Bibate Pharmaceutical's CDK4/6 inhibitors are approved for Phase 3 clinical trials

ArticleMedicine Guanlan

On December 22, Bibate Pharmaceutical announced that its phase 3 clinical trial application of the CDK4/6 inhibitor BEBT-209 combined with fulvestrant in the treatment of HR+/HER2- advanced breast cancer has been approved by the China National Medical Products Administration.

BEBT-209 is an investigational CDK4/6 inhibitor independently developed by Bibetter Pharmaceuticals

The early results of the Phase 1/2 clinical trial showed that, compared with the control group, BEBT-209 has higher plasma exposure and better safety in breast cancer patients (the incidence of leukopenia and neutropenia is lower, and no Non-hematological toxicity above grade 3); Moreover, the efficacy of BEBT-209 group is also better.

The CDE approved this time is a multi-center, randomized, controlled, double-blind phase 3 clinical study, which aims to evaluate the localization of BEBT-209 combined with fulvestrant in the treatment of HR+/HER2- in the disease progression after previous endocrine therapy.

In addition to the above-mentioned Phase 3 clinical trials, BEBT-209 has two other clinical trials for the treatment of advanced breast cancer being launched

According to the latest report of the World Health Organization (WHO), breast cancer has replaced lung cancer as the world's most common malignant tumor in 2020

Reference materials:

[1] BEBT-209 was approved for Phase III clinical trials.