As global biopharma companies look to China not only as a late‑stage enrollment engine, but also as a strategic early‑development geography, a recurring question arises: Should we start with an Investigator‑Initiated Trial (IIT), or proceed directly via a formal China IND?

While the IND pathway remains essential for registrational intent, China IITs offer distinct advantages in speed, flexibility, and data generation, especially during early clinical exploration. This article addresses common questions sponsors raise when evaluating China IITs, and how they compare with a typical China IND‑enabled trial.