ChinaHealth

Leukemia in China

China has approved inaticabtagene, a CD19 CAR-T, for adult relapsed or refractory B-cell ALL, and olverembatinib for resistant CML, including T315I-mutated disease. Neither is FDA-approved; olverembatinib is in an FDA-cleared phase 3 trial. Access is through hospital hematology departments or clinical trials.
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Treatments available

TreatmentsStatus in ChinaStatus in USSources
Inaticabtagene autoleucel (CD19 CAR-T) for adult r/r B-ALLApproved in ChinaNot approvedPubMed CentralAscentage Pharma / SEC
Olverembatinib (third-generation BCR-ABL1 TKI) for resistant CMLApproved in ChinaClinical trialAlliance for Regenerative MedicineAscentage Pharma
Allogeneic stem cell transplantAvailableApproved in China

Hospitals with documented programs

Informational listings from cited public sources, not recommendations.

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (上海交通大学医学院附属瑞金医院) building exterior
ShanghaiRuijin Hospital, Shanghai Jiao Tong University School of Medicine上海交通大学医学院附属瑞金医院International deptVerified

Clinical trials

399studies listed as recruiting with a site in China on ClinicalTrials.gov, as of 2026-10-26. See the list

We link trials only; enrollment decisions belong to trial teams. Since May 2026, charging patients to join clinical research is prohibited in China, as reported by AFP.

Frequently asked

Is there a China-only CAR-T for leukemia?

Yes. Inaticabtagene (Juventas) was NMPA-approved in November 2023 for adult relapsed or refractory B-cell acute lymphoblastic leukemia. It is not FDA-approved.

[1] PubMed Central[2] BioInformant

What is olverembatinib's status?

NMPA approved it in November 2021 for TKI-resistant CML with the T315I mutation and in November 2023 for CML resistant to or intolerant of earlier TKIs. The company states it is not yet FDA-approved and is running the POLARIS-2 phase 3 trial.

[1] Ascentage Pharma[2] Ascentage Pharma / SEC

Sources

  1. Redefining CAR-T regulation: China's responses to address secondary cancer risks of CAR-T therapy (Table 1)
    PubMed Central · official · accessed 2026-10-26
    “Table 1 lists zevor-cel (NMPA, 2024-02-23), inati-cel (NMPA, 2023-11-07) and eque-cel/Fucaso (NMPA, 2023-06-30).”
  2. Therapies approved in China
    Alliance for Regenerative Medicine · official · accessed 2026-10-26
  3. Olverembatinib approved for new indications in CML
    Ascentage Pharma · official · accessed 2026-10-26
    “In November 2021, olverembatinib was approved in China for adult patients with TKI-resistant CML-CP or CML-AP harboring the T315I mutation.”
  4. Ascentage Pharma press release, May 31, 2026 (SEC 6-K exhibit)
    Ascentage Pharma / SEC · official · accessed 2026-10-26
    “Olverembatinib is currently under investigation and has not yet been approved by the US FDA.”
  5. 16 CAR-T Therapies and Counting
    BioInformant · news · accessed 2026-10-26
    “Seven therapies have been approved by the U.S. FDA.”

Information only. Not medical advice, diagnosis or a treatment recommendation. Talk to your doctor. In an emergency, call your local emergency number.