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.
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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.
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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.
