Teriplizumab is expected to be approved in the U.S. in April next year

On October 31, Junshi Biotech announced that the FDA has accepted and granted priority review for the Biological Products License (BLA) for two nasopharyngeal cancer indications for teriprizumab.

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

It is worth mentioning that the FDA has not approved any tumor immunotherapy for the treatment of nasopharyngeal cancer

The nasopharyngeal cancer indication for teriplizumab has previously been "dual-approved" by the FDA for breakthrough therapy

Based on the identification of breakthrough therapy, Junshi Biotech announced in March 2021 that it would begin rolling submission of the BLA of teriprizumab for the treatment of relapsed or metastatic nasopharyngeal carcinoma to the FDA and obtained rolling review.

In September 2021, Junshi Bio announced the completion of the rolling submission of BLA for the above two indications

Since the beginning of this year, under the domestic R&D internal volume, major pharmaceutical companies are actively seeking innovative drugs to go overseas

Today, Junshi appointed Dr.

During his work at the FDA, Dr.

According to Insight statistics, currently 4 domestic PD-1 models have submitted BLAs to the FDA

Progress in overseas supervision of domestic PD-1

As of November 1, 2021, Insight is organized according to the company’s official information

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