Genor Biopharma Secures NMPA Approval for Lerociclib to Treat Advanced Breast Cancer
Genor Biopharma Holdings Ltd. has received approval from the China National Medical Products Administration (NMPA) for its drug Lerociclib (GB491), a selective CDK4/6 inhibitor. This drug is intended for adult patients with HR+/HER2- locally advanced or metastatic breast cancer, to be used with an aromatase inhibitor or fulvestrant. This approval marks a significant achievement for Genor Biopharma and highlights its collaboration with G1 Therapeutics Inc.
Genor Biopharma Holdings Ltd. has announced that the China National Medical Products Administration (NMPA) has granted approval for the new drug application of Lerociclib (GB491). This novel, highly potent, selective oral bioavailable cyclin-dependent kinases 4 and 6 inhibitor (CDK4/6i) has been co-developed by Genor Biopharma and G1 Therapeutics Inc. It is designed for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. Lerociclib will be used in combination with an aromatase inhibitor as initial endocrine-based therapy, or with fulvestrant in patients whose disease has progressed following endocrine therapy. This approval represents a significant milestone for Genor Biopharma and showcases the successful collaboration with G1 Therapeutics Inc.
