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# Junshi Bio Orphan Status for Soft Tissue Sarcoma
- URL: https://www.fdaweb.com/junshi-bio-orphan-status-for-soft-tissue-sarcoma/
- Published: 2020-09-18T12:00:00.000Z
- Updated: 2026-09-14T16:29:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147680

FDA has granted Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma. This is the third such designation granted to Toripalimab, with earlier designations for treating mucosal melanoma and nasopharyngeal carcinoma.

Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types and obvious tumor heterogeneity, according to the company. Current standard of care mainly uses cytotoxic anti-tumor drugs, which have significant adverse reactions and poor tolerance.

Toripalimab is described as an anti-PD-1 monoclonal antibody. It received its first approval for second-line treatment of metastatic melanoma in 12/2018 in China. The company says more than 30 clinical studies covering more than 10 indications have been conducted in China, the U.S. and other countries.