Beijing, China, Cambridge, Massachusetts, USA and Basel, Switzerland -- December 22, 2023 -- Baiji Shenzhou (NASDAQ Code: bgne; Hong Kong stock exchange code: 06160; Shanghai Stock Exchange code: 688235), a global biotechnology company, today announced that the US Food and Drug Administration (FDA) has approved brukinsa ® (zebutinib, Chinese trade name: buyueze ®） Update the manual and include it in the comparison of Yike ® (ibrutinib) was used to treat previously treated patients with relapsed or refractory (r/r) chronic lymphocytic leukemia (CLL). The results of the phase 3 Alpine trial showed that it was superior in terms of progression free survival (PFS).

Mehrdad Mobasher, MD, chief medical officer of Baiji Shenzhou hematology, and master of public health, said, "Alpine is the first and only head to head phase 3 trial comparing the PFS superiority of ibrutinib in CLL patients. In early 2023, baiyueze ® Approved in the United States for the treatment of CLL patients. Since then, more Alpine PFS analysis data submitted by US showed that Hyatt ® It has become the preferred Btk inhibitor for the treatment of CLL, consolidating its position as an important treatment option. In the treatment decision-making, doctors and patients have a clear understanding of bayonet ® A comprehensive understanding of the significant efficacy and differentiated safety data demonstrated in CLL treatment is crucial. "

This specification update is based on the pre-set analysis results of the alpine trial, which proves that zebutinib has better efficacy and cardiac function related safety characteristics than ibrutinib in r/r CLL patients. This result was presented as the latest breakthrough summary at the 64th American Society of Hematology (ash) annual meeting, and was also published in the New England Journal of medicine. The updated instructions included the PFS superiority results of zebutinib vs. ibrutinib in r/r CLL patients assessed by the investigator and IRC at a median follow-up of 31 months (hr: 0.65 [95% CI, 0.49-0.86] P = 0.0024). In addition, bayonet ® Showed better safety characteristics related to cardiac function. The incidence of atrial fibrillation and atrial flutter in the zebutinib treatment group was significantly lower than that in the ibrutinib group (5.2% vs 13.3%), and there was no death due to cardiac adverse events, while six deaths due to cardiac adverse events occurred in the ibrutinib group (0% vs 1.9%).

At the 65th ash annual meeting held recently, Baiji Shenzhou released the longer follow-up data of the alpine trial. The data with a median follow-up of 39 months showed that among r/r CLL patients who had received zebutinib for more than three years, zebutinib continued to show a sustained PFS benefit compared with ibrutinib (hr: 0.68 [95% CI, 0.53-0.86] p=0.0011), and a sustained PFS benefit was also observed in multiple subgroups including 17p deletion /tp53 mutation (hr: 0.52 [95% CI, 0.33-0.83] p=0.0047). At the same time, a consistent PFS benefit was observed in multiple sensitivity analyses, indicating that the PFS advantage of zebutinib mainly stems from its effectiveness, rather than tolerability. The overall safety and tolerability characteristics were consistent with the previous analysis results of the alpine trial, including that the reported incidence of cardiovascular events in the zebutinib treatment group was consistently lower than that in the ibrutinib group. The most common (≥ 20%) post-treatment adverse reactions were covid-19 related, neutropenia, hypertension, and upper respiratory tract infection.