China-Originated Innovation
China-Originated Assets: A Western BD Reader's Guide to Diligence
The diligence questions that matter most for a China-originated asset aren't the usual ones. Export approvals, data comparability, and regulatory screening deserve earlier attention than valuation.
The step most diligence teams miss until it's too late
China's 2023 revision to its Human Genetic Resources (HGR) rules classifies genomic data as a strategic asset requiring export approval before it can leave the country. Teams that treat this as a late-stage regulatory formality routinely find it stalls data-room access for weeks. Ask for HGR filing status in the first call, not after term sheet.
Speed claims are usually real, but verify the comparison
Chinese clinical enrollment genuinely runs faster than US timelines in many indications, helped by GCP mutual recognition between regulators. The diligence question isn't whether the speed is real. It's whether the trial design, endpoints, and patient population are comparable enough to the intended registration pathway to carry that speed advantage forward.
Screening now runs both directions
US-side compliance (BIOSECURE-flagged entity lists, HGR export approval) gets the attention, but it's not the only screen that matters. Confirm early which structure the counterparty actually wants: regional license, global license, co-development, or platform deal. Each implies a different diligence scope, and asking late costs more time than asking wrong.
For biotech partnering or asset strategy discussions, contact Kerlann Advisory.