HENLIUS (02696) announced that FULINNING® (Fulvestrant Citrate Capsules) has been included in the 2025 National Reimbursement Drug List (NRDL) under Category B. The approved indication covers its use in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer who have progressed after prior endocrine therapy. The updated NRDL will take effect on January 1, 2026.
FULINNING® is an innovative CDK4/6 small molecule inhibitor licensed by the company. It was first approved in China in May 2025 for the above-mentioned indication. In September 2025, an additional indication was approved for FULINNING® in China, allowing its use in combination with aromatase inhibitors as initial endocrine therapy for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.