XUANZHUBIO-B (02575) Final Analysis of Phase III Trial for Bireociclib Plus Fulvestrant in HR+/HER2- Advanced Breast Cancer Published in Top-Tier Journal JAMA Oncology

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XUANZHUBIO-B (02575) announced that the final analysis results of the Phase III BRIGHT-2 clinical study for its self-developed novel CDK2/4/6 inhibitor, Bireociclib, have been formally published online in the prestigious international medical journal JAMA Oncology (a medical Category 1 journal with an impact factor of 20.1). The BRIGHT-2 study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial conducted in China, designed to evaluate the efficacy and safety of Bireociclib combined with fulvestrant in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer whose disease progressed after prior endocrine therapy. The study was led by Academician Xu Binghe from the Chinese Academy of Medical Sciences Cancer Hospital and conducted across 64 hospitals in China. The company had previously reported the interim analysis results of the BRIGHT-2 study in the journal Nature Communications in April 2025. The newly published final analysis results include an additional 11 months of observation beyond the interim analysis, extending the median follow-up time to 19 months, further revealing the maturity and robustness of Bireociclib's survival benefits. The final analysis results of the BRIGHT-2 study demonstrate that Bireociclib combined with fulvestrant provided clinically meaningful and durable benefits to patients.

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