Recently, the drug registration application for the additional indication of FUTUONING (fovinaciclib citrate capsules), a novel CDK4/6 inhibitor, has been approved by the National Medical Products Administration (NMPA). The approved indication is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor2 (HER2)-negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy. Previously, in combination with fulvestrant, FUTUONING has been approved for the treatment of patients with HR+/HER2- recurrent or metastatic breast cancer with disease progression following endocrine therapy. With a pipeline that spans the entire treatment journey, Henlius has achieved comprehensive coverage across all breast cancer subtypes. The company continues to solidify its leadership in first-line treatment for both HER2+ and HR+ subtypes, bringing more diverse treatment options to patients.
Breast cancer is the most common malignancy among women worldwide and in China, with HR+/HER2- accounting for about 80% of all breast cancer cases [1]. CDK4/6 inhibitors exert their therapeutic effect by binding to the adenosine triphosphate (ATP) sites of CDK4 and CDK6 kinases, thereby inhibiting their activity. This action disrupts the phosphorylation of retinoblastoma (Rb) protein and arrests cell cycle progression from the G1 to the S phase, effectively suppressing tumor cell proliferation. Furthermore, CDK4/6 inhibitors downregulate upstream estrogen receptor signaling pathways and demonstrate synergistic efficacy when combined with endocrine therapy, helping to delay and potentially reverse the development of endocrine resistance [2].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, including the "CACA-CBCS (2025 Edition)," the "Chinese Society of Clinical Oncology Breast Cancer Diagnosis and Treatment (CSCO BC) Guidelines (2025 Edition)," and the United States National Comprehensive Cancer Network (NCCN) guidelines.
FUTUONING is an oral, potent, highly selective CDK4/6 inhibitor with a novel structure. It was included in China’s National Major New Drug Innovation Program in 2018. Clinical studies demonstrated that the drug significantly prolonged median progression-free survival (PFS), reduced the risk of disease progression, and showed a manageable safety profile, providing patients with a new treatment option. It is an innovative small-molecule CDK4/6 inhibitor with independent intellectual property rights, owned by Avanc Pharmaceutical Co., Ltd (“Avanc Pharma”), a member enterprise of Fosun Pharma. Its commercialization in China is led by Henlius, utilizing its robust and well-established commercialization platform. In September, the company efficiently completed the first batch of product shipments and the implementation of the first prescriptions nationwide, while continuously expanding market coverage to ensure that the innovative treatment option benefit more advanced breast cancer patients as soon as possible.
Henlius has demonstrated a strong commitment to advancing breast cancer treatment, establishing a comprehensive pipeline that addresses all stages and types of breast cancer through both independent development and strategic collaborations. Its core product trastuzumab HANQUYOU (trade name: HERCESSI™ in the U.S., Zercepac® in Europe) has been approved in over 50 countries and regions. The extended adjuvant treatment HANNAIJIA (neratinib), can be sequenced with trastuzumab to further reduce recurrence risk. The pertuzumab biosimilar HLX11 has been accepted for review by regulatory agencies in China, the U.S., and the EU，with potential approval in the U.S. in the second half of this year. The company’s self-developed novel epitope anti-HER2 antibody HLX22 is under Phase 2 clinical trials in HR-positive/HER2-low breast cancer. In addition, Henlius is advancing next-generation molecules such as oral selective estrogen receptor modulator (SERM) lasofoxifene (HLX78), KAT6A/B inhibitor HLX97, LIV-1-targeting ADC HLX41, HER2×HER2 bispecific epitope ADC HLX49 and HER2 ADC HLX87 through its robust innovation platforms and collaborative R&D. Looking ahead, the company will continue to enhance synergy across its pipeline and develop an integrated diagnostic and therapeutic ecosystem spanning the entire disease continuum, striving to deliver comprehensive solutions to a broader population of breast cancer patients.
About FUTUONING
FUTUONING (Fovinaciclib), a novel CDK4/6 inhibitor, received approval from NMPA in May 2025. Its currently approved indications are as follows: 1) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor2 (HER2)-negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy; 2) 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 with disease progression following endocrine therapy. Henlius is responsible for the commercialization of FUTUONING in China.
