What is the market status, price and medical insurance reimbursement status of Retifanlimab (Zynyz)?

As of2025 year5 months, Retifanlimab (trade name: Zynyz) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The drug can be used in combination with carboplatin and paclitaxel as a first-line treatment option; it can also be used as a monotherapy for patients who are ineffective or intolerant to platinum-based chemotherapy. In addition, Retifanlimab is approved for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

In China, Retifanlimab has not yet been approved for marketing by the National Medical Products Administration (NMPA). However, given its approval in the United States and Europe, it is expected that it may enter the Chinese market in the future. Currently, patients can apply for the use of the drug through the "first-in-first-out" policy in areas such as Hainan's Boao Lecheng International Medical Tourism Pilot Zone, but they must follow relevant regulations and procedures.

For price information, Zynyz has a market price in the United States of approximately 20ml (500mg/bottle)15,748.45USD. Since it has not yet been launched in China, the specific price has not yet been determined. However, it is foreseeable that if it is launched in the future, the price may be affected by medical insurance negotiations and market competition.

Currently, Zynyz has not been included in China’s national medical insurance directory. However, with the accumulation of clinical data and the advancement of policies, it may be included in medical insurance coverage in the future. Patients can follow relevant policy developments from the National Medical Insurance Bureau and local medical insurance departments to obtain the latest information.

https://www.fda.gov/drugs/resources-information-approved-drugs