On December 7, 2025, the National Reimbursement Drug List for Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance (2025 edition) (the “NRDL”) was released. Six products from Henlius were included in the updated edition of NRDL. Among them, its innovative breast cancer product CDK4/6 inhibitor FUTUONING (fovinaciclib citrate capsules, referred to as "Fovinaciclib") was included for the first time, for the indication of in combination with Fulvestrant for the treatment of adult patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative recurrent or metastatic breast cancer, who have experienced disease progression after prior endocrine therapy. The new edition of the NRDL will be officially come into effect on 1 January 2026.
Breast cancer remains the most prevalent malignancy among women worldwide and in China. HR-positive/HER2-negative is the most common molecular subtype, accounting for approximately 65-70% of all breast cancer cases [1]. The combination of CDK4/6 inhibitors with endocrine therapy is the recommended standard treatment for HR+/HER2- advanced breast cancer, as endorsed by major guidelines in China and internationally. FUTUONING, an innovative small-molecule CDK4/6 inhibitor developed by Avanc Pharmaceutical Co., Ltd (“Avanc Pharma”), is an oral, potent, and highly selective novel-structure drug. It was included in China’s National Science and Technology Major Project for “Significant New Drugs Creation” in 2018. Clinical data confirmed that FUTUONING significantly extended median progression-free survival (PFS), reduced disease progression risk, and demonstrated a manageable safety profile, offering a new treatment option for patients. In 2025, FUTUONING has been approved in China for the treatment of locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in patients who are initiating or have progressed on endocrine therapy, comprehensively covering first-line and second-line treatments for advanced HR+/HER2- breast cancer. Henlius holds exclusive rights to commercialize the product in China. The successful inclusion of the innovative CDK4/6 inhibitor FUTUONING in the NRDL will significantly enhance the accessibility and the affordability of this drug, helping more HR+/HER2- advanced breast cancer patients benefit from this innovative treatment regimen.
Henlius remains patient-centered and continues to focus on the treatment of major diseases such as breast cancer, lung cancer, and gastric cancer, striving to provide more affordable and high-quality treatment regimens for patients. To date, Henlius has launched 10 products globally, with six of them included in the NRDL, continuously improving the accessibility of high-quality drugs. In addition to FUTUONING, which has been newly included in the reimbursement list, the company's reimbursed products also include the first China-developed biosimilar drug HANLIKANG; trastuzumab biosimilar HANQUYOU (trade name: HERCESSI™ in the U.S., Zercepac® in Europe), approved in over 50 countries worldwide; bevacizumab biosimilar HANBEITAI, approved in multiple Latin American countries; adalimumab biosimilar HANDAYUAN; and HANNAIJIA (neratinib), an extended adjuvant therapy for early-stage breast cancer.
In the future, Henlius will continue to advance the research and development and accessibility of innovative drugs, providing more high-quality and accessible treatment options to improve the health and lives of patients in China and around the world.
【Reference】
[1] Huppert LA, Gumusay O, Idossa D, Rugo HS. Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative early stage and metastatic breast cancer. CA Cancer J Clin. 2023 Sep-Oct;73(5):480-515. doi: 10.3322/caac.21777. Epub 2023 Mar 20. PMID: 36939293.