Disitamab vedotin 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.
- Medicine type
- Biologic
- Therapeutic area
- Oncology
- Indications recorded in the public source
- Gastric cancer: for HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, after at least two systemic chemotherapy regimens; this indication is conditionally approved. Urothelial carcinoma: (1) monotherapy for HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic disease after platinum-based chemotherapy; (2) with toripalimab for HER2-expressing (IHC 1+, 2+ or 3+) locally advanced or metastatic disease. Breast cancer: (1) HER2-positive advanced breast cancer with liver metastases after trastuzumab (or a biosimilar) and a taxane; (2) adults with unresectable or metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-negative) and liver metastases, after at least one systemic treatment in the metastatic setting, or recurrence during adjuvant chemotherapy or within 12 months after completing it.
- Indication source and scope
- Source date(s): 2026-04-07, 2026-10-23. Manufacturer prescribing information for Mainland China. Evidence review: 23 October 2026.
- 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-overexpressing locally advanced or metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, after at least two systemic chemotherapy regimens; (2) HER2-overexpressing locally advanced or metastatic urothelial carcinoma after platinum-based chemotherapy.
- 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.cnpharm.com/c/2022-06-01/827272.shtml
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.remegen.cn/uploadfile/2026/05/27/8dc483e94ba0149fba757c30f0e955b96a163b43432ac.pdf
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