Nephrology · CKD Anaemia · 2026
Roxadustat for renal anaemia,
China-first HIF-PHI access.
First-in-class oral HIF-PHI, NMPA-approved December 2018 — before US/EU. An oral alternative to ESA injections for dialysis and non-dialysis CKD anaemia. Workup at China’s reference nephrology centres with bilingual report and home-nephrologist handover.
Dec 2018
World-first NMPA approval
Dialysis CKD anaemia indication
NMPA register
$90–160
Roxadustat / month
NMPA-listed post-NRDL pricing
Hospital pharmacy quotes
Oral 3×/week
vs ESA injections
No cold chain · self-administered
Drug label
Not FDA
China / EU / Japan only
FDA declined approval 2021 — US patients lack HIF-PHI
FDA CRL 2021
Non-inferior
vs epoetin (DOLOMITES)
Hb response in dialysis CKD
Phase-3 program
Inflammation
Effective in high-hepcidin
Where ESAs often resistant
Mechanism
Tiers & pricing
Six pathways, transparent pricing.
Nephrology workup + cycle 1
Nephrology consult, renal panel, full iron panel, CBC, ECG, BP profile, first month of roxadustat, bilingual report.
$550–950
Refill / month (oral)
Roxadustat at hospital-pharmacy NMPA-listed price. Optional remote 4–6-week titration check-ins.
$90–160
Iron repletion
Oral or IV iron sucrose / carboxymaltose if ferritin / TSAT below threshold. Required for response in many patients.
$80–350
Annual re-evaluation
Full panel, CV risk re-assessment, dose review. Recommended at minimum yearly.
$350–550
Daprodustat / vadadustat
Second-generation HIF-PHIs at NMPA-listed pricing. Selection by nephrologist.
$110–200 / month
Dialysis pathway support
Coordination with home dialysis unit for dose titration and IV iron schedule.
$450–800
Top centres
Where international patients
start HIF-PHI therapy.
Peking University First Hospital, Renal Division 北大第一医院肾内科
Class A · National nephrology reference centre · CKD anaemia trial site · long-term cohort data
Ruijin Hospital, Nephrology 瑞金医院肾内科
Class A · large dialysis service · strong CKD-MBD and anaemia management
Peking Union Medical College Hospital 北京协和医院
Class A · diagnostic excellence · atypical anaemia phenotyping · multidisciplinary review
First Affiliated Hospital, Sun Yat-sen University 中山大学附属第一医院
Class A · large dialysis volume · regional nephrology referral centre
FAQ
Roxadustat in China — answered.
- What is roxadustat and why is China the access point?
- Roxadustat (FG-4592, marketed as 爱瑞卓 in China and Evrenzo in Japan/EU; FibroGen / AstraZeneca / Astellas) is a first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It stabilises HIF-α, increasing endogenous erythropoietin and improving iron utilisation. NMPA approved roxadustat in December 2018 — the world’s first regulatory approval — for anaemia of chronic kidney disease in dialysis-dependent patients, expanded in 2019 to non-dialysis CKD. It was subsequently approved in Japan (2019) and EU (2021). The FDA declined approval in 2021 citing the cardiovascular safety profile in the US program, so US patients seeking HIF-PHI therapy currently lack a domestic option.
- Who is potentially appropriate?
- NMPA label indications: anaemia of chronic kidney disease in (1) patients on dialysis (haemodialysis or peritoneal dialysis), or (2) non-dialysis CKD stages 3–5 with haemoglobin below treatment threshold per local guidelines. Standard pre-prescription workup at the partner nephrology centre includes: nephrology consult; renal function panel (eGFR, urinalysis, urine ACR); CBC with reticulocyte count; full iron panel (ferritin, transferrin saturation, serum iron, TIBC); B12, folate; CRP / hsCRP; thyroid function; intact PTH; vitamin D; cardiovascular risk assessment; rule out concurrent haematologic malignancy or active bleeding before initiation.
- What does it cost?
- NMPA-listed price after national reimbursement (NRDL): approximately $90–160/month for typical adult dosing (70–100mg three times weekly for non-dialysis; weight-based for dialysis). International patient package — 2-day nephrology workup including consult, full iron and renal panel, ECG, first month of medication, and bilingual report — $550–950. Refills: month-to-month at hospital-pharmacy pricing. Compared to chronic ESA (darbepoetin) therapy at US prices (~$700–1,400/month plus injection administration), oral roxadustat is dramatically cheaper and self-administered.
- How does it compare to ESAs (epoetin, darbepoetin)?
- Pivotal phase-3 programs: in dialysis-dependent CKD, roxadustat showed non-inferior haemoglobin response vs epoetin alfa (DOLOMITES, ROCKIES, HIMALAYAS, SIERRAS); in non-dialysis CKD, it was superior to placebo for haemoglobin correction (ALPS, ANDES, OLYMPUS). Practical advantages over ESAs: oral dosing (no injection burden); independence from cold-chain logistics; benefit even in inflammatory states with high hepcidin where ESA-resistance is common; potential reduction in IV iron requirement. Cardiovascular safety: pooled meta-analysis (Provenzano et al.) found similar MACE rates vs ESA in dialysis patients but a numerical signal in non-dialysis patients — the FDA non-approval was driven by this. Treating nephrologists weigh CV risk individually.
- Can I bring it home? Refill workflow?
- Yes — roxadustat is a non-controlled prescription medication and most countries (where it is approved or where personal-use import is permitted) allow a 90-day supply with original labelling and a physician’s letter. We provide bilingual prescription, English drug-information sheet, and an attending-nephrologist letter for customs. For US patients: roxadustat is not FDA-approved, so cross-border supply is governed by FDA personal-use enforcement guidance (typically permitted for individual personal use of non-domestic-substitute drugs without commercial intent) — we recommend reviewing FDA personal-importation guidance with your customs broker. For EU / Japan / China-resident patients, refill via local prescription is generally available.
- Side effects and monitoring?
- Common: hypertension (monitor BP closely, especially first 6 weeks); peripheral oedema; hyperkalaemia in dialysis patients; nausea; diarrhoea; thrombosis (particularly vascular access thrombosis in dialysis — minimise by careful Hb-rate-of-rise control); upper respiratory infection. Less common but serious: deep vein thrombosis, pulmonary embolism (overall thromboembolic risk in pooled analyses). Monitoring: Hb every 2–4 weeks during titration, then monthly; iron panel every 3 months; BP at every visit; lipids periodically (HIF-PHIs reduce LDL — a potentially favourable off-target effect). We provide a 24/7 contact for the first 60 days plus a structured handover document for your home nephrologist.
- What about other Chinese-origin HIF-PHIs?
- Beyond roxadustat there are several NMPA-approved second-generation HIF-PHIs with different pharmacokinetics: enarodustat (Akros / Mitsubishi Tanabe; NMPA-approved for dialysis CKD), daprodustat (GSK; NMPA-approved 2023), vadadustat (NMPA-approved 2023), and domestically-developed agents in late-stage trials. Selection by treating nephrologist depends on dialysis status, comorbidity, and prior ESA experience.
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For information only. Not medical advice. Roxadustat is not FDA-approved. CKD anaemia management decisions must be made by a treating nephrologist with full case review and individualized cardiovascular risk assessment.