藥明康德Co-CEO楊青博士：從科學發現到產業化落地，CRDMO如何賦能歐洲創新生態 | Bilingual

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長期以來，歐洲擁有深厚的科研積淀，活躍的創新生態，持續孕育著大量科學發現成果和生物技術集群。

然而，一個現實問題愈發受到關注：為什么歐洲擁有優秀的科學研究基礎，卻仍有不少創新成果、人才和資本流向其他地區？如何進一步釋放歐洲創新潛力？

日前，在德國柏林舉行的bio:cap生命科學與AI創新投資大會上，圍繞“如何加速歐洲創新”這一核心議題，藥明康德聯席首席執行官楊青博士受邀發表主題演講，分享了他的觀察與思考。

在楊青博士看來，歐洲生物醫藥產業當前面臨的核心課題并非科學創新不足，而是如何提升從早期科學發現到產業化落地的轉化效率。

作為歐洲創新生態圈的長期參與者與賦能者，藥明康德正依托“一體化、端到端”的CRDMO平臺，助力行業伙伴提升創新成果轉化與執行效率，讓更多科學發現更穩健、更高效地走向商業化生產，更快抵達全球患者。

以下是演講實錄。

從科學發現到產業化：歐洲創新面臨“轉化缺口”

歐洲歷來是全球基礎科學研究的重鎮，匯聚了眾多高水平的科研機構、優秀的科研人才，以及源源不斷的早期創新項目儲備。

然而，歐洲當下面臨的挑戰，并非缺乏基礎研究與發現，而是在成果轉化與產業化環節存在斷層。一個值得行業共同思考的問題是：如何將歐洲的科研優勢，轉化為具有投資價值、能夠實現規模化生產的藥物，并最終更快惠及患者？

種種信號清晰可見。英國、德國、瑞士等歐洲各地的創新中心持續釋放活力，大量創新項目和初創企業不斷涌現。然而，歐洲吸引的全球生物醫藥資本卻相對有限：63%流向了美國，而歐洲僅占7%。同時，歐洲臨床試驗的全球份額已從22%降至12%，許多有潛力的創新企業選擇在歐洲以外的地區上市或擴大規模。

造成這一現象的重要原因之一，是基礎研究與新藥研發項目啟動之間仍然存在一定的轉化斷層。正是這一“轉化缺口”，使得資金、人才以及創新資源持續流向其他市場。人們常常將歐洲與波士頓等成熟創新中心進行比較，問題并不在于歐洲缺乏創新想象力，而在于是否具備足夠的能力、經驗和資源，幫助創新成果順利跨越從科學發現到產業化落地的關鍵階段。

如今，資本不僅關注科學創新本身，也越來越看重執行落地的能力。投資者的關注焦點已經發生轉變：運營準備度、可生產性以及可控的研發進度，其重要性已不亞于科學的新穎性。尤其是在風險偏好相對審慎的歐洲市場，企業能否展示明確的CMC（化學、生產和控制）開發路徑、可靠的生產能力布局以及清晰的監管策略，往往會對融資和項目推進產生重要影響。

這也為產業生態中的賦能者創造了機遇。通過提供工藝開發、專業經驗、針對新分子療法及化合物的難題解決能力，以及穩健的質量體系，一體化CRDMO平臺和創新產業集群能夠幫助企業提升項目的投資價值。

對于創新企業而言，盡早引入具備相關能力和經驗的合作伙伴，有助于延長資金使用周期并加速達成關鍵里程碑；對于投資機構而言，若能優先評估這些能力，將有助于識別出具備規模化潛力的創新項目。

如果歐洲希望進一步提升創新轉化效率，有三個關鍵因素需要協同推進：一體化能力、完善的產業基礎設施，以及深度融入本地創新生態。

一體化協同：加速創新成果轉化

一體化意味著，我們不能再將藥物研究、開發和生產視為孤立的短跑，而應將其視為一場協同推進的接力賽。現實中，許多項目的推進往往在交接環節停滯：工藝轉移受阻、監管文件延誤，發展勢頭也會隨之減弱。

當藥物發現科學家、工藝開發團隊和生產工程師，使用統一的標準和數字化工具開展協同工作時，技術轉移便不再是制約項目推進的瓶頸。團隊能夠在不消耗過多資源的情況下，迅速積累經驗、學習并靈活調整方向，從而把握影響商業化成功的關鍵時間窗口。因此，找到能夠共同快速推進創新項目的合作伙伴至關重要。

我想再次強調，速度已經不僅僅是效率問題，更是影響產業競爭力的重要因素。在當今生物技術行業，資本、人才以及創新項目往往都會向執行效率更高的生態體系集聚。

與美國以及近年來快速發展的中國市場相比，歐洲創新生態仍面臨一些挑戰，例如服務體系相對分散、融資周期較長以及運營復雜度較高等。而這些挑戰最終都會影響創新成果的轉化效率，進而影響患者：關鍵里程碑的延遲意味著后續融資更加困難，創新機會也可能隨之流失。

正因如此，CRDMO模式，即覆蓋藥物研究、開發和生產全過程的“端到端、一體化”平臺，能夠帶來切實的改變。通過打通不同環節之間的壁壘，CRDMO幫助創新項目縮短從實驗室到臨床、再到商業化生產的轉化周期，加速創新成果惠及患者。

過去25年來，藥明康德在服務全球客戶的過程中，持續見證了一體化協同與跨區域合作所創造的價值。以最近的一個項目為例，藥明康德瑞士庫威基地承接了一家客戶的3期臨床及商業化生產項目。多個團隊跨區域緊密協作，在5個月內完成了生產工藝轉移和規模化生產，助力客戶按計劃完成新藥上市申請（NDA）遞交并順利獲批。

對于創新企業而言，速度能夠增強投資者對項目的信心；對于投資機構而言，速度則意味著項目具備更強的執行能力和落地潛力。這也再次證明，攜手合作、共建生態圈、摒棄孤島思維，是行業前行并保持競爭力的必由之路。

基礎設施則是執行能力的另一項具象體現。歐洲需要更多能夠支撐創新成果轉化的能力平臺，包括中試生產設施、針對不同技術路線的發展路徑驗證以及商業化生產能力，讓創新企業能夠在本地完成工藝驗證和產業化推進，而無需消耗大量資金自建工廠。這對于企業留在本地成長、擴大規模具有重要意義。

藥明康德將德國慕尼黑基地作為歐洲藥物發現重要樞紐進行長期投入，同時持續擴大瑞士庫威基地的制劑生產能力，正是基于這樣的考量：讓研發發現扎根本地，實現商業化規模生產，并將兩者納入我們的全球運營網絡，以提供靈活高效的產能保障。這既支持了全球采購與供應鏈協作，增強了運營韌性，也有助于在當地留存更多創新價值，同時通過全球網絡實現開放協作與資源高效整合。

質量與信任是推動高效合作的重要基礎。歐洲長期以來在監管體系、質量管理以及數據治理等方面建立了較高標準。這些標準并非流程上的障礙，而是促成高效、安全合作的保障。全球協作依然是推動生物醫藥創新的重要力量，而合作需要建立在透明、合規和高質量的基礎之上。

因此，具備本地運營能力以及可靠合規記錄的合作伙伴尤為重要：當合作各方能夠基于透明可追溯的流程開展合作，并接受持續、嚴格的審查時，信任便會不斷累積。僅2025年，藥明康德就接受了來自全球客戶、監管機構以及獨立第三方的741次質量審查，且無嚴重發現項。持續的高標準質量體系和透明運營，不僅是贏得客戶信任的重要基礎，也為全球創新合作提供了有力支撐。

深耕歐洲生態：藥明康德持續賦能創新轉化

醫藥創新生態不僅需要科學家、創業者和投資人，也需要那些能夠幫助項目降低執行風險而非主導創新方向的賦能者。

CRDMO模式正是重要的賦能力量之一。通過提供端到端的研發與生產能力，CRDMO能夠幫助創新項目跨越從科學發現到產業化落地之間的轉化鴻溝：

它讓初創企業能夠在無需耗費巨資自建全套能力和產能的情況下，便能夠驗證項目的開發路徑和規模化生產可行性；同時，它也為投資人提供了更加清晰的項目執行依據和風險評估基礎。在實踐中，這意味著更少的重復交接、更順暢的項目推進，以及更具可預測性的研發時間表。

在過去的工作中，我曾見證許多項目在研究、開發和生產團隊使用同一套標準協同運作時，實現了顯著加速。許多實際案例表明，原本可能需要數年完成的技術轉移和開發工作，最終在數月內順利完成，從而支持項目按計劃完成注冊申報，并獲得更多投資機構的關注和支持。這些案例并非為單一服務商背書，而是體現了一體化能力對于整個創新生態的系統性價值。

對于新分子類型和新療法而言，這種協同帶來的價值尤為突出。由于這些新分子在合成、分析、純化以及測試過程中仍存在諸多未知挑戰，其開發往往需要不斷迭代。如何縮短學習曲線、提升執行效率，已經成為推動創新成果向前發展的關鍵因素之一。

總結而言，歐洲當前面臨的機遇，在于將強大的科學創新能力與支撐產業化落地的執行體系有效連接起來，使創新成果能夠真正實現投資價值、規模化發展，并最終惠及患者。

當創新企業將執行能力納入創新體系建設，資本更加關注項目落地能力，產業決策者持續推動基礎設施建設與能力共享時，歐洲將不僅能夠持續孕育出色的創新成果，也能夠更高效地將這些成果轉化為真正惠及患者的創新藥物。

藥明康德始終將自身定位為創新生態中的長期賦能者。過去25年來，我們持續建設各類能力平臺，并將這些能力連接成協同網絡，幫助客戶以更高效、更穩健地推進項目。無論是在德國慕尼黑和瑞士庫威的持續投入，還是全球化CRDMO平臺建設，以及長期積累的監管合規記錄，都是我們為創新生態發展所做出的具體努力。

我們的目標并非取代投資機構、產業集群或其他生態參與者，而是通過降低執行風險、提升項目可預見性，幫助創新項目吸引更多資源支持。我們致力于讓創新成果從實驗室走向患者的路徑變得更加順暢、高效和可靠。

早在2016年，也就是十年前，藥明康德通過收購德國慕尼黑的Crelux，首次在歐洲建立了運營實體。如今，慕尼黑基地的團隊規模和實驗室面積均已增長至當年的四倍。通過持續投入，這一基地已經發展成為藥明康德全球平臺中早期生物學發現的重要中心之一。

藥明康德承諾，未來將繼續在歐洲投入更多產能與能力建設，積極參與歐洲創新生態的發展，與產業伙伴共同推動科學成果加速轉化，助力更多創新藥物更快惠及全球患者。

Dr. Steve Yang, Co-CEO of WuXi AppTec: How Can CRDMO Accelerate Innovation in Europe?

Editor's Note

For decades, Europe has been home to world-class scientific research, a vibrant innovation ecosystem, and thriving biotechnology clusters that continue to generate groundbreaking discoveries.

Yet an increasingly important question has emerged: Why do many innovations, talents, and investments still migrate to other regions despite Europe's strong scientific foundation? More importantly, how can Europe further unlock its innovation potential?

At the recent bio:cap Life Science & AI Investival held in Berlin, Germany, Dr. Steve Yang, Co-CEO of WuXi AppTec, delivered a keynote address on the theme of accelerating innovation in Europe, sharing his observations and perspectives on the future of the region's biopharmaceutical industry.

In Dr. Yang's view, Europe's greatest challenge today is not a lack of scientific innovation. Rather, it lies in improving the efficiency with which early-stage discoveries are translated into real-world applications and ultimately commercialized.

As a long-term enabler of Europe's innovation ecosystem, WuXi AppTec leverages its integrated, end-to-end CRDMO platform to help partners enhance execution and accelerate the translation of scientific breakthroughs. By enabling discoveries to move more efficiently and reliably into commercial manufacturing, the company aims to bring innovative therapies to patients around the world faster.

The following is an edited transcript of Steve Yang's remarks.

Bridging the Gap in Translation

Europe has always been a global powerhouse of basic research, world-class labs, brilliant talent and an extraordinary pipeline of early-stage ideas.

The issue we have today is not a shortage of fundamental academic research and discovery. It is a gap in translation and industrialization. The question shaping our decade is simple: how do we turn Europe's scientific excellence into investable, scalable and deliverable medicines and get them to patients faster?

The signals are unmistakable. Hubs across the UK, DACH, and all over the continent are bustling with creativity and early?stage companies. Yet Europe captures only a sliver of global biotech capital: 63% goes to the U.S., only 7% to Europe. The share of clinical trials has declined from 22% to 12% and many promising companies list and scale outside of the region.

The “gap in translation” - the gap between basic research and the initiation of drug discovery and development projects is what drives funders, talent and capital to other markets. As the panelists from the previous panel described and shared their experience, compared Boston to Europe. It's not a problem of imagination; it’s a problem of enabling capabilities and capacities.

Today, capital follows execution, not just science. The investor community has shifted: operational readiness, manufacturability and de?risked timelines now weigh as heavily as scientific novelty. In Europe’s more risk?averse markets, demonstrating credible CMC pathways, manufacturer commitment and mapped regulatory steps can be decisive.

This creates an opportunity for enablers. By offering process development, expertise, experience in problem-solving for new therapeutics modalities and compounds, and robust quality systems, enablers like CRDMOs and clusters make companies more investable.

Founders who partner early preserve runway and accelerate milestones. Investors who prioritize build capabilities distinguish scalable companies from promising concepts.

If Europe is to accelerate, three things must move together:integrated execution, visible and relevant infrastructure, and deep local embeddedness.

Integrated Execution Accelerating the Translation of Innovation

Integrated execution means we stop treating discovery, development and manufacturing as separate sprints and instead run them as one coordinated race. Too often progress stalls at handoffs: project transfers stumble, regulatory files slip, and momentum is lost.

When discovery scientists, process developers, and manufacturing engineers plan and deliver in parallel using shared metrics and digital tools, transfer stops being the choke point. Teams can “fail fast”, learn and pivot without burning runway, and that preserves the time windows that determine commercial success. Finding the right partner to move fast forward together with your ideas is critical.

Speed, I want to emphasize again, speed is a structural competitiveness issue. In biotech today, speed drives where capital, talent, and deal flows.

Compared with the US, increasingly China and European innovation cycles face more challenges due to fragmented service ecosystems, extended funding timelines, and operational complexity. This matters to the patients: missed milestones mean follow-on capital is harder to secure and push opportunities somewhere else.

This is why the CRDMO model - a genuine end?to?end contract research, development and manufacturing organization can change the game as a catalyst and an enabler. By removing silos and delivering a repeatable, integrated process, a CRDMO shortens the transition from lab to clinic, ultimately to market, to patients.

Over 25 years at WuXi AppTec, we have seen what coordinated planning and cross-site execution can accomplish. In one recent case, our Couvet site in Switzerland assumed Phase 3 manufacturing for a customer. Multiple teams collaborating across regions, completing the manufacturing process transition and scaling production in five months, enabled an on?time NDA submission that led to timely approval.

That isn’t a marketing line; it’s the difference between meeting a market window and missing it. For founders and entrepreneurs, that speed converts science into investor confidence. For investors, it converts promise into buildability. This is a testament that partnering up and working together, building one ecosystem and not thinking in silos, is the only way to move forward while becoming competitive.

Infrastructure is another physical expression of execution. Europe needs visible pilot plants, modality?specific roadmaps and commercial manufacturing capacity so founders can validate processes locally without draining runway to build their own facilities. This is how companies stay at the scale here rather than elsewhere.

Our long-term investment in Munich as a European discovery hub, and the expansion in Couvet in Switzerland for drug product manufacturing are purposeful:root discovery locally, scale commercially and link both into our global network to provide flexibility and redundancy.That approach supports global sourcing, strengthens resilience, and helps us keep value in the region while also maintaining openness through a global operating network.

Quality and trust are the moats that make accelerated collaboration possible. Europe has set the gold standard for regulatory compliance, high-quality auditable systems, and strong data governance, not bureaucratic roadblocks - they are safeguards that enable rapid, safe partnerships. Global collaboration remains one of biotech's greatest accelerators, but it must be done transparently and to the highest standards.

That's why a local presence with demonstrated compliance matters: trust grows when partners can rely on auditable processes and consistent inspections. At WuXi AppTec, we see this every year. Last year, we hosted 741 audits from global customers, regulatory authorities and third parties with zero critical findings.

Embedded in Europe's Ecosystem to Accelerate Innovation

A pragmatic point about roles: ecosystems need enablers; this organization — organizations that can de risk execution without a dominating strategy.

In that spirit, the CRDMO model is one such enabler.By offering end-to-end development and manufacturing capabilities, CRDMOs can bridge the gap in translation.

They allow entrepreneurs and founders to test and validate for scale, without the capital cost of building every capability and the capacity in-house. And they offer investors clearer execution evidence. In practice, this means fewer fragile handoffs and more predictable timelines.

I have seen many programs accelerate when discovery, development and manufacturing teams operate on the same playbook. Many concrete examples from my experience show transitions completing in months rather than years, enabling on-time regulatory filings and better investor traction. Those examples are not an endorsement of any single provider. Instead, they illustrate the system value of integrated capability.

Such acceleration is even more important for therapeutic compounds in new modalities. These new modalities, they usually require iterative learning to progress, as there are so many unknowns to synthesize, analyze, purify, and test those new modality compounds.

To summarize, Europe’s opportunity is to connect scientific strength with the execution infrastructure that makes innovation investable, scalable, and deliverable.

If entrepreneurs and founders treat execution as part of their craft, if investors reward build?ability alongside novelty, and if clusters and policymakers invest in visible pathways and a shared capacity, Europe will not only continue to produce brilliant ideas, but increasingly to industrialize them into medicines and treat patients faster.

At WuXi AppTec, we see our role as a long-term enabler of that transition as part of the ecosystem.For 25 years, we have built capabilities and connected them into networks that help teams move faster and more predictably. Our investment in Munich and Couvet, our global CRDMO platform and our track record of regulatory compliance are practical contributions to a healthier ecosystem.

Not to replace funders or clusters, but to help them de-risk execution and attract capital.We aim to be the partner that makes the pathway from discovery to patient simpler, faster, and more reliable.

In 2016, ten years ago, we established our first presence in Europe through the acquisition of Crelux in Munich. Today, Crelux has quadrupled in headcount and lab space. Through our additional investment, it has become a global center of excellence in discovery biology on our global platform.

At WuXi AppTec, we are committed to building more capability and capacity in Europe and to contributing as a member of the European enabler community and ecosystem. Together with global partners, we will move from producing great ideas to delivering great medicines at scale to patients.

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