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On October 31, Junshi Biological issued an announcement stating that its subsidiary TopAlliance Biosciences, Inc.
According to the acceptance letter, the FDA granted priority review to the BLA and stated that it does not plan to convene an advisory committee meeting to review the BLA.
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
This BLA is based on the data results of the POLARIS-02 study (NCT02915432) and the JUPITER-02 study (NCT03581786)
Nasopharyngeal carcinoma is a malignant tumor that occurs in the mucosal epithelium of the nasopharyngeal area and is one of the common malignant tumors of the head and neck
Teriplizumab is China's first domestically produced monoclonal antibody targeting PD-1 to be approved for marketing.
In February 2021, the marketing application for new indications for the first-line treatment of locally recurring or metastatic nasopharyngeal carcinoma patients with teriprizumab combined with cisplatin and gemcitabine was accepted by the State Food and Drug Administration
As of the disclosure date of this announcement, Tereprizumab has been granted 2 breakthrough therapy designations, 1 fast track designation, 1 priority review designation and 3 projects by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.
