Baiji Shenzhou BTK inhibitor Zebutini new adaptive disease listing application was accepted by the FDA

On February 17, Baiji Shenzhou announced that the U.S. FDA had accepted a new application (SNDA) for the treatment of patients with Fahrenheit globulinemia (WM), with the PDUFA dated October 18, 2021.
Zebtini is a small molecular inhibitor of Bruton's Tyrosine Kinase (BTK), developed by scientists in Baiji Shenzhou.
the United States, where it received accelerated approval in November 2019 to treat patients with block cell lymphoma (MCL) who have received at least one treatment in the past.
In China, Zebtini obtained conditional approval in China in June 2020 for the treatment of two adaptations in adult chronic lymphoblastic leukemia (CLL)/small lymphocyte lymphoma (SLL) patients who have received at least one treatment in the past, and in adult MCL patients who have received at least one treatment in the past.
According to the latest prospectose, previously published by Baiji Shenzhou, the company has conducted 29 clinical trials of Zebutini monotherapy or co-use drugs worldwide, 9 of which are registered clinical trials involving more than 3,100 patients, including more than 2,400 overseas patients.
addition, the press release noted that more than 20 Zebtini-related listing applications have been submitted, covering 45 countries and regions around the world, including the United States, China and the European Union, on five continents.
The sNDA, which was accepted by the FDA, includes data from 351 WM patients, based primarily on data on the safety and effectiveness of Zebutinib's Global Phase 3 ASPEN clinical trials for the treatment of WM patients, and support data from two Zebutini clinical trials, key Phase 2 clinical trials in China for the treatment of recurring/refractic WM patients and global Phase 1/2 clinical trials for the treatment of patients with B-cell malignancies.
same time, safety data for 779 patients in six Zebutinist clinical trials were included in the sNDA. "WM is a rare and very serious disease, and we are very pleased that the FDA has accepted Bai Yueze's application for a new adaptation for the treatment of the disease," said Dr. Huang Weixuan, Chief Medical Officer of Hematology, Baiji Shenzhou,
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recent years, BTK inhibitors have improved the overall treatment of WM, but patients with different subsypes have different mitigations, and toxicity remains a problem.
will continue to communicate with the FDA over the next few months and look forward to a new treatment for WM patients in the United States.
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