Direct answer
Satri-cel is approved only in China, where it is given at CARsgen-certified hospitals — 55 centres were certified before launch — for Claudin18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines of therapy.23
It is not approved in Europe or the United Kingdom. Panacea has it with Biogenther in the Dominican Republic.
Vein to vein
How a dose of satri-cel is made
An autologous CAR-T is manufactured for one patient from that patient's own T cells. In the pivotal studies the median time from manufacturing to release was 18 days, and the shortest was 16 — a pace that matters, because in the randomised trial 16 of the 104 patients assigned to satri-cel were never infused.13
- LeukapheresisThe patient's white blood cells are collected at the treating hospital. Everything that follows is made from this single collection.
- Gene transferThe T cells are engineered to carry the humanised anti-Claudin18.2 chimeric antigen receptor.
- ExpansionThe engineered cells are grown to a treatment dose — 250 million CAR-T cells per infusion in the pivotal trial.1
- Release testing and cryopreservationThe batch is tested, released and frozen for the journey back — median 18 days to release, shortest 16.3
- Lymphodepletion and infusionFludarabine and cyclophosphamide on days 1–3 with nab-paclitaxel on day 2 clear space for the cells; satri-cel is then infused, up to three times.61
Who qualifies
The approved patient
| Requirement | What it means | Source |
|---|---|---|
| Claudin18.2-positive | Immunohistochemistry 2+ or 3+ membrane staining in at least 40% of tumour cells, on a biopsy | 1 |
| HER2-negative | HER2-positive gastric cancers take a different treatment path | 2 |
| Tumour type | Advanced gastric or gastro-oesophageal junction adenocarcinoma | 2 |
| Line of therapy | Disease progressed after at least two prior lines | 2 |
Testing the tumour for Claudin18.2 is therefore the first step of every route to satri-cel. The biology of that test, and why the threshold sits at 40%, is on the target page.
In China
Price, insurance and the hospitals that give it
The launch price reported by The Paper is 990,000 yuan per patient. CARsgen is assembling payment from innovative payment schemes, Huiminbao city-level insurance and commercial insurance; Huiminbao caps are typically 300,000 to 500,000 yuan, so no single route covers the whole price.3 In August 2026 the company reported that satri-cel had passed preliminary formal review for the 2026 National Commercial Insurance Innovative Drug Catalogue.4
Treatment is given only at certified centres: 55 were certified before launch, and the roll-out is focused first on about 100 leading oncology hospitals and top-tier general hospitals across China.34
Outside China
What the rest of the world has — and does not
| Region | Status | Source |
|---|---|---|
| China | Approved by the NMPA, 22 June 2026 | 2 |
| United States | FDA RMAT and orphan-drug designations; no approval. Phase 1b/2 study NCT04404595 (United States and Canada) active, not recruiting | 5 7 |
| European Union | EMA orphan designation and PRIME (November 2021); no marketing authorisation | 5 |
| United Kingdom | No marketing authorisation | 5 |
CARsgen says it will pursue marketing-authorisation filings in selected regional hub markets, without naming them.4
Access through Panacea
Where to get satri-cel outside China
Satri-cel is not approved in Europe or the UK. Panacea has it with Biogenther in the Dominican Republic.
Biogenther is the Dominican Republic company of Bogdan Dicoias, founder of Panacea Bio Chem, and his direct involvement in the regenerative-medicine field — biogenther.com.
Continue
The rest of the resource
Current literature
Trending in the field
Recent literature touching Claudin18.2 and solid-tumour CAR-T — retrieved from PubMed, 15 September 2026.
- First CAR T-Cell Therapy Approved for Solid Tumors — Cancer Discov, 2026 Sep 1
- Long-term control of peritoneal metastases following claudin 18.2-targeted CAR T-Cell therapy in advanced gastric cancer — J Hematol Oncol, 2026 Jul 1
- Impact of concomitant medications on efficacy of CLDN18.2-specific CAR-T cell therapy in advanced gastric cancer — Br J Cancer, 2026 Feb
- A two-step scoring model incorporating visceral-to-subcutaneous fat ratio and systemic immunoinflammatory index for predicting cytokine release syndrome severity — Cancer Immunol Immunother, 2026 Mar 9
Literature
References
Retrieved at the identifier given on 15 September 2026. Chinese-language sources are cited as published, with the outlet named.
Questions
Frequently asked
Where can I get satri-cel?
In China, at hospitals certified by CARsgen for the approved indication — 55 centres were certified before launch, with the roll-out focused on about 100 leading oncology and top-tier general hospitals. Satri-cel is not approved in Europe or the United Kingdom. Panacea has it with Biogenther in the Dominican Republic.
Is satri-cel approved in Europe, the UK or the United States?
No. China's NMPA approved it on 22 June 2026. Outside China it holds FDA RMAT and orphan-drug designations and EMA orphan and PRIME status, which speed development but are not marketing authorisations.
How long does it take to make satri-cel?
In the pivotal studies the median time from manufacturing to release testing sign-off was 18 days, and the shortest was 16 days.
How much does satri-cel cost?
The launch price reported in Chinese business media is 990,000 yuan per patient. Payment is being assembled from innovative payment schemes, Huiminbao city insurance — whose caps are typically 300,000 to 500,000 yuan — and commercial insurance.
Who qualifies for satri-cel?
Adults with Claudin18.2-positive (immunohistochemistry 2+ or 3+ in at least 40% of tumour cells), HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma whose disease progressed after at least two prior lines of therapy.
