多年以后,陈民章博士回想起了初识药明康德的情景。当时他在一家医药公司工作,药明康德还是外部合作伙伴,他未曾预料有朝一日会和药明康德一道书写下历史。
“药明康德提供的服务给我留下了深刻印象,后来我也决定加入这家公司。”陈民章博士说道。如今,药明康德已从一间650平米的实验室,成长为一家全球性企业,员工人数约38,000人。陈民章博士也从药明康德的客户,成为了药明康德的联席首席执行官。
在药明康德成立25周年之际,陈民章博士应邀接受知名产业媒体BioWorld专访,回顾公司的发展历程,并分享药明康德独特的CRDMO业务模式如何为生物医药行业的客户们降低研发门槛,提升研发效率,为全球病患带来突破性的治疗方案。
一体化的CRDMO平台
二十多年前,许多创新生物医药公司仍然信奉亲力亲为,在公司内部搭建了从研发到生产的全流程。然而这种模式不仅重复而低效,更是给小型生物技术公司带来了沉重的负担。在此契机下,药明康德应运而生。“我们的使命是赋能客户,使他们能够更高效地研发新药。”陈民章博士说道。
其背后的核心就是药明康德的CRDMO模式,能自上而下打通药物发现(R)、开发(D)到商业化生产(M)的全链条。在赋能的分子类型上,药明康德的服务领域也从最初的小分子药物,扩展到多肽、寡核苷酸以及更为复杂的偶联物。在CRDMO模式之前,无论是从产业链还是分子类型角度,客户倘若想要推进一个研发项目,往往需要在不同的阶段与不同的服务商进行协调。这不仅会增加项目的复杂性,还会提升失败的风险。与之相反,一体化的CRDMO赋能平台能够让原本分散的流程变得集中,让新药研发变得更为简便和高效,从而缩短新药问世的时间。
但对陈民章博士而言,药明康德的赋能模式又“远远不止于在同一屋檐下”——“真正的一体化,指的是无论在新药开发的哪个阶段,无论是哪种药物分子类型,项目团队和客户以及所有利益相关方之间都要保持无缝协作和透明沟通。”
陈民章博士分享了近期一个复杂多肽分子的赋能案例。当时客户的项目时间很紧,需要在11个月内完成IND申报所需的所有CMC资料,然而该多肽分子本身的合成路径难以放大,还缺少关键的起始原料。另外,它的后续制剂方案也存在不小的挑战。
“烈火见真金。在这样的紧急时刻,才能体现出药明康德不仅仅是服务供应商,更是能够理解项目背后的科学、客户的预算、以及研发时间紧迫性的合作伙伴。”陈民章博士说道。在接下来的日子里,药明康德团队的科学家平行推动起始原料和API工艺开发、制剂、分析、生产以及CMC资料的撰写工作,最终帮助客户提前一个月完成IND申报。该项目目前已进入2期临床阶段,初步临床结果相当积极。
“看到团队的努力转化为造福病患的一个个新疗法,这让我们倍感欣慰。”陈民章博士感叹道,“这也完美契合我们建立CRDMO平台的初衷。新药研发过程充满着复杂性和不确定性,而我们能结合自身的科学专长、平台能力、以及高效执行,加速为客户与病患带来更多更有效的新药。”
规模驱动的“药明康德速度”
在搭建一体化端到端CRDMO平台的同时,在过去25年里,药明康德还在持续加大投入,逐步扩大自己的研发和生产规模。目前,药明康德在全球拥有20多个研发生产基地,能依照客户的项目需求即时启动任何项目,并高效完成。对内,这种规模带来的优势使得公司能够逐年提升设备利用率,并不断加大对于行业新技术的投资。对外,这一规模能为客户的项目带来明显的提速效应,业内也将其称作“药明康德速度”。
但基础设施并不是全部。“人们常说我们的优势在于CRDMO模式,或是先进的设施和技术,这些都没错。”陈民章博士说,“但另一个核心优势是我们的员工,他们是成功的基石。”
陈民章博士还记得,当他刚刚加入药明康德时,公司只有100位工艺化学家,如今这一数字已超过3,000名,团队的工艺开发专业能力更是上了几个台阶。
这一庞大的科学家储备也让药明康德能够依照客户需求,快速组建最优团队,第一时间启动项目,客户无需额外等待。“能为每一个客户配备最合适的团队、技术以及生产设施,第一时间启动他们的项目,是我们一贯的承诺。”陈民章博士补充道。这使得我们能在行业里以速度取胜,赋能客户更高效地达到每一个新药开发的里程碑。
根据知名投行杰富瑞(Jefferies)今年4月的一篇分析报告,像药明康德这样的公司“可帮助美国医药行业降低30%至60%的成本”。
在药明康德成立初期,不少客户抱着“试试看”的心态,是从小型、简单的项目开始的。而随着药明康德在过去25年里不断依靠能力与规模赢得客户信任,这些小型的合同变成了大规模的合作,短期的合作演变成更为长久的伙伴关系。
“在一些特殊时刻,当时间紧迫,客户又迫切需要规模化生产时,我们会挺身而出,让全球医药供应链变得更为稳固和牢靠。”陈民章博士说道,“很多客户与药明康德合作过之后,就再也没有离开。我们有一些合作了25年的长期客户,他们见证了药明康德的整个历史。”
造福全球患者的全球网络
成立至今,药明康德始终不忘初心,致力于实现“让天下没有难做的药,难治的病”的愿景。如今,公司的赋能平台正承载着全球30多个国家与地区数千家合作伙伴的创新研发项目。
“我们在公司里常说‘做对的事,把事做好’,这是我们的核心价值观。”陈民章博士指出,“我们希望造福行业、造福客户、最终造福患者。”
迄今,药明康德已为数十款得到美国FDA批准的创新疗法赋能。这些疗法涵盖癌症、糖尿病、以及罕见病等多个不同的疾病领域,惠及全球数以百万计的患者。“我们的客户经常向我们分享许多感人的患者故事,我们协助赋能的药物改变了他们的人生。”陈民章博士说道。
对患者的影响还将继续。药明康德始终恪守全球质量和法规标准,并已多次通过来自美国、欧盟、中国、日本、韩国、瑞士等多个国家和地区药品监管机构的核查认证。
2025年3月,药明康德位于常州及泰兴的两个API生产基地接连通过FDA检查,FDA未签发任何“483表格”(检查发现项报告)。
这一结果再次彰显了药明康德始终恪守全球最高质量标准,坚定赋能合作伙伴加速新药研发,造福全球患者的不懈承诺。其中,支持多肽、寡核苷酸、以及复杂偶联物研发生产的常州基地接受了未预先通知的“飞行检查”,涵盖六大GMP系统和21款已获FDA批准的产品。FDA检查官提前一天完成所有核查,未发现任何不符合项。
全球范围内,药明康德也在近10年不断扩大其布局,在欧洲、美国和亚太地区投资新的基地,以更好地赋能全球客户。其位于瑞士库威(Couvet)的基地近期完成了扩建,口服制剂产能翻倍;其在美国特拉华州米德尔顿(Middletown,Delaware)的制剂研发和生产基地预计将在2026年底前投入运营;在亚太地区,药明康德的新加坡基地预计在2027年投入运营。
▲药明康德瑞士库威基地的喷雾干燥车间的破土动工仪式
“公司在全球的布局能为客户提供更多选择,也能助力打造更具韧性的全球产业供应链。”陈民章博士提到。
2024年,在商业化产品的交付方面,药明康德的准时交付率为100%。在接近30,000批次的生产中,实际偏差率小于0.3%。
下一个25年
当被问及下一个25年时,陈民章博士微笑着说:“对我来说,未来是我们与合作伙伴肩并肩、通过一个个项目共同创造出来的。”
毫无疑问,药明康德将继续致力于为全球客户提供赋能——客户的成功,就是药明康德的成功。此外,公司也将继续通过现实世界的成果来衡量其影响力:即其帮助开发的疗法如何改善了人们的生活。
“我们常说要一边仰望星空,一边脚踏实地。”陈民章博士说,“你必须向前看,但你也要每天努力,把事情做得更好。”
正是这种心态,结合全球化的规模、科学的严谨性与一体化的CRDMO模式,推动了药明康德在过去25年的腾飞。这也将继续成为公司塑造未来25年的基石。
25 Years of Impact: How WuXi AppTec is Enabling the Development of Innovative Therapeutics
When Minzhang Chen was working at a pharmaceutical company two decades ago, he first discovered WuXi AppTec. Back then, WuXi AppTec was one of the contract service providers his company used. He could not have anticipated that he would one day be part of WuXi AppTec's history.
"I just liked working with them so much that I joined them," Chen told BioWorld.
Today, Chen is co-CEO of WuXi AppTec. The company, which started with a laboratory of 7,000 square feet, has grown into a global organization with around 38,000 employees, supporting drug research, development, and manufacturing for clients across the pharmaceutical and biotechnology industries.
2025 marks WuXi AppTec's 25th anniversary, so BioWorld spoke with Chen about the company's evolution and how its integrated Contract Research, Development, and Manufacturing Organization (CRDMO) model has enabled global pharmaceutical innovation.
An integrated CRDMO
Years ago, many innovator companies kept the manufacturing process in house. Following that model proved to be a repetitive, inefficient investment and a significant burden for smaller organizations. WuXi AppTec was founded to boost efficiency in the drug discovery and development process.
"Our mission is to enable our customers to discover and develop new drugs more efficiently and effectively," Chen said.
At the heart of WuXi AppTec's approach is its integrated CRDMO model. Initially focused on synthetic chemistry services, the company has since expanded its capabilities beyond small molecules to peptides, oligonucleotides, and complex conjugates. Today, WuXi AppTec offers end-to-end support, from early discovery to commercial manufacturing.
This integrated model reduces fragmentation and accelerates timelines. Without it, a customer may need to coordinate with multiple service providers for each stage of development - adding complexity and risk.
For Chen, WuXi AppTec's model goes well beyond the cliché of having services under one roof.
"True integration," he explained, "means seamless coordination and transparency across project teams, leadership, clients, and all stakeholders - regardless of modality or development stage."
Chen pointed to a recent project involving a complex peptide molecule with challenges in synthesis and formulation. The customer needed a complete CMC package for IND filing in just 11 months. The synthesis route wasn't scalable, and key starting materials were in short supply. "What made the difference was how our teams engaged - not just as suppliers, but as partners who understood the science, the budget, and the urgency."
WuXi AppTec's scientists executed starting material and API process development, formulation, analytical, manufacturing, and CMC writing in parallel. The IND was submitted one month ahead of schedule, and the program has since progressed into phase II with promising clinical outcomes.
"It's incredibly rewarding to witness that progress - to see how our team's efforts helped accelerate a potentially life-changing therapy," Chen said. "That's exactly why we built this platform the way we did: combining scientific expertise, platform capabilities, and integrated execution to turn complexity into meaningful results."
Capacity that accelerates delivery
In addition to its integrated model, WuXi AppTec's scale - built steadily over the past 25 years - has been a major driver of what many call "WuXi Speed."
The company has invested heavily in infrastructure, expanding from a single lab to more than 20 sites worldwide, ensuring it has the physical capacity to launch projects without delay. Because of the scale, WuXi AppTec was able to constantly invest in new technologies and continuously improve facility utilization rate and new technology adoption rate.
But infrastructure is just one part of the equation. "It's easy to say our strength lies in our CRDMO model or our state-of-the-art facilities and technologies - and that's true," said Chen. "But another key strength is our people. They are at the heart of our success. Our teams embrace innovation and adapt quickly to serve our customers."
When Chen joined the company, WuXi AppTec had 100 process chemists. Today, that number exceeds 3,000. "They are very, very knowledgeable, and they've continued to improve," he said.
The vast talent pool allows WuXi AppTec to assign the right team and begin work as soon as a customer is ready, minimizing wait times and accelerating development timelines. "Being able to say 'yes' to a project immediately, with the right team, technology and facility in place, is a commitment we take seriously," Chen added.
A problem solver
This approach positions WuXi AppTec not just as a service provider, but as a problem-solver, and a strategic and trusted partner. According to Chen, the company takes a deliberate, expertise-driven approach to assembling the right pieces at the right time - enabling faster delivery and helping clients reach key milestones with greater efficiency.
Companies such as WuXi AppTec "could help U.S. pharma cut costs by 30% to 60%," Jefferies analysts said in April.
Over time, these capabilities and capacity have built customer trust. "We step up when our customer needs capacity and when time is sensitive. We make the pharmaceutical supply chain more resilient," Chen said. In its early years, many clients started with small, simple projects. As WuXi AppTec proved itself, transactions became collaborations, and collaborations evolved into long-term partnerships.
"For many customers, once they started working with us, they stayed," said Chen. "We've worked with some for 25 years. That's the entire history of WuXi AppTec."
A global network for global patients
From the beginning, WuXi AppTec has worked toward a single vision: "Every drug can be made, and every disease can be treated." Today, the company supports around 6,000 customers in more than 30 countries.
"We always say: do the right thing, and do it right," Chen said. "We want to benefit the industry, benefit our customers, and ultimately, benefit patients."
WuXi AppTec has contributed to the development and FDA approval of dozens of innovative therapies, including treatments for cancer, diabetes, and rare diseases. Chen believes these therapies have reached millions of patients worldwide.
"Our customers have shared many touching stories with us from patients who said the drugs we helped to make changed their lives." he said.
The company is committed to continuing that impact. Its operations conform to the highest global quality and regulatory standards, including those from the FDA, EMA, and NMPA, etc. In March 2025, the company's Changzhou and Taixing API manufacturing sites passed back-to-back FDA inspections without a single observation or Form 483.
The Changzhou site, which supports small molecules, oligonucleotides, peptides, and conjugates, was inspected for 21 FDA-approved products and completed its inspection a day ahead of schedule without a single observation.
WuXi AppTec has also expanded its global footprint over the past decade, investing in facilities across Europe, the United States, and Asia to support clients around the world. For example, the company's Couvet, Switzerland, site recently doubled its oral dose capacity. In the U.S., a new drug product manufacturing facility in Middletown, Del., is set to launch operations before the end of 2026. A new API facility in Singapore is expected to begin operating in 2027.
"Having a global network allows us to provide more options and a more resilient supply chain," Chen noted.
In 2024, WuXi AppTec supported customers' commercial products with 100% on-time delivery. Across nearly 30,000 batches, the deviation rate was less than 0.3%.
Looking ahead
Asked about the next 25 years, Chen smiled. "For me, the future is something we build project by project, side by side with our partners," he said.
It's clear that WuXi AppTec will continue enabling its customers because its success is directly tied to theirs.
The company will also continue to measure its impact by real-world outcomes: how the therapies it helps develop improve lives.
"You need to look ahead, always forward," Chen said. "But you also have to do the hard work to make things better every day. As we often say at WuXi AppTec, to quote Teddy Roosevelt: keep your eyes on the stars and your feet on the ground."
That mindset - combined with global scale, scientific rigor, and an integrated model - has fueled WuXi AppTec's growth over the past 25 years. And it's the foundation for how the company intends to shape the next 25.
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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