2025年12月3日，复宏汉霖（2696.HK）与锦州奥鸿药业有限责任公司（简称“奥鸿药业”）宣布就创新型小分子 CDK4/6 抑制剂枸橼酸伏维西利胶囊（简称“伏维西利”，商品名复妥宁）达成合作，加速其商业化进程。复妥宁已在中国获批用于内分泌初始或者既往接受内分泌治疗后进展的局部晚期或者转移性的激素受体（HR）阳性、人表皮生长因子 2 （HER2）阴性的乳腺癌患者，全面覆盖晚期HR+/HER2-乳腺癌的一线和二线治疗。复妥宁由奥鸿药业开发，复宏汉霖拥有其在中国的商业化独占许可和权利。

复宏汉霖首席商务发展官兼高级副总裁

曹平女士表示

CDK4/6抑制剂是HR阳性乳腺癌的基石治疗药物，复宏汉霖通过此次合作进一步夯实公司在乳腺癌治疗领域的领先地位，为患者提供全面、优质的治疗选择。

复宏汉霖首席商务官兼高级副总裁

余诚先生表示

复宏汉霖致力构建覆盖乳腺癌全程全域的产品管线。依托成熟的商业化平台，公司将加速推进复妥宁的市场渗透，提升治疗可及性，惠及更广泛的患者群体。

奥鸿药业首席执行官彭昱晖先生表示

复妥宁是奥鸿药业研发的国家1类新药，能够显著延长乳腺癌患者中位无进展生存期，适合作为长期用药选择，并且对未绝经患者疗效更佳。相信本次与复宏汉霖的商业化合作，将很快为中国的乳腺癌患者带来长期临床获益。

乳腺癌是全球及中国女性最常见的恶性肿瘤。HR阳性/HER2阴性是乳腺癌中最常见的亚型，约占所有乳腺癌的65-70% ^[1]。CDK4/6抑制剂联合内分泌治疗已成为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。复妥宁为奥鸿药业开发的创新型小分子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。

复宏汉霖通过和奥鸿药业合作，将进一步加速复妥宁的市场覆盖，让创新疗法惠及广大晚期乳腺癌患者。通过自主研发与战略引进，复宏汉霖持续打造覆盖乳腺癌全亚型的完整治疗生态，上市产品包括中美欧等全球50多个国家和地区获批上市曲妥珠单抗生物类似药汉曲优(美国商品名：HERCESSI，欧洲商品名：Zercepac)，首个美国获批的帕妥珠单抗生物类似药POHERDY，早期强化辅助治疗药物汉奈佳（奈拉替尼），可与汉曲优形成协同治疗。同时，复宏汉霖加速布局新表位抗HER2单抗HLX22、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，持续推进覆盖乳腺癌各分型分期的单药及联合疗法临床研究，通过强化管线协同效应提升治疗价值。 

未来，复宏汉霖将继续聚焦未被满足的临床需求，加速推进乳腺癌全线治疗方案的落地，切实提升患者生存质量及长期获益。

【参考文献】

[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.

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10款产品，4个上市申请分别获中国药监局和欧盟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）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。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 Collaborates with Avanc Pharma to Advance Commercialization of Breast Cancer Drug FUTUONING in China

Shanghai, China – December 3, 2025 – Henlius (2696.HK) announced  collaboration with Avanc Pharmaceutical Co., Ltd (“Avanc Pharma”) to advance the commercialization of fovinaciclib citrate capsules (brand name: FUTUONING), a novel CDK4/6 inhibitor developed by Avanc Pharma in China. 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.

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, stated: “CDK4/6 inhibitors serve as the backbone therapy for HR-positive breast cancer. Henlius has further strengthened its leading position in the field of breast cancer treatment through the collaboration, providing patients with comprehensive and high-quality treatment options.” 

Kurt Yu, Chief Commercial Officer and Senior Vice President of Henlius, noted: “Henlius is committed to building a comprehensive product pipeline covering all subtypes of breast cancer. Leveraging our mature commercialization platform, we will accelerate the market penetration of FUTUONING, enhancing treatment accessibility to benefit broader patient populations.”

Yuhui Peng, CEO of Avanc Pharma, stated: “FUTUONING is a first-class innovative drug developed by Avanc Pharma. It can significantly extend the median progression-free survival in breast cancer patients, making it an ideal long-term treatment option, especially showing better efficacy in premenopausal patients. We believe that this commercialization cooperation with Henlius will bring long-term clinical benefits to breast cancer patients quickly in China.”

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 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.

Henlius collaborates with Avanc Pharma to further accelerate the market coverage of FUTUONING, enabling innovative therapies to benefit a broader range of advanced breast cancer patients. Through in-house R&D and strategic partnerships, the company has built an integrated treatment ecosystem spanning all breast cancer subtypes. Its marketed products include HANQUYOU (trade name: HERCESSI in the U.S., Zercepac in Europe), a trastuzumab biosimilar approved in over 50 countries and regions including China, the U.S., and Europe; POHERDY, the first pertuzumab biosimilar approved in the U.S.; HANNAIJIA (neratinib), an extended adjuvant therapy, forming a sequential treatment approach with HANQUYOU to reduce recurrence risk. Meanwhile, Henlius is advancing next-generation molecules such as novel epitope anti-HER2 antibody HLX22, 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. Building on this foundation, Henlius remains committed to advancing monotherapies and combination regimens across all breast cancer subtypes, enhancing therapeutic value through strengthened pipeline synergies.

Moving forward, Henlius remains committed to addressing unmet clinical needs and accelerating the delivery of comprehensive breast cancer treatment solutions, with the goal of significantly improving patients' quality of life and long-term outcomes.

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. To date, 10 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China 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, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

To learn more about Henlius, visit and connect with us on LinkedIn at ·收藏 ·点赞 ·在看

(复宏汉霖)