China’s biopharma sector is moving rapidly beyond its traditional strengths in generics and domestic manufacturing, with growing numbers of companies pursuing globally competitive assets, international partnerships, and more sophisticated development strategies.
As part of our ongoing series exploring the rise of China’s pharma market, we speak with Wayne Wen, Associate Director of Commercial Development at Lonza’s Nansha site, about the forces driving this transition. Responsible for customer offerings and strategy across the Asia-Pacific region, Wen brings experience in process development, program management, and advanced technologies for small-molecule drug substances. Here, we discuss the manufacturing challenges companies face as they expand internationally and how expectations of CDMO partners are changing.
From your perspective at Lonza’s Nansha site, how has China’s biopharma ecosystem evolved in recent years – particularly in terms of development and manufacturing maturity?
China is rapidly emerging as a global innovation hub in biopharma, with a clear acceleration in R&D capabilities. Many companies are moving beyond generics and “me-too” assets to pursue first-in-class and best-in-class therapeutics. This is particularly evident in areas such as antibody-drug conjugates, where we are seeing strong momentum across the region.
At the same time, there is significant investment in infrastructure to support next-generation therapeutics, including large-scale biologics manufacturing and advanced modalities. In our work with drug developers, we see growing maturity in the understanding of chemistry, manufacturing, and controls requirements, with increased focus on process development, analytical characterization, and alignment with global regulatory expectations.
Although capabilities still vary across organizations, quality mindsets are evolving from basic compliance toward quality by design and lifecycle management, especially among companies seeking to advance internationally. Overall, China is transitioning from a volume-driven base to a more innovation-led ecosystem, with rising demand for experienced partners to help translate scientific advances into robust, scalable processes.
What is driving the shift from a primarily domestic biopharma market toward a more globally integrated development and manufacturing ecosystem?
Several forces are driving China’s shift toward a more globally integrated biopharma ecosystem. Capital and policy dynamics play a central role, with domestic pricing pressures and constraints on certain capital flows shaping how companies grow and compete, while highly efficient Chinese biotech innovators continue to attract strong global investment. This has led to a distinct model in which companies retain China rights and partner with multinational pharmaceutical companies through ex-China licensing.
At the same time, the ecosystem itself has matured rapidly. A deeper talent base, advanced manufacturing infrastructure, and a well-developed network of development and manufacturing organizations are enabling end-to-end capabilities from discovery through commercial scale. In our experience, this is improving alignment with international regulatory and quality standards and making it easier for companies to bridge domestic development with global markets.
As more Chinese companies look beyond the domestic market, how are their expectations of CDMO and manufacturing partners changing?
As Chinese biopharma companies expand globally, expectations of CDMO partners are shifting from transactional support to strategic collaboration. Companies are leveraging partners to address rising development costs, accelerated timelines, shared risk, and reduced complexity.
This is driving demand for integrated, end-to-end capabilities across development and manufacturing, alongside strong global regulatory expertise, including readiness for FDA and EMA inspections. At the same time, speed, flexibility, and hands-on technical advice have become critical, particularly for programs targeting accelerated pathways or multiple regions.
Where do Chinese biotech and biopharma companies typically face the biggest challenges when moving from domestic development toward global clinical or commercial supply?
Despite strong momentum, companies face several recurring challenges when moving beyond the domestic market. Navigating global regulatory requirements can be complex, particularly for next-generation modalities where standard chemistry, manufacturing, and controls pathways may not fully apply.
Early-stage processes are also not always designed for commercial scale, often requiring rework to meet global manufacturing and quality expectations. In addition, gaps in inspection-ready quality systems, along with the complexity of global supply chains, technology transfer, and sourcing, can introduce delays and compliance risks.
Addressing these challenges requires earlier integration of CMC and development considerations into process design. Taking a more holistic view of the product lifecycle and balancing CMC readiness with speed can help reduce downstream risk and support smoother progression into global clinical and commercial supply.
What role can CDMOs play in helping companies build manufacturing processes that are scalable, robust, and aligned with global expectations?
From our perspective at Lonza’s Nansha site, CDMOs play a critical role in enabling global success through strategic collaboration: building scalability into process design early, embedding global regulatory expectations into CMC and analytical development, and leveraging platform technologies to enhance robustness and speed.
Equally important is the ability to support seamless technology transfer and commercial scale-up, ensuring continuity from clinical development to market supply. This positions CDMOs as both technical partners and risk-management enablers.
Are you seeing Chinese companies engage manufacturing partners earlier in development than they might have done in the past? What is driving that change?
We are seeing a clear transition toward earlier engagement between biopharma companies and manufacturing partners. As molecules and technologies become more complex, companies are becoming more aware of scale-up and regulatory risks, while also navigating compressed development timelines and rising investor expectations for rapid global progress. As a result, sponsors are seeking more strategic CDMO partnerships that better align development, manufacturing, and regulatory strategies and improve the likelihood of success.
Looking ahead, how do you expect China’s role in global biopharma manufacturing and innovation to evolve over the next five years or so?
We see China evolving from a primarily domestic market into a more integrated and influential force in global biopharma innovation and manufacturing.
In the near term, we can expect China to strengthen its role in the global ecosystem, both as a service provider and as a growing source of innovation, with more globally competitive assets reaching international markets. This progress is being supported by continued investment in high-quality, globally compliant manufacturing capacity and by a more sophisticated CDMO ecosystem that can support full-lifecycle development.
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