FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma - Seite 2

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need. Toripalimab and Axitinib combination was the world’s first clinical application of PD-1 checkpoint blockade with a VEGFR inhibitor for the treatment of mucosal melanoma in a Phase Ib study (NCT03086174). The results of the study were published in the Journal of Clinical Oncology in August 2019. The study showed that the combination of Toripalimab with Axitinib in the first-line setting achieved an ORR of 48.3% and a disease control rate (DCR) of 86.2% for advanced mucosal melanoma with a manageable safety profile. The median progression-free survival (mPFS) was 7.5 months. In March 2020, Toripalimab in combination with Axitinib for the treatment of mucosal melanoma was granted the Orphan-Drug Designation (ODD) by the FDA.

About Fast Track Designation (FTD)
The FTD aims to facilitate the development and accelerate the review process of treatments for serious or life-threatening diseases or conditions that remain unmet clinical needs. The FTD is designed to make important new drugs accessible to patients faster. According to FDA regulations, drugs that receive FTDs will be granted an accelerated review process through various forms, including but not limited to (1) more frequent interactions and meetings with the FDA to discuss drug development and clinical trial design; (2) eligibility for priority review and accelerated approval after meeting relevant criteria; (3) rolling review, which means instead of waiting until all sections of the NDA are completed, a company can submit completed sections of its biologic license application (BLA) or new drug application (NDA) for review on a rolling basis.

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.