一本书，点亮前路，药明康德DMPK以二十年经验积累助力行业前行

2025年秋天，一本深蓝色封面的专业著作摆上了国际学术会议的展台。

在国际外源物代谢研究学会年会（ISSX）新书研讨会现场，这本名为《Drug Metabolism and Pharmacokinetics：Frontiers，Strategies，and Applications》的新书刚亮相，就吸引了与会科学家的目光。有人翻开目录，看到蛋白降解靶向嵌合体、抗体偶联药物、多肽、寡核苷酸等新分子类型的专门章节时，饶有兴致地阅读起来。

这本书的内容，正是药明康德药物代谢与动力学部（DMPK）在新兴分子领域“探路”多年的心血力作。

新分子时代的新需求

简单来说，DMPK这门学科主要是研究药物进入体内后，身体对它做了什么——即吸收、分布、代谢、排泄（ADME）的动态规律，再结合药效与安全性，综合判断一个候选分子是否有潜力成为好药，以及合适的给药频率与方式。

二十年来，药明康德DMPK部门已从百人扩展至千余人规模，发展成为全球备受认可的专业团队。在此期间，这支团队赋能了全球客户的上万个管线和数千个临床候选化合物，其中许多已成功迈入后期开发阶段，乃至获批上市，最终送到患者手中。

这些成果中，也包括近年来快速崛起的多种新分子疗法。

当前，各类新分子药物如雨后春笋般涌现：能精准“拆解”致病蛋白的蛋白降解靶向嵌合体、可定向结合靶细胞的抗体偶联药物、以及能精准调控细胞受体信号或上游表达过程的肽类和寡核苷酸类分子……

然而，新的挑战也随之而来——尽管在新分子领域的DMPK研究活跃、探索路径多样，但全球不同地区、机构所积累的经验较为分散，业内仍缺乏一套系统的工具书。

“如果药明康德能出版这样一本书，我相信那不仅是我个人的期待，更是行业同仁的众望所归。”一位曾在学术机构和医药企业任职数十年的药物化学科学家，在书籍同行评审时如是说。

照亮行业的道路

这位专家之所以这么说，主要有两方面原因。其一，新分子领域发展迅速。尽管不少论文和综述能够及时跟踪前沿进展，但系统介绍该领域的书籍因编写周期长，往往存在明显的滞后性。其二，撰写此类新书的门槛较高，不仅要求作者对行业新领域有深度理解和丰富实践，还需具备将相关知识经验系统化归纳总结的能力。

多年前，药明康德DMPK团队刚涉足这些新兴分子时，也曾在不断尝试与探索中前行，踩过不少“坑”，攻克过诸多难关。

如今，凭借在新分子领域积累的大量经验，团队在反复实践中不断探索与迭代，已经沉淀出了可验证的成熟方法，致力于高效应对各类新分子DMPK研究中的挑战。

回望来路，正如一群人在黑暗的荒原中摸索前行，而长期沉淀出的方法、经验与知识，便如途中留下的探照灯。“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？” 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提出了一个引人深思的问题。

于是，他和团队作出了一个决定：将多年来沉淀的通用方法经验公开分享——“每个人点燃一盏灯，就能照亮一片土地；每个人分享一些信息，就能更快找到正确的方向，脚下的路也越走越宽广。”

为生物医药产业提供专业指南

2024年春天，在沈良博士的主持下，一个百余人的核心编撰工作组成立了，成员均为DMPK团队中在一线深耕多年的资深科学家。

书籍的基本框架敲定后，编撰工作正式启动，而挑战也接踵而至。

第一个难题是如何从大量经验中提炼精华。面对内部海量的方法论储备和经验总结，以及已成型的百余篇日常技术总结作为初始素材，DMPK内容团队系统化地梳理了海量的繁杂素材，从中提取更具指导价值的整合性实践策略；并积极整理行业的更新进展，确保内容与时俱进，契合前沿药物研发趋势。

第二个难题在于内容深度的把控。沈良博士明确要求，内容必须紧扣工具书的定位，避免理论和背景的堆砌，确保书中所展示的内容对这一领域的研究人员具有实际指导意义——无论是对有经验的从业者，还是药代动力学专业的在读学生，都能有所收获。这一要求与团队作为全球一体化CRDMO的定位息息相关——凭借丰富的新分子赋能经验，团队具备将分散的知识“连点成线、连线成面”的能力，从而助力提升行业整体效率。

编撰过程中，涉及百余位作者、跨越多个基地的全球协作，同样是一大挑战。如何协同多章节同时推进编撰？如何确保符合出版要求？为此，各领域专家牵头负责各章节的内容统筹与标准统一，就犹如药明康德的CRDMO模式一般，在统一的质量标准下齐头并进，提升效率。

最终，2025年6月，这本浓缩大量实践经验、长达576页、逾百万字的专著电子版和印刷版先后问世。

经手此书出版的Wiley出版社高级编辑Jonathan T. Rose感叹道：“当我刚开始审阅初稿时，它的实用性和前瞻性就让我眼前一亮。它与众不同的地方在于，能够将前沿研究转化为清晰的、可应用的策略。许多出版物都涉及新兴疗法，但鲜少有出版物能像这本专著一样，全书贯穿深度的探讨与结构化的知识梳理。”

书籍出版后，收获了诸多积极反馈。在ISSX、美国药学科学家协会年会（AAPS）、药物代谢和讨论组大会（DMDG）等国际学术会议上，印刷版正式亮相，许多同行翻阅后表示，书中实用的方法与清晰的指引颇具参考价值。

如今，电子版与印刷版已累计售出数千本，读者覆盖27个国家或地区，遍及北美、欧洲、亚洲。

一本书的“火种”，点亮了一条路

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

有人问沈良博士：“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。”

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——唯有如此，才能高效构建全球研发协作网络，最终造福病患。

一本书的诞生，往往是一个更宏大故事的开篇。对药明康德DMPK团队而言，这本书的完成也并非终点，而是一个新的起点。未来，随着科学技术的发展与药物分子类型的不断演进，团队将紧跟行业趋势，在赋能更多创新疗法的实践中持续积累经验、沉淀方法和知识，继续以开放的姿态为行业赋能。

“知识共享的循环已经启动。”沈良博士表示，“我们分享了经验，行业给予了反馈，这些反馈又会促使我们继续探索、继续优化。”

科学的进步，从来不是一家公司的独奏。正如这本深蓝色封面的专著，它不只是药明康德出版的一本工具书，更是一份邀请函——邀请整个行业，共同奏响“让天下没有难做的药、难治的病”的交响曲。

Lighting the Way: A New Book by WuXi AppTec DMPK Leverages 20 Years of Experience to Drive Industry Advancement

In the autumn of 2025, a dark-blue-covered book published by a professional publisher was displayed at the booth of an international academic conference.

At the new book launch symposium during the International Society for the Study of Xenobiotics (ISSX) Meeting, this new book called Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications had just appeared and generated interest among conference attendees.

Some participants flipped through the catalog and expressed interest upon seeing chapters on novel modalities such as Proteolysis-Targeting Chimeras, antibody-drug conjugates (ADCs), peptides, and oligonucleotides.

Simply put, drug metabolism and pharmacokinetics (DMPK) mainly studies what the body does to the drug after it enters the body, that is, the dynamic law of absorption, distribution, metabolism, and excretion (ADME), combined with the drug's efficacy and safety, to comprehensively determine whether a candidate molecule has the potential to become a viable drug, as well as the appropriate dosage regimen.

The book consolidates the work of the WuXi AppTec DMPK, which had been “exploring the path” in the DMPK field for novel modalities over the past decade.

New Needs in the Era of Novel Modalities

Over the past two decades, WuXi AppTec DMPK has grown from a hundred to over a thousand employees and has become a recognized professional team worldwide. Over this period, the team has supported customers worldwide across the full development journey, with candidate compounds advancing through late-stage development and, in a number of cases, reaching patients as approved therapies – including a growing range of modality treatments.

When various novel modalities spring up: Proteolysis-Targeting Chimeras that can accurately "disassemble" pathogenic proteins, ADCs that can target specific cells, and peptides and oligonucleotides that can precisely regulate cell receptor signaling or upstream expression processes …New challenges have also emerged — although there were active studies and diverse exploration paths in DMPK strategies for novel drug modalities, the experience accumulated across different regions and institutions worldwide was so scattered, that it was difficult to find a systematic reference book.

“It has never happened before that I looked at a book proposal and then said to myself: 'ha, this is the book that I need right now!' But this one did.……If WuXi AppTec could publish such a book, I would not be surprised many authors feel that the book is very timely.” A medicinal chemist evaluated the proposal for this book as a peer reviewer, who has decades of experience at companies, also time in academia.

Helping Illuminate the Path for the Industry

The peer reviewer highlighted that this book would fill a critical gap, offering timely guidance on the new advancements. “While research papers and review articles can generally keep up with the pace of the advancements in novel modalities, books largely lag behind for good reason — the materials are new, and it takes a special kind of authors who keep up with the progress and is able to digest and summarize them.”

Many years ago, when the WuXi AppTec DMPK team first came into contact with these novel modalities, they also moved forward by trying and exploring, experienced a series of “trial and error” and conquered a lot of difficulties.

Today, with extensive experience in novel modalities, the team has explored and iterated through repeated practice to consolidate verifiable and practical approaches, aiming to efficiently address the DMPK challenges associated with various novel modalities.

Looking back at the journey they have traveled, it seems like a large group groped forward across a dark wilderness, and the methodologies and lessons distilled from that long journey now stand like searchlights left along the way. "If each lamp shines alone, when will the path of the entire industry be illuminated?" Dr. Liang Shen, Vice President, Global Head of DMPK Department at WuXi AppTec, asked a thought-provoking question.

He and the team made a decision: to openly share their generalizable methods and practical experience accumulated over the years —“When everyone lights a lamp, the field becomes better illuminated; when everyone shares some information, then the promising direction will be found faster, and the roads below us will be wider and wider.”

Producing a Practical Reference for the Biomedical Industry

In the spring of 2024, under the auspices of Dr. Liang Shen, a compilation working group with more than 100 core members was established. All of them were senior scientists from WuXi AppTec DMPK team, who had ploughed on the front lines for many years.

Once the basic framework of the book was finalized, compilation was officially launched and challenges ensued.

The first challenge was how to extract essential information from plenty of experience. Faced with a vast internal methodological and experience that had been reserved, as well as over 100 existing daily technical summaries as initial materials, the content group of DMPK systematically sorted through the massive and complex materials, from which the integration practice strategies with more instructive value were extracted; meanwhile, they actively sorted out the update progress of the industry to ensure that the content would be up-to-date and aligned with frontier drug development trends within a few years.

The second challenge was controlling the depth of the content. Dr. Liang Shen explicitly required the content focus on the book’s role as a reference book, avoiding theory and background overload. The goal was to ensure that the content serves as a practical reference useful for both researchers and students involved in pharmacokinetics. This is closely related to the team's positioning as a globally integrated CRDMO — with extensive enabling experience in novel modalities, with the ability to “connect decentralized knowledge points into lines and then into surfaces”, thereby improving the overall efficiency of the industry.

The compilation process involved global collaboration among over a hundred authors across multiple locations, posing a significant challenge to the team. How to coordinate the simultaneous compilation of multiple chapters? How to ensure compliance with the publication requirements? To address these questions, DMPK experts from each field took the lead in coordinating and standardizing the content of each chapter, much like WuXi AppTec's CRDMO model, ensuring simultaneous progress under consistent quality standards to improve efficiency.

Eventually, in June 2025, the electronic and printed versions of this monograph — which condensed extensive practical experience, amounted to 576 pages and over one million words — were released successively.

Jonathan T. Rose, Senior Editor at Wiley Publishing, who oversaw the publication of this book, lamented: “When I first reviewed this proposal, its practical and forward-looking approach stood out.What sets this book apart, is its ability to turn frontier research into clear and applicable strategies.Many publications touch on emerging modalities, but few offer the depth and structure of a full book.”

The book received positive attention following publication. At international academic conferences such as ISSX, the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, and the Drug Metabolism and Discussion Group (DMDG) Conference, the printed version of the book immediately attracted attention upon its unveiling. After reading the book, many colleagues stated that its practical approaches and clear guidelines were valuable references.

Nowadays, the electronic and printed versions have sold thousands of copies, reaching readers in 27 countries or regions, throughout North America, Europe, and Asia.

A Book that Lit the Spark, and a Path Caught the Light

“We're not publishing this book merely for the sake of publishing it.” Dr. Liang Shen said, “but to help the industry avoid detours, so that more patients have a better chance of accessing innovative medicines sooner.”

When asked whether sharing experience could reduce demand for their services, Dr. Liang Shen smiled and responded that openness can foster broader progress and collaboration.

Dr. Liang Shen believes that true progress is not just about one company's victory, but about the entire industry taking a step forward together. “You share a model, I improve a method, and he or she verifies a hypothesis” — gradually in this way, a global collaboration network could be efficiently formed to benefit patients.

The birth of a book often marks the beginning of a grander story. For the WuXi AppTec DMPK team, the completion of this book is not an end, but a new beginning. In the future, as science and technology advanced and drug modalities continue to evolve, the team will closely track industry trends, continuously accumulate practical experience, approaches, and knowledge in enabling more innovative therapies, and continue to enable the industry.

“We hope this work will contribute to the cycle of knowledge sharing,” said Dr. Liang Shen. “We shared our experience, the industry provided feedback, which in turn will prompt us to continue exploring and optimizing.”

Scientific progress is rarely a solo performance by one company; it’s more often a collective effort. Just like this monograph with dark blue cover, it is not just a reference book published by WuXi AppTec, but also an invitation — an invitation to the entire industry to join in a symphony, which named “Every drug can be made, and every disease can be treated”.

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