Olverembatinib tablets | China Drugs List
Public reference information, not medical advice, a prescription or an offer to supply a medicine. Confirm current approval, availability and suitability with licensed professionals.
- Medicine type
- Chemical medicine
- Therapeutic area
- Oncology
- Indications recorded in the public source
- For adults with chronic-phase CML resistant and/or intolerant to first- and second-generation TKIs. Also for adults with chronic- or accelerated-phase CML resistant to any TKI and with a T315I mutation confirmed using a fully validated test. Conditional approval was based on response rates in a single-arm trial: major cytogenetic response in chronic phase and complete hematologic response in accelerated phase.
- Indication source and scope
- Source date(s): 2024. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- Prescribing-information limitations
- Complete official prescribing information obtained. Mainland China label.
- China availability status
- Historical Chinese approval verified; current continuous market availability has not been checked for every product.
- Overseas status
- Market-by-market verification pending.
- Insurance classification
- Included in national insurance (Category B)
- Insurance edition
- 2025 edition; effective 1 January 2026
- Insurance restrictions
- Restricted to: (1) adults with chronic-phase CML resistant and/or intolerant to first- and second-generation TKIs; or (2) adults with T315I-mutated chronic- or accelerated-phase CML.
- Insurance period
- 2025-01-01 to 2026-12-31
- Insurance verification notes
- Matched by exact or normalized ingredient/formulation name. Reimbursement still depends on the dosage form and listed payment restrictions.
Sources
- https://www.cnpharm.com/c/2022-06-01/827272.shtml
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.nhsa.gov.cn/attach/Ypsn2024/YPSN202400153/YPSN202400153.pdf
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