Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma
SHANGHAI, China, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug designation to Toripalimab for the treatment of soft tissue sarcoma. This is the third such designation granted to Toripalimab. The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.
About Soft Tissue Sarcoma
About Orphan Drug Designation
n April 2020, the supplemental New Drug Application (“NDA”) of Toripalimab Injection for the treatment of new indications of recurrent/metastatic nasopharyngeal carcinoma after failure of second-line and above systemic treatment has been accepted by the NMPA. The supplemental NDA is the world’s first NDA of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In addition, JUPITER-02 study (NCT03581786), a Phase III clinical study of Toripalimab Injection combined with chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma has completed the enrollment. In May 2020, the supplemental NDA of Toripalimab Injection for the treatment of new indications of locally advanced or metastatic urothelial carcinoma after systemic treatment has been accepted by the NMPA. The two supplemental NDAs were included in the process of priority review by the NMPA in July 2020. Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA in September 2020.
In March 2020, Toripalimab in combination with axitinib in the treatment of mucosal melanoma was granted the orphan-drug designation by the FDA. In May 2020, Toripalimab was granted the orphan-drug designation by the FDA in the treatment of nasopharyngeal carcinoma.
About Junshi Biosciences
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