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TUOYI (AA-Med Pty Ltd)
Product name
TUOYI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
201 (255 working days)
Active ingredients
toripalimab
Registration type
NCE/ NBE
Indication
TUOYI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC).
TUOYI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or after a platinum-containing chemotherapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.