Treatment of soft tissue sarcoma! Regency BioPD-1 has been recognized as the FDA's third orphan drug.

On September 17th, Junshi Bio announced that its Pintripri single anti-treatment soft tissue sarcoma had been approved by the FDA as an orphan drug, which was the third orphan drug qualification obtained by Ripley single anti-treatment mucosal melanoma and nasopharyngeal cancer, respectively.
soft tissue sarcoma is a rare heterogeneous tumor, its pathological type is complex, tumor heterogeneity is obvious, the current clinical treatment of soft tissue sarcoma drugs are mainly cytotoxic anti-tumor drugs, its adverse reactions are relatively large, and immunotherapy drugs are relatively lacking, so the development of immunotherapy drugs has important clinical significance and value.
-Ripley monoantigen injection was approved in China in December 2018 for the treatment of local progression or metastasis melanoma after previous standard treatment failures.
April 2020, a new adaptation application for the treatment of relapsed/metastatic nasopharyngeal cancer that had previously failed to receive second-line and above systemic treatment was accepted by the National Drug Administration.
May 2020, a new adaptation application for Therepri monoantigen injections used to treat local progressions or metastatic urethra cancers that have been systematically treated in the past was accepted by the National Drug Administration.
2020, these two new adaptation listing applications have been included in the priority review process by the State Drug Administration.
September 2020, the treatment of Ripley monoantigens for nasopharyngeal cancer was recognized by the FDA as a breakthrough therapy.
, also known as rare diseases, refers to drugs used to prevent, treat, and diagnose rare diseases.
This FDA-issued orphan drug qualification will help Ripley monoantigen enjoy some policy support in the U.S. in terms of follow-up research and development, registration, and commercialization, including, but not limited to, (1) tax credits for clinical trial costs;
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