Today, pirrolimus has been officially included in the National Medical Insurance Drug List! On December 7, 2025, the National Healthcare Security Administration announced the adjusted results of the 2025 National Medical Insurance Drug List, wherein pirrolimus tablets—a Class 1 innovative drug and CDK4/6 inhibitor independently developed by Xuanzhu Biotech—was successfully added to the list, providing new medical insurance reimbursement benefits for patients with advanced breast cancer.

Piloside is China's first and currently the only approved CDK4/6 inhibitor for monotherapy in hormone receptor-positive (HR+) / human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Both of its approved indications are covered by medical insurance reimbursement: monotherapy for patients who have failed multiple lines of treatment, and combination therapy with fulvestrant for patients with disease progression after prior endocrine therapy. Clinical study data demonstrate that piloside monotherapy achieves a median progression-free survival of 11 months and a median overall survival of up to 29 months in patients with advanced breast cancer who have failed multiple lines of treatment, representing the best global outcomes; in combination therapy scenarios, it significantly extends the median progression-free survival to 17.5 months and reduces the risk of disease progression or death by 57.3% in patients with liver metastases.

This drug exhibits a unique multi-target inhibition mechanism, achieving excellent therapeutic efficacy while demonstrating low incidence of hematological toxicity and gastrointestinal adverse reactions, with a diarrhea rate of grade ≥3 occurring in only 6.4%, thereby ensuring optimal patient safety and tolerability.

With the implementation of medical insurance coverage for piraroxil, its accessibility will be significantly improved, effectively alleviating patients' financial burden. China reports approximately 357,200 new cases of breast cancer annually, among which about 70% are HR+/HER2-subtypes. The medical insurance coverage for piraroxil will benefit a large number of patients with advanced-stage breast cancer.