Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab in Combination with Pfizer’s Axitinib for the Treatment of Mucosal Melanoma
SHANGHAI, China, March 30, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877) today announced that the U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma. Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi. Toripalimab received its first approved for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019.
About the Combination Therapy
Mucosal melanoma is a rare type of melanoma that develops in the mucosal epithelium. It responds poorly to traditional chemotherapy, and is less responsive to immunotherapy when compared with cutaneous melanoma. Preclinical studies have shown that simultaneous inhibition of immune checkpoints with Vascular endothelial growth factor receptor (VEGFR) can increase lymphocyte infiltration and suppress tumor growth synergistically. On August 12, 2019, results of the Phase 1b study using toripalimab in combination with axitinib to treat advanced mucosal melanoma (NCT03086174) was published in the Journal of Clinical Oncology. The study showed that the combination achieved an objective response rate (ORR) of 48.3% and a disease control rate (DCR) of 86.2% in patients with advanced mucosal melanoma who have not received systemic chemotherapy. The median progression-free survival (mPFS) time was 7.5 months. A three-arm Phase II study, comparing the combination of toripalimab and axitinib versus each monotherapy is currently in progress (ClinicalTrials.gov Identifier: NCT03941795).
Impact of the Designation
The orphan-drug designation granted by the FDA is beneficial for the continuous development of the Combination Therapy and the receipt of certain policy support in terms of registration and commercialization of the Combination Therapy in the United States, including but not limited to (1) tax credits for clinical trial costs; (2) waiver of application fees for new drugs; and (3) 7 years of market exclusivity without being affected by patent.
About Junshi Biosciences
Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, and neurologic diseases. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Wujiang, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network.
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