在新药研发的漫长旅程中，时间已成为决定成败的关键变量。对于一家正在开发创新疗法的公司而言，能否在正确的时间抵达关键里程碑，不仅关乎分子的命运，更直接决定了能否尽早为病患带来希望与生机。

一家生物技术公司正在开发一款用于肝外递送的脂质siRNA偶联药物，因项目涉及两步偶联反应、工艺复杂且单元操作众多，该公司在早期阶段即选择与药明康德旗下专注于多肽和寡核苷酸的一体化CRDMO平台WuXi TIDES合作。接手项目后，团队通过系统性的工艺重构与优化，攻克了多个技术难题，高质量完成GLP批次的生产与交付。

该批关键物料交付后不久，药物的潜在价值获得行业认可，成功实现对外授权，由一家国际药企获得其全球权益。新权益方将该分子继续留在药明康德平台上推进，并将合作范围从原料药拓展至制剂。

在WuXi TIDES一体化团队的紧密协作下，原料药团队持续优化工艺、确保稳定供应;制剂团队同步推进处方开发与工艺研究;分析团队无缝支持从工艺开发到生产的全流程。配合统一的分析方法与质量体系，进而加快了开发进度，并降低了方法交接与供应稳定性风险。从临床前候选化合物(PCC)确认后的原料药工艺开发到IND申报，团队仅用了9个月。

对于一款工艺如此复杂的寡核苷酸偶联药物而言，这一速度在行业中并不多见。

这是药明康德以一体化CRDMO赋能平台支持客户实现里程碑授权交易的一个缩影。

根据2025年药明康德投资者开放日上披露的数据：2024年至2025年上半年，全球发生授权合作或交易的213个化学合成分子中，药明康德支持了62个，占比29%。其中，53个分子在授权合作或交易前就在药明康德平台进行研发，分子权益变化后，项目在平台上的保留率达到了100%。

基于对药明康德平台能力的信任，权益变更后，客户选择将项目继续留在药明康德，这样既可避免交接造成的时间与运营风险，又能利用一体化平台将早期项目更高效、更高质量地推进至后期。这种端到端的连续性与全球各基地统一的质量体系，是分段研发服务模式难以匹敌的优势，也有助于加速授权分子在更多国家和地区获批上市。

图片来源：123RF

当复杂分子遇上“分子迁徙”：创新浪潮下的现实课题

过去十年，全球生物医药行业经历了一场深刻的结构性变化。

一方面，中小型生物科技公司凭借其灵活、专注、敢于押注前沿靶点的特质，已成为探索前沿创新的核心力量。然而，它们普遍面临一个共同瓶颈：缺乏从早期发现到商业化生产的完整基础设施。与此同时，全球生物医药行业正进入“分子迁徙”时代——授权许可已演变为重要的融资渠道，并购也一直是行业主题。

另一方面，行业内的研发项目本身也在发生深刻变化：创新小分子药物正变得越来越复杂，多肽、寡核苷酸及其各类偶联药物等新分子类型不断涌现。这类复杂分子往往涉及新型化学反应、大量单元操作、高度定制化的工艺路径，以及更高要求的质量控制，给整个研发进程带来了前所未有的挑战，更对能力规模提出了更高要求。

在此背景下，越来越多复杂的分子项目正被委托给那些具备全面、深厚的技术能力以及规模优势，并能真正将项目“做好、做快”的赋能平台。

作为全球医药创新的赋能者，药明康德正是这一趋势中的重要实践者。从2000年一间实验室起步，公司始终跟随科学、跟随客户、跟随分子，逐步构建起集研究、开发和生产于一体的一体化CRDMO模式。

凭借二十多年来在化学业务领域积累的丰富经验，药明康德为应对复杂分子的研发与生产挑战，奠定了坚实基础。凭借多年沉淀的工艺开发经验、专业能力以及不断扩展的产能，平台能够在提高效率、控制开发成本的同时降低项目风险，从容应对各类复杂分子的开发需求。

一体化平台：速度、质量与协同力

在医药创新领域，客户的信任，往往是建立在可被持续验证的交付成果之上——速度与质量。

速度在新药研发中从来不是新鲜话题。但真正的速度，不在于某一环节的极限压缩，而在于所有环节的并行启动与无缝衔接，减少跨环节、跨团队带来的摩擦与风险。这也正是药明康德一体化CRDMO平台回应客户关切的方式：如何真正加速，以及如何确保高质量交付。

几年前，一款尚在临床阶段的在研多肽分子被托付给WuXi TIDES团队，客户提出的要求非常直接——快。

在WuXi TIDES覆盖工艺研发、分析、制剂生产等在内的一体化团队的高度协同下，通常需约两周时间才能完成的实验室规模毒理批样品交付，被缩短至三天交付样品，五天出具完整报告，为客户的毒理研究争取了宝贵时间。制剂团队并非等待原料药全部就绪后才启动，而是在工艺开发早期便同步介入，并凭借平台能力及经验，利用非常有限的原料完成了处方筛选与工艺设计的预研工作。当原料药批次顺利产出，制剂生产几乎实现了“零时差”衔接。而且，分析工作支持贯穿始终，确保每一批次产品均符合高标准。

正是这种模式，让“速度”不再是应急响应的结果，而是一体化平台的系统能力——每一个环节都不是在等待中启动，而是在协同中加速。速度的真正价值，则最终体现在产品质量与里程碑的稳步推进上。而一体化平台的另一个核心能力，恰恰在于将质量保障嵌入每一个环节——从工艺开发到分析方法，从原料药到制剂，确保每一步都经得起验证。

这款多肽分子凭借扎实的质量表现和突出的临床潜力，成功获得国际药企青睐，达成了授权协议。直到今天，关于它的临床进展仍在不断传来。

在药明康德的赋能平台上，类似这样的客户案例还有很多。现代药物研发的复杂度决定了其速度需要一整套系统的支撑。它需要各环节之间高效协同，更离不开团队对工艺和风险的深入理解以及扎实的执行力。而质量，始终源于团队对科学的尊重和对细节的把控。只有当这些真正结合在一起，公司才有底气去兑现对客户的承诺。

多年来，药明康德持续夯实一体化、端到端的CRDMO平台的能力和规模，以应对行业不断发展的挑战，满足客户日益增长的需求。正是这背后持续迭代的技术能力、横跨研究、开发到生产的一体化的能力和规模，以及众多客户项目的持续稳健交付，构筑起这份从容不迫的底气。

100% Retention Rate: How WuXi AppTec’s Integrated Platform Helped Clients Secure Global Partnerships

In the long journey of novel drug development, time is a critical variable that can determine success or failure. For a company developing an innovative therapy, reaching key milestones at the right time can not only affect the fate of the molecule but also determine how soon patients can gain access to hope and life-saving treatment.

A biotechnology company developing a complex lipid–siRNA conjugate for extrahepatic delivery, a program that involved two-step conjugation reactions, intricate processes, and multiple unit operations, chose to partner with WuXi TIDES, the integrated CRDMO platform of WuXi AppTec supporting drug discovery, development, and manufacturing of oligonucleotides, peptides, and related synthetic conjugates. After joining the project, the team systematically re-engineered and optimized the process, addressed multiple technical challenges ahead of expectations and delivered the GLP batch on time.

Shortly after the delivery of this key batch, the molecule’s potential was recognized by the industry, resulting in an out-licensing agreement in which a global pharmaceutical company acquired its global rights. The new rights holder subsequently chose to advance the molecule on the WuXi TIDES platform, expanding the collaboration from active pharmaceutical ingredient (API) to drug product.

Through close collaboration within WuXi TIDES, the API team continuously optimized the process to ensure stable supply while the formulation team advanced formulation development and process research in parallel. The analytical team provided seamless support across the workflow, from process development through manufacturing. By using unified analytical methods and a consistent quality system, the team accelerated development and reduced method handover and supply risks. From PCC confirmation to IND filing, the team supported the customer in completing the application within 9 months, a pace that is relatively uncommon for a complex oligonucleotide conjugate of this kind.

This case illustrates how WuXi AppTec’s integrated CRDMO platform supports customers in achieving key development milestones.

Figures disclosed at the company’s 2025 Investor Day help illustrate the role of integrated platforms. Among the 213 chemically synthesized molecules involved in licensing deals or transactions globally from 2024 to the first half of 2025, WuXi AppTec supported 62, or 29%. Of these, 53 molecules were already on the platform prior to the change in ownership. After the transaction, the retention rate of these molecules on the platform reached 100%.

Based on their deep trust in WuXi AppTec’s expertise and commitment, clients often choose to keep projects on WuXi AppTec’s CRDMO platform following ownership changes. This decision not only avoids the delays and operational risks associated with technical and material handovers but also leverages WuXi AppTec’s end-to-end capabilities to drive more efficient, higher-quality progression from early to late stages. This continuity, supported by a unified global quality system, outperforms fragmented outsourcing and helps accelerate approvals across additional markets.

Image source: 123RF

When Complex Molecules Meet “Molecular Migration”

Over the past decade, the global biopharmaceutical industry has undergone meaningful structural change.

On the one hand, small and mid-sized biotech companies have become a core force in exploring frontier innovation. These companies are agile, focused, and willing to pursue novel targets. However, they commonly face a shared constraint: a lack of complete infrastructure from early discovery to commercial manufacturing. At the same time, the global biopharmaceutical industry has entered an era of “molecular migration,” where licensing has evolved into a major financing channel and M&A remains a recurring industry theme.

On the other hand, the molecules being developed themselves are undergoing significant change. Innovative small molecule drugs are becoming increasingly complex, and new molecular modalities such as peptides, oligonucleotides, and various conjugates are continuously emerging. These complex molecules often involve novel chemical reactions, numerous unit operations, highly customized process paths, and more demanding quality control—presenting unprecedented challenges to the entire development journey and placing greater demands on capability and scale.

Against this backdrop, a growing number of complex molecule programs are being entrusted to enabling platforms that possess comprehensive, deep technical capabilities, along with scale advantages, and that can truly deliver projects both efficiently and with high quality.

As a global enabler of innovation, WuXi AppTec is a practitioner of this trend. Starting from a single laboratory in 2000, the company has consistently followed the science, followed its customers, and followed the molecules, gradually building an integrated CRDMO model that encompasses research, development, and manufacturing.

Leveraging over two decades of accumulated experience in the chemistry business, WuXi AppTec has laid a solid foundation to address the development and manufacturing challenges of complex molecules. With years of process know-how, deep technical expertise, and continuously expanding capacity, the platform delivers efficiency, value, and quality while confidently addressing the development needs of a wide range of complex molecules.

The Integrated Platform: Speed, Quality, and Synergy

In the field of pharmaceutical innovation, customer trust is often built on deliverables that can be consistently validated—speed and quality.

Speed is never a new topic in the industry. However, true speed does not come from excessive compression of any single step; it comes from the parallel initiation and seamless handover of all steps, minimizing cross stage and cross team frictions and risks. This is how WuXi AppTec’s integrated CRDMO platform responds to what customers care about most: how to truly accelerate, and how to ensure high-quality delivery.

A peptide molecule in the clinical stage was entrusted to the WuXi TIDES team. The customer’s request was direct: speed.

Through close collaboration across the integrated WuXi TIDES team—covering process development, analytics, and manufacturing—the delivery of a laboratory-scale GLP batch, which typically takes about 2 weeks, was shortened to 3 days for sample delivery and 5 days for a complete report, saving valuable time for the customer’s toxicology studies. The formulation team did not wait until the typical API handoff; instead, they became involved early in process development and, leveraging platform capabilities and experience, completed formulation screening and preliminary process design. Throughout the project, analytical support was embedded at every stage, ensuring that each batch met high standards.

It is this model that makes speed not a matter of emergency response, but a systemic capability of an integrated platform—where every step is not waiting to start, but accelerating through collaboration. The true value of speed, in turn, is reflected in product quality and the steady advancement of milestones. Another core strength of an integrated platform lies in embedding quality assurance into every step—from process development to analytical methods, from API to drug product—ensuring that each step can withstand scrutiny.

Owing to its quality profile and clinical potential, this peptide molecule attracted interest from an international pharmaceutical company, and a licensing agreement was reached. Updates on its clinical development continue to emerge.

There are many similar client cases on the WuXi AppTec platform. The complexity of drug development requires system level capabilities: effective cross stage collaboration, deep understanding of process and risk, and disciplined execution. Quality depends on scientific rigor and attention to detail. When these elements align, the company can reliably meet client needs.

Over the years, WuXi AppTec has consistently strengthened its capabilities and capacity to meet customers’ evolving needs and to address the industry’s most pressing challenges. The daily work of process optimization, the automated transitions between manufacturing lines, the coordinated progression of programs across the platform—all of it together forms the solid foundation of an enabling platform.