Two policy developments are reshaping the regulatory and compliance backdrop for biotech dealmaking tied to China. A separate report said calls for expanding the COINS Act are growing, with advocates pushing Treasury to extend outbound investment curbs to biotechnology-related cross-border drug dealmaking. In parallel, China issued new investigator-initiated trial (IIT) rules expected to reduce “gray market” conduct by tightening regulatory oversight of IITs while clarifying legal pathways for other modalities beyond cell and gene therapies. For companies operating in both jurisdictions, these developments increase the importance of deal structuring, compliance planning, and careful documentation around clinical study frameworks and partnership rights. Together, the changes point to tighter control mechanisms across the value chain—from how trials are governed in China to how certain outbound investment structures are evaluated in the U.S.—with potential knock-on effects for timelines and contracting.