對(duì)話盧羽：從零到一，一體化平臺(tái)賦能全球TIDES療法新浪潮 | 逐夢(mèng)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(shí)驗(yàn)室，到覆蓋亞洲、歐洲和北美的全球網(wǎng)絡(luò)。從早期的化學(xué)合成服務(wù)，到貫穿研究（R）、開發(fā)（D）和生產(chǎn)（M）的一體化平臺(tái)。從第一位客戶，到全球三十多個(gè)國(guó)家的數(shù)千合作伙伴。不斷發(fā)展的，是規(guī)模與能力；始終堅(jiān)守的，是夢(mèng)想與承諾。

致敬來時(shí)路，共譜新篇章！在這一系列訪談中，我們以“逐夢(mèng)者”視角，回顧藥明康德成長(zhǎng)發(fā)展的崢嶸歲月，回望賦能客戶創(chuàng)新的并肩往事，更以獨(dú)特的“藥明精神”展望未來新篇章。

幾年前，在美國(guó)波士頓，一家生物技術(shù)公司正面臨“生死挑戰(zhàn)”。盡管擁有前沿的科學(xué)構(gòu)想，但在將藍(lán)圖轉(zhuǎn)化為現(xiàn)實(shí)藥物的過程中，他們遇到了幾乎無法逾越的障礙——規(guī)模化生產(chǎn)。

這家公司正在開發(fā)一種叫做PPMO的復(fù)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(fā)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(xiàn)實(shí)很骨感。他們找了很多家CDMO，但沒有一家有能力大規(guī)模生產(chǎn)這么復(fù)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(yùn)，交由藥明康德旗下專攻寡核苷酸和多肽療法的WuXi TIDES團(tuán)隊(duì)。

“這是他們的第一個(gè)臨床項(xiàng)目。”藥明康德高級(jí)副總裁，WuXi TIDES平臺(tái)負(fù)責(zé)人盧羽女士回憶道。彼時(shí)，這支團(tuán)隊(duì)已經(jīng)有了大量PPMO合成經(jīng)驗(yàn)，很快找到了解決方案。為了趕上關(guān)鍵的臨床申報(bào)日期，從PMO，多肽到PPMO，從原料藥到制劑，前后總共有六支團(tuán)隊(duì)平行推進(jìn)，高效攻堅(jiān)，最終在11個(gè)月里完成了IND申報(bào)所需要的所有CMC工作。

“No one else could do the work like WuXi AppTec.”項(xiàng)目結(jié)束后，客戶給予WuXi TIDES團(tuán)隊(duì)非常高的評(píng)價(jià)。再之后，這家公司獲得了更多資金支持，也啟動(dòng)了更多臨床項(xiàng)目。“這些項(xiàng)目也都繼續(xù)選擇藥明康德進(jìn)行CMC的工作。”盧羽補(bǔ)充說道。

這些為全球創(chuàng)新者提供的高質(zhì)量服務(wù)，正是藥明康德建立TIDES平臺(tái)的原因，也是藥明康德成立以來，持續(xù)建立新能力、拓展規(guī)模，以更好地賦能全球合作伙伴的一個(gè)縮影。

“他們認(rèn)為這是對(duì)的事情，就去做了”

2012年剛加入藥明康德時(shí)，盧羽負(fù)責(zé)商業(yè)拓展。2017年前后，在做市場(chǎng)調(diào)研時(shí)，兩個(gè)名詞開始頻繁出現(xiàn)：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(gè)嶄新的紀(jì)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(jī)遇。

行業(yè)預(yù)測(cè)，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(jiān)管機(jī)構(gòu)對(duì)這類新興分子的質(zhì)量有著極高的要求，業(yè)內(nèi)能提供高質(zhì)量服務(wù)的CDMO公司寥寥無幾。于是，一場(chǎng)“創(chuàng)業(yè)”在藥明康德內(nèi)部悄然開始。在盧羽眼中，這也是令她興奮的全新機(jī)遇。“我比較喜歡做創(chuàng)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(fù)雜的分子的領(lǐng)域，但“行業(yè)、客戶、公司都需要這樣一個(gè)團(tuán)隊(duì)的出現(xiàn)。公司也需要一個(gè)人去做這個(gè)事情，那我不管三七二十一就去做了。”

事后回憶，在WuXi TIDES平臺(tái)搭建的初期，她面臨的第一個(gè)挑戰(zhàn)，就是缺少懂這兩類分子的人才。于是，團(tuán)隊(duì)“兩條腿走路”，一方面啟動(dòng)外部招聘，一方面從藥明康德內(nèi)部招攬一批對(duì)新分子業(yè)務(wù)有極大熱情的員工加入，同時(shí)著手搭建符合TIDES能力發(fā)展的人才培養(yǎng)體系，推動(dòng)個(gè)人和平臺(tái)加速成長(zhǎng)。

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(fā)團(tuán)隊(duì)，開始了“拓荒”之旅。此后數(shù)年，隨著技術(shù)和能力的逐步積累，平臺(tái)逐漸駛向發(fā)展的快車道。2022年底，藥明康德進(jìn)一步整合了藥物發(fā)現(xiàn)和藥物開發(fā)團(tuán)隊(duì)升級(jí)該平臺(tái)為WuXi TIDES——專注于多肽、寡核苷酸及相關(guān)化學(xué)偶聯(lián)物的一體化、端到端CRDMO平臺(tái)。

如今，WuXi TIDES已成長(zhǎng)發(fā)展為藥明康德化學(xué)業(yè)務(wù)板塊的核心平臺(tái)之一。短短數(shù)年，TIDES團(tuán)隊(duì)的科學(xué)家已經(jīng)超過了1600人，并在發(fā)展的過程中建立起了無數(shù)“從零到一”的新能力。

其中，盧羽提到了一個(gè)關(guān)于“手性氨基酸檢測(cè)”的故事。彼時(shí)，全球只有德國(guó)一家公司能夠做相關(guān)的檢測(cè)。這意味著全世界所有的多肽公司都需要將樣品寄往德國(guó)一家實(shí)驗(yàn)室進(jìn)行分析，才能對(duì)合成質(zhì)量進(jìn)行反饋。

“先不說額外的時(shí)間和成本，無法實(shí)時(shí)監(jiān)控質(zhì)量，這對(duì)我們來說是不可接受的。”盧羽說。在她看來，如果要抓質(zhì)量，就要從高質(zhì)量的檢測(cè)方法源頭抓起，實(shí)時(shí)進(jìn)行反饋和調(diào)整。

幾個(gè)月后，WuXi TIDES的分析團(tuán)隊(duì)開發(fā)出了自己的手性氨基酸質(zhì)量檢測(cè)方法。

這很好地詮釋了這一平臺(tái)從零到一的搭建過程——“無非是兩點(diǎn)，前瞻布局及團(tuán)隊(duì)的高效執(zhí)行。更準(zhǔn)確地說，無非是做對(duì)的事，把事做好。”

“我相信你們能做好，因?yàn)槟銈兪撬幟骺档隆?/strong>

平臺(tái)搭建起來了，但客戶在哪里？答案來自藥明康德多年來在醫(yī)藥行業(yè)積累的信譽(yù)。

“我們的CRDMO平臺(tái)，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(huì)慢慢轉(zhuǎn)到后期。”盧羽說道，“但我們多肽平臺(tái)的第一個(gè)項(xiàng)目，一上來就是后期。”

從業(yè)內(nèi)常規(guī)看，這是一個(gè)“反常識(shí)”的操作。后期開發(fā)對(duì)質(zhì)量、速度等的要求要遠(yuǎn)遠(yuǎn)高于早期，而WuXi TIDES又是一個(gè)剛剛成立不久的新團(tuán)隊(duì)，還沒有多肽大規(guī)模生產(chǎn)的經(jīng)驗(yàn)。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(yè)務(wù)平臺(tái)早已展開了多年的合作，無論是質(zhì)量體系，還是技術(shù)能力，彼此可謂知根知底。“我相信你們能做好，因?yàn)槟銈兪撬幟骺档隆！北R羽至今仍對(duì)客戶的話記憶猶新。

團(tuán)隊(duì)最終沒有辜負(fù)客戶的信任。

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

在質(zhì)量的保駕護(hù)航下，全球合作伙伴們也一次次領(lǐng)略到了“藥明速度”。

“我們很多項(xiàng)目只需要9到10個(gè)月，就能完成IND申報(bào)所需要的全部CMC工作，比行業(yè)平均水平至少快6個(gè)月。”盧羽說。

無論是研發(fā)項(xiàng)目，還是對(duì)于患者，時(shí)間就是生命。6個(gè)月在爭(zhēng)分奪秒的新藥研發(fā)中，是決定性的優(yōu)勢(shì)。

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(gè)階段都有多個(gè)團(tuán)隊(duì)平行推進(jìn)，無縫銜接，從而節(jié)省時(shí)間；另一方面，則是立足在藥明康德平臺(tái)上，對(duì)于技術(shù)和規(guī)模的持續(xù)深耕。

“我們最大的不同，在于將小分子化學(xué)領(lǐng)域積累多年的技術(shù)平臺(tái)，自然延伸至寡核苷酸和多肽等新興領(lǐng)域。”盧羽指出，WuXi TIDES團(tuán)隊(duì)不僅運(yùn)用傳統(tǒng)固相合成工藝，更融合了液相合成、生物酶催化、流動(dòng)化學(xué)等多元技術(shù)，更好地為客戶提供賦能。

在多肽產(chǎn)能方面，WuXi TIDES平臺(tái)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(wàn)升。盧羽表示，隨著產(chǎn)能高速增長(zhǎng)，團(tuán)隊(duì)經(jīng)驗(yàn)快速積累，其工藝開發(fā)和生產(chǎn)效率“不斷刷新行業(yè)紀(jì)錄”。

“患者經(jīng)不起等待”

回顧過去的歷程，藥明康德不僅在服務(wù)全球客戶，也在賦能整個(gè)行業(yè)。

平臺(tái)發(fā)展早期，全球寡核苷酸關(guān)鍵原料供應(yīng)極為脆弱——眾多關(guān)鍵試劑依賴單個(gè)供應(yīng)商。盧羽回憶起一個(gè)緊急需求：幾年前在全球新冠爆發(fā)的高峰，某客戶需要在9個(gè)月內(nèi)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(zhàn)。”她坦言，當(dāng)時(shí)全球供應(yīng)鏈?zhǔn)艿綐O大的考驗(yàn)，光采購(gòu)用于寡核苷酸生產(chǎn)的原料、試劑、包材就需數(shù)月周期。"我們開拓了多種創(chuàng)新路徑突破供應(yīng)瓶頸，最終如期交付。"

而這段經(jīng)歷，也帶來一個(gè)深刻的體悟：“我們?cè)谑澜绺鞯氐目蛻艉突颊叨嫉炔黄稹！?/p>

從那時(shí)起，WuXi TIDES平臺(tái)開始自建能力，生產(chǎn)各種復(fù)雜的單體、配體與連接子等關(guān)鍵原料；同時(shí)攜手外部供應(yīng)商共同提高寡核苷酸生產(chǎn)中用到的每一個(gè)試劑、原料等的質(zhì)量標(biāo)準(zhǔn)。“我們始終與合作伙伴協(xié)同共進(jìn)，”盧羽女士說。如今，每種關(guān)鍵物料都有了多家合格供應(yīng)商，構(gòu)建起更穩(wěn)健韌性的產(chǎn)業(yè)生態(tài)。在她看來，這正是團(tuán)隊(duì)賦能整個(gè)生態(tài)系統(tǒng)的價(jià)值體現(xiàn)。

在去年的一場(chǎng)國(guó)際會(huì)議中，一位深耕領(lǐng)域數(shù)十載的行業(yè)先驅(qū)向藥明康德表達(dá)感謝：“他說藥明康德降低成本，縮短周期，讓創(chuàng)新療法更加可及，這給整個(gè)寡核苷酸療法行業(yè)帶來了變革。”盧羽感慨：“獲得業(yè)內(nèi)領(lǐng)袖的認(rèn)可，意味著我們正在創(chuàng)造真正的價(jià)值。”

展望未來，新一波創(chuàng)新浪潮正在涌現(xiàn)。

多肽領(lǐng)域，GLP-1藥物持續(xù)重塑全球醫(yī)療格局；多肽偶聯(lián)藥物（PDC）、放射性偶聯(lián)藥物（RDC）以及多肽寡核苷酸偶聯(lián)藥物（POC）等復(fù)雜偶聯(lián)物正開拓靶向遞送新邊界。寡核苷酸療法加速?gòu)暮币姴U(kuò)展至心血管、中樞神經(jīng)系統(tǒng)疾病，乃至體重管理領(lǐng)域；以多肽、脂質(zhì)體、抗體為代表的新型遞送系統(tǒng)，也在持續(xù)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(shí)CRDMO模式、加速全球化布局，以及高效運(yùn)營(yíng)，WuXi TIDES團(tuán)隊(duì)也期待在未來繼續(xù)攜手產(chǎn)業(yè)，推動(dòng)創(chuàng)新。

"只要我們持續(xù)聚焦一體化、創(chuàng)新與卓越運(yùn)營(yíng)，"盧羽表示，"就能持續(xù)賦能行業(yè)，加速多肽與寡核苷酸藥物研發(fā)，讓更多患者早日受益于突破性療法。"

始終感恩

如果用一個(gè)詞來形容WuXi TIDES平臺(tái)的發(fā)展，盧羽的選擇是——“感恩”。

圖片來源：123RF

“正是站在藥明康德整個(gè)公司的肩膀上，才能在短短幾年時(shí)間里為業(yè)界打造一個(gè)獨(dú)特的新分子平臺(tái)，才能為客戶賦能、為行業(yè)以及患者帶來真正的改變。”她感恩公司給予的廣闊平臺(tái)，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(dòng)。“聽起來這個(gè)目標(biāo)高不可攀……但其實(shí)我越來越體會(huì)到，每天在做的事情就是朝著這個(gè)目標(biāo)努力。”

“當(dāng)客戶說，因?yàn)槟銈兊膮⑴c，讓一種曾經(jīng)稀缺的療法變得可及可負(fù)擔(dān)，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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