Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Locally Advanced or Metastatic Urothelial Carcinoma

SHANGHAI, China, May 07, 2020 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877) a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for toripalimab as a 2nd line treatment for patients with locally advanced or metastatic urothelial carcinoma who have received systemic therapy.

Urothelial carcinoma is the most common (more than 90%) histologic type of bladder cancer in China. Bladder cancer incidence is estimated to be 80,000 cases per year in the country. It ranked ninth for all cancer deaths in China, accounting for about 14% of bladder cancer deaths worldwide.

The sNDA is based on the results of POLARIS-03 study (NCT03113266), which is a Phase II, open-label, multi-center registration trial conducted in China to evaluate the efficacy and safety of toripalimab as a 2nd line treatment for patients with locally advanced or metastatic urothelial carcinoma who have failed standard systemic treatment. A total of 151 patients were enrolled in the study. Preliminary results presented during ASCO-GU 2020 meeting on 6 January 2020, showed the objective response rate (ORR) was 25.7% in 148 evaluable patients and the ORR was 41.3% in 46 PD-L1+ patients . In China, patients with advanced urothelial carcinoma after failure of standard chemotherapy have limited treatment options. If approved, toripalimab could offer an alternative 2nd line treatment option for the patients regardless PD-L1 expression status.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences. Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019.

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, neurologic diseases, and Infectious disease. 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 Suzhou, 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. For more information, please visit: http://junshipharma.com/en/Index.html

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