Gelonghui, March 13, 丨 Jiahe Bio-B (06998.HK) announced that on March 13, 2024, the China National Drug Administration (“NMPA”) has officially accepted a new drug marketing license application (“NDA”) for patients with advanced breast cancer (GB491, Lerociclib) combined with letrozole to treat hormone receptor (HR) positive and negative human epidermal growth factor receptor 2 (HER2-) without prior systemic anti-tumor treatment.

Previously, GB491, Lerociclib hydrochloride tablets (, Lerociclib) combined with fluvizil for treating patients with HR+/ HER2-locally advanced or metastatic breast cancer who had progressed after previous endocrine treatment was accepted by the NMPA on March 28, 2023, and clinical site verification was successfully completed.

Lerociclib hydrochloride tablets (GB491, Lerociclib) is a highly selective oral CDK4/6 inhibitor for the treatment of breast cancer developed by the company in collaboration with G1 Therapeutics, Inc. (NASDAQ: GTHX) (“G1 Therapeutics”) of the United States. Since June 2020, the company has obtained an exclusive license from G1 Therapeutics for GB491, Lerociclib hydrochloride tablets (, Lerociclib) in several Asia-Pacific countries (excluding Japan).