编者按：“让天下没有难做的药，难治的病”，是初心，更是愿景。二十五年来，药明康德步履不停：从一间实验室，到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务，到贯穿研究（R）、开发（D）和生产（M）的一体化平台。从第一位客户，到全球三十多个国家的数千合作伙伴。不断发展的，是规模与能力；始终坚守的，是梦想与承诺。

致敬来时路，共谱新篇章！在二十五周年之际，我们以“逐梦者”视角，回顾药明康德成长发展的峥嵘岁月，回望赋能客户创新的并肩往事，更以独特的“药明精神”展望未来新篇章。

去年夏天，傅小勇博士迎来了一位老朋友的访问。

多年前，这位老朋友还是一家初创公司的高管，就一款抗癌新药与药明康德子公司合全药业展开合作。

合全药业团队从该药物的第一个生产批次做起，一直支持到了这款药物商业化阶段生产，完成全周期的闭环。

最终，药物成功推向市场，成为一款延长无数癌症患者生命的“重磅炸弹”。这家初创公司也被一家大型药企收购，迎来新的发展篇章。

再次见到傅小勇博士，这名高管难掩激动：“小勇，之前的抗癌药，你们将上市时间提前了数月，成千上万的患者因此可以更早地获得治疗。”

如今，这位曾经的合作伙伴已经创立新公司，为患者开发全新药物。他也决定在新的征程中再次与药明康德携手并进——“无论外部环境如何变化，我们新公司的每一款产品，都将继续使用药明康德的服务。”这名高管说道。

对傅小勇博士而言，他又一次深切体会到“药明速度”对客户、对患者的深远影响。对于合作伙伴投以的信任，他深表感激。

这个案例，是药明康德二十五年来以一体化CRDMO模式赋能新药研发，赢得客户信任的一个缩影。

一体化平台，推动速度与质量“飞轮”

2012年，傅小勇博士成为药明康德的一员，亲历了公司小分子CRDMO模式的发展与完善。从化学早期研发业务起步，药明康德逐渐打通了早期发现（R）、工艺开发（D）到商业化生产（M）的全链条。

作为药明康德化学业务的重要组成部分，合全药业多年来快速发展，已在亚洲、北美及欧洲地区设立研发及生产基地，为全球合作伙伴提供从小分子原料药到制剂的一体化赋能。

如今，作为药明康德执行副总裁、合全药业负责人，傅小勇博士正在带领团队，以“药明速度”支持全球合作伙伴，将一款款小分子新药加速推向市场，给无数患者带来新生。

数据是最好的证明。根据公开数据，2024年初到2025年上半年期间，在美国FDA批准的40款小分子新药中，药明康德支持了其中的8款。

药明康德是如何做到的？

面对这个问题，傅小勇博士语气坚定：“我们能在高质量标准下，以极高的执行速度为客户提供服务。”

在医药行业深耕几十年，傅小勇博士见过太多“速度决定成败”的案例。

创新药研发总是在与时间赛跑。“有时早启动临床一个月，可能就意味着未来上市时间提前一年甚至数年。”

对于医药企业，速度意味着可以更快将新药推向市场，更早将资源投入后续研发，形成创新的良性循环。

对于患者，新药问世的速度更是直接决定了有多少患者能尽早控制病情，乃至挽救生命。

文章开头的抗癌药故事，正是“药明速度”助力众多新药提前上市的一个缩影。

体现药明康德能力的另一个关键词是质量。

“公司高水平的全球质量体系是基石，这使我们能够满足全球监管机构的严格要求。”傅小勇博士充满底气。

二十五年来，药明康德持之以恒地建立起了覆盖新药研发全生命周期的质量体系。

数据显示，2009年以来，药明康德化学业务平台成功通过全球监管机构的审计超过140次。得益于出色的质量记录，25次新药上市批准前检查（PAI，Pre-Approval Inspection）获得美国FDA和EMA豁免。

严格的质量管理不仅让客户感到安心，同时也反哺了速度优势。

在很多人的直觉中，质量与速度似乎是一对矛盾体。但在新药的工艺开发和生产领域，逻辑则完全不同。

对此，傅小勇博士以第一批放大生产为例解释：当工艺从实验室转移到工厂时，温度、设备性能等一系列因素的变化可能导致批次失败，而失败可能意味着数周甚至数月的返工，以及大量材料损失。从实验室到生产工厂，高质量的“一次性成功”对客户而言至关重要。

只有确保了质量，速度才能真正转变为更快的项目进度。

而将速度与质量完美衔接在一起的，正是药明康德的一体化平台优势。

傅小勇博士描述了一个场景：如果客户委托供应商A生产原料药，却将制剂生产交给了供应商B。原料药完成后，供应商B必须重新验证材料、文件和方法。“整个交接过程可能耗时数周，更不用说过程中可能存在的其他风险。”

相比之下，药明康德的一体化模式能够在“同一屋檐下”执行不同环节，原料药的很多质量体系与分析方法可以直接应用于制剂生产，缩短关键路径的用时。

同时，在一体化平台上，药明康德的不同团队能够高效协调，从原料药到制剂的工艺开发和生产各环节平行启动、无缝衔接。例如在完成原料药工艺开发并准备进行放大生产时，可以在放大批次生产之前，提前启动少量样品制备用于制剂工艺开发，提前启动一系列实验室研发工作，从而避免了流程间的时间延误。

“这种一体化模式可以帮助客户的项目提前1~2个月甚至更长时间进入临床。”傅小勇博士解释道。

修炼内功，应对小分子新挑战

从业三十多年，傅小勇博士持续见证着小分子产业的发展趋势和挑战。

当前，小分子依然占据全球新药研发管线的半壁江山。为了攻克更多疾病靶点，尤其是曾经“不可成药”的靶点，小分子药物的结构愈发复杂、分子量也持续增加。

过去，制药行业内流行着一套评估小分子化合物成药可能性的“里宾斯基五规则”（Lipinski's rule of five）。这套规则的第一条，就指出化合物的分子量应该小于500道尔顿，否则分子在体内的溶解度将大打折扣。

而数据显示，过去5年，分子量超过600道尔顿的小分子比例增加了63%，合成步骤超过20步、甚至30~50步的复杂分子也逐渐增多。

这种分子复杂性的增加，对新药工艺开发和生产的质量和效率提出了更高要求。

但在傅小勇博士看来，这恰恰是药明康德更好地赋能合作伙伴的巨大机会。

原因很好理解。经过25年的发展和积累，药明康德通过不断理解创新趋势和客户需求，已提前布局、建立了解决复杂分子挑战的全面的技术和能力。

例如，为提升复杂药物分子的溶解度，合全药业多年来打造了包括喷雾干燥、热熔挤出、纳米悬浮、液体胶囊、脂质纳米颗粒等全方位的工艺技术平台。

其中，喷雾干燥技术被业内普遍认为是提升复杂分子口服吸收效率最有效的手段。

在这一技术领域，从上海外高桥、到常州、泰兴基地，合全药业已经建立了从实验室规模到商业化阶段的全面喷雾干燥能力。在瑞士库威基地，全新的喷雾干燥生产线也预计将于明年第四季度全面投入运营。

“即使在全球范围内，也只有少数公司拥有如此大规模的喷雾干燥产能。”傅小勇博士提到。

不仅是喷雾干燥，合全药业还在酶催化、连续化生产以及制剂新技术等领域不断投入，更好地赋能全球客户的新药研发。

随着平台能力与产能的提升，药明康德有能力解决更多客户面临的新挑战，为更多复杂的新药铺平问世的道路。

傅小勇博士提到两个案例。在一项合作中，一款复杂候选药物分子的初始总收率低至几十个PPM（parts per million）级别。换言之，在整个化学合成过程中，目标产物的产量微乎其微，仅有理论产量的百万分之几十。

即使是对于身经百战的傅小勇博士而言，这也是他“从业几十年来从未见过的化学挑战”。

好在，药明康德长期、全面的能力可以随时应对挑战。在合全药业技术团队与客户合作重新设计合成路线后，难题最终被攻克。药明康德已为客户提供数百公斤的原料药以支持临床试验，如今，公司正在进行更大规模生产，以支持这款分子未来潜在的商业化需求。

在另一个案例中，一位客户发来紧急请求：一款已上市药物因某一供应商生产批次的杂质问题，需要在短时间内解决问题。若不及时解决，众多依赖这款药物的患者将面临“断供”的困境。

患者的生命不是儿戏。接到客户需求后，合全药业第一时间行动，多个团队高效协作，开发、验证了新的分析方法，并生产出了客户需要的大量原料，最终为客户化解了危机。

完成这一切，药明康德仅仅用了35天。

廿五载坚守，回应生命期许

在药明康德，这样的故事“太多了”，傅小勇博士如是说。面对客户的需求，“我们不仅要有挺身而出的担当，更要有解决问题的能力。”

这正是药明康德成立25年来，每一天的使命所在。“我们要不断为客户做对的事，并且把事做好。”他补充道。

作为从业几十年的科学家和企业管理者，傅小勇博士见过那些无药可用的遗憾，也理解每个病患对生机的渴望。他深有体会的是，药物研发不只是科学，不只是数字，而是对生命的回应。这也是“让天下没有难做的药，难治的病”这一愿景的具象。

“不管分子有多复杂，不管挑战有多艰难，我们会继续提供高质量、高效的服务，助力全球合作伙伴将创新科学尽快变为创新疗法，为患者造福。”

Building Trust Through Integration

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.

During a routine meeting, the CEO leaned across the table and said quietly,

“Xiaoyong, you may not realize it, but you helped us launch our cancer drug several months ahead of schedule. It was just months ahead, but it meant thousands of patients started treatment sooner.”

Dr. Xiaoyong Fu remembers the moment vividly. Years have passed since his team at WuXi STA had guided that program from first batch to blockbuster. That company has since been acquired, yet its leaders, now building a new biotech, returned to tour WuXi AppTec sites, walking the same production floors where the drug had first taken shape. “They told me that no matter how the world changes, every product from their new company will be developed with WuXi STA,” Fu recalls. “That is the highest form of trust we can earn.”

Speed with Quality

WuXi STA is WuXi AppTec’s global small-molecule CDMO platform, spanning Asia, Europe, and North America. Its integrated model links Development and Manufacturing within a single Operating System, so molecules can move seamlessly from idea to medicine. APIs and drug products are developed under one quality framework, with analytical methods and safety assessments connected like cogs in a well-tuned machine.

For Dr. Xiaoyong Fu, the executive vice president of WuXi AppTec, and head of WuXi STA, the work is a responsibility: “Our guiding principle is to deliver every project at the highest quality and the fastest speed possible, so our clients gain the greatest benefit.”

That benefit is twofold. Socially, the faster a program advances, the sooner it reaches the clinic, proves itself in human, and becomes a therapy for patients. Even a single day matters, let alone weeks or months. Economically, earlier market entry helps clients recover R&D costs sooner and reinvest earlier, creating a virtuous cycle that brings more medicines to patients in the future.

Speed, however, is not haste. “It’s precision, orchestration, and the discipline to deliver faster without ever lowering the bar,” Fu explains. Consider the first scale-up batch: when a process moves from lab to plant, temperature, mixing, and equipment behavior change dramatically. A failed first batch can mean weeks or months of rework, lost material, and delay. “From lab to plant, that ‘first-time-right’ execution is what matters most to our clients.”

The solution is systemic. During scale-up, tightly coordinated teams move as one. The R&D scientists who developed the process are on site for initial production runs, resolving issues before they escalate. Plant engineers partner closely with R&D to ensure smooth execution. A central planning team coordinates which projects run in which reactors, keeping every program on schedule and safe.

“That’s how we ensure every project proceeds smoothly, efficiently, and without surprises.” Fu says.

The Power of Integration

The first scale-up batch is only one facet of WuXi STA’s integrated system. Process R&D, including formulation process development, is inherently complex. It’s not something that a small team can accomplish alone.

Consider a common scenario: a client asks WuXi STA to make the API but sends formulation to another vendor. Once the API is finished, materials, documents, and methods must be requalified. That handoff can add weeks. “When we finalize an API process and prepare for scale-up plant batch, we typically run a demo batch in lab and prepare representative API material for formulation process development, and launch a series of laboratory DP R&D work in advance,” Fu says. “Without integration, there can be a month or more of idle time between those steps.”

On the other hand, under WuXi STA’s unified quality system, many API analytical methods can be adapted directly for drug-product work, accelerating the downstream development and shaving time from the critical path. Just as important, a dedicated project management team acts as the bridge between internal operations and clients. “Each molecule involves many complex steps during execution,” Fu notes. “If we asked clients to coordinate every detail, it would be overwhelming.” The project management team streamlines the process by connecting every department and discipline, ensuring clear communication and seamless collaboration.

That end-to-end continuity from API to formulation can save one to two months, and in some cases even more.

“For any company aiming for first-in-human, starting a month or more earlier creates tremendous value,” Fu adds. “Our efficiency and integration translate directly into faster progress and greater success for our clients.”

Meet the Challenges

Fu has lived the evolution of modern drug development. Over 30 years in the field have shown him how small molecules have grown ever more intricate, many now exceeding 500 Daltons, defying “Lipinski's Rule of Five,” or other dogmas about what makes a drug “druggable.”

“The easy molecules are gone,” he says, “Today’s molecules are heavier, more complex, and harder to synthesize. But that’s where our strength lies, making the complex possible, and making it fast.”

For example, due to the increasing molecular size and complexity of modern compounds, some molecules have poor bioavailability when developing oral formulations such as tablets or capsules, meaning the compound is barely absorbed in the body.

To meet this challenge and help clients advance better drugs, WuXi STA has invested in spray-drying technology, a proven approach to enhance bioavailability for low-solubility compounds. The company’s global sites offer capabilities from lab scale to commercial scale; at Couvet, Switzerland, a new five-story facility has been completed to house PSD4 equipment, with the spray-drying line expected to be fully operational in early Q4 next year.

“Globally, only a few CDMOs possess such large-scale spray-drying capacity,” Fu notes.

As the platform’s capabilities and capacity improve daily, WuXi STA is serving more clients and solving newer challenges. In one case, a partner’s complex candidate began with an overall yield as low as a few dozen parts per million (PPM), “something I’d never seen in decades of chemistry,” Fu says. After teaming up with the client to redesign the route, WuXi STA has since supplied hundreds of kilograms of API to support clinical trials, and is now scaling up to meet the molecule’s potential commercial demand.

In another urgent case, a marketed therapy faced a potential supply halt due to an impurity issue. Within 35 days, WuXi STA developed a process to reject the impurity and verified new analytical methods and produced compliant material at scale to avert the shortage.

“If we hadn’t delivered on time, patients would have faced a shortage,” Fu says. “That’s when you realize our work isn’t just about chemistry; it’s about continuity of care.”

Trust, Translated into Chemistry

From saving programs on the brink of regulatory rejection to enabling first-in-class molecules to reach the clinic, WuXi STA’s work is defined by one throughline: trust.

Fu often cites a company credo: “Doing the Right Thing, Doing It Right.”

“That’s what our clients see in us,” he says. “No matter the molecule, no matter the challenge, we deliver with quality, with speed, and with purpose. That’s how we turn science into impact.”

免责声明：本文 仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗 方案指导，请前往正规医院就诊。

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