对话卢羽：从零到一，一体化平台赋能全球TIDES疗法新浪潮 | 逐梦者说 | Bilingual

编者按：“让天下没有难做的药，难治的病”，是初心，更是愿景。自成立以来，药明康德步履不停：从一间实验室，到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务，到贯穿研究（R）、开发（D）和生产（M）的一体化平台。从第一位客户，到全球三十多个国家的数千合作伙伴。不断发展的，是规模与能力；始终坚守的，是梦想与承诺。

致敬来时路，共谱新篇章！在这一系列访谈中，我们以“逐梦者”视角，回顾药明康德成长发展的峥嵘岁月，回望赋能客户创新的并肩往事，更以独特的“药明精神”展望未来新篇章。

几年前，在美国波士顿，一家生物技术公司正面临“生死挑战”。尽管拥有前沿的科学构想，但在将蓝图转化为现实药物的过程中，他们遇到了几乎无法逾越的障碍——规模化生产。

这家公司正在开发一种叫做PPMO的复杂疗法。它不仅需要分别合成用于治疗的寡核苷酸分子，和用于递送的多肽分子，还需要将两者通过特殊的方法连在一块，才能发挥其治疗功效。

尽管每一步的合成步骤从原理上看都很清晰，但无奈现实很骨感。他们找了很多家CDMO，但没有一家有能力大规模生产这么复杂的分子以满足临床需求。眼看投资人的投入即将见底，这家公司决定将自己的命运，交由药明康德旗下专攻寡核苷酸和多肽疗法的WuXi TIDES团队。

“这是他们的第一个临床项目。”药明康德高级副总裁，WuXi TIDES平台负责人卢羽女士回忆道。彼时，这支团队已经有了大量PPMO合成经验，很快找到了解决方案。为了赶上关键的临床申报日期，从PMO，多肽到PPMO，从原料药到制剂，前后总共有六支团队平行推进，高效攻坚，最终在11个月里完成了IND申报所需要的所有CMC工作。

“No one else could do the work like WuXi AppTec.”项目结束后，客户给予WuXi TIDES团队非常高的评价。再之后，这家公司获得了更多资金支持，也启动了更多临床项目。“这些项目也都继续选择药明康德进行CMC的工作。”卢羽补充说道。

这些为全球创新者提供的高质量服务，正是药明康德建立TIDES平台的原因，也是药明康德成立以来，持续建立新能力、拓展规模，以更好地赋能全球合作伙伴的一个缩影。

“他们认为这是对的事情，就去做了”

2012年刚加入药明康德时，卢羽负责商业拓展。2017年前后，在做市场调研时，两个名词开始频繁出现：寡核苷酸和多肽。

寡核苷酸方面，Alnylam的RNAi疗法在临床研究中取得突破，即将开启一个崭新的纪元；而GLP-1类药物的横空出世，也让她看到了“多肽”这类老药的新机遇。

行业预测，未来几年，寡核苷酸和多肽类药物的需求量将高速上升。然而，监管机构对这类新兴分子的质量有着极高的要求，业内能提供高质量服务的CDMO公司寥寥无几。于是，一场“创业”在药明康德内部悄然开始。在卢羽眼中，这也是令她兴奋的全新机遇。“我比较喜欢做创新，做从零到一的东西。”卢羽笑着说道。尽管她先前从未涉足寡核苷酸和多肽这两类复杂的分子的领域，但“行业、客户、公司都需要这样一个团队的出现。公司也需要一个人去做这个事情，那我不管三七二十一就去做了。”

事后回忆，在WuXi TIDES平台搭建的初期，她面临的第一个挑战，就是缺少懂这两类分子的人才。于是，团队“两条腿走路”，一方面启动外部招聘，一方面从药明康德内部招揽一批对新分子业务有极大热情的员工加入，同时着手搭建符合TIDES能力发展的人才培养体系，推动个人和平台加速成长。

2018年，药明康德正式成立专注于寡核苷酸和多肽疗法的工艺开发团队，开始了“拓荒”之旅。此后数年，随着技术和能力的逐步积累，平台逐渐驶向发展的快车道。2022年底，药明康德进一步整合了药物发现和药物开发团队升级该平台为WuXi TIDES——专注于多肽、寡核苷酸及相关化学偶联物的一体化、端到端CRDMO平台。

如今，WuXi TIDES已成长发展为药明康德化学业务板块的核心平台之一。短短数年，TIDES团队的科学家已经超过了1600人，并在发展的过程中建立起了无数“从零到一”的新能力。

其中，卢羽提到了一个关于“手性氨基酸检测”的故事。彼时，全球只有德国一家公司能够做相关的检测。这意味着全世界所有的多肽公司都需要将样品寄往德国一家实验室进行分析，才能对合成质量进行反馈。

“先不说额外的时间和成本，无法实时监控质量，这对我们来说是不可接受的。”卢羽说。在她看来，如果要抓质量，就要从高质量的检测方法源头抓起，实时进行反馈和调整。

几个月后，WuXi TIDES的分析团队开发出了自己的手性氨基酸质量检测方法。

这很好地诠释了这一平台从零到一的搭建过程——“无非是两点，前瞻布局及团队的高效执行。更准确地说，无非是做对的事，把事做好。”

“我相信你们能做好，因为你们是药明康德”

平台搭建起来了，但客户在哪里？答案来自药明康德多年来在医药行业积累的信誉。

“我们的CRDMO平台，通常都是从早期开始合作，随着彼此之间信任的建立，这些合作也会慢慢转到后期。”卢羽说道，“但我们多肽平台的第一个项目，一上来就是后期。”

从业内常规看，这是一个“反常识”的操作。后期开发对质量、速度等的要求要远远高于早期，而WuXi TIDES又是一个刚刚成立不久的新团队，还没有多肽大规模生产的经验。但在合作伙伴看来，这样的决定并不突兀。

先前，这家公司与药明康德的其他业务平台早已展开了多年的合作，无论是质量体系，还是技术能力，彼此可谓知根知底。“我相信你们能做好，因为你们是药明康德。”卢羽至今仍对客户的话记忆犹新。

团队最终没有辜负客户的信任。

从第一位客户起步，如今，WuXi TIDES团队正在为数百位客户提供一体化的赋能服务，且这一数字还在不断增长。根据今年药明康德投资者开放日的最新数据，相比2024年上半年，WuXi TIDES的药物发现客户数量增加了21%，为客户交付的化合物数量增加46%。2024年7月至2025年6月，团队完成了超过2000批次的生产。自2019年以来，其支持的新分子实体（NCE）工艺验证（PPQ）的成功率高达100%，交出一份完美的答卷。

在质量的保驾护航下，全球合作伙伴们也一次次领略到了“药明速度”。

“我们很多项目只需要9到10个月，就能完成IND申报所需要的全部CMC工作，比行业平均水平至少快6个月。”卢羽说。

无论是研发项目，还是对于患者，时间就是生命。6个月在争分夺秒的新药研发中，是决定性的优势。

卢羽提到，药明速度的背后，一方面自然是一体化、端到端的CRDMO模式，使得每个阶段都有多个团队平行推进，无缝衔接，从而节省时间；另一方面，则是立足在药明康德平台上，对于技术和规模的持续深耕。

“我们最大的不同，在于将小分子化学领域积累多年的技术平台，自然延伸至寡核苷酸和多肽等新兴领域。”卢羽指出，WuXi TIDES团队不仅运用传统固相合成工艺，更融合了液相合成、生物酶催化、流动化学等多元技术，更好地为客户提供赋能。

在多肽产能方面，WuXi TIDES平台的固相合成釜体积从2022年的6000升提升到2024年的41000升，并在2025年9月底已提升至超过10万升。卢羽表示，随着产能高速增长，团队经验快速积累，其工艺开发和生产效率“不断刷新行业纪录”。

“患者经不起等待”

回顾过去的历程，药明康德不仅在服务全球客户，也在赋能整个行业。

平台发展早期，全球寡核苷酸关键原料供应极为脆弱——众多关键试剂依赖单个供应商。卢羽回忆起一个紧急需求：几年前在全球新冠爆发的高峰，某客户需要在9个月内完成百余批次、总量超400公斤的寡核苷酸交付以用作新冠疫苗的佐剂——“无论是需求量，还是交付速度，都极具挑战。”她坦言，当时全球供应链受到极大的考验，光采购用于寡核苷酸生产的原料、试剂、包材就需数月周期。"我们开拓了多种创新路径突破供应瓶颈，最终如期交付。"

而这段经历，也带来一个深刻的体悟：“我们在世界各地的客户和患者都等不起。”

从那时起，WuXi TIDES平台开始自建能力，生产各种复杂的单体、配体与连接子等关键原料；同时携手外部供应商共同提高寡核苷酸生产中用到的每一个试剂、原料等的质量标准。“我们始终与合作伙伴协同共进，”卢羽女士说。如今，每种关键物料都有了多家合格供应商，构建起更稳健韧性的产业生态。在她看来，这正是团队赋能整个生态系统的价值体现。

在去年的一场国际会议中，一位深耕领域数十载的行业先驱向药明康德表达感谢：“他说药明康德降低成本，缩短周期，让创新疗法更加可及，这给整个寡核苷酸疗法行业带来了变革。”卢羽感慨：“获得业内领袖的认可，意味着我们正在创造真正的价值。”

展望未来，新一波创新浪潮正在涌现。

多肽领域，GLP-1药物持续重塑全球医疗格局；多肽偶联药物（PDC）、放射性偶联药物（RDC）以及多肽寡核苷酸偶联药物（POC）等复杂偶联物正开拓靶向递送新边界。寡核苷酸疗法加速从罕见病扩展至心血管、中枢神经系统疾病，乃至体重管理领域；以多肽、脂质体、抗体为代表的新型递送系统，也在持续突破肝脏递送的限制，为更多疾病的治疗带来可能。

通过夯实CRDMO模式、加速全球化布局，以及高效运营，WuXi TIDES团队也期待在未来继续携手产业，推动创新。

"只要我们持续聚焦一体化、创新与卓越运营，"卢羽表示，"就能持续赋能行业，加速多肽与寡核苷酸药物研发，让更多患者早日受益于突破性疗法。"

始终感恩

如果用一个词来形容WuXi TIDES平台的发展，卢羽的选择是——“感恩”。

图片来源：123RF

“正是站在药明康德整个公司的肩膀上，才能在短短几年时间里为业界打造一个独特的新分子平台，才能为客户赋能、为行业以及患者带来真正的改变。”她感恩公司给予的广阔平台，感恩与一群志同道合的同事并肩奋斗，更加感恩来自客户的携手和信赖。

而那句“让天下没有难做的药，难治的病”，在她心中也从一句宏大的愿景，化为每一天的具体行动。“听起来这个目标高不可攀……但其实我越来越体会到，每天在做的事情就是朝着这个目标努力。”

“当客户说，因为你们的参与，让一种曾经稀缺的疗法变得可及可负担，加速了新药的问世——这便是我们工作的意义。”

Building WuXi TIDES, From Zero to One

Editor’s Note: “Every drug can be made and every disease can be treated”.Since 2000,from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey and in celebration of new beginnings, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

Late at night, after a long day filled with back-to-back meetings and calls across different time zones, Yu Lu sits down at her piano. Her fingers move gently across the keys, practicing chords she only recently began to learn. She says that starting something new keeps her calm and focused.

“Learning piano at this age reminds me that every beginning looks a little messy,” she laughs. “But that’s also what makes creating something from zero to one so satisfying.”

That same love of learning and building shaped her career. Now, Lu leads WuXi TIDES, WuXi AppTec’s integrated CRDMO platform supporting drug discovery, development, and manufacturing for oligonucleotides, peptides, and related conjugated medicines. As WuXi AppTec celebrates its 25th anniversary, we invited Lu to look back on the journey of building the TIDES platform, and how an idea in 2017 has now become a reliable partner helping hundreds of innovative companies bring new treatments to life.

The First Note

When people ask how WuXi TIDES began, Lu’s answer is always simple. At the time, she was working in business operations. “As our services grew, we always think about what could drive the next wave of progress,” she recalls.

Market research pointed to two promising new modalities: oligonucleotides and peptides. In 2017, both were at a turning point.

For oligonucleotides, many large pharmaceutical companies had stepped back from the field, but pioneers like Alnylam, Ionis, and Arrowhead were proving that the science worked. Patisiran, an RNA interference therapy, showed strong results in trials and was approved by the FDA the next year. That approval brought fresh confidence to the entire industry.

At the same time, peptide research is about to start a new era with the arrival of GLP-1 receptor agonists for diabetes and later, weight management. These long-acting peptide drugs were changing the way chronic diseases were treated.

Yet, the world’s development and manufacturing capacity was far behind the growing demand.

With every challenge comes an opportunity. “No one at WuXi AppTec had done this before, including me,” she says. “But I believed it was the right direction for the future.”

By early 2018, WuXi AppTec had formed its first oligonucleotide and peptide process development teams. Two years later, the group launched its first large scale oligonucleotide manufacturing plant and first large scale peptide plant. In 2022, WuXi TIDES officially came to life as one of the only global platforms combining discovery, development, and manufacturing for both oligonucleotides and peptides.

The journey, Lu says, felt like running several startups inside one company. “Our biggest challenge was finding and developing talent,” she recalls. “We brought together people who shared the same passion for new modalities, some were new graduates, others came from different departments within WuXi AppTec, and we built a training system to help them grow quickly.”

Today, WuXi TIDES has more than 1,600 scientists, most trained through its own programs, including customized TIDES courses and cross-team workshops. “Our people’s ability to learn on their own is amazing,” she says. “That’s why we’ve been able to move forward so quickly.”

The Power of WuXi Speed

Speed, Lu says, is one of WuXi TIDES’ most irreplaceable strengths.

Many of its projects complete all the CMC work needed for IND filing in just nine to ten months, about six months faster than the industry average.

How do they do it? “Because of our end-to-end integration,” Lu explains. “From discovery to commercial manufacturing, multiple teams work at the same time. Very few others can do that.”

Technology also plays a big role. Built on WuXi AppTec’s long experience in chemistry, the TIDES platform brings together solid-phase and liquid-phase synthesis, biocatalysis, flow chemistry, and more.

Lu’s drive for innovation is tied closely to her commitment to quality, something she and her team built from zero. “In the early days of our peptide platform, there was a test for chiral amino acids that only one company in the world could do,” she recalls. “Everyone had to ship samples there, which took weeks to get results and made real-time quality control impossible.”

Instead of accepting the delay, Lu asked her analytical team to develop their own method. Within a few months, WuXi TIDES had created a reliable in-house solution. “That’s what defines us,” she says. “Whenever we face a challenge that affects quality, our attitude is simple. If it’s the right thing to do, we’ll do it, no matter how hard it is.”

All these capabilities come together to help clients move faster. When a Boston biotech developing a treatment for Duchenne muscular dystrophy couldn’t find anyone able to scale their first clinical candidate, WuXi TIDES stepped in.

Teams across peptide, PMO, PPMO conjugation, drug product, and analytical worked together to accelerate the program, bringing it to IND in just 11 months.

Soon after, the company secured new funding and expanded its research pipeline. “The client told us, ‘No one else could do the work like WuXi TIDES,’” Lu says with a smile. “That’s exactly why we built this platform.”

Enabling an Industry

WuXi TIDES has not only supported its clients — it has helped reshape the entire industry.

When the platform first started, the global supply of oligonucleotide materials was fragile. Many key reagents came from just few suppliers. Lu recalls one urgent case a few years ago when a client needed more than 400 kilograms across 100 batches of a critical oligonucleotide as a vaccine adjuvant to fight COVID-19 pandemic, one of the largest production campaigns ever attempted in the oligonucleotide field.

“The demand and speed required were unlike anything we had seen before,” Lu says. At that time, even buying a single raw material could take months, yet WuXi TIDES had only nine months to deliver. “We found ways, actually many ways, to overcome the supply challenges and still deliver on time,” she says. That experience taught her a lasting lesson. “Our clients and patients around the world simply cannot wait.”

Since then, WuXi TIDES has built its own internal production for complex monomers and linkers. At the same time, it worked side by side with external suppliers covering a wide range of key materials used in oligonucleotide production to raise their quality standards. “We didn’t work in isolation,” Lu explains. “We grew together with our partners.”

Now, several qualified vendors can supply every critical raw material, making the entire system stronger and more resilient. To Lu, this is how her team enables the whole ecosystem.

At a major conference last year, one of the field’s long-time leaders expressed his thanks to WuXi TIDES. “He told us our work had transformed the oligonucleotide industry, reducing costs, accelerating timelines, and making these medicines more affordable,” Lu recalls. “Coming from someone who had been a pioneer for decades, that recognition meant a lot. It showed that what we’re doing truly makes a difference.”

Looking ahead, Lu already sees the next wave of innovation taking shape.

In peptides, GLP-1 drugs continue to reshape global healthcare, while complex conjugates such as PDCs, RDCs, and POCs are opening new frontiers in targeted delivery. In oligonucleotides, new treatments are expanding from rare diseases to cardiovascular and central nervous system disorders, and even into weight-management therapies.

WuXi TIDES is keeping pace by strengthening its CRDMO model, expanding its research base by nearly 50 percent in the past year, and advancing green chemistry and operational excellence across its sites. New facilities in Singapore, Couvet (Switzerland), and Middletown (United States) are helping the platform become truly global.

“If we keep focusing on integration, innovation, and excellence,” Lu says, “we can continue supporting the industry, speeding up the development of peptide and oligonucleotide drugs, and helping more patients receive life-changing therapies sooner.”

The Next ‘Zero to One’

If Lu had to choose one word to describe her journey, it would be gratitude.

Source: 123RF

“I’m grateful to every department across WuXi AppTec for supporting TIDES, and grateful to have stood on the shoulders of so many great colleagues,” she says. “I’m also thankful for the chance to build something new with teams who share the same vision.”

When clients tell her that, thanks to WuXi TIDES, their medicines reached patients faster and at lower cost, she feels the company’s mission “every drug can be made and every disease can be treated” coming to life.

“It might sound like a distant dream,” she says, “but every day, with every project, we move a little closer. No matter the type of medicine, our goal is always the same, to bring out its full potential and deliver new hope to people around the world.”

And just like the music she plays at the piano late at night, it’s a journey that always begins and begins again, from zero to one.

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