Recently, Junshi Biotech announced that the FDA has accepted the Biological License Application (BLA) for two nasopharyngeal cancer indications for teriprizumab and granted priority review. At the same time, it does not plan to arrange an advisory committee meeting. The award of priority review means that the original 10-month standard review time will be shortened to 6 months, and overseas listing will be accelerated. The proposed PDUFA target review date is April 2022.

The two indications accepted this time for teriprizumab are: combined gemcitabine/cisplatin as the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma; single drug for recurrent or metastatic nasopharyngeal carcinoma containing platinum Second-line and above treatment after treatment. Its BLA is mainly based on the data results of the POLARIS-02 study (NCT02915432) and the JUPITER-02 study (NCT03581786). The two clinical results have been published in Journal of Clinical Oncology (IF=44.544) and Nature Medicine (IF=53.440) respectively this year.

It is worth mentioning that the FDA has not approved any tumor immunotherapy for the treatment of nasopharyngeal cancer. If triprolizumab is approved, it will bring new key treatment options for nasopharyngeal cancer patients in the United States.

The nasopharyngeal cancer indication for teriplizumab has previously been awarded the "dual designation" for breakthrough therapy by the FDA. In September 2020, teriprizumab was approved as a breakthrough therapy by the FDA for second-line and above treatment after platinum-containing treatment for relapsed or metastatic nasopharyngeal carcinoma. In August 2021, teriprizumab combined with gemcitabine/cisplatin was recognized as a breakthrough therapy by the FDA as the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma.

Based on the identification of breakthrough therapy, Junshi Biotech announced in March 2021 that it would start rolling submission of the BLA of teriprizumab to the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma and obtained rolling review. It is the first official announcement to submit to the FDA The domestically-made anti-PD-1 monoclonal antibody that was applied for marketing made the first shot of domestically-made PD-1 going overseas.

In September 2021, Junshi Bio announced the completion of the rolling submission of BLA for the above two indications. Today, this product was officially accepted by the FDA and entered the priority review process.