Trastuzumab rezetecan for injection | 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
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Medicine type
- Biologic
- Therapeutic area
- Oncology
- Indications recorded in the public source
- 1. Monotherapy for adults with unresectable locally advanced or metastatic NSCLC with an activating HER2 (ERBB2) mutation who have received at least one systemic therapy. This indication has conditional approval; full approval depends on confirmatory study results. 2. Monotherapy for adults with locally advanced or metastatic HER2-positive breast cancer who have received at least one anti-HER2 treatment. 3. Monotherapy for adults with HER2-positive colorectal cancer after failure of oxaliplatin, fluorouracil and irinotecan.
- Indication source and scope
- Source date(s): 2026-08-04. 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
- Limited to adults with unresectable locally advanced or metastatic NSCLC with an activating HER2 (ERBB2) mutation who have received at least one systemic therapy.
- 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.hengrui.com/product/innovativeMedicine.html?type=1
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