Xuanzhu Biopharmaceutical Co., Ltd. (2575) has received marketing approval from the National Medical Products Administration of China for a new indication of its innovative drug Bireociclib (Xuanyuening). The newly approved indication combines Bireociclib with an aromatase inhibitor for first-line treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. This is the third approved indication in China following earlier approvals for use with fulvestrant and as a single agent, making Bireociclib the first and only drug in China covering comprehensive HR+/HER2- advanced breast cancer treatment lines.
According to industry data, HR+/HER2- breast cancer constitutes about 75% of all breast cancer cases in China, with around 30% of those patients presenting advanced disease. The latest research shows that the country’s new breast cancer cases rose from 322,200 in 2018 to 374,700 in 2024 and may reach 435,000 by 2032. Meanwhile, the market size for CDK4/6 inhibitors in China is forecast to hit 13.00 billion by 2032.
This approval is based on results from the BRIGHT-3 Phase III clinical trial, which evaluated the efficacy and safety of Bireociclib combined with letrozole or anastrozole in 58 centers across China. Interim analysis revealed a reduction in disease progression or death risk by 47% overall, rising to 64% among patients with liver metastases. The Bireociclib group’s objective response rate reached 63.50%, markedly higher than the 42.50% recorded in the control group. Common adverse events such as diarrhea and neutropenia were largely Grade 1–2 and manageable through supportive care or dose adjustments.
Bireociclib is characterized as the first approved CDK2/4/6 inhibitor in China, originally cleared in May 2025 for combination with fulvestrant as well as monotherapy in specific HR+/HER2- advanced or metastatic breast cancer cases. In December 2025, its approved indications were included in the National Reimbursement Drug List, becoming effective on January 1, 2026.