By Fineline Cube China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the market filing for its cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, lerociclib (GB491), has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) local advanced or metastatic breast cancer in patients who have received prior endocrine therapy combined with fulvestrant.
Lerociclib’s Background and Indication
Lerociclib, an oral CDK4/6 inhibitor, was discovered by the US biotech company G1 Therapeutics. It is designed to treat breast cancer patients who have progressed after initial endocrine therapy. Genor Bio has secured exclusive rights to develop and commercialize lerociclib in the Asia-Pacific region, excluding Japan, through a USD 46 million licensing deal with G1 Therapeutics in June 2020.
Potential Impact of Lerociclib in the Asia-Pacific Region
The acceptance of the market filing for review by the NMPA is a significant step towards making lerociclib available to patients in China and potentially across the Asia-Pacific region. If approved, lerociclib could provide an additional treatment option for patients with HR+/HER2- advanced or metastatic breast cancer who have exhausted other endocrine therapy options.-Fineline Info & Tech