Baiji Shenzhou: Baize Safety Ball 3 Clinical Test Rationale301 Research reaches the main end point
Author:Daily Economic News Time:2022.08.09
In the evening of today (August 9), Baiji Shenzhou (SH688235, 116.63 yuan, a market value of 157.368 billion yuan) issued an announcement saying that the company's product Baizawan (Deleley Mipidu) global trial Rationale301 research reached reaching reached The main end point is that among adult patients who are not available in the first line of hepatocytal carcinoma, compared with Sorafini, Baizean shows the non -inferiority in the total survival period. Report a new security warning.
Baizean is a self-developed PD-1 antibody drug in Baiji Shenzhou. It was listed in China in 2019. As of June 30, a total of 9 adaptive diseases were approved. 1 monoclonal antibody; Sorafini is a tumor drug developed by Bayer Pharmaceutical Company in Germany.
The announcement showed that the study was entered into more than 600 patients from the United States, Europe and Asia. The company plans to display the research data of Rationale 301 at a future academic conference.
However, whether the clinical trial results can support drug submission of new indications for listing, whether it can be finally obtained for listing, and when to obtain listing approval, there is still uncertainty.
Daily Economic News
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