Glofitamab 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
- Roche Pharma (Schweiz) AG
- Medicine type
- Biologic
- Therapeutic area
- Oncology
- Indications recorded in the public source
- 1. Monotherapy for adults with relapsed or refractory DLBCL who have received at least two lines of systemic therapy. 2. With gemcitabine and oxaliplatin for adults with relapsed or refractory DLBCL NOS who are ineligible for autologous stem-cell transplantation (ASCT).
- Indication source and scope
- Source date(s): 2025, 2026. Indications transcribed from the public NHSA manufacturer submission; this is not verification of the complete current label.
- Prescribing-information limitations
- Complete official prescribing information obtained. The available full label is from an overseas jurisdiction; a complete current Chinese label remains unavailable. Chinese indications are supported separately by Chinese sources.
- 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: 1. Adults with relapsed or refractory DLBCL after at least two lines of systemic therapy. 2. Adults with relapsed or refractory DLBCL NOS who are ineligible for ASCT.
- 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.nmpa.gov.cn/directory/web/nmpa/images/1707039824076019627.pdf
- https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
- https://www.nhsa.gov.cn/attach/Ypsn2025/YPSW202500383/YPSW202500383.pdf
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