By Fineline Cube 
China’s Genor Biopharma Co., Ltd (HKG: 6998) announced that it has received marketing clearance from the National Medical Products Administration (NMPA) for its cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor lerociclib (GB491). The drug is approved for the treatment of HR-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer in adult patients.
Approved Indications and Treatment Options
The approved indications for lerociclib include its use in combination with an aromatase inhibitor as first-line endocrine therapy, as well as in combination with fulvestrant for patients who have progressed after prior endocrine therapy. This approval provides additional treatment options for patients with HR+/HER2- breast cancer, addressing a significant unmet medical need in this patient population.
Partnership and Development Milestones
Lerociclib is a differentiated oral CDK4/6 inhibitor discovered by US biotech G1 Therapeutics. In June 2020, Genor Biopharma entered into a USD 46 million licensing deal with G1 Therapeutics, securing exclusive development and commercialization rights to the drug in the Asia-Pacific region, excluding Japan. This partnership has enabled Genor to bring this innovative therapy to patients in need across the region.-Fineline Info & Tech