Western pharmaceutical companies are no longer seeking cheap 'me-too' assets in China. Instead, they are paying premium prices for genuinely innovative drugs, as evidenced by a 10x increase in deal size over five years and a surge in patent filings from the region.
The increasing innovation and speed from China puts pressure on the U.S. biotech ecosystem. To remain competitive, the U.S. must focus on collaboration and address its own systemic issues, such as slow trial execution and the high cost of getting a drug to the IND stage.
Recent events, like Moderna's rescinded 'refusal to file' letter, reveal that alignment with FDA staff on trial design is no guarantee. Senior leaders, notably Vinay Prasad, are reportedly overturning prior agreements, creating extreme uncertainty and making it impossible for companies to trust the regulatory guidance they receive.
Despite the FDA leadership co-authoring an editorial supporting single-trial approvals, the industry is skeptical. The agency's recent inconsistent actions mean no executive or investor can confidently build a development strategy or financial model based on this policy, rendering the announcement largely ineffective.
Eli Lilly's deal with Innovent outsources R&D through Phase 2 to China. This leverages China's faster clinical development environment, allowing Lilly to de-risk assets before committing to costly global trials, effectively creating an externalized early-stage pipeline.
While AI for novel drug discovery has lofty goals, its most practical value lies in accelerating development. This includes applying AI to de-risked assets for new indications, improving delivery methods, and designing faster, more effective clinical trials, which is where the real bottleneck lies.
Despite facing a patent cliff of up to $300 billion by 2030 and knowing that most innovation is externally sourced, big pharma's M&A activity remains surprisingly tepid. This paradox suggests a major disconnect between strategic necessity and the industry's current risk appetite or deal-making capacity.
New analysis suggests Merck's blockbuster drug Keytruda may have patent protection until 2033, far beyond current consensus. This is based on defensible formulation patents, a strategy similar to AbbVie's successful defense of Humira, which could significantly reshape the immuno-oncology market.
While Compass's psilocybin shows strong Phase 3 data, its 6-8 hour in-office administration is a major commercial hurdle compared to J&J's Spravato (2 hours). The key investment thesis is that its significantly longer-lasting effect will justify the logistical complexity for patients, providers, and payers.
Market sentiment has shifted. Even companies with strong commercial launches, like Alnylam, are selling off due to a perceived lack of near-term pipeline news. Investors are rewarding companies taking on clinical risk (like Vertex) more than those executing commercially, creating a 'what's next' valuation culture.