新型疗法破局“不可成药”：药明康德Co-CEO杨青博士谈肿瘤创新背后的产业支撑 | Bilingual

在肿瘤研究领域，KRAS长期被认为是难以成药的靶点。如今，这一局面正在改变。

随着sotorasib和adagrasib等多款KRAS靶向药物相继获批，不仅在临床层面验证了直接靶向KRAS的可行性，更为不同类型的癌症患者带来了全新的治疗选择。 

“看到一批KRAS药物快速走向市场，并满足不同患者的治疗需求，是一件非常令人振奋的事情。”杨青博士表示，KRAS并非新发现的靶点。关键突破之一，在于研究人员找到了可以被药物利用的结合口袋，为分子设计打开了新的空间。

如今KRAS的探索仍在继续。由于存在多种突变，不同突变往往需要针对性设计抑制剂；与此同时，行业也在积极研发覆盖多种突变的药物。药明康德则为不同客户提供研发和生产支持，参与KRAS药物开发的不同环节。

KRAS的突破，只是近年来肿瘤创新的一个缩影。靶向蛋白降解剂、共价抑制剂、寡核苷酸、抗体偶联药物（ADC）等创新方向加速涌现，为科学家提供了更多解析疾病机制和干预靶点的工具。

杨青博士认为，新型疗法的价值不只是提高靶向精准度。它们也让过去难以成药的靶点有了新的突破路径，并为应对获得性耐药、探索穿过血脑屏障的药物等带来更多可能。

“越复杂的‘锁’，需要越精密的‘钥匙’。”

杨青博士坦言，随着靶点变得更加复杂，新分子的开发难度同步升级。“这些分子从原理上看很有潜力，但真正设计出来并不容易。” 

这种复杂性体现在多个方面：分子量更大、结构更复杂；需要针对特定生物化学和药理功能进行定制设计；物理化学性质更加复杂，使合成、纯化、分析和生产都面临更多挑战。

复杂分子对研发与生产提出了更高要求，也让不同环节之间的协同变得更加重要。在这一背景下，一体化模式的价值凸显：药物发现、开发和生产不再是彼此割裂的环节，而是形成更紧密的反馈闭环。

“一些在实验室规模下有效的解决方案，到了生产阶段未必能够顺利放大。我们需要不断调整，并把早期阶段积累的经验反馈到后续开发和生产中。”杨青博士表示，这样可以减少反复试错，也有助于提高研发效率。

对创新者而言，一体化意味着不必为每个项目从头搭建完整的研发与生产体系。平台可以将不同环节的能力连接起来，也能够让积累的经验和资源在不同项目中得到复用。

在靶向蛋白降解领域，耶鲁大学的克雷格·克鲁斯（Craig Crews）教授开创了PROTAC（蛋白降解靶向嵌合体）疗法，并创立了Arvinas公司将这项技术推向商业化。

药明康德自2016年起便为Arvinas提供一体化支持，并几乎全程参与产业转化历程。2026年5月，首款PROTAC药物获美国FDA批准上市。从平台技术到患者用药，前后经历了约十年。 

一个创新分子从实验室走向患者，往往需要经历漫长的产业转化。尤其对复杂分子而言，让研发与生产更好地衔接，不只是提高效率，也有助于推动创新持续向前。

一体化之外，杨青博士反复提到两个关键词：能力与产能。能力决定能否解决复杂技术问题，产能则决定项目能否及时推进，同时保持高质量。

围绕这两点，药明康德持续推进全球产能布局和能力建设。

美国特拉华州米德尔顿基地预计于2026年第四季度投入运营，开展大规模制剂生产；瑞士库威基地新增PSD-4喷雾干燥车间也预计同期投入运营；新加坡基地也在建设中，预计于2027年投入运营，进一步提升全球原料药供应能力。

能力建设则始终围绕科学和客户需求展开。秉持“跟随科学”的原则，药明康德持续加强新分子能力，并推进自动化和数字化运营。自动化可以提升研发效率、减少人为误差，也有助于降低项目整体成本。

质量同样至关重要。仅2026年上半年，药明康德就接受了来自全球客户、监管机构以及独立第三方的465次质量审查，均无严重发现项。公司建立了符合全球标准的统一质量体系，确保实验室和生产基地的数据满足全球不同市场的监管要求。

杨青博士也强调，药明康德的角色始终是赋能者，而不是药物开发者。客户负责药物的监管申报、审批和商业化，药明康德则提供研发、生产及相关数据支持。

从研发和生产能力，到严苛的质量体系，药明康德所提供的不只是某一项服务，而是贯穿研发与生产不同阶段的能力和资源，让创新项目能够更高效、高质量地向前推进。

患者仍在等待

展望肿瘤创新的前景，杨青博士保持乐观。

从流行病学研究来看，全球抗癌取得了显著进展。癌症患者的生存率和生活质量不断改善。针对不同癌症类型、亚型和基因突变，治疗选择也越来越多。

这些积极变化不仅来自更多新药，也来自联合治疗的发展。新型疗法可以与标准治疗结合，不同新药之间也可以探索联合使用，为临床带来更多选择。

但肿瘤治疗仍有大量未被满足的需求，创新也因此没有终点。

杨青博士认为，未来的肿瘤创新仍离不开全球合作。“疾病没有国界。”跨越地域的科学与产业协作，可以让不同地区的知识、资源和能力更好地汇聚起来。

与此同时，全球化的研发与生产平台，也让创新者能够借助已有能力，更快验证想法、推进项目。

从科学发现到患者获得治疗，仍然需要跨越漫长的转化过程。如何缩短这段距离，让更多突破性的科学成果更快惠及病患，仍是整个行业需要回答的问题。

“患者还在等待。”杨青博士表示，这也是推动肿瘤创新持续向前的动力。

From “Undruggable” to New Therapies: Dr. Steve Yang on What It Takes to Advance Oncology Innovation

Why New Oncology Targets Require New Development Capabilities

The next breakthroughs in precision oncology will depend not only on discovering new targets, but also on the industry’s ability to develop, manufacture and scale increasingly complex molecules.

For example, KRAS was once considered the textbook example of an “undruggable” target. However, today multiple KRAS inhibitors, including sotorasib and adagrasib, are available.

“It’s been very exciting to see these drugs move quickly to the market and address the unmet needs of patients,” Dr. Yang said. “KRAS itself is not new. The breakthrough was the discovery of a druggable pocket on the KRAS molecule—opening a new path for drug discovery.”

Different KRAS mutations may require mutation-specific inhibitors, and researchers are working on approaches that address them. This work is part of a broader expansion in oncology drug discovery. A growing range of new modalities—including targeted protein degraders (TPDs）, covalent inhibitors, oligonucleotides and antibody-drug conjugates (ADCs)—is expanding the scientific toolbox.

Some of these approaches can reach previously undruggable targets, while others are being developed to address drug resistance or cross the blood-brain barrier to reach brain metastases.

The More Complex the Molecule, the More Integration Matters

“The more complex the lock is, the more sophisticated the key needs to be,” Dr. Yang explained. “Integration is important because developing a new therapeutic modality requires coordination among discovery, development, and manufacturing, across scientific and technical disciplines, and between bench and bedside.” 

Through its integrated, end-to-end Contract Research, Development, and Manufacturing Organization (CRDMO) platform, WuXi AppTec provides its partners with access to scientific expertise, technologies and manufacturing capabilities throughout the drug-development process.

That continuity becomes especially important during scale-up. A process that works in the laboratory may not work the same way at manufacturing scale. Teams need to learn from those differences, adjust the process, and feed what they learn back into development.

Targeted protein degradation offers a good example. At Yale University, Professor Craig Crews helped pioneer the PROTAC approach and founded Arvinas to commercialize the technology. WuXi AppTec has provided integrated support to Arvinas since 2016. 

The relationship illustrates the sustained coordination that complex modalities can require across discovery, development and manufacturing. In May 2026, the FDA approved vepdegestrant, developed by Arvinas and Pfizer, marking the first approval of a PROTAC protein degrader.

Capacity and Capability: Keeping Projects Moving

“Capacity ensures projects can progress without delay, and capability provides the expertise to problem-solve technical challenges while maintaining high quality,” Dr. Yang said.

WuXi AppTec continues to expand its global network. In the United States, a new site in Middletown, Delaware, will provide large-scale drug manufacturing and formulation capabilities starting in the fourth quarter of 2026. In Singapore, a large manufacturing facility for late-stage APIs is expected to be operational in early 2027. WuXi AppTec is also expanding capacity and capabilities at its manufacturing facility in Couvet, Switzerland.

Physical capacity must be matched by the technical capabilities needed to use it effectively. WuXi AppTec continues to deepen its expertise in new modalities and expand automation and digital operations across its network. Automation can increase throughput and reduce process variability, which may lower project costs over time.

But quality, said Dr. Yang, remains the most important consideration, ahead of innovation and integration. In the first half of 2026 alone, WuXi AppTec underwent 465 quality audits from global customers, regulatory agencies, and independent third parties, all with no critical findings. 

The company operates a unified global quality system built to satisfy the requirements of major regulators, so data generated in its laboratories and plants can support filings across markets. Those systems support customers’ regulatory submissions, but ownership of the drug and the regulatory relationship remains with the customer.

“We are an enabler. Customers own the drug and the regulatory relationship. WuXi AppTec provides the research, the manufacturing and the data to back them,” Dr. Yang said.

Remaining Focused on Unmet Needs

Dr. Yang remains optimistic about the direction of oncology research. “We have seen from many epidemiology studies that our fight against cancer on a global basis has made tremendous progress,” he said.

Survival and quality of life have improved in many cancers, and treatment options increasingly reflect tumor subtype and mutation status. Progress has come from new drugs as well as combination therapies that pair newer modalities with established treatments.

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