China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its Phase III clinical study for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, has successfully reached the primary endpoint in patients with HR+/HER2- advanced breast cancer that has progressed after previous endocrine therapy combined with fulvestrant.
Positive Mid-Term Analysis and Recommendations for Early Market Filing
The independent data monitoring committee experts unanimously agreed that the mid-term analysis results have not only met but exceeded the preset threshold, demonstrating significant statistical differences and clinical significance compared to the control group. As a result, they have recommended unblinding the study and proceeding with an early market filing, a significant step towards making this treatment available to patients.
NMPA Accepts Filing for Phase II Study in Prostate Cancer
In addition to the breast cancer study, the National Medical Products Administration (NMPA) has accepted the filing for a Phase II study of birociclib combined with abiraterone plus prednisone for the treatment of advanced or metastatic prostate cancer. This acceptance marks another important milestone for Sihuan Pharmaceutical as it expands the potential indications for birociclib.-Fineline Info & Tech
