Hainan Boao Lecheng: the special-access channel for drugs and devices
Inside the Boao Lecheng pilot zone in Hainan, designated hospitals may use overseas-approved drugs and medical devices that are not yet registered on the mainland. This page records what that channel is, what it has introduced, and what is not published.
- Special access
What it is
Boao Lecheng is a national pilot zone in Qionghai, Hainan Province, where designated hospitals may use drugs and medical devices approved abroad but not yet registered on the mainland, together with certain special foods. The figures below are the provincial and official-media record; a special-access listing applies inside the zone under stated conditions, not nationwide.
Official status
| Item | Status | Basis | Date | Source |
|---|---|---|---|---|
| Innovative drugs, devices and special foods introduced (cumulative) — over 560 | Special access | Hainan Provincial People's Government release | 2026-05-13 | https://www.hainan.gov.cn/hainan/wjjg/202605/a1819ce7190a4548b0b48783cf6a7204.shtml |
| Innovative drugs, devices and special foods introduced (cumulative) — over 580 | Special access | China Daily Hainan report (official media) | 2026-06-07 | https://hain.chinadaily.com.cn/a/202606/07/WS6a250a23a310942cc49b058a.html |
| Products accelerated to market through the real-world evidence channel — 26 | Special access | China Daily Hainan report (official media) | 2026-06-07 | https://hain.chinadaily.com.cn/a/202606/07/WS6a250a23a310942cc49b058a.html |
| Special-access product uses by patients, 2026 Q1 — over 30,000, up 69.85% year on year | Special access | Hainan Provincial People's Government release (2026 Q1 figures) | 2026-05-13 | https://www.hainan.gov.cn/hainan/wjjg/202605/a1819ce7190a4548b0b48783cf6a7204.shtml |
| Products carried through the 'Lecheng trial use, Hainan production' route — 3 | Special access | China Daily Hainan report (official media) | 2026-06-07 | https://hain.chinadaily.com.cn/a/202606/07/WS6a250a23a310942cc49b058a.html |
Where it is available
- Pilot zone
- Boao Lecheng International Medical Tourism Pilot Zone, Qionghai, Hainan Province. Source Pilot zone
- Who may use it
- Designated hospitals inside the zone, under the zone's own rules. Hainan's medical products administration requires informed consent that sets out the product's status and that no equivalent mainland product is available, full procurement and follow-up records, and adverse-event reporting. Source Who may use it
- Special foods
- The zone is the only area in China allowed to import certain overseas-approved health foods and food for special medical purposes on a temporary basis; 16 such special foods had been introduced as of May 2026. Source Special foods
- Designated hospitals
- Not published — no official list of designated hospitals, and no per-product availability at a named hospital, was retrieved for this page.
Updates
What we do not know
- The cumulative count rolls month by month (553 in January 2026, over 560 in May 2026, over 580 in June 2026) and includes special foods, so it is not a count of drugs alone.
- A special-access listing applies inside the pilot zone under stated conditions. It is not a mainland marketing authorisation and it does not make a product available nationwide.
- The pilot zone's own administration website (lecheng.gov.cn) did not respond when this page was compiled, so the figures here come from the Hainan provincial government and official media instead.
- Designated hospitals are not published here: no official list was retrieved, so that is recorded as not published rather than estimated.
- Inclusion in the channel is a regulatory fact. It is not a recommendation and it says nothing about whether a product is suitable for any particular patient.