US Treasury proposes COINS Act rules that restrict biotech investment in China but leave big pharma licensing deals untouched

The U.S. Treasury Department released draft regulations that add biotechnology to the Comprehensive Outbound Investment National Security (COINS) Act, labeling pharmaceutical compounds as prohibited technology for outbound transactions to "countries of concern" such as China.

The definition spans a broad array of modalities, from small‑molecule drugs and vaccines to cell and gene therapies, monoclonal antibodies and their delivery systems, potentially limiting U.S. biotech firms' ability to invest or collaborate in China.

The proposal, however, explicitly exempts routine in‑licensing agreements and fee‑for‑service R&D collaborations, which have historically underpinned multibillion‑dollar deals between Western pharma companies and Chinese partners, providing some relief to big‑pharma licensing activities.

The rules remain in draft form and are open for comment, so the ultimate impact will depend on how the Treasury balances national‑security concerns with the biotech sector's need for cross‑border innovation.