沈良博士:新药标签下的“幕后英雄” | 逐梦者说 | Bilingual_腾讯

你有没有好奇过，为什么医生开药时总说“每天两次，饭后服用”？或者为什么有些药一天吃三次，而另一些却只需一周打一针？

这背后，其实藏着一门看不见的科学——DMPK。这四个字母可能不会出现在药瓶上，也不会被写进电视剧里的医疗桥段，但它，才是真正掌控药物“行动轨迹”的幕后英雄。

DMPK，全名叫药物代谢与动力学（Drug Metabolism and Pharmacokinetics），是药明康德副总裁、药物代谢与动力学部全球负责人沈良博士深耕多年的领域。他常说：“这门科学，不显山露水，却是确保药物能按时、按量起效，以及药效持续多久的关键。”

“想象一下，你吞下一粒药片，它就像一位微型特工，开始了在体内的‘秘密任务’。”沈良博士笑着比喻，“而我们的工作，就是通过一双‘火眼金睛’——看它从哪里进入血液，去了哪些器官，待了多久，什么时候开始干活，又是什么时候悄悄撤离。”

这个过程听起来像科幻，却是实打实的科学：药物如何被吸收？在体内怎么分布？被肝脏如何代谢？又如何通过肾脏排出？每一个环节，都直接影响着——该吃多少？隔多久再吃？以及，该用怎样的方式，是口服，还是输液？

正是这份对“药物全周期”的深刻理解，让沈良攻读药代动力学博士学位时，就坚定了自己的方向。“DMPK不是研发的某个阶段，而是贯穿始终的成药性评价。”他说，“从最早期的分子筛选，到临床前研究，再到人体试验，都需要对药物的成药性做出评价，帮我们选出那些真正有潜力成为好药的分子。”

正是这份洞察，让他选择了在2009年加入药明康德。“在这里，我有机会参与到成千上万款药物的上市中。对于我来说，这条道路更有意义。”

那时，药明康德的DMPK团队只有百余人；十五年过去，这支“DMPK天团”已壮大到千人规模，成为全球最具实力的专业团队之一。而沈良博士当初的梦想，也早已落地生根——他们助力的数千个候选药物中，已有许多成功迈入临床，甚至获批上市，真正走到了患者手中。

每一款新药都来之不易

“想象一下，有几千个化合物浩浩荡荡地走进DMPK的考场，而最终能成功通关的，可能只有两三个。”沈良博士比喻道，“这就是DMPK——一场严苛却至关重要的‘选拔赛’。”

虽然大多数分子会在研发长跑中悄然退场，但DMPK的使命，正是在这场淘汰赛中精准识别出那些真正有潜力的“种子选手”，让它们有机会成长为改变患者生命的疗法。

在药明康德覆盖研究、开发与生产的一体化CRDMO平台上，沈良博士带领的DMPK团队，就像是连接药物发现与治疗之间的一座极具考验的“独木桥”。

沈良博士深刻理解DMPK环节对于客户的意义，“只有准确预测药物在人体内的表现，才能帮助客户选出最有可能转化成功的临床分子。”

“我们既‘跟随客户’，也‘跟随分子’。”沈良博士说。在上游，团队紧密对接客户需求，与化学和生物学团队并肩作战，确保每一个新分子的设计都具备良好的成药前景；到了下游，则切换模式，专注“护送”分子前行——通过药明康德专属的IND申报服务WIND平台，将潜力分子顺利推向毒理学研究，直至递交临床试验申请（IND），迈向真正的临床验证。

回想起多年前参与的一款抗肿瘤药的研发历程，沈良博士仍记忆犹新：“从第一个实验数据，到最终写进药品说明书的那一刻，我们全程陪伴客户走过每一步。”在项目早期，团队就秉持“以终为始”的理念，根据分子类型、适应症和药物特性，量身定制试验方案和申报策略。“今天你在说明书中看到的一行关键信息，背后可能是我们几年前就在布局的科学判断。”

尽管DMPK的核心目标始终如一——理解身体如何对待药物，并推动其向临床转化——但在药明康德，没有“一刀切”的解决方案。小分子、靶向蛋白降解剂、抗体类药物、多肽、寡核苷酸……在新分子蓬勃涌现的今天，每一个项目都有独特的属性与需求，因此“定制化”渗透在每一个细节之中：从实验设计到数据分析，从用药选择到剂量预测。正是这些看似微小的决策，往往决定了一个分子的命运走向。

在这条通往新药的路上，不是所有分子都能走到终点，但每一个分子，都值得用专业和严谨认真对待。

一场争分夺秒的科学竞速

一年前，一场无声的赛跑在实验室的灯光下悄然展开——没有发令枪，却分秒必争；没有观众呐喊，却时刻都在“冲刺”。

一家初创生物科技公司正处于融资前的关键时刻：要在短短几周内合成超过1000个复杂化合物，并完成全套药性评价，几乎是“药物研发界的极限挑战”。他们辗转多家研发机构，得到的答案几乎都是：“不可能。”

直到他们拨通了药明康德的电话。

这个项目在药明康德平台上仿佛被按下“加速键”。200多名合成科学家迅速集结，多条技术路线并行推进。分子在化学实验室中诞生，又以最快的速度流转——60分钟内，就会被送入DMPK实验室。一体化平台的高效协作在这里体现得淋漓尽致。

“我们不是在接力，而是在同步奔跑。”沈良博士回忆道，“那边反应还在收尾，这边的测试已经准备就绪。整个流程，像一条精密咬合的齿轮链，环环相扣，几乎零延迟。”

潮水般的样品涌入实验室，自动化平台全速运转，定制化流程高效匹配，每一个环节都在与时间赛跑。实打实的测试和观察时间是半点儿也不能压缩的，但流程和执行的效率在充沛的专业人员、先进设备体系的支持下却可以提升到极致。

最终，这个项目打破了行业体外实验通常需要3到5天的“铁律”，药明康德的DMPK团队硬是将体外ADME实验周期压缩到了36小时；就连耗时较长需要5-7天的体内PK实验，也仅需72小时。

这场“超级协同”最终交出了一份远超客户预期的成绩单：项目刚结束，客户立刻追加合作——因为他们知道，这不是偶然，而是一支“常备军”的真实实力。在三个月的时间里，药明康德总计为这一客户完成了超1000个化合物的体内PK测试、5000个化合物的体外ADME测试。

“如果不是药明康德，我们根本不可能跑出这样的速度。”这家公司的CEO在接受媒体采访时感慨，“我们考察过全球多家机构，但没有一家能像他们一样，在几天之内就为我们调集几百名科学家，为一个项目全力以赴。”

而这惊人的“药明速度”，并非一日炼成。

早在2015年，DMPK部门便着手启动数字化变革，开始电子化平台的建设，并引进第一台自动化工作站，用于体外ADME化合物和单一流程样品制备。2018年药明康德首个全自动化体外ADME平台诞生，2022年，首个自主设计的大型体内PK样品处理自动化工作站落地，大幅提升了整体的分析通量和效率。

作为DMPK部门的负责人，沈良博士深知未来的趋势，质量效率与数字化、自动化系统的重要性。“如今，我们DMPK的体内外自动化实验室已进化到第五代，日均处理数万样本，并实现多地实时互联。”

来访的客户走进实验室，常忍不住惊叹：“这个实验室是全自动运转的吗？真是太有科技感了！”

把“不可能”变成“我们可以”

对沈良博士来说，新药研发不只是科学，更是一份使命和责任。“我们能在客户以为已经‘不可能’的时候，说出‘我们可以’。”

那一次，他正坐在东京成田机场的候机厅准备转机去夏威夷参加重要的行业大会，一封紧急的项目咨询邮件跳了出来：一家生物科技公司急需启动一项超大规模的药性研究，而且希望两周内开工。

这项要求，放在行业里几乎等于要“造一百多架飞机”，意味着所需的所有关键资源均需要有大规模的常规备库，专业人员、场地、设施，大到核心发动机小到一颗螺丝钉……

沈良博士通过专业经验很快就判断出，行业内通常这种规模的项目光排期就要3到6个月，甚至更久，两周内启动这个要求，几乎没有哪家公司能做到。“我当时觉得，我们可能是客户最后的希望了。”

沈良博士立刻下达了指令，“查一下我们所有场地和资源的排期，再确认下自动化平台未来两周的负载能力。”

在团队的支持下，飞往夏威夷的几小时航程中，项目方案已经初步完成。参加完行业大会后，他干脆连夜直飞波士顿——带着出差的团队抵达客户的公司，从流程到时间表，一字一句敲定细节。

短短数天后，药明康德就为这个项目调集了巨大规模的场地、资源和专业研究人员，实验室里，一切都已就位：仪器校准完毕，人员分组明确，第一批次给药计划精确到小时。项目如期启动，三个月后，高质量结果出炉——不仅赶上了关键节点，还成了客户新一轮融资路演中最亮眼的一章。

沈良博士后来笑着说，“多年以前，我们就开始一直在努力打造‘2C’，一个是能力（Capability），一个是规模（Capacity）。因为我们知道，客户在关键的时刻真的会需要我们，需要有一家这样有能力有规模的公司支持他们往前走。”

横跨多地、千人协同，这是药明康德的DMPK团队一次又一次不让客户失望的底气。

一本书的背后是“科学无界”

在新药研发的世界里，实用性的方法往往被锁在实验室的最深处，藏在厚厚的专利文件里；但也会有人觉得，科学需要共享，共享是为了整个行业的进步。

那几年，新分子药物像雨后春笋般冒出来：PROTAC®能精准“拆解”致病蛋白，ADC像导弹一样直击癌细胞，还有那些强大的肽类和寡核苷酸分子……可问题是——没人真正知道该怎么系统地研究它们的代谢与药动药效。

研究探索路径多样，但缺乏成功经验的系统分享。许多公司出于对创新成果的保护，倾向于谨慎展示。然而，沈良博士却提出了一个引人深思的问题：“如果每盏灯都独自闪烁，我们何时才能照亮整个行业的道路？”

基于这一理念，他做出了一个决定：将团队多年的研究心得与实践经验，毫无保留地公开分享。

他带着团队，把这些年做过上万个项目的经验——那些踩过的坑、优化过的方法、攻克的技术难关——一字一句整理成书。不是内部手册，而是面向全球出版的权威专著：《Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications》，由国际知名出版社Wiley发行。

有人问他：“你不担心别人学会了，就不需要你们了吗？”

他笑了：“我们是一群有自驱力的人，不怕被模仿。真正跑得远的，从来不是守着藏宝图的人。”

书籍一发布，反响出乎意料。印刷版在ISSX、AAPS、DMDG等国际学术会议上刚摆上桌就吸引了大量关注的目光；科研人员纷纷通过线上渠道踊跃订购。许多同行在阅读后表示，书中详实的案例与清晰的指引极具参考价值，药明康德DMPK科学家在新分子领域的经验值得学习。

对于沈良博士而言，“让天下没有难做的药，难治的病”，这份愿景不是说出来的，而是做出来的。正如这本书的意义，不止于知识本身。它更传递了一种理念：科学的进步不应被壁垒所阻隔。

“我们不是为了写书而出书，”沈良博士说，“是为了让大家不走弯路，是为了让更多的病患早日用上新药好药。”

“一个人或者一家公司，能做的都是有限的，”沈良博士说，“但当全行业一起走，路就宽了。”

沈良博士相信，真正的进步，不只是一家公司赢了，而是整个行业往前迈了一步。你分享一个模型，我改进一种方法，他验证一个假设——就这样，点连成线，线织成网，一张覆盖全球的研发协作网络悄然成形。

而他对未来的期待，更加充满理想。

“你知道吗？随着年龄增长，身体对药物的代谢会变慢。这意味着，老年人用药必须更加精准。”他说这话时，眼神亮了起来，“随着慢病时代及老龄化社会的到来，DMPK，就是那个能让‘千人一方’变成‘一人一方’的关键。”

但无论技术走多远，他始终记得自己为何出发。在他的办公室里，没有华丽的装饰，柜子里陈列着一排排专业书籍和客户赠送的奖杯。

如果DMPK是新药分子从实验室走到患者病床的一座桥，那么这座桥，没有砖石，也没有钢筋。

它是用科学铺就，以信任为基，靠分享连接，通往的，是每一个生命都值得拥有的希望。

The Invisible Bridge: How DMPK Turns Chemistry into Cures

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.”