Yiouda health on September 13, today, Baiji Shenzhou announced its independently developed PD-1 monoclonal antibody baizean ® The new drug marketing application (BLA) has been officially accepted by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC
) after previous systematic treatment. This is Bai zean ® The first application outside China is also another important milestone in the expansion of globalization after the independent research and development of new anti-cancer drug zebutinib has been approved in the United States and other countries. According to the prescription drug user fees Act (PDUFA), FDA ® The target date for making a decision on the listing application is July 12, 2022.
It is reported that this listing application was jointly declared by Baiji Shenzhou and Novartis, which is also the conclusion reached by the two sides in January this year ® An important step after authorized transaction cooperation in many overseas countries. Up to now, baizean ® Five indications have been approved in China, and four new indications have been accepted by nmpa. It can be predicted that with the subsequent overseas declaration, baizean ® The process of globalization will be accelerated in an all-round way.
Baiji Shenzhou is accelerating the expansion of baize'an ® And carry out extensive clinical research. Up to now, baizean ® A total of 35 clinical trials were carried out worldwide, of which 17 were registered clinical trials, covering high-risk cancers such as lung cancer, liver cancer, esophageal squamous cell carcinoma and gastric cancer. The total number of patients included in the global group reached more than 7700, including 2500 overseas patients.