近日,创新型CDK4/6抑制剂复妥宁®(枸橼酸伏维西利胶囊)新增适应症的药品注册申请获得国家药品监督管理局(NMPA) 批准。本次获批适应症为用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性(HR+/HER2-)局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗。此前,复妥宁®已获批联合氟维司群用于既往接受内分泌治疗后出现疾病进展的HR+/HER2-的复发或转移性乳腺癌。截至目前,复宏汉霖凭借全程全域的管线布局,已实现对乳腺癌所有亚型的覆盖,并持续夯实在HER2+及HR+领域的一线治疗优势,为乳腺癌患者带来更丰富治疗选择。
乳腺癌是全球以及中国女性最常见的恶性肿瘤之一。HR+/HER2-是乳腺癌中最常见的分子亚型,约占所有乳腺癌的80% [1]。CDK4/6抑制剂可通过与CDK4 和CDK6激酶的三磷酸腺苷(ATP)结合位点结合,抑制其活性,干扰网膜母细胞瘤(Rb)的磷酸化,阻断细胞周期从G1 期到S 期的进程,抑制肿瘤细胞增殖。此外,CDK4/6 抑制剂还能抑制上游雌激素受体信号通路的表达,与内分泌治疗之间存在协同增效的作用,达到延缓和逆转内分泌耐药的目的[2]。CDK4/6抑制剂联合内分泌治疗已成为《CACA-CBCS(2025版)》《中国临床肿瘤学会乳腺癌诊疗(CSCO BC)指南(2025版)》及美国国立综合癌症网络(NCCN)等国内外权威指南一致推荐的HR+/HER2-晚期乳腺癌治疗标准疗法。
复妥宁®为复星医药子公司奥鸿药业拥有自主知识产权的创新型小分子CDK4/6抑制剂,是一种口服、强效、高选择性、全新结构的创新小分子药物,于2018年被列入国家“重大新药创制”科技重大专项。该新药能够显著延长患者中位无进展生存期,降低疾病进展的风险,整体安全性可控,为患者提供了新的治疗选择。复妥宁®在中国的商业化推广由复宏汉霖负责,依托成熟的商业化体系,公司于9月高效完成产品的首批发货以及全国各地的首处方落地,并持续扩大市场覆盖,让创新治疗选择尽早惠及更多晚期乳腺癌患者。
复宏汉霖深耕乳腺癌治疗领域,通过自主研发与合作引进,已建立覆盖乳腺癌全程全域治疗管线。公司乳腺癌核心产品曲妥珠单抗汉曲优®(美国商品名:HERCESSI™,欧洲商品名:Zercepac®)已在全球50多个国家和地区获批上市;早期强化辅助治疗药物汉奈佳®(奈拉替尼)与汉曲优®续贯协同,降低复发风险;帕妥珠单抗生物类似药HLX11的上市申请获中美欧监管机构受理, 有望于下半年在美国获得批准。新表位抗HER2单抗HLX22针对HER2低表达HR阳性乳腺癌的II期临床研究正在同步开展中。同时,复宏汉霖加速布局新型内分泌疗法拉索昔芬片HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2 ADC HLX87等多元类型高潜创新分子。未来,公司将持续强化管线协同,构建贯穿全病程的诊疗生态,为更多乳腺癌患者提供全面的解决方案。
【参考文献】
[1] Jerzak KJ, Bouganim N, Brezden-Masley C, et al. HR+/HER2- Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review. Curr Oncol. 2023;30(6):5425-5447. Published 2023 Jun 2. doi:10.3390/curroncol30060411
[2] CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性乳腺癌临床应用专家共识(2023版)
关于复妥宁
复妥宁®(枸橼酸伏维西利胶囊)是一款创新型小分子CDK4/6 抑制剂,于2025年5月正式获得国家药品监督管理局(NMPA)上市注册批准。目前已获批适应症包括:1)用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗;2)联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子 2 (HER2) 阴性的复发或转移性成年乳腺癌患者。该产品在中国的商业化推广由复宏汉霖负责。
关于复宏汉霖
复宏汉霖(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已在全球获批上市9款产品,5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控,不断夯实一体化综合生产平台,其中,公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖约50个分子,并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前,公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®(斯鲁利单抗,欧洲商品名:Hetronifly®)、自主研发的中美欧三地获批单抗生物类似药汉曲优®(曲妥珠单抗,美国商品名:HERCESSI™,欧洲商品名:Zercepac®)、国内首个生物类似药汉利康®(利妥昔单抗)、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验,对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
Henlius Achieves Breakthrough in First-Line Breast Cancer Therapy: Innovative CDK4/6 Inhibitor FUTUONING Approved for New Indication
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.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 9 products have been approved for marketing worldwide, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
联系方式
媒体:PR@Henlius.com
投资者:IR@Henlius.com
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