Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has accepted its filing for another indication approval of lerociclib (GB491), a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. The new indication seeks to utilize lerociclib in combination with letrozole for patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer who have not previously undergone systemic anti-tumor therapies.
This follows a previous filing accepted by the NMPA in March of last year for the same drug in combination with fulvestrant, targeting HR+, HER2- locally advanced or metastatic breast cancer patients who had been pre-treated with endocrine therapy.
Lerociclib is a differentiated oral CDK4/6 inhibitor originally discovered by US biotech G1 Therapeutics. In June 2020, Genor Biopharma secured exclusive development and commercialization rights for the drug in the Asia-Pacific region (excluding Japan) through a USD 46 million licensing agreement with G1 Therapeutics.- Flcube.com
