Zolbetuximab 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

Astellas Pharma Europe B.V.

Medicine type

Biologic

Therapeutic area

Oncology

Indications recorded in the public source

In combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patient selection requires a validated test: CLDN18.2 positivity is defined as moderate-to-strong membranous CLDN18 staining in at least 75% of tumor cells by immunohistochemistry.

Indication source and scope

Source date(s): 2024-12-25, 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

Japan: local approval / launch announcements and official price sources obtained. Indications and dates are specified in each price record; other markets not exhaustively reviewed.

Insurance classification

Not matched in the 2025 national list; manual review pending

Insurance edition

2025 edition; effective 1 January 2026

Insurance verification notes

No match in the extracted directory is not proof of exclusion. Compound formulations still require manual review.

Sources

• https://www.cnpharm.com/upload/resources/file/2025/03/18/170990.pdf
• https://www.nhsa.gov.cn/module/download/downfile.jsp?classid=0&filename=a32f9f2f3fc046afaf08471f87456ce3.pdf
• https://www.astellas.com.cn/system/files/zolbetuximab-inf_chn-prescriber_china_20250103.pdf

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