Pyrotinib maleate 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
- Recurrent or metastatic breast cancer: (1) with capecitabine for HER2-positive disease, with or without prior trastuzumab treatment; patients must previously have received an anthracycline- or taxane-based chemotherapy regimen. (2) With trastuzumab and docetaxel for HER2-positive recurrent or metastatic disease without prior anti-HER2 treatment in the advanced setting. Early or locally advanced breast cancer: with trastuzumab and docetaxel as neoadjuvant treatment for HER2-positive disease. The neoadjuvant indication received conditional approval based on an increase in the surrogate endpoint of pathological complete response. Full approval depends on an ongoing adjuvant study confirming long-term clinical benefit in early or locally advanced breast cancer.
- Indication source and scope
- Source date(s): 2025-09-24. Manufacturer prescribing information for Mainland China.
- 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) HER2-positive recurrent or metastatic breast cancer; or (2) neoadjuvant treatment of HER2-positive early or locally advanced breast cancer.
- 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://m.cnpharm.com/c/2019-07-01/497890.shtml
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.hengrui.com/product/innovativeMedicine.html?type=1
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