China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have experienced disease progression following prior endocrine therapy combined with fulvestrant.
Birociclib’s Distinctive Features and Clinical Benefits
Birociclib is noted for its unique molecular structure design and leading technological advantages in the field of CDK4/6 inhibitors. The drug offers the benefits of single-drug effectiveness, continuous administration, and the ability to pass through the blood-brain barrier, which are significant for patients with advanced breast cancer. Phase III clinical trials have demonstrated that the combination of birociclib with fulvestrant provides clinically and statistically meaningful benefits, positioning it as a potential new treatment option for patients in need.
Implications for Breast Cancer Treatment in China
The acceptance of the NDA for review by the NMPA is a significant step forward for Sihuan Pharmaceutical as it seeks to bring birociclib to market. If approved, birociclib could offer a new therapeutic approach for patients with HR+/HER2- advanced breast cancer, particularly those who have seen disease progression after initial endocrine therapy.-Fineline Info & Tech
