Quarterly Market Perspective: China IITs, Approvals and Commercial
Dear all,
I hope you’re well, and managing to stay cool as Europe makes another attempt at becoming the Mediterranean. Given your interest in IITs and China, we wanted to share our latest quarterly market perspective.
Our overall view is that recent regulatory changes point to a more mature, higher-quality market, particularly for innovative therapies and rare diseases.
Clinical
New IIT regulations are being implemented rapidly with three important implications:
Stronger quality standards: Historically, IITs varied significantly in their approval, CMC, and operational standards. In some cases, limited oversight contributed to serious and avoidable patient-safety issues. The new framework introduces much-needed safeguards through more standardised goal posts and stricter approval, CMC, and research-management requirements.
A formal accelerated commercialisation pathway: Therapies may now be commercialised through IITs, offering a faster and less capital-intensive route to market. Pricing remains unrestricted for now, although this is unlikely to continue indefinitely.
Continued support for advanced therapies: Cell and gene therapies addressing high unmet need, particularly rare diseases, are expected to remain prioritised.
Over the next year, we expect further standardisation of IIT pre-trial safety reviews and additional challenges to foreign companies seeking to conduct IITs without a local partner or intermediary. This does not fundamentally alter the process but should create greater consistency in what hospital ECs/SCs and PIs must review before granting local approval.
Overall, these changes should favour companies using robust, well-governed IIT models, improve data quality, and increase confidence in well-conducted studies.
Approvals and regulatory
IIT and customs approvals have slowed temporarily as stakeholders adapt to the new framework, with a backlog of more than 100 applications since May. We expect timelines to normalise as the transition progresses.
Rare diseases continue to receive strong support through enhanced exclusivity protection, broader accelerated approval pathways, and potential trial waivers. Innovative gene and cell therapies are likely to benefit most.
Commercial and BD&L
International interest in Chinese innovation is accelerating, particularly for Chinese gene and cell therapy assets.
Within China, the commercial insurance list is a positive development. However, as we have previously noted, it addresses only part of the broader GTM challenge. Regional implementation appears uneven, as expected, and further Q4 updates should provide greater clarity on the list’s practical impact.
Finally, the significant increase in rare-disease support that began in late 2024 continues to gain momentum. In addition to clinical and regulatory progress, we are seeing growth in China-originated innovation and improvements in diagnostic and treatment infrastructure. Multiple digital and AI-enabled systems are now being implemented, driving tangible improvements in time to diagnosis and patient access to care.