沈良博士：新藥標簽下的“幕后英雄” | 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。二十五年來，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！在二十五周年之際，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。

你有沒有好奇過，為什么醫生開藥時總說“每天兩次，飯后服用”？或者為什么有些藥一天吃三次，而另一些卻只需一周打一針？

這背后，其實藏著一門看不見的科學——DMPK。這四個字母可能不會出現在藥瓶上，也不會被寫進電視劇里的醫療橋段，但它，才是真正掌控藥物“行動軌跡”的幕后英雄。

DMPK，全名叫藥物代謝與動力學（Drug Metabolism and Pharmacokinetics），是藥明康德副總裁、藥物代謝與動力學部全球負責人沈良博士深耕多年的領域。他常說：“這門科學，不顯山露水，卻是確保藥物能按時、按量起效，以及藥效持續多久的關鍵。”

“想象一下，你吞下一粒藥片，它就像一位微型特工，開始了在體內的‘秘密任務’?！鄙蛄疾┦啃χ扔?，“而我們的工作，就是通過一雙‘火眼金睛’——看它從哪里進入血液，去了哪些器官，待了多久，什么時候開始干活，又是什么時候悄悄撤離。”

這個過程聽起來像科幻，卻是實打實的科學：藥物如何被吸收？在體內怎么分布？被肝臟如何代謝？又如何通過腎臟排出？每一個環節，都直接影響著——該吃多少？隔多久再吃？以及，該用怎樣的方式，是口服，還是輸液？

正是這份對“藥物全周期”的深刻理解，讓沈良攻讀藥代動力學博士學位時，就堅定了自己的方向?！?strong>DMPK不是研發的某個階段，而是貫穿始終的成藥性評價。”他說，“從最早期的分子篩選，到臨床前研究，再到人體試驗，都需要對藥物的成藥性做出評價，幫我們選出那些真正有潛力成為好藥的分子?！?/p>

正是這份洞察，讓他選擇了在2009年加入藥明康德?！霸谶@里，我有機會參與到成千上萬款藥物的上市中。對于我來說，這條道路更有意義?！?/p>

那時，藥明康德的DMPK團隊只有百余人；十五年過去，這支“DMPK天團”已壯大到千人規模，成為全球最具實力的專業團隊之一。而沈良博士當初的夢想，也早已落地生根——他們助力的數千個候選藥物中，已有許多成功邁入臨床，甚至獲批上市，真正走到了患者手中。

每一款新藥都來之不易

“想象一下，有幾千個化合物浩浩蕩蕩地走進DMPK的考場，而最終能成功通關的，可能只有兩三個。”沈良博士比喻道，“這就是DMPK——一場嚴苛卻至關重要的‘選拔賽’。”

雖然大多數分子會在研發長跑中悄然退場，但DMPK的使命，正是在這場淘汰賽中精準識別出那些真正有潛力的“種子選手”，讓它們有機會成長為改變患者生命的療法。

在藥明康德覆蓋研究、開發與生產的一體化CRDMO平臺上，沈良博士帶領的DMPK團隊，就像是連接藥物發現與治療之間的一座極具考驗的“獨木橋”。

沈良博士深刻理解DMPK環節對于客戶的意義，“只有準確預測藥物在人體內的表現，才能幫助客戶選出最有可能轉化成功的臨床分子。”

“我們既‘跟隨客戶’，也‘跟隨分子’。”沈良博士說。在上游，團隊緊密對接客戶需求，與化學和生物學團隊并肩作戰，確保每一個新分子的設計都具備良好的成藥前景；到了下游，則切換模式，專注“護送”分子前行——通過藥明康德專屬的IND申報服務WIND平臺，將潛力分子順利推向毒理學研究，直至遞交臨床試驗申請（IND），邁向真正的臨床驗證。

回想起多年前參與的一款抗腫瘤藥的研發歷程，沈良博士仍記憶猶新：“從第一個實驗數據，到最終寫進藥品說明書的那一刻，我們全程陪伴客戶走過每一步?！?strong>在項目早期，團隊就秉持“以終為始”的理念，根據分子類型、適應癥和藥物特性，量身定制試驗方案和申報策略。“今天你在說明書中看到的一行關鍵信息，背后可能是我們幾年前就在布局的科學判斷。”

盡管DMPK的核心目標始終如一——理解身體如何對待藥物，并推動其向臨床轉化——但在藥明康德，沒有“一刀切”的解決方案。小分子、靶向蛋白降解劑、抗體類藥物、多肽、寡核苷酸……在新分子蓬勃涌現的今天，每一個項目都有獨特的屬性與需求，因此“定制化”滲透在每一個細節之中：從實驗設計到數據分析，從用藥選擇到劑量預測。正是這些看似微小的決策，往往決定了一個分子的命運走向。

在這條通往新藥的路上，不是所有分子都能走到終點，但每一個分子，都值得用專業和嚴謹認真對待。

一場爭分奪秒的科學競速

一年前，一場無聲的賽跑在實驗室的燈光下悄然展開——沒有發令槍，卻分秒必爭；沒有觀眾吶喊，卻時刻都在“沖刺”。

一家初創生物科技公司正處于融資前的關鍵時刻：要在短短幾周內合成超過1000個復雜化合物，并完成全套藥性評價，幾乎是“藥物研發界的極限挑戰”。他們輾轉多家研發機構，得到的答案幾乎都是：“不可能?！?/p>

直到他們撥通了藥明康德的電話。

這個項目在藥明康德平臺上仿佛被按下“加速鍵”。200多名合成科學家迅速集結，多條技術路線并行推進。分子在化學實驗室中誕生，又以最快的速度流轉——60分鐘內，就會被送入DMPK實驗室。一體化平臺的高效協作在這里體現得淋漓盡致。

“我們不是在接力，而是在同步奔跑。”沈良博士回憶道，“那邊反應還在收尾，這邊的測試已經準備就緒。整個流程，像一條精密咬合的齒輪鏈，環環相扣，幾乎零延遲?！?/p>

潮水般的樣品涌入實驗室，自動化平臺全速運轉，定制化流程高效匹配，每一個環節都在與時間賽跑。實打實的測試和觀察時間是半點兒也不能壓縮的，但流程和執行的效率在充沛的專業人員、先進設備體系的支持下卻可以提升到極致。

最終，這個項目打破了行業體外實驗通常需要3到5天的“鐵律”，藥明康德的DMPK團隊硬是將體外ADME實驗周期壓縮到了36小時；就連耗時較長需要5-7天的體內PK實驗，也僅需72小時。

這場“超級協同”最終交出了一份遠超客戶預期的成績單：項目剛結束，客戶立刻追加合作——因為他們知道，這不是偶然，而是一支“常備軍”的真實實力。在三個月的時間里，藥明康德總計為這一客戶完成了超1000個化合物的體內PK測試、5000個化合物的體外ADME測試。

“如果不是藥明康德，我們根本不可能跑出這樣的速度?！边@家公司的CEO在接受媒體采訪時感慨，“我們考察過全球多家機構，但沒有一家能像他們一樣，在幾天之內就為我們調集幾百名科學家，為一個項目全力以赴。”

而這驚人的“藥明速度”，并非一日煉成。

早在2015年，DMPK部門便著手啟動數字化變革，開始電子化平臺的建設，并引進第一臺自動化工作站，用于體外ADME化合物和單一流程樣品制備。2018年藥明康德首個全自動化體外ADME平臺誕生，2022年，首個自主設計的大型體內PK樣品處理自動化工作站落地，大幅提升了整體的分析通量和效率。

作為DMPK部門的負責人，沈良博士深知未來的趨勢，質量效率與數字化、自動化系統的重要性?！叭缃?，我們DMPK的體內外自動化實驗室已進化到第五代，日均處理數萬樣本，并實現多地實時互聯。”

來訪的客戶走進實驗室，常忍不住驚嘆：“這個實驗室是全自動運轉的嗎？真是太有科技感了！”

把“不可能”變成“我們可以”

對沈良博士來說，新藥研發不只是科學，更是一份使命和責任?！拔覀兡茉诳蛻粢詾橐呀洝豢赡堋臅r候，說出‘我們可以’?！?/p>

那一次，他正坐在東京成田機場的候機廳準備轉機去夏威夷參加重要的行業大會，一封緊急的項目咨詢郵件跳了出來：一家生物科技公司急需啟動一項超大規模的藥性研究，而且希望兩周內開工。

這項要求，放在行業里幾乎等于要“造一百多架飛機”，意味著所需的所有關鍵資源均需要有大規模的常規備庫，專業人員、場地、設施，大到核心發動機小到一顆螺絲釘……

沈良博士通過專業經驗很快就判斷出，行業內通常這種規模的項目光排期就要3到6個月，甚至更久，兩周內啟動這個要求，幾乎沒有哪家公司能做到?！拔耶敃r覺得，我們可能是客戶最后的希望了。”

沈良博士立刻下達了指令，“查一下我們所有場地和資源的排期，再確認下自動化平臺未來兩周的負載能力?！?/p>

在團隊的支持下，飛往夏威夷的幾小時航程中，項目方案已經初步完成。參加完行業大會后，他干脆連夜直飛波士頓——帶著出差的團隊抵達客戶的公司，從流程到時間表，一字一句敲定細節。

短短數天后，藥明康德就為這個項目調集了巨大規模的場地、資源和專業研究人員，實驗室里，一切都已就位：儀器校準完畢，人員分組明確，第一批次給藥計劃精確到小時。項目如期啟動，三個月后，高質量結果出爐——不僅趕上了關鍵節點，還成了客戶新一輪融資路演中最亮眼的一章。

沈良博士后來笑著說，“多年以前，我們就開始一直在努力打造‘2C’，一個是能力（Capability），一個是規模（Capacity）。因為我們知道，客戶在關鍵的時刻真的會需要我們，需要有一家這樣有能力有規模的公司支持他們往前走?！?/p>

橫跨多地、千人協同，這是藥明康德的DMPK團隊一次又一次不讓客戶失望的底氣。

一本書的背后是“科學無界”

在新藥研發的世界里，實用性的方法往往被鎖在實驗室的最深處，藏在厚厚的專利文件里；但也會有人覺得，科學需要共享，共享是為了整個行業的進步。

那幾年，新分子藥物像雨后春筍般冒出來：PROTAC?能精準“拆解”致病蛋白，ADC像導彈一樣直擊癌細胞，還有那些強大的肽類和寡核苷酸分子……可問題是——沒人真正知道該怎么系統地研究它們的代謝與藥動藥效。

研究探索路徑多樣，但缺乏成功經驗的系統分享。許多公司出于對創新成果的保護，傾向于謹慎展示。然而，沈良博士卻提出了一個引人深思的問題：“如果每盞燈都獨自閃爍，我們何時才能照亮整個行業的道路？”

基于這一理念，他做出了一個決定：將團隊多年的研究心得與實踐經驗，毫無保留地公開分享。

他帶著團隊，把這些年做過上萬個項目的經驗——那些踩過的坑、優化過的方法、攻克的技術難關——一字一句整理成書。不是內部手冊，而是面向全球出版的權威專著：《

Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications

有人問他：“你不擔心別人學會了，就不需要你們了嗎？”

他笑了：“我們是一群有自驅力的人，不怕被模仿。真正跑得遠的，從來不是守著藏寶圖的人。”

書籍一發布，反響出乎意料。印刷版在ISSX、AAPS、DMDG等國際學術會議上剛擺上桌就吸引了大量關注的目光；科研人員紛紛通過線上渠道踴躍訂購。許多同行在閱讀后表示，書中詳實的案例與清晰的指引極具參考價值，藥明康德DMPK科學家在新分子領域的經驗值得學習。

對于沈良博士而言，“讓天下沒有難做的藥，難治的病”，這份愿景不是說出來的，而是做出來的。正如這本書的意義，不止于知識本身。它更傳遞了一種理念：科學的進步不應被壁壘所阻隔。

“我們不是為了寫書而出書，”沈良博士說，“是為了讓大家不走彎路，是為了讓更多的病患早日用上新藥好藥。”

“一個人或者一家公司，能做的都是有限的，”沈良博士說，“但當全行業一起走，路就寬了。”

沈良博士相信，真正的進步，不只是一家公司贏了，而是整個行業往前邁了一步。你分享一個模型，我改進一種方法，他驗證一個假設——就這樣，點連成線，線織成網，一張覆蓋全球的研發協作網絡悄然成形。

而他對未來的期待，更加充滿理想。

“你知道嗎？隨著年齡增長，身體對藥物的代謝會變慢。這意味著，老年人用藥必須更加精準?！彼f這話時，眼神亮了起來，“隨著慢病時代及老齡化社會的到來，DMPK，就是那個能讓‘千人一方’變成‘一人一方’的關鍵?！?/p>

但無論技術走多遠，他始終記得自己為何出發。在他的辦公室里，沒有華麗的裝飾，柜子里陳列著一排排專業書籍和客戶贈送的獎杯。

如果DMPK是新藥分子從實驗室走到患者病床的一座橋，那么這座橋，沒有磚石，也沒有鋼筋。

它是用科學鋪就，以信任為基，靠分享連接，通往的，是每一個生命都值得擁有的希望。

The Invisible Bridge: How DMPK Turns Chemistry into Cures

Editor’s Note: “Every drug can be made and every disease can be treated”. Over the past 25 years, 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.

Most patients never see the letters D-M-P-K on a pill bottle. But as Dr. Liang Shen explains, “we’re the ones who make sure the medicine you take actually works as intended.”

DMPK is short for Drug Metabolism and Pharmacokinetics, a long name for a simple concept: it studies what the body does to a drug. DMPK scientists look at four things: how a drug is absorbed, distributed, metabolized, and eliminated. “We give scientists a pair of X-ray glasses,” Liang says. “We can see how a drug travels and changes inside the body.”

That goal brought Liang to WuXi AppTec in 2009. At that time, DMPK department only had over a hundred people working on two floors. “I wanted to help more compounds become drug candidates and raise the chance of clinical success,” he says.

Fifteen years later, that small team has grown tenfold big to one of the largest and most advanced DMPK organizations in the world. Today, it runs in vitro and in vivo DMPK studies, helping thousands of potential drugs move one step closer to becoming treatments for people everywhere.

A Platform That Follows the Molecule

In WuXi AppTec’s integrated model that connects Research, Development, and Manufacturing, Liang’s DMPK team is the bridge between drug discovery and clinical development.

“We follow both the clients and the molecules,” Liang explains. His team closely collaborates with upstream chemistry and biology departments to improve drug properties. At development stage, his team ensures projects move smoothly into IND-enabling and clinical phases.

In simple terms, his team helps a compound grow from an idea in the lab to a potential medicine. They design tests, measure exposure, predict how the drug will behave in the human body, and prepare the data that regulators eventually see on every approved drug label.

One of Liang’s favorite stories is an oncology drug WuXi AppTec supported from its first screening test all the way to market approval. “From the first test tube to the final commercialization,” he says, “we supported our client at every stage.”

That is just one example. Every year, tens of thousands of molecules pass through Liang’s department, but only a few make it to the finishing line. “Our job is to make sure the ones that do have a real chance to cure people,” he says.

This ability to predict how a drug will behave in humans based on early studies is what Liang calls “the start of good translation.”

Each Piece Built for Speed

In drug research, people often say that you can only have two out of three things: speed, quality, and cost. Liang’s DMPK team works every day to prove that all three can exist together.

A biotech company once brought WuXi AppTec a challenge: it had 1,000 new compounds to test in just three months. Liang’s team designed a customized plan. They used automation platforms to run lab tests, kept data flowing around the clock, and coordinated studies in different facilities. The result: 5,000 compounds in vitro ADME assays and 1,000 compounds in vivo PK studies completed ahead of schedule.

“The client’s CEO told us, ‘Without WuXi AppTec, this kind of speed wouldn’t be possible,’” Liang recalls.

That speed doesn’t happen by chance; it’s built into the system. Every part of WuXi AppTec’s DMPK operation is designed to move faster and smarter.

In 2015, WuXi DMPK started its digital revolution by building electronic platforms. Three years later, WuXi AppTec’s first fully automated ADME platform was launched. In 2022, the first fully automated self-designed PK sample preparation workstation started operation in DMPK’s Shanghai headquarter.

“Automation isn’t about replacing scientists,” Liang explains. “It gives them more time to think.” As the department head, he knows the future trend of DMPK industry, and deeply understands the importance of digitalization and automation, and how they play important roles to improve data quality and operation efficiency.

Today, WuXi DMPK’s automation has gone through five generations. The fully automated labs now run tens of thousands of samples every day, track quality in real time, and connect studies across sites. Clients who see it in action often describe it as “a space station for drug research.”

Making the Impossible Possible

For Liang, size and scale are just as important as speed when it comes to serving clients.

He still remembers one moment clearly. At Tokyo’s Narita Airport, while waiting for a flight to a major DMPK international conference in Hawaii, his phone buzzed. A new email arrived from a U.S. biotech company—urgent, detailed, and almost impossible. They needed a large study done within a few months, ideally starting in just two weeks.

Most companies would have turned it down. In this industry, big studies usually mean long lead time, often six to nine months before work can even begin.

But Liang didn’t hesitate. Standing in the airport terminal, he opened his laptop, called his team, and began planning: checking lab space, staff schedules, and material supplies.

By the time he landed in Hawaii, the plan was already taking shape. After the conference, he changed his travel plans and flew directly to Boston to meet the client. On the overnight flight, he kept revising the proposal until it was perfect.When they met, the client was impressed: not just by the plan, but by the commitment behind it.

The real success came afterward. Within ten days, the WuXi DMPK site was fully prepared: rooms ready, teams assigned, and every dosing schedule timed to the minute. The study started on time, finished in three months, and produced flawless data. The client reached its next fundraising milestone and has since returned to work with WuXi AppTec on three more big projects this year.

“It’s not about saying yes to everything,” Liang says, thinking back on that experience. “It’s about having a system that can deliver yes when it really counts.”

That system, built over WuXi AppTec’s 25-year journey, now defines its DMPK platform: more than a thousand scientists working across multiple sites, running tens of thousands of studies each year, quietly translating the science of how molecules move through the body into life-saving medicines for patients around the world.

Science Without Walls

But perhaps Liang’s most distinctive legacy lies not only in what his team has built, but what they’ve chosen to share.

“Drug development is changing faster than ever,” Liang says. New types of medicines like PROTAC?s, antibodies, XDCs, peptides, and oligonucleotides are appearing one after another. Yet there wasn’t a single DMPK book that clearly explained how to study these new modalities, what challenges might pop out, or how to solve them.

“Our team works on these frontier projects every day,” Liang says. “We’ve gathered huge amount of practical experience.” While many organizations keep such knowledge internally, Liang’s group decided to do the opposite. They partnered with Wiley, a leading global publisher, to release

Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications

“With this book, we wanted to share our strategies, lessons, and insights with the whole scientific community,” he explains. “If others can learn from our experience and avoid common mistakes, that helps everyone move faster. It’s our responsibility to give back to the industry.”

The book quickly became a trusted reference for scientists and researchers. “Knowledge only grows when it’s shared,” Liang says. “We’re not afraid of being copied. Our strength is that we never stop moving forward.”

The response was beyond expectations. Within weeks of its release, printed copies sold out at major scientific conferences. “People were scanning QR codes to order it right at our booth,” he smiles.

By summer, more than 1,500 copies had been distributed worldwide, each one quietly spreading WuXi AppTec’s philosophy:empowering not just clients, but the entire scientific community.

A Collective Impact

When asked what comes next, Liang’s thoughts return to DMPK itself.

“As people age, their metabolism slows, and that changes how drugs work,” he explains. “DMPK will play a key role in designing precision medicines for older adults, for chronic illnesses, and even for healthy aging.”

He’s also watching new types of molecules like degraders, oligonucleotides, and peptides come together with digital technologies. “The next frontier isn’t just measuring the endpoints,” he says. “It’s being able to understand it in real time.”

For Liang, his years at WuXi AppTec have never been about personal achievement, but about creating impact together. “Here, we support thousands of research programs,” he says. “Through WuXi AppTec, my work helps the whole industry move faster.”

免責聲明：本文 僅作信息交流之目的，文中觀點不代表藥明康德立場，亦不代表藥明康德支持或反對文中觀點。本文也不是治療方案推薦。如需獲得治療 方案指導，請前往正規醫院就診。

版權說明：歡迎個人轉發至朋友圈，謝絕媒體或機構未經授權以任何形式轉載至其他平臺。轉載授權請在「藥明康德」微信公眾號回復“轉載”，獲取轉載須知。