As xenotransplantation moves from headline-making firsts toward the possibility of regulated clinical use, the question is no longer just whether gene-edited pig organs can work. It is also how they will be reviewed, standardized, reimbursed, and scaled. This spring underscored that divide. In the United States, FDA clearance of the first human heart xenotransplant trial put pig-heart research onto a pathway that could eventually support an approvable biologic product. In China, Order 818 brought xenotransplantation under a new biomedical technology framework, a track that appears likely to emphasize hospital-led research and clinical translation rather than a traditional drug-style approval route.
To better understand what these regulatory choices mean for companies, hospitals, investors, and patients, Medical Design Briefs spoke with Boyang Wang, founder of the Singapore-based longevity fund Immortal Dragons . Wang discusses why the United States has concentrated on company-driven heart and kidney programs aimed at living-patient trials; why China has become associated with liver, lung, and multi-organ firsts; and why comparing progress across the two countries may become increasingly difficult.
Medical Design Briefs: How do you interpret the FDA's clearance of the first human heart xenotransplant trial, and why does it matter that the United States has framed gene-edited pigs and their organs through an FDA-approvable biopharma pathway?
Boyang Wang: The significance isn't "another world first," it's a category shift. The two earlier pig-heart cases, Bennett in 2022 and Faucette in 2023, were compassionate-use, more of a one-off surgery. The cleared heart trial is the first time anyone is generating pig-heart data designed to support a Biologics License Application (BLA), which might be able to become a marketable, reimbursable therapy in the future.
What makes that possible is a regulatory choice the U.S. made years ago: it treats the gene-edited pig as a "source animal," which means intentional genomic altered animals regulated by FDA's veterinary side, and the organ as a biologic licensed through CBER. That puts xenotransplantation on exactly the same rails as a drug, which has reproducible manufacturing standards, defined endpoints, a clear reimbursement path. So the clearance matters less as a medical milestone than as confirmation that the U.S. has decided to build this as an industry.
MDB: You have argued that the United States and China are now regulating the same underlying science through two very different systems. What is the most important practical difference between the FDA's IND-style pathway and China's Order 818 hospital-research track?
BW: The FDA route ends in a license, a BLA that can be marketed and get reimbursed nationwide, anchored on living-patient data (for kidney, the primary endpoint is the organ still functioning at six months).
China's side must be observed with more caution. Order 818 took effect on May 1, 2026, but it's still closer to a skeleton than a finished system. The implementing rules that actually determine how a technology like xenotransplantation lands, including the working procedures, the technology-versus-drug delineation guidance, the filing checklists, were only issued right before the law came into force, several of them as provisional or trial versions, and the field is still waiting on fuller detail.
So far, the insights we've obtained are a projection from the current shape, not a closed question: as the framework stands, the high-probability path is that xeno is regulated as a "new biomedical technology" under the health commission, not the drug-registration track. Which would make the endpoint approval to apply a technique at qualified Class A Grade III hospitals, gated by institutional and ethics review rather than a central federal license.
The FDA path produces a product; the 818 path, as it's shaping up, looks set to produce a procedure. One ends in something you can sell anywhere; the other in something a specific hospital is cleared to do. The open question on the Chinese side is how sharply that destination gets drawn once the detailed rules land.
MDB: Why has the United States produced company-driven heart and kidney xenotransplant programs aimed at living-patient trials, while China has become known for liver, lung, and multi-organ firsts in brain-dead research subjects?
BW: The root are the founders of each ecosystem. America's pioneers are companies and platform scientists like George Church, David Ayares, and Martine Rothblatt, building United Therapeutics and eGenesis, so the goal from day one is a licensable product. They've concentrated on heart and kidney for a relatively clean reason: Those are organs whose function you can directly observe and measure. A kidney makes urine and clears creatinine, a heart pumps, and that gives the kind of objective endpoints a trial needs. The kidney leads the formal-trial push for one extra reason the heart doesn't have: dialysis is a fallback, so if the graft fails the patient doesn't die. China's pioneers are the people who built gene-edited pigs, agricultural scientists like Pan Dengke, and surgical chiefs at military and academic hospitals like Dou Kefeng and He Jianxing, so the pull is toward world firsts, which means reaching for the hardest organs: liver, lung, multi-organ.
One extra note: China is not only doing brain-dead work. There are living-patient cases too, including the auxiliary pig liver in Anhui, and a living pig-kidney recipient in Xi'an who went close to eight months. The brain-dead, or decedent model is not unique to China; it's an established research pathway in the U.S. as well, where NYU Langone and others have run pig-organ studies in brain-dead bodies. In the U.S., brain death is legal death and a decedent isn't a "human subject," so the work proceeds on next-of-kin consent and institutional review. China hasn't passed a standalone brain-death law, but a brain-dead patient can lawfully become an organ donor through family consent plus ethics and institutional approval.
MDB: In the U.S. model, gene-edited pigs are treated as "biopharm animals" and the organs as biologics. What does that separation make possible for companies, regulators, and investors that may be harder to achieve under China's framework?
BW: What the U.S. framing unlocks: Treating the pig as a biopharm animal and the organ as a biologic turns a surgery into an ownable, transferable asset. The edited pig line becomes a patentable manufacturing platform, so investors can underwrite the herd as the factory. And a BLA is a single national marketing authorization: it carries data exclusivity, plugs into reimbursement, and can be sold, licensed, or acquired as a discrete asset with a clear IND-to-trial-to-BLA ladder investors can price.
What China's 818 framing unlocks: We are still expecting more detailed implementations to China's decree 818, the current read is that 818 treats xeno as a "new biomedical technology" with a clinical-translation pathway rather than a drug, it does three things the BLA model can't. First, speed to patient: after clinical research, a qualified hospital can apply to translate the technology into approved use and bill for it, without the full multi-phase registration trial a BLA demands, putting patients years ahead. Second, iteration: surgeon-led technique can iterate case by case, try a new organ or a multi-organ combination, and improve the protocol without re-running a giant trial each time. Third, a lower bar to the first attempt: no 75-million-dollar GMP facility or full sponsor apparatus needed, just a qualified hospital, a pig supplier, and ethics approval, which produces distributed multi-center competition instead of a two-company oligopoly.
China's model buys speed, iteration, and earlier access, but the output stays institution-bound and hard to standardize, scale, or export. The US buys a slower path to a single asset that's ownable, transferable, and global. One optimizes for a product you can sell anywhere, the other for getting a technique to a patient sooner.
MDB: China's Order 818 formally places xenotransplantation under a "new biomedical technology" track rather than a traditional drug pathway. How might that shape the kinds of evidence Chinese hospitals generate — and the kinds of trials they are less likely to pursue?
BW: Because 818 routes xenotransplantation through hospital-led clinical research and translation rather than drug registration, it rewards feasibility and firsts. The evidence it generates is rich but single-institution: case series, surgically and immunologically detailed, short-to-medium-term, often in decedent settings. It is structurally less likely to produce the large, multi-center, pre-specified-endpoint, registration-grade trial that a marketing license requires, the equivalent of the FDA's six-month living-function endpoint. When the endpoint is approved use of a technique at qualified institutions rather than a product sold nationally, there is little pressure to run the long, expensive, standardized living-patient trials that generate transferable, regulator-grade longitudinal data.
The trajectory matters more than the snapshot. 818 is also the scaffold that could give China the regulatory ladder toward formal living-patient trials it previously lacked. In institutionalizing the decedent gray zone, it narrows it, and may push Chinese programs toward the rigorous living-patient evidence they have been criticized for skipping. The likely near-term output is therefore deep feasibility and first-in-human data, thin on the multi-center longitudinal rigor a marketing authorization demands, with that gap closing only if and as the implementing rules build out the trial track.
MDB: Do you think China's decedent-subject xenotransplant milestones should be viewed as scientific leadership, regulatory workaround, clinical steppingstone, or some combination of all three?
BW: All three, in different proportions. The scientific leadership is real and not inflated. The auxiliary pig liver in the Journal of Hepatology, the world-first pig lung in Nature Medicine, and the multi-organ work are genuine firsts on the hardest organs, in top journals.
On workaround, the word overstates it. The brain-dead, or decedent, gray zone exists in both countries. A decedent is not a human research subject under either the U.S. or the Chinese framework, and American teams use the pathway as well. The accurate description is a strategic path choice that reflects each system's structure, not a circumvention of rules.
As a steppingstone, it is real but bounded. Decedent work generates feasibility, surgical, and short-term immunology data, but cannot generate the long-term living-function data an approvable therapy requires. These milestones are therefore not yet a therapy, and the common overreach is reading "world first in a brain-dead recipient" as "China is close to treating patients."
MDB: Looking ahead, what would have to change for the United States and China to compare xenotransplantation data meaningfully — given that the pigs, edits, endpoints, evidence standards, and gatekeepers are all different?
BW: On the current trajectory, the two systems may not become comparable. They are decoupling into non-interoperable standards rather than converging, and that is the central point. Meaningful comparison would require alignment across at least five layers, none of which is converging now. The pig itself differs by breed and by edit count, with United Therapeutics at ten edits, eGenesis at sixty-nine, and Chinese programs ranging from six to ten, alongside different positions on whether to inactivate PERV. The genetics and the disclosure of which edits were made, and why, are not standardized. The endpoints do not map: a six-month living-function endpoint versus survival measured in days to weeks in non-living recipients. The evidence tiers differ: registration-grade living-patient trials versus single-institution feasibility series. And the gatekeepers and data-transparency regimes differ, with the FDA and CBER on one side and the health-commission hospital track on the other.
Concrete comparability would require a shared international standard, with common donor characterization and endpoint definitions adopted by both regulators, living-patient longitudinal data generated against the same endpoints on both sides, and cross-border data recognition. In 2026 the last of these is moving in the opposite direction. Export controls, genetic-resource restrictions, and broader decoupling are pushing the data apart rather than together. The more probable outcome is not a single scoreboard but two parallel ecosystems, in which an organ approved in one country cannot be transplanted or approved in the other, and "who is ahead" ceases to be a coherent question.
Conclusion
Xenotransplantation is often discussed as a race — one country, one company, or one research team moving ahead of another. However, Wang's view suggests a more complicated reality. The United States and China may be moving toward different definitions of progress, shaped as much by regulatory architecture as by surgical or genetic engineering advances. For engineers, investors, and clinicians watching the field, the key question may not simply be which organ works first, but which system can turn early success into reliable, repeatable, and broadly accessible care.
