To overcome the difficulty of running clinical trials in China, Zymeworks partnered with a local company, B1. This provided crucial access to a large patient population for indications like gastric cancer, significantly speeding up its global drug development program.
Instead of an exclusive deal, Zymeworks shared its platform non-exclusively with multiple pharma giants. This multi-partner strategy validated the technology, generated capital, and built a portfolio of royalty interests before the company developed its own internal pipeline.
US biotechs increasingly use sites like Australia to accelerate development, as Create Medicines did by moving from concept to clinic in under 12 months. What was once viewed with suspicion is now a key strategy to generate data faster and more cheaply, competing with the speed of China's ecosystem.
China has developed a first-rate biotech effort, enabling U.S. firms to buy or license preclinical assets more efficiently than building them domestically. This creates an arbitrage opportunity, leveraging China's R&D capabilities while relying on U.S. expertise and capital for global commercialization.
China is no longer just a low-cost manufacturing hub for biotech. It has become an innovation leader, leveraging regulatory advantages like investigator-initiated trials to gain a significant speed advantage in cutting-edge areas like cell and gene therapy. This shifts the competitive landscape from cost to a race for speed and novel science.
China's ability to accelerate biotech development stems from faster patient recruitment for clinical trials. With a large, treatment-naive patient population willing to participate in studies, early-stage oncology trials can be completed in about half the time it takes in the US. This provides a significant strategic advantage for de-risking assets more quickly and cheaply.
Driven by significant government investment, China is rapidly becoming a leader in biotech R&D, licensing, and outsourcing. This shift is a top-of-mind concern for US biotech and pharma executives, with China now involved in a majority of top R&D licensing deals.
Amidst growing uncertainty at the US FDA, biotech companies are using a specific de-risking strategy: conducting early-stage clinical trials in countries like South Korea and Australia. This global approach is not just about cost but a deliberate move to get fast, reliable early clinical data to offset domestic regulatory instability and gain a strategic advantage.
China is poised to become the next leader in biotechnology due to a combination of structural advantages. Their regulatory environment is moving faster, they have a deep talent pool, and they can conduct clinical trials at a greater speed and volume than the U.S., giving them a significant edge.
The next decade in biotech will prioritize speed and cost, areas where Chinese companies excel. They rapidly and cheaply advance molecules to early clinical trials, attracting major pharma companies to acquire assets that they historically would have sourced from US biotechs. This is reshaping the global competitive landscape.
Despite US-China tensions threatening innovation, the likely outcome is 'coopetition'—a blend of competition and collaboration—as global pharmaceutical firms navigate the dual imperatives of advancing innovation and ensuring supply chain resilience.