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长期以来,欧洲拥有深厚的科研积淀,活跃的创新生态,持续孕育着大量科学发现成果和生物技术集群。

然而,一个现实问题愈发受到关注:为什么欧洲拥有优秀的科学研究基础,却仍有不少创新成果、人才和资本流向其他地区?如何进一步释放欧洲创新潜力?

日前,在德国柏林举行的bio:cap生命科学与AI创新投资大会上,围绕“如何加速欧洲创新”这一核心议题,药明康德联席首席执行官杨青博士受邀发表主题演讲,分享了他的观察与思考。

杨青博士看来,欧洲生物医药产业当前面临的核心课题并非科学创新不足,而是如何提升从早期科学发现到产业化落地的转化效率。

作为欧洲创新生态圈的长期参与者与赋能者,药明康德正依托“一体化、端到端”的CRDMO平台,助力行业伙伴提升创新成果转化与执行效率,让更多科学发现更稳健、更高效地走向商业化生产,更快抵达全球患者。

以下是演讲实录。

从科学发现到产业化:欧洲创新面临“转化缺口”

欧洲历来是全球基础科学研究的重镇,汇聚了众多高水平的科研机构、优秀的科研人才,以及源源不断的早期创新项目储备。

然而,欧洲当下面临的挑战,并非缺乏基础研究与发现,而是在成果转化与产业化环节存在断层。一个值得行业共同思考的问题是:如何将欧洲的科研优势,转化为具有投资价值、能够实现规模化生产的药物,并最终更快惠及患者?

种种信号清晰可见。英国、德国、瑞士等欧洲各地的创新中心持续释放活力,大量创新项目和初创企业不断涌现。然而,欧洲吸引的全球生物医药资本却相对有限:63%流向了美国,而欧洲仅占7%。同时,欧洲临床试验的全球份额已从22%降至12%,许多有潜力的创新企业选择在欧洲以外的地区上市或扩大规模。

造成这一现象的重要原因之一,是基础研究与新药研发项目启动之间仍然存在一定的转化断层。正是这一“转化缺口”,使得资金、人才以及创新资源持续流向其他市场。人们常常将欧洲与波士顿等成熟创新中心进行比较,问题并不在于欧洲缺乏创新想象力,而在于是否具备足够的能力、经验和资源,帮助创新成果顺利跨越从科学发现到产业化落地的关键阶段。

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如今,资本不仅关注科学创新本身,也越来越看重执行落地的能力。投资者的关注焦点已经发生转变:运营准备度、可生产性以及可控的研发进度,其重要性已不亚于科学的新颖性。尤其是在风险偏好相对审慎的欧洲市场,企业能否展示明确的CMC(化学、生产和控制)开发路径、可靠的生产能力布局以及清晰的监管策略,往往会对融资和项目推进产生重要影响。

这也为产业生态中的赋能者创造了机遇。通过提供工艺开发、专业经验、针对新分子疗法及化合物的难题解决能力,以及稳健的质量体系,一体化CRDMO平台和创新产业集群能够帮助企业提升项目的投资价值。

对于创新企业而言,尽早引入具备相关能力和经验的合作伙伴,有助于延长资金使用周期并加速达成关键里程碑;对于投资机构而言,若能优先评估这些能力,将有助于识别出具备规模化潜力的创新项目。

如果欧洲希望进一步提升创新转化效率,有三个关键因素需要协同推进:一体化能力、完善的产业基础设施,以及深度融入本地创新生态。

一体化协同:加速创新成果转化

一体化意味着,我们不能再将药物研究、开发和生产视为孤立的短跑,而应将其视为一场协同推进的接力赛。现实中,许多项目的推进往往在交接环节停滞:工艺转移受阻、监管文件延误,发展势头也会随之减弱。

当药物发现科学家、工艺开发团队和生产工程师,使用统一的标准和数字化工具开展协同工作时,技术转移便不再是制约项目推进的瓶颈。团队能够在不消耗过多资源的情况下,迅速积累经验、学习并灵活调整方向,从而把握影响商业化成功的关键时间窗口。因此,找到能够共同快速推进创新项目的合作伙伴至关重要。

我想再次强调,速度已经不仅仅是效率问题,更是影响产业竞争力的重要因素。在当今生物技术行业,资本、人才以及创新项目往往都会向执行效率更高的生态体系集聚。

与美国以及近年来快速发展的中国市场相比,欧洲创新生态仍面临一些挑战,例如服务体系相对分散、融资周期较长以及运营复杂度较高等。而这些挑战最终都会影响创新成果的转化效率,进而影响患者:关键里程碑的延迟意味着后续融资更加困难,创新机会也可能随之流失。

正因如此,CRDMO模式,即覆盖药物研究、开发和生产全过程的“端到端、一体化”平台,能够带来切实的改变。通过打通不同环节之间的壁垒,CRDMO帮助创新项目缩短从实验室到临床、再到商业化生产的转化周期,加速创新成果惠及患者。

过去25年来,药明康德在服务全球客户的过程中,持续见证了一体化协同与跨区域合作所创造的价值。以最近的一个项目为例,药明康德瑞士库威基地承接了一家客户的3期临床及商业化生产项目。多个团队跨区域紧密协作,在5个月内完成了生产工艺转移和规模化生产,助力客户按计划完成新药上市申请(NDA)递交并顺利获批。

对于创新企业而言,速度能够增强投资者对项目的信心;对于投资机构而言,速度则意味着项目具备更强的执行能力和落地潜力。这也再次证明,携手合作、共建生态圈、摒弃孤岛思维,是行业前行并保持竞争力的必由之路。

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基础设施则是执行能力的另一项具象体现。欧洲需要更多能够支撑创新成果转化的能力平台,包括中试生产设施、针对不同技术路线的发展路径验证以及商业化生产能力,让创新企业能够在本地完成工艺验证和产业化推进,而无需消耗大量资金自建工厂。这对于企业留在本地成长、扩大规模具有重要意义。

药明康德将德国慕尼黑基地作为欧洲药物发现重要枢纽进行长期投入,同时持续扩大瑞士库威基地的制剂生产能力,正是基于这样的考量:让研发发现扎根本地,实现商业化规模生产,并将两者纳入我们的全球运营网络,以提供灵活高效的产能保障。这既支持了全球采购与供应链协作,增强了运营韧性,也有助于在当地留存更多创新价值,同时通过全球网络实现开放协作与资源高效整合。

质量与信任是推动高效合作的重要基础。欧洲长期以来在监管体系、质量管理以及数据治理等方面建立了较高标准。这些标准并非流程上的障碍,而是促成高效、安全合作的保障。全球协作依然是推动生物医药创新的重要力量,而合作需要建立在透明、合规和高质量的基础之上。

因此,具备本地运营能力以及可靠合规记录的合作伙伴尤为重要:当合作各方能够基于透明可追溯的流程开展合作,并接受持续、严格的审查时,信任便会不断累积。仅2025年,药明康德就接受了来自全球客户、监管机构以及独立第三方的741次质量审查,且无严重发现项。持续的高标准质量体系和透明运营,不仅是赢得客户信任的重要基础,也为全球创新合作提供了有力支撑。

深耕欧洲生态:药明康德持续赋能创新转化

医药创新生态不仅需要科学家、创业者和投资人,也需要那些能够帮助项目降低执行风险而非主导创新方向的赋能者。

CRDMO模式正是重要的赋能力量之一。通过提供端到端的研发与生产能力,CRDMO能够帮助创新项目跨越从科学发现到产业化落地之间的转化鸿沟:

它让初创企业能够在无需耗费巨资自建全套能力和产能的情况下,便能够验证项目的开发路径和规模化生产可行性;同时,它也为投资人提供了更加清晰的项目执行依据和风险评估基础。在实践中,这意味着更少的重复交接、更顺畅的项目推进,以及更具可预测性的研发时间表。

在过去的工作中,我曾见证许多项目在研究、开发和生产团队使用同一套标准协同运作时,实现了显著加速。许多实际案例表明,原本可能需要数年完成的技术转移和开发工作,最终在数月内顺利完成,从而支持项目按计划完成注册申报,并获得更多投资机构的关注和支持。这些案例并非为单一服务商背书,而是体现了一体化能力对于整个创新生态的系统性价值。

对于新分子类型和新疗法而言,这种协同带来的价值尤为突出。由于这些新分子在合成、分析、纯化以及测试过程中仍存在诸多未知挑战,其开发往往需要不断迭代。如何缩短学习曲线、提升执行效率,已经成为推动创新成果向前发展的关键因素之一。

总结而言,欧洲当前面临的机遇,在于将强大的科学创新能力与支撑产业化落地的执行体系有效连接起来,使创新成果能够真正实现投资价值、规模化发展,并最终惠及患者。

当创新企业将执行能力纳入创新体系建设,资本更加关注项目落地能力,产业决策者持续推动基础设施建设与能力共享时,欧洲将不仅能够持续孕育出色的创新成果,也能够更高效地将这些成果转化为真正惠及患者的创新药物。

药明康德始终将自身定位为创新生态中的长期赋能者。过去25年来,我们持续建设各类能力平台,并将这些能力连接成协同网络,帮助客户以更高效、更稳健地推进项目。无论是在德国慕尼黑和瑞士库威的持续投入,还是全球化CRDMO平台建设,以及长期积累的监管合规记录,都是我们为创新生态发展所做出的具体努力。

我们的目标并非取代投资机构、产业集群或其他生态参与者,而是通过降低执行风险、提升项目可预见性,帮助创新项目吸引更多资源支持。我们致力于让创新成果从实验室走向患者的路径变得更加顺畅、高效和可靠。

早在2016年,也就是十年前,药明康德通过收购德国慕尼黑的Crelux,首次在欧洲建立了运营实体。如今,慕尼黑基地的团队规模和实验室面积均已增长至当年的四倍。通过持续投入,这一基地已经发展成为药明康德全球平台中早期生物学发现的重要中心之一。

药明康德承诺,未来将继续在欧洲投入更多产能与能力建设,积极参与欧洲创新生态的发展,与产业伙伴共同推动科学成果加速转化,助力更多创新药物更快惠及全球患者。

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

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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.

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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.

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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.

免责声明:本文仅作信息交流之目的,文中观点不代表药明康德立场,亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导,请前往正规医院就诊。

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