢？

陳金玲博士：庫威基地服務(wù)的是全球客戶群體，不僅面向歐洲，更廣泛地覆蓋北美、亞洲等世界各地。在這里生產(chǎn)的創(chuàng)新藥物，最終也將造福全球患者。

選址歐洲中部，特別是落戶瑞士的優(yōu)勢十分顯著：這里匯聚了全球生物技術(shù)和制藥行業(yè)的頂尖人才，我們得以組建一支卓越的專業(yè)團隊。同時，瑞士完善的產(chǎn)業(yè)環(huán)境，有助于我們維持高標(biāo)準(zhǔn)的質(zhì)量體系，并配備一流的生產(chǎn)設(shè)施，從而為客戶持續(xù)提供卓越的服務(wù)。

VC Magazin：在歐洲布局生產(chǎn)能力，將如何進一步賦能生命科學(xué)行業(yè)及其整個生態(tài)圈的發(fā)展？

陳金玲博士：歐洲本身就擁有深厚的創(chuàng)新土壤。卓越的基礎(chǔ)研究、完善的基礎(chǔ)設(shè)施以及活躍的投資環(huán)境交匯于此，加速了早期概念向患者療法的轉(zhuǎn)化。

藥明康德在歐洲的生產(chǎn)基地常態(tài)化接受監(jiān)管機構(gòu)的嚴(yán)格審查。這種高標(biāo)準(zhǔn)的合規(guī)記錄，為申辦方在后期工藝開發(fā)、生產(chǎn)和供應(yīng)方面提供了信心，這無疑是一個顯著優(yōu)勢。此外，歐洲優(yōu)越的地理位置，使得藥品在臨床和商業(yè)化階段的物流觸達都非常便捷，進一步增強了該地區(qū)推動全球生命科學(xué)生態(tài)圈發(fā)展的潛力。

03

以穩(wěn)健能力賦能創(chuàng)新

VC Magazin：在與初創(chuàng)企業(yè)的合作中，他們通常反饋的挑戰(zhàn)有哪些？藥明康德如何協(xié)助解決？

陳金玲博士：初創(chuàng)企業(yè)普遍面臨幾類挑戰(zhàn)。首先是資源有限，資金與人員規(guī)模受限。其次是經(jīng)驗不足，往往缺乏貫穿整個開發(fā)鏈條的實踐積累。盡管團隊精簡，但他們研發(fā)項目的復(fù)雜性并未因此降低。事實上，許多現(xiàn)代藥物分子的結(jié)構(gòu)日益復(fù)雜，可能帶來人體內(nèi)的溶解度差、滲透性弱和生物利用度低等難題。

為應(yīng)對這些挑戰(zhàn)，藥明康德依托深厚的技術(shù)積累和規(guī)模化能力，為其提供解決方案。2025年，藥明康德為客戶成功合成并交付超過42萬個新化合物，其中小分子CDMO管線中在研分子超過3400個。豐富的項目經(jīng)驗讓我們構(gòu)建了穩(wěn)健的能力體系，能夠高效應(yīng)對各類研發(fā)挑戰(zhàn)。

為有效管理復(fù)雜項目，我們持續(xù)擴大投入，建能力、擴規(guī)模。我們的基地配備了先進的設(shè)施、自動化系統(tǒng)以及完善的質(zhì)量體系，這些都是保障后期商業(yè)化生產(chǎn)成功的關(guān)鍵所在。同時，我們還應(yīng)用前沿技術(shù)手段應(yīng)對大分子與復(fù)雜分子的特定挑戰(zhàn)。

正是這些持續(xù)的投入和全面的能力，讓我們能夠賦能客戶將候選化合物快速推進至臨床研究及后續(xù)開發(fā)階段。

VC Magazin：在庫威基地，藥明康德如何保障知識產(chǎn)權(quán)和數(shù)據(jù)隱私，確保客戶信息的安全與合規(guī)？

陳金玲博士：知識產(chǎn)權(quán)（IP）保護是我們運營的基石，更是客戶成功的生命線。無論是在庫威基地，還是藥明康德的全球網(wǎng)絡(luò)，我們利用多重工具和方法嚴(yán)密守護客戶的IP，以此贏得合作伙伴的信賴。從入職第一天起，所有員工都必須接受嚴(yán)格的IP保護培訓(xùn)。我們恪守全球標(biāo)準(zhǔn)，對違規(guī)行為采取“零容忍”態(tài)度，并在每一個運營基地推行統(tǒng)一的最佳實踐，以高度的一致性，筑牢客戶信任。

‘We’ve built robust capabilities to tackle a wide range of issues efficiently’

At WuXi AppTec’s Couvet site in Switzerland, an integrated CRDMO approach is being designed to accelerate the path from discovery to commercial manufacturing. Dr Jinling Chen explains how combining research, development, and manufacturing helps life sciences companies bring innovative medicines to patients more swiftly and more reliably.

VC Magazin: Life sciences involve laboratory and organisational costs that a start-up must cover in its early stages. CDMOs, which focus on development and manufacturing, as well as CROs specialising in research, are a strong alternative. In your CRDMO model, you combine both. What exactly does CRDMO deliver?

Chen: Pharmaceutical development and manufacturing are closely related, and the success of manufacturing strongly depends on the robustness of the development process. The CRDMO model integrates research (R), development (D), and manufacturing (M), ensuring that choices made during discovery are informed by development feasibility, and that manufacturing considerations are taken into account during the development phase. This approach helps ensure not only successful filing for approval but also a robust manufacturing process. This leads to a smooth transition to the manufacturing stage and reliable commercial supply of the material. Ultimately, the CRDMO model saves time, reduces costs, and mitigates risks by tightly linking development and manufacturing.

VC Magazin: What differentiates your CRDMO model from other providers, and why is it particularly attractive for smaller companies?

Chen: Our CRDMO stands out because it integrates the entire process from drug discovery, development, and manufacturing into one organisation, helping eliminate handoffs, while ensuring unwavering quality. Unlike other providers that may start with development (D) and then move to manufacturing (M) or vice versa, we have grown these capabilities together organically. This means we can offer comprehensive services, including drug substance production, drug product manufacturing, and analytical testing, for a wide range of products from small molecules to oligo, peptides, and conjugates. Additionally, our global operations span from Asia to Europe and North America, allowing us to provide efficient and high-quality services to our customers and partners worldwide. This all-in-one approach is particularly attractive for smaller companies as it reduces complexity, saves time, and lowers costs.

VC Magazin: Your site in Couvet, Switzerland, plays an important role for your CRDMO platform. Who belongs to your customer base in Switzerland, and what distinguishes this location?

Chen: Our Couvet site serves a global customer base. We have clients from North America, Europe, Asia, and other parts of the world. So, it’s not just European customers; the medicines enabled by us are intended for global use. Having the site in Central Europe, specifically in Switzerland, is advantageous because it allows us to attract top talent in the biotech and pharmaceutical industry. Additionally, the location enables us to maintain high-quality systems and top-notch equipment. This helps us deliver the best quality to our customers.

VC Magazin: What advantages do European manufacturing facilities offer for the life sciences industry and its ecosystem?

Chen: The dedication of Europe’s innovation hubs to accelerate translation of early-stage ideas into patient therapies has been well demonstrated in terms of the excellent basic research, infrastructure, and dynamic investments. Our European manufacturing facilities are routinely inspected by regulatory authorities. These inspections provide sponsors with greater confidence in late-stage process development, manufacturing, and supply, which is a significant advantage. Additionally, Europe’s geographic location allows for easy access to medicines at both clinical and commercial stages, further enhancing its potential in advancing the life sciences industry and its ecosystem.

VC Magazin: What challenges do the start-ups you collaborate with report, and how do you address them?

Chen: Start-ups typically face several challenges. Firstly, there are the limited resources; they often have constrained financial resources and a small team. Secondly, there’s often a lack of experience in all aspects of development. Although the complexity of their projects does not decrease just because the team is small. Many modern molecules have very complex structures, which can lead to issues such as poor solubility, permeability, and low bioavailability in human bodies. To address these challenges, we leverage our extensive expertise and capacity. WuXi AppTec handles more than 420,000 compounds each year with more than 3,400 molecules in our small molecule CDMO pipeline. We’ve built robust capabilities to tackle a wide range of issues efficiently. We’ve also made significant investments in expanding our capabilities and capacities to manage complex projects effectively. Our sites are equipped with state-of-the-art facilities, automated systems, and quality systems, which are crucial for late-stage commercial manufacturing. Additionally, we use advanced technical tools to address specific challenges related to large complex molecules. All these investments and capabilities enable us to help our clients advance their compounds quickly into clinical studies and subsequent stages of development.

VC Magazin: From your perspective, what added value does CRDMO ultimately bring for the end customer – the patient?

Chen: The CRDMO model is about helping innovative medicines reach patients faster while maintaining the highest standards of quality. This means enabling better treatment options for patients. That is central to both the mission of our CRDMO model and the vision of WuXi AppTec: ‘every drug can be made, and every disease can be treated’.

VC Magazin: How does WuXi AppTec handle intellectual property and data privacy at the Couvet site to ensure client confidentiality and regulatory compliance?

Chen: Intellectual property (IP) protection is fundamental to our operations and to our customers’ success. We safeguard customers’ IP using numerous tools and methods, fostering trust with our valued partners – not just at the Couvet site, but across the entire WuXi AppTec network. From day one, all teams are trained on IP protection. We adhere rigorously to global standards, have zero tolerance for non‐compliance, and require that every site employ uniform best practices to ensure consistency and trust.