Skip to main content

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

Written by Customer Service on . Posted in Public Companies.

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 ToripalimabToripalimab 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 BiosciencesEstablished 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.htmlContact InformationIR Team:
info@junshipharma.com  
+ 86 021-2250 0300Solebury Trout
Michael Levitan
mlevitan@soleburytrout.com
+1 646.378.2920

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.