China’s regulatory environment for investigator-initiated clinical trials is tightening, slowing the pathway that allows academics and sponsors to start studies without central sign-off. STAT reported that new government restrictions and recent patient deaths have caused investigator-initiated trials to “slow to a trickle,” raising timeline concerns for U.S. biotechs that have relied on faster Chinese human-testing routes. The shift also affects rare-disease development models that use China’s IIT pathway to scale genetic and other advanced therapies at lower costs.