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Approved solid-tumour CAR-T

Satri-cel access begins with the exact label, biomarker, and treating programme.

Satri-cel (satricabtagene autoleucel; CT041; Kailimei®) was approved by China’s NMPA on 22 June 2026 for a narrowly defined later-line gastric or gastroesophageal-junction cancer population. Approval does not establish individual eligibility, hospital acceptance, insurance payment, or suitability for another solid tumour.

This is intensive cellular therapy—not a medicine-only purchase

Hospital-led review must cover pathology, CLDN18.2 and HER2 testing, prior treatment, disease pace, fitness, collection and manufacturing, bridging treatment, lymphodepletion, cytopenia, infection, cytokine-release syndrome, intensive-care rescue, discharge, and long-term follow-up.

01

The current approved population

The manufacturer’s approval announcement describes adults with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal-junction adenocarcinoma who have failed at least two prior treatment lines.

  • CLDN18.2 membrane staining intensity at least IHC 2+ in at least 40% of tumour cells in the pivotal trial
  • HER2-negative disease
  • Advanced gastric or gastroesophageal-junction adenocarcinoma
  • Failure of at least two prior treatment lines
Earlier-line, perioperative, pancreatic, biliary and other solid-tumour uses remain investigational unless a future regulator-approved label states otherwise.
02

What the randomised phase 2 study found

CT041-ST-01 was an open-label, multicentre trial in China. In the intention-to-treat population, median progression-free survival was 3.25 months with satri-cel versus 1.77 months with physician’s-choice treatment (hazard ratio 0.37). These group-level results do not predict an individual outcome.

  • 266 screened; 156 randomised
  • 104 allocated to satri-cel and 52 to physician’s choice
  • Study funded by CARsgen
  • The registered pivotal study is closed to new patients
PubMed — Lancet phase 2 trial
03

Safety and monitoring

Among 88 treated satri-cel patients in the pivotal safety population, 99% experienced a grade 3 or higher treatment-emergent adverse event and 95% experienced cytokine-release syndrome. Severe lymphocyte, white-cell, and neutrophil reductions were common.

  • Named cellular-therapy team and 24/7 escalation
  • Infection, transfusion, neurology, pharmacy and intensive-care capability
  • Written discharge, prophylaxis, emergency and late-effects plan
  • Accepting home oncologist and cross-border handover before travel
04

Verified commercial pathway — Shanghai

Jiahui International Cancer Center reported on 17 August 2026 that a patient from New Zealand completed satri-cel treatment in Shanghai, was discharged after more than one month, and received physician-to-physician return-home handover.

Jiahui provider report
Independent provider profile; this does not imply a HarbourBridge partnership. Current acceptance, exact team, product supply, timing and quotation must be reconfirmed.
05

Verified commercial pathway — Beijing

Beijing GoBroad Hospital reported issuing China’s first commercial CT041 prescription after screening, pathology review, biomarker assessment, multidisciplinary evaluation, and treatment planning.

GoBroad provider report
Independent provider profile; this does not imply a HarbourBridge partnership. Current acceptance, completion pathway, exact team, product supply, timing and quotation must be reconfirmed.
06

Price reference—not a complete treatment range

A 25 June 2026 Cailian Press report states a satri-cel product price of RMB 990,000 per patient dose. Neither verified hospital page publishes a complete international-patient episode range.

  • Public product reference: RMB 990,000
  • Complete episode: RMB 990,000 plus hospital-specific testing, collection, lymphodepletion, admission, medicines, toxicity management and follow-up
  • Responsible upper limit: unavailable from current public sources
  • Required next step: itemised written quotation from the treating hospital
Cailian Press price report
This is not a hospital offer, total-cost estimate, savings claim, or insurance-coverage statement. Satri-cel has no like-for-like approved UK or US price comparator because the product is not approved there as of the evidence date.
07

Before a hospital approach

A case dossier should include the current pathology report and tissue availability, CLDN18.2 assay details, HER2 result, treatment timeline and response, recent imaging, performance status, organ function, infections, medicines, disease-related complications, funding route, caregiver plan, and named home clinician.

CARsgen approval announcementOpen the secure consultation
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