Henlius' FUTUONING approved for China's national reimbursement drug list

Shanghai Henlius Biotech, Inc. disclosed that its innovative CDK4/6 small molecule inhibitor, FUTUONING (Fovinaciclib Citrate Capsules), has been included in Category B of the National Drug List for Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance (Year 2025). This inclusion covers its use in combination with Fulvestrant for adult patients with hormone receptor (HR) positive and human epidermal growth factor-2 (HER2) negative recurrent or metastatic breast cancer who have progressed after prior endocrine therapy. The new NRDL will take effect on January 1, 2026.

FUTUONING received marketing approval in mainland China in May 2025 for its initial indication. A second indication, in combination with an aromatase inhibitor as initial endocrine therapy for HR positive and HER2 negative locally advanced or metastatic breast cancer, was approved in September 2025.

The company states this inclusion reflects the National Healthcare Security Administration's recognition of FUTUONING's clinical value and innovation, enhancing patient accessibility and benefiting the drug's marketing and sales strategy.