We provide your therapy to patients faster and build the real-world evidence your later filings need.
Most sponsors treat Japan as a late-cycle licensing. It should be a first step.
The ASRM authorizes provision in months, under a certified committee that lets you build registrational-grade evidence in parallel. Used well, a safety-cleared asset can be in human use while your team keeps running trials.
How ASRM stacks against the alternatives.
| Pathway | What it authorizes | Typical timeline |
|---|---|---|
| ASRM · Japanour route | Provision of therapy via certified medical institutions. | Months to begin, after committee review. |
| PMD Act · Japan · CEA | Conditional, time-limited marketing approval (up to 7 years). | Faster than standard — but requires exploratory trials. |
| FDA standard · U.S. | Full product marketing approval. | 7–12 years. |
Independent, peer-reviewed work advanced under the ASRM — public record, not performed by Unchain.
Seven patients received bilateral grafts of iPSC-derived dopaminergic progenitor cells — the precursors of the neurons Parkinson's destroys — into the putamen. No serious adverse events, no graft overgrowth. Graft survival and dopamine production confirmed; motor benefit at the primary endpoint.
Your Japan Operational Partner.
We take no rights to your underlying technology, at any stage of engagement.
We connect you to the right clinics & committees without you setting your own subsidiary or local hires.
We manage patient tracking, ensuring you will collect data that generates revenue instead of costing you.
If we fit your asset, you will know in one call.
Engagement terms are structured per partnership and discussed under NDA.
An early-commercialization partner in Japan. We provide your therapy to patients under the ASRM and build the real-world evidence your later filings need as your Japan presence, not a licensee. Global rights stay with you.
No. Full IP ownership and strategic control stay with you. We de-risk the asset, build the evidence, and produce revenue. We do not take rights to your technology at any stage of engagement.
We will tell you so in the first call. Unchain operates exclusively under the ASRM at the moment; however, we can introduce you to our strategic partners who can help you.
Schedule a meeting with us.
A real reply from the team. We respond within two business days.