Shanghai, China, March 13, 2024 – Genor Biopharma (Stock code: 6998.HK) announced today that the China National Medical Products Administration (NMPA) has officially accepted the new drug application for GB491 (Lerociclib, cyclin-dependent kinase 4/6 inhibitor) combined with Letrozole for the treatment of HR-positive, HER2-negative patients with advanced breast cancer who have not previously undergone systemic antitumor therapy.
Previously, the new drug application for GB491 (Lerociclib) in combination with Fulvestrant as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy has been accepted on March 28, 2023, and has successfully completed clinical on-site inspection.
About GB491 (Lerociclib)
GB491 (Lerociclib) is a highly selective oral CDK4/6 inhibitor for the treatment of breast cancer. It was developed by Genor Biopharma and G1 Therapeutics. The company in-licensed exclusive rights of GB491 (Lerociclib) from G1 Therapeutics, Inc. (Nasdaq: GTHX) in certain APAC countries excluding Japan in June 2020.
