對話盧羽：從零到一，一體化平臺賦能全球TIDES療法新浪潮 | 逐夢者說 | Bilingual

編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。自成立以來，藥明康德步履不停：從一間實驗室，到覆蓋亞洲、歐洲和北美的全球網絡。從早期的化學合成服務，到貫穿研究（R）、開發（D）和生產（M）的一體化平臺。從第一位客戶，到全球三十多個國家的數千合作伙伴。不斷發展的，是規模與能力；始終堅守的，是夢想與承諾。

致敬來時路，共譜新篇章！在這一系列訪談中，我們以“逐夢者”視角，回顧藥明康德成長發展的崢嶸歲月，回望賦能客戶創新的并肩往事，更以獨特的“藥明精神”展望未來新篇章。

幾年前，在美國波士頓，一家生物技術公司正面臨“生死挑戰”。盡管擁有前沿的科學構想，但在將藍圖轉化為現實藥物的過程中，他們遇到了幾乎無法逾越的障礙——規模化生產。

這家公司正在開發一種叫做PPMO的復雜療法。它不僅需要分別合成用于治療的寡核苷酸分子，和用于遞送的多肽分子，還需要將兩者通過特殊的方法連在一塊，才能發揮其治療功效。

盡管每一步的合成步驟從原理上看都很清晰，但無奈現實很骨感。他們找了很多家CDMO，但沒有一家有能力大規模生產這么復雜的分子以滿足臨床需求。眼看投資人的投入即將見底，這家公司決定將自己的命運，交由藥明康德旗下專攻寡核苷酸和多肽療法的WuXi TIDES團隊。

“這是他們的第一個臨床項目。”藥明康德高級副總裁，WuXi TIDES平臺負責人盧羽女士回憶道。彼時，這支團隊已經有了大量PPMO合成經驗，很快找到了解決方案。為了趕上關鍵的臨床申報日期，從PMO，多肽到PPMO，從原料藥到制劑，前后總共有六支團隊平行推進，高效攻堅，最終在11個月里完成了IND申報所需要的所有CMC工作。

“No one else could do the work like WuXi AppTec.”項目結束后，客戶給予WuXi TIDES團隊非常高的評價。再之后，這家公司獲得了更多資金支持，也啟動了更多臨床項目。“這些項目也都繼續選擇藥明康德進行CMC的工作。”盧羽補充說道。

這些為全球創新者提供的高質量服務，正是藥明康德建立TIDES平臺的原因，也是藥明康德成立以來，持續建立新能力、拓展規模，以更好地賦能全球合作伙伴的一個縮影。

“他們認為這是對的事情，就去做了”

2012年剛加入藥明康德時，盧羽負責商業拓展。2017年前后，在做市場調研時，兩個名詞開始頻繁出現：寡核苷酸和多肽。

寡核苷酸方面，Alnylam的RNAi療法在臨床研究中取得突破，即將開啟一個嶄新的紀元；而GLP-1類藥物的橫空出世，也讓她看到了“多肽”這類老藥的新機遇。

行業預測，未來幾年，寡核苷酸和多肽類藥物的需求量將高速上升。然而，監管機構對這類新興分子的質量有著極高的要求，業內能提供高質量服務的CDMO公司寥寥無幾。于是，一場“創業”在藥明康德內部悄然開始。在盧羽眼中，這也是令她興奮的全新機遇。“我比較喜歡做創新，做從零到一的東西。”盧羽笑著說道。盡管她先前從未涉足寡核苷酸和多肽這兩類復雜的分子的領域，但“行業、客戶、公司都需要這樣一個團隊的出現。公司也需要一個人去做這個事情，那我不管三七二十一就去做了。”

事后回憶，在WuXi TIDES平臺搭建的初期，她面臨的第一個挑戰，就是缺少懂這兩類分子的人才。于是，團隊“兩條腿走路”，一方面啟動外部招聘，一方面從藥明康德內部招攬一批對新分子業務有極大熱情的員工加入，同時著手搭建符合TIDES能力發展的人才培養體系，推動個人和平臺加速成長。

2018年，藥明康德正式成立專注于寡核苷酸和多肽療法的工藝開發團隊，開始了“拓荒”之旅。此后數年，隨著技術和能力的逐步積累，平臺逐漸駛向發展的快車道。2022年底，藥明康德進一步整合了藥物發現和藥物開發團隊升級該平臺為WuXi TIDES——專注于多肽、寡核苷酸及相關化學偶聯物的一體化、端到端CRDMO平臺。

如今，WuXi TIDES已成長發展為藥明康德化學業務板塊的核心平臺之一。短短數年，TIDES團隊的科學家已經超過了1600人，并在發展的過程中建立起了無數“從零到一”的新能力。

其中，盧羽提到了一個關于“手性氨基酸檢測”的故事。彼時，全球只有德國一家公司能夠做相關的檢測。這意味著全世界所有的多肽公司都需要將樣品寄往德國一家實驗室進行分析，才能對合成質量進行反饋。

“先不說額外的時間和成本，無法實時監控質量，這對我們來說是不可接受的。”盧羽說。在她看來，如果要抓質量，就要從高質量的檢測方法源頭抓起，實時進行反饋和調整。

幾個月后，WuXi TIDES的分析團隊開發出了自己的手性氨基酸質量檢測方法。

這很好地詮釋了這一平臺從零到一的搭建過程——“無非是兩點，前瞻布局及團隊的高效執行。更準確地說，無非是做對的事，把事做好。”

“我相信你們能做好，因為你們是藥明康德”

平臺搭建起來了，但客戶在哪里？答案來自藥明康德多年來在醫藥行業積累的信譽。

“我們的CRDMO平臺，通常都是從早期開始合作，隨著彼此之間信任的建立，這些合作也會慢慢轉到后期。”盧羽說道，“但我們多肽平臺的第一個項目，一上來就是后期。”

從業內常規看，這是一個“反常識”的操作。后期開發對質量、速度等的要求要遠遠高于早期，而WuXi TIDES又是一個剛剛成立不久的新團隊，還沒有多肽大規模生產的經驗。但在合作伙伴看來，這樣的決定并不突兀。

先前，這家公司與藥明康德的其他業務平臺早已展開了多年的合作，無論是質量體系，還是技術能力，彼此可謂知根知底。“我相信你們能做好，因為你們是藥明康德。”盧羽至今仍對客戶的話記憶猶新。

團隊最終沒有辜負客戶的信任。

從第一位客戶起步，如今，WuXi TIDES團隊正在為數百位客戶提供一體化的賦能服務，且這一數字還在不斷增長。根據今年藥明康德投資者開放日的最新數據，相比2024年上半年，WuXi TIDES的藥物發現客戶數量增加了21%，為客戶交付的化合物數量增加46%。2024年7月至2025年6月，團隊完成了超過2000批次的生產。自2019年以來，其支持的新分子實體（NCE）工藝驗證（PPQ）的成功率高達100%，交出一份完美的答卷。

在質量的保駕護航下，全球合作伙伴們也一次次領略到了“藥明速度”。

“我們很多項目只需要9到10個月，就能完成IND申報所需要的全部CMC工作，比行業平均水平至少快6個月。”盧羽說。

無論是研發項目，還是對于患者，時間就是生命。6個月在爭分奪秒的新藥研發中，是決定性的優勢。

盧羽提到，藥明速度的背后，一方面自然是一體化、端到端的CRDMO模式，使得每個階段都有多個團隊平行推進，無縫銜接，從而節省時間；另一方面，則是立足在藥明康德平臺上，對于技術和規模的持續深耕。

“我們最大的不同，在于將小分子化學領域積累多年的技術平臺，自然延伸至寡核苷酸和多肽等新興領域。”盧羽指出，WuXi TIDES團隊不僅運用傳統固相合成工藝，更融合了液相合成、生物酶催化、流動化學等多元技術，更好地為客戶提供賦能。

在多肽產能方面，WuXi TIDES平臺的固相合成釜體積從2022年的6000升提升到2024年的41000升，并在2025年9月底已提升至超過10萬升。盧羽表示，隨著產能高速增長，團隊經驗快速積累，其工藝開發和生產效率“不斷刷新行業紀錄”。

“患者經不起等待”

回顧過去的歷程，藥明康德不僅在服務全球客戶，也在賦能整個行業。

平臺發展早期，全球寡核苷酸關鍵原料供應極為脆弱——眾多關鍵試劑依賴單個供應商。盧羽回憶起一個緊急需求：幾年前在全球新冠爆發的高峰，某客戶需要在9個月內完成百余批次、總量超400公斤的寡核苷酸交付以用作新冠疫苗的佐劑——“無論是需求量，還是交付速度，都極具挑戰。”她坦言，當時全球供應鏈受到極大的考驗，光采購用于寡核苷酸生產的原料、試劑、包材就需數月周期。"我們開拓了多種創新路徑突破供應瓶頸，最終如期交付。"

而這段經歷，也帶來一個深刻的體悟：“我們在世界各地的客戶和患者都等不起。”

從那時起，WuXi TIDES平臺開始自建能力，生產各種復雜的單體、配體與連接子等關鍵原料；同時攜手外部供應商共同提高寡核苷酸生產中用到的每一個試劑、原料等的質量標準。“我們始終與合作伙伴協同共進，”盧羽女士說。如今，每種關鍵物料都有了多家合格供應商，構建起更穩健韌性的產業生態。在她看來，這正是團隊賦能整個生態系統的價值體現。

在去年的一場國際會議中，一位深耕領域數十載的行業先驅向藥明康德表達感謝：“他說藥明康德降低成本，縮短周期，讓創新療法更加可及，這給整個寡核苷酸療法行業帶來了變革。”盧羽感慨：“獲得業內領袖的認可，意味著我們正在創造真正的價值。”

展望未來，新一波創新浪潮正在涌現。

多肽領域，GLP-1藥物持續重塑全球醫療格局；多肽偶聯藥物（PDC）、放射性偶聯藥物（RDC）以及多肽寡核苷酸偶聯藥物（POC）等復雜偶聯物正開拓靶向遞送新邊界。寡核苷酸療法加速從罕見病擴展至心血管、中樞神經系統疾病，乃至體重管理領域；以多肽、脂質體、抗體為代表的新型遞送系統，也在持續突破肝臟遞送的限制，為更多疾病的治療帶來可能。

通過夯實CRDMO模式、加速全球化布局，以及高效運營，WuXi TIDES團隊也期待在未來繼續攜手產業，推動創新。

"只要我們持續聚焦一體化、創新與卓越運營，"盧羽表示，"就能持續賦能行業，加速多肽與寡核苷酸藥物研發，讓更多患者早日受益于突破性療法。"

始終感恩

如果用一個詞來形容WuXi TIDES平臺的發展，盧羽的選擇是——“感恩”。

圖片來源：123RF

“正是站在藥明康德整個公司的肩膀上，才能在短短幾年時間里為業界打造一個獨特的新分子平臺，才能為客戶賦能、為行業以及患者帶來真正的改變。”她感恩公司給予的廣闊平臺，感恩與一群志同道合的同事并肩奮斗，更加感恩來自客戶的攜手和信賴。

而那句“讓天下沒有難做的藥，難治的病”，在她心中也從一句宏大的愿景，化為每一天的具體行動。“聽起來這個目標高不可攀……但其實我越來越體會到，每天在做的事情就是朝著這個目標努力。”

“當客戶說，因為你們的參與，讓一種曾經稀缺的療法變得可及可負擔，加速了新藥的問世——這便是我們工作的意義。”

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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