CAR-T cell therapy

Nine CAR-T products are approved in China, and the label decides who qualifies

As of 16 October 2026, China's National Medical Products Administration (NMPA) has approved nine CAR-T products: five target CD19 for lymphoma or B-cell acute lymphoblastic leukaemia (B-ALL), three target BCMA for multiple myeloma, and one targets Claudin18.2 in advanced stomach cancer, the first CAR-T approved anywhere for a solid tumour, according to its maker¹. Each label names the disease, the earlier treatment lines required and sometimes a positive target test; that wording is the first eligibility filter.

Conditional approvals still owe confirmatory data. Chinese line requirements can be stricter than US ones: Carvykti is approved in the US after one earlier line for lenalidomide-refractory myeloma²⁵, in China only after three. Axi-cel in China is Kite's Yescarta, made locally under a technology transfer²⁶. No first Chinese prescription of cilta-cel had been reported by June 2025²⁷, so confirm that the hospital can order it.

What it costs: China's list prices are about a third of US prices

For the same molecule, China's list price is about a third of the US one: axi-cel costs CNY 1.2 million²⁸, about US$178,300 at the central parity rate of 12 October 2026, CNY 673.13 per US$100²⁹, against US$548,900 for Yescarta on 1 January 2026³⁰.

Yicai, citing industry observers, reported in December 2025 that prices in China start from CNY 1 million, or US$141,430⁴⁵; three products now list lower, and CNY 1 million is about US$148,600 at October 2026 rates. These are drug list prices; they exclude the hospital's charges for cell collection, chemotherapy, the inpatient stay and side-effect care, so ask for a written estimate.

National basic medical insurance does not pay for CAR-T. In December 2025 the National Healthcare Security Administration put axi-cel, inati-cel, relma-cel, eque-cel and zevor-cel on its first Commercial Health Insurance Innovative Drug List for 2026–2027⁴⁶, a reference for commercial insurers that the basic insurance fund does not pay for^47,48. Relma-cel and inati-cel passed the initial review for the 2026 basic list⁴⁹, which only qualifies them for the next stage⁵⁰. City "Huiminbao" plans help residents: Shanghai's 2026 plan pays 30% of listed CAR-T drug costs, up to CNY 500,000^51,52, but only for people in Shanghai's basic medical insurance⁵³. Without Chinese basic insurance, plan to pay the full list price unless your own insurer confirms in writing that it covers CAR-T given in China.

Time in China: about two months from cell collection

Plan for roughly two months in China from cell collection to the end of monitoring, after an assessment visit. Every step happens in mainland China: labels such as relma-cel's require a manufacturer-certified hospital⁵⁴, cells go from that hospital to the company's plant⁵⁵, and Chinese rules restrict sending patient material abroad for CAR-T manufacture⁵⁶.

Adding the medians gives three to five weeks to infusion plus four weeks nearby: seven to nine weeks from collection, before the assessment visit and any wait for a collection date. Axi-cel manufacturing failed for under 1% of trial patients⁸⁸. US labels shortened these rules in June 2025, when the FDA removed the products' safety programme (REMS)⁸⁹; Chinese labels filed with the national insurer in 2025 and 2026 still say four weeks, so book accommodation for the longer stay. Hotels register foreign guests with the police. In a rented flat or other non-hotel home, the guest or host must register within 24 hours of arrival, online or at a police station; the host helps with the first online filing, and skipping it can bring a warning or a fine¹³⁹. Shanghai Rentals explains the steps for Shanghai¹⁴⁰.

Who qualifies, and what to send before you travel

Send records that prove the labelled diagnosis, the earlier treatments and current fitness. Age matters too: among blood-cancer products, only puzol-cel is approved for children, for B-ALL from age 3 to 21²²; the rest are labelled for adults. For satri-cel, the pivotal trial counted Claudin18.2 as positive at staining of 2+ or more in at least 40% of tumour cells⁹⁰. Labels such as zevor-cel's delay infusion for unresolved serious side effects, uncontrolled infection or active graft-versus-host disease⁹¹. Trial criteria add fitness limits: the zevor-cel trial took patients aged 18 to 75⁹² with ECOG performance status 0–1 and adequate organ and marrow function⁹³.

What a hospital reviews:

• the pathology report with diagnosis, subtype and date, plus any target test the label requires: CD19 for puzol-cel, Claudin18.2 and HER2 for satri-cel;
• every earlier treatment line, including any CAR-T or BCMA-directed therapy, with drugs, start and stop dates, best response and the date of relapse or progression;
• stem-cell transplant history, including graft-versus-host disease;
• the latest scans, with reports and image files;
• recent blood counts, kidney and liver tests, and hepatitis B, hepatitis C and HIV results, which US labels require before collection⁹⁴;
• performance status, heart, lung and neurological history, and any current infection.

Drug trials approved by China's regulator must be registered on the Center for Drug Evaluation's public platform⁹⁵; many also appear on ChiCTR, a WHO primary registry open to trials from all countries⁹⁶, or on ClinicalTrials.gov, as the eque-cel (ChiCTR2000033946)⁹⁷ and satri-cel (NCT04581473)⁹⁸ pivotal trials did. Whether someone living abroad can join depends on each protocol and its follow-up; eque-cel trial patients are followed for at least 15 years⁹⁹. The Drug Administration Law also allows compassionate use at trial institutions for life-threatening diseases without effective treatment, after review and informed consent¹⁰⁰. Bloomberg reported in June 2026 that a New Zealand myeloma patient spent seven weeks on a trial in Shanghai, at a total cost of about US$65,000 including hospital care and airfare^101,102. Outside trials, CARsgen reported that a cancer centre collected cells from an expatriate patient within two weeks of satri-cel's approval¹⁰³.

Risks, and the follow-up to arrange at home

Cytokine release syndrome (CRS) occurs with every product, neurological toxicity ranges from rare to common, blood counts can stay low for weeks, and a rare risk of T-cell cancers makes follow-up lifelong. Grading and patient groups differ, so rates are not directly comparable.

In China's own cilta-cel trial, with data to July 2021, CRS occurred in 97.9% of 48 patients, 35.4% at grade 3 or 4¹²⁵, and eight of ten deaths after infusion were due to treatment-related adverse events¹²⁶. Ask how the treating team manages toxicity with the product it proposes.

On 28 November 2023 the FDA reported T-cell cancers after BCMA- and CD19-directed CAR-T¹²⁷ and on 18 April 2024 announced a boxed warning: these cancers may appear within weeks of infusion and can be fatal¹²⁸. A 2024 review co-written at an NMPA laboratory says China requires CAR-T labels to highlight this risk and advises lifelong monitoring¹²⁹; the zevor-cel label lists secondary cancer as an important precaution¹³⁰. Manufacturers' US safety studies follow patients for 15 years¹³¹.

Before leaving, ask for a written summary of product, dose, infusion date, complications and follow-up plan, then arrange these label-based checks with the home haematologist:

• blood counts at regular intervals¹³²;
• immunoglobulin levels, with infection precautions, antibiotic prophylaxis and immunoglobulin replacement as needed¹³³;
• no live vaccines from six weeks before lymphodepletion until immune recovery¹³⁴;
• hepatitis B monitoring where relevant, because reactivation has occurred¹³⁵;
• lifelong watch for new cancers, reported to the manufacturer, which arranges sample testing¹³⁶;
• no donation of blood, organs, tissues or cells¹³⁷;
• the patient card or treatment summary at every appointment¹³⁸.

Before booking flights, get written confirmation of the proposed product, the hospital's certification for it, the price, the expected collection date and the minimum stay.