FUTUONING Sets Sail Commercially with First Prescriptions Across China

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SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- These days, the first prescriptions of FUTUONING (fovinaciclib citrate capsules) were issued by more than ten hospitals across China, including Fudan University Shanghai Cancer Center, Cancer Hospital of the Chinese Academy of Medical Sciences, The First Affiliated Hospital Zhejiang University School of Medicine, The First Affiliated Hospital of Anhui Medical University, Shandong Cancer Hospital, Shanghai Tenth People's Hospital, Nanjing Drum Tower Hospital and The Affiliated Hospital of Qingdao University.

FUTUONING, a CDK4/6 inhibitor, is indicated 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. 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.

Mr. Kurt Yu, Chief Commercial Officer and Senior Vice President of Henlius, stated: "The first batch delivery of FUTUONING marks its official entry into the commercial stage, with full-scale supply nationwide. Leveraging our well-established commercialization system, we will spare no effort to accelerate market access and terminal coverage for FUTUONING, continuously improving its accessibility so that more patients can benefit from this innovative therapy as early as possible."

Breast cancer is the most common malignancy among women worldwide and in China. HR-positive/HER2-negative breast cancer is the most prevalent subtype, accounting for approximately 65–70% of all cases ^[1]. Endocrine therapy-based regimens are the standard of care and have significantly improved patient outcomes ^[2]. However, 30–50% of patients eventually develop endocrine resistance, leading to recurrence or metastasis ^[3]. Research shows that the proliferation of such cancer cells is highly dependent on the CDK4/6 pathway, and CDK4/6 inhibitors suppress tumor cell proliferation and induce apoptosis by specifically inhibiting CDK4/6 kinase activity.

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. On September 1, Avanc Pharma successfully completed the first batch delivery of FUTUONING in Jinzhou, Liaoning Province, China. Subsequently, Henlius proactively planned for commercial channels and supply chain management. With the efficient operation of its wholly-owned subsidiary Henlius Pharmaceutical Trading Ltd. and the close collaboration of strategic distribution partners, FUTUONING was promptly delivered across the country, swiftly stored in warehouses and placed on shelves, reaching 44 cities in 29 provinces.

Breast cancer is one of Henlius' core therapeutic focuses. The company has built a diversified pipeline covering the full disease spectrum and all molecular subtypes of breast cancer. By combining its in-house commercialization team with global partnerships, Henlius has established a worldwide commercial network and continues to unlock the commercial value of its breast cancer portfolio. Henlius has built a 600+ member breast cancer commercialization team, covering key areas including market access, channel expansion, and medical promotion. Through refined operations and digitalized management, the company has achieved industry-leading commercialization efficiency. Its core product trastuzumab HANQUYOU (Hercsessi™ in the U.S., Zercepac^® in Europe) has been approved in over 50 countries and regions and is reimbursed in China, the UK, France, Germany, and more. Neratinib HANNAIJIA, for extended adjuvant treatment of HER2-positive early breast cancer, 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, and is expected to gain FDA approval in the second half of this year, enabling dual HER2-targeted synergy with trastuzumab. 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, and HER2×HER2 bispecific epitope ADC HLX49 through its robust innovation platforms and collaborative R&D.

Looking ahead, Henlius will continue to focus on unmet clinical needs, accelerate the rollout of comprehensive treatment solutions for breast cancer, and improve patients' quality of life and long-term survival outcomes.

About FUTUONING

FUTUONING(Fovinaciclib), a novel CDK4/6 inhibitor, received approval from NMPA in May 2025. It is indicated 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.

SOURCE Henlius