Skip to main content

Day: December 25, 2022

Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Written by Customer Service on . Posted in Public Companies.

– FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA – – Junshi Biosciences and Coherus are actively engaged in ongoing discussions with the FDA to support the inspections and gain approval of toripalimab for patients with NPC in the U.S. as quickly as possible – SHANGHAI, China and REDWOOD CITY, Calif., Dec. 25, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic...

Continue reading

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.

Cookie Notice

We use cookies to improve your experience on our website

Information we collect about your use of Goldea Capital website

Goldea Capital website collects personal data about visitors to its website.

When someone visits our websites, we use a third party service, Google Analytics, to collect standard internet log information (such as IP address and type of browser they’re using) and details of visitor behavior patterns. We do this to allow us to keep track of the number of visitors to the various parts of the sites and understand how our website is used. We do not make any attempt to find out the identities or nature of those visiting our websites. We won’t share your information with any other organizations for marketing, market research or commercial purposes and we don’t pass on your details to other websites.

Use of cookies
Cookies are small text files that are placed on your computer or other device by websites that you visit. They are widely used to make websites work, or work more efficiently, as well as to provide information to the owners of the site.