Zebutinib recommended as 'Class I priority' in international guidelines

The National Comprehensive Cancer Network (NCCN) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Guidelines, First Edition 2023, were recently updated. In this guideline update, Zebutinib, a BTK inhibitor developed by Bazhens, was upgraded to "Class I priority" for first-line del(17p)/TP53 mutation-free, and received the highest level of recommendation in the international guideline.

Zebutinib was established in 2012, and through innovative optimization of the molecular structure, it has improved target occupancy and minimized off-target effects, resulting in highly efficient, safe and reliable properties that significantly reduce the risk of cardiac-related AEs with the first-generation BTK inhibitor ibrutinib.

In terms of clinical evidence-based exploration, Baekje Shenzhou, with extraordinary self-confidence and courage, chose to directly enter the main battlefield of the BTK inhibitor market, CLL/SLL, in a "head-to-head" trial, which was a short battle with ibrutinib, which used to occupy the first-line treatment class I recommendation in the NCCN guidelines, and demonstrated the potential of zebutinib. This demonstrates the potential "best-in-class" therapeutic effect of Zebutinib.

Now, five BTK inhibitors have been approved worldwide, including ibrutinib, akatinib, tirarutinib, obutinib, and zebutinib, which are basically laid out in the field of hematology and autoimmune diseases. The subsequent market competition will enter a white-hot stage. The CLL/SLL indication of Zebutinib is expected to be approved by the FDA in January 2023, and will open up unlimited imagination with the "best-in-class" therapeutic potential confirmed in the global phase 3 head-to-head trial and the highest level of recommendation in the current international guidelines, and the clinical use pattern of BTK inhibitors will enter a brand new stage.

On July 26, 2022, Zebutinib was selected as a candidate for the Prix Galien USA Awards for Best Biotechnology Product, which is known as the Nobel Prize in medicine.