Regulatory notice · FR-M5-03 Innovative pharmaceuticals and devices listed here are authorized for clinical administration inside designated institutions of the Boao Lecheng Pilot Zone only; overseas cross-border online sales and direct domestic delivery are strictly prohibited. P-SV-06 · FR-M5-03
Boao Lecheng special licensed therapeutics & devices

Special Drugs & Devices in-zone fast-track

博鳌乐城特许药械 · 同步全球创新药与前沿器械

Case-by-case access to international cutting-edge therapeutics and high-precision devices approved through the Pilot Zone mechanism — before conventional domestic market release, and always under specialist supervision.

State Council Decree [2013] No. 33 · Boao Lecheng Pilot Zone Real-World Data (RWD) clinical evaluation centre In-zone administration only — no overseas delivery
390+innovative drugs & devices under the pilot fast-track
0time gap with the global release of listed therapies
100%in-hospital cold-chain tracked administration
MDTacademician-led MDT board evaluation
Demonstration catalog · updated monthly

Authorized special pharmaceuticals & devices

Verified entries regulated under the Hainan Pilot Zone fast-track provision; clinical use is subject to specialist consultation and on-site qualification.

Cardiovascular & metabolic devices On-site ready

Mavacamten (Camzyos®)

玛伐凯泰胶囊

Generic mavacamten · targeted myocardial inhibitor

Bristol Myers SquibbUnited States

Clinical indication

Symptomatic obstructive hypertrophic cardiomyopathy in adults (NYHA II–III), to improve functional capacity and reduce outflow obstruction.

Pilot Zone docket: HN-PILOT-2023-CD014 Batch verification: LOT# B882-US-EXP2026
Cardiovascular & metabolic devices On-site ready

Micra™ AV2 Leadless Pacemaker

无导线双腔起搏器

Transcatheter pacing system · dual-chamber AV synchrony

MedtronicUnited States / Ireland

Clinical indication

AV block requiring dual-chamber pacing without transvenous leads or surgical pockets — lower infection and occlusion risk.

Pilot Zone docket: HN-PILOT-2023-MD089 Cath-lab status: Hybrid interventional suite ready
Targeted oncology & immunotherapy On-site ready

Epcoritamab (Epkinly®)

CD3×CD20 双特异性抗体

CD3×CD20 bispecific human IgG1

AbbVie / GenmabSwitzerland / Denmark

Clinical indication

Relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

Pilot Zone docket: HN-PILOT-2024-ON033 Cold-chain tracking: 2–8 °C controlled vault
Cardiovascular & metabolic devices On-site ready

Freesolve™ Magnesium Scaffold

可吸收镁合金冠脉支架

Resorbable magnesium drug-eluting coronary scaffold

BiotronikGermany

Clinical indication

De novo coronary lesions needing temporary scaffolding with full bioabsorption at twelve months.

Pilot Zone docket: HN-PILOT-2023-MD112 Regulatory track: CE marked · RWD priority
Targeted oncology & immunotherapy By reservation

177Lu-vipivotide tetraxetan (Pluvicto®)

镥-177 PSMA 靶向放射配体

PSMA-directed radioligand therapy · lutetium-177

NovartisSwitzerland

Clinical indication

PSMA-positive metastatic castration-resistant prostate cancer after androgen-receptor pathway inhibition and a taxane.

Pilot Zone docket: HN-PILOT-2024-RL005 Isotope logistics: Direct isotope inflow sync
Regenerative implants & cells On-site ready

Vyznova™ Corneal Endothelial Cells

培养人角膜内皮细胞

Cultured human corneal endothelial cell suspension

ActualEyes Inc.Japan (PMDA)

Clinical indication

Bullous keratopathy from corneal endothelial decompensation — cell injection instead of full-thickness keratoplasty.

Pilot Zone docket: HN-PILOT-2023-RG021 Delivery protocol: Anterior-chamber micro-injection

The catalog above is a demonstration baseline. Availability follows batch inflow and is confirmed in writing by the medical office after on-site qualification (FR-M5-03); it is not an online shop.

Regulatory fast-track architecture

Four steps from dossier to supervised therapy

Under special statutory authorization, patients access globally approved medicines through a streamlined four-stage medical compliance path inside the zone.

Dossier

Medical record pre-assessment

Medical history, pathology and imaging are reviewed through the encrypted GL-02 portal.

24–48 h turnaround

Board

Expert committee approval

The multidisciplinary team and the Boao academician board confirm indication fit and issue the clinical authorization.

Institutional sign-off

Import

Personalized import authorization

Zone authorities clear the designated batch and cold-chain transport to the hospital vault inside the pilot zone.

2–8 °C GPS-tracked

Care

Supervised administration

Licensed specialists administer the therapy in sterile inpatient suites with Real-World Data follow-up.

JCI hospital environment

Consult the Boao medical board about eligibility

If your condition requires a therapy not yet approved in your home region, the MDT prepares a documented case match and a written eligibility path — no online sales, ever.