Bireociclib 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.
- Company
- Xuanzhu Biopharmaceutical Co., Ltd.
- Medicine type
- Chemical medicine
- Therapeutic area
- Oncology
- Indications recorded in the public source
- For HR-positive, HER2-negative locally advanced or metastatic breast cancer: (1) with an aromatase inhibitor as initial endocrine therapy; (2) with fulvestrant after progression on previous endocrine therapy; or (3) as monotherapy after progression following at least two endocrine treatments and one chemotherapy regimen in the metastatic setting.
- Indication source and scope
- Source date(s): 2026-04, 2026-03. Includes indications supported by approval announcements; see the linked sources for the applicable label version. Additional indications may be supported by newer announcements or submissions rather than the older full label; see the indication sources.
- Prescribing-information limitations
- Indications checked against an official public submission. The full original prescribing information is still unavailable.
- 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) With fulvestrant for adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. (2) Adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after at least two endocrine treatments and one chemotherapy regimen in the metastatic setting.
- Insurance period
- 2026-01-01 to 2027-12-31
- 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.cde.org.cn/main/news/viewInfoCommon/b93aba16ec47467317057dca4aac8437
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.xuanzhubio.com/new/323.html
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