China Investigator-Initiated Trials (IITs) can offer significantly greater speed, flexibility and cost efficiency than traditional IND trials. In Part 1 of our China IIT Spotlight Series, we explore how IITs differ in study design, regulation and execution.

China’s clinical and regulatory landscape is entering a more mature phase, with tighter IIT quality standards, new accelerated commercialisation pathways, and continued support for innovative cell and gene therapies and rare diseases.

MFN pricing, tariffs and China’s growing role in global biopharma are reshaping go-to-market strategy—but the biggest impact may be longer term. We explore what these shifts mean for pricing, DTC models, “beyond-the-pill” innovation, earlier US-EU-China planning, and why integrated China and Western-market expertise is becoming essential for global biopharma strategy.