2025年12月3日，復宏漢霖(2696.HK)與錦州奧鴻藥業(yè)有限責任公司(簡稱“奧鴻藥業(yè)”)宣布就創(chuàng)新型小分子CDK4/6抑制劑枸櫞酸伏維西利膠囊(簡稱“伏維西利”，商品名復妥寧)達成合作，加速其商業(yè)化進程。復妥寧已在中國獲批用于內(nèi)分泌初始或者既往接受內(nèi)分泌治療后進展的局部晚期或者轉(zhuǎn)移性的激素受體(HR)陽性、人表皮生長因子2(HER2)陰性的乳腺癌患者，全面覆蓋晚期HR+/HER2-乳腺癌的一線和二線治療。復妥寧由奧鴻藥業(yè)開發(fā)，復宏漢霖擁有其在中國的商業(yè)化獨占許可和權(quán)利。

　　復宏漢霖首席商務發(fā)展官兼高級副總裁

　　曹平女士表示

　　 CDK4/6抑制劑是HR陽性乳腺癌的基石治療藥物，復宏漢霖通過此次合作進一步夯實公司在乳腺癌治療領域的領先地位，為患者提供全面、優(yōu)質(zhì)的治療選擇。

　　復宏漢霖首席商務官兼高級副總裁

　　余誠先生表示

　　復宏漢霖致力構(gòu)建覆蓋乳腺癌全程全域的產(chǎn)品管線。依托成熟的商業(yè)化平臺，公司將加速推進復妥寧的市場滲透，提升治療可及性，惠及更廣泛的患者群體。

　　奧鴻藥業(yè)首席執(zhí)行官彭昱暉先生表示

　　復妥寧是奧鴻藥業(yè)研發(fā)的國家1類新藥，能夠顯著延長乳腺癌患者中位無進展生存期，適合作為長期用藥選擇，并且對未絕經(jīng)患者療效更佳。相信本次與復宏漢霖的商業(yè)化合作，將很快為中國的乳腺癌患者帶來長期臨床獲益。

　　乳腺癌是全球及中國女性最常見的惡性腫瘤。HR陽性/HER2陰性是乳腺癌中最常見的亞型，約占所有乳腺癌的65-70%[1]。CDK4/6抑制劑聯(lián)合內(nèi)分泌治療已成為國內(nèi)外權(quán)威指南一致推薦的HR+/HER2-晚期乳腺癌治療標準療法。復妥寧為奧鴻藥業(yè)開發(fā)的創(chuàng)新型小分子CDK4/6抑制劑，是一種口服、強效、高選擇性、全新結(jié)構(gòu)的創(chuàng)新小分子藥物，于2018年被列入國家“重大新藥創(chuàng)制”科技重大專項。該新藥能夠顯著延長患者中位無進展生存期，降低疾病進展的風險，整體安全性可控，為患者提供了新的治療選擇。

　　復宏漢霖通過和奧鴻藥業(yè)合作，將進一步加速復妥寧的市場覆蓋，讓創(chuàng)新療法惠及廣大晚期乳腺癌患者。通過自主研發(fā)與戰(zhàn)略引進，復宏漢霖持續(xù)打造覆蓋乳腺癌全亞型的完整治療生態(tài)，上市產(chǎn)品包括中美歐等全球50多個國家和地區(qū)獲批上市曲妥珠單抗生物類似藥漢曲優(yōu)(美國商品名：HERCESSI，歐洲商品名：Zercepac)，首個美國獲批的帕妥珠單抗生物類似藥POHERDY，早期強化輔助治療藥物漢奈佳(奈拉替尼)，可與漢曲優(yōu)形成協(xié)同治療。同時，復宏漢霖加速布局新表位抗HER2單抗HLX22、新型內(nèi)分泌療法拉索昔芬片HLX78、KAT6A/B抑制劑HLX97、LIV-1靶點ADC HLX41、HER2xHER2雙表位ADC HLX49、HER2ADC HLX87等多元類型高潛創(chuàng)新分子，持續(xù)推進覆蓋乳腺癌各分型分期的單藥及聯(lián)合療法臨床研究，通過強化管線協(xié)同效應提升治療價值。

　　未來，復宏漢霖將繼續(xù)聚焦未被滿足的臨床需求，加速推進乳腺癌全線治療方案的落地，切實提升患者生存質(zhì)量及長期獲益。

　　【參考文獻】

　　[1]Huppert LA,Gumusay O,Idossa D,Rugo HS.Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor2-negative early stage and metastatic breast cancer.CA Cancer J Clin.2023Sep-Oct;73(5):480-515.doi:10.3322/caac.21777.Epub2023Mar20.PMID:36939293.

　　 Henlius Collaborates with Avanc Pharma to Advance Commercialization of Breast Cancer Drug FUTUONING in China Shanghai, China–December3,2025–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 CDK4/6inhibitor 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 receptor2(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:“CDK4/6inhibitors 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 approximately65-70%of all breast cancer cases[1].The combination of CDK4/6inhibitors 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 CDK4/6inhibitor 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”in2018.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 over50countries 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-HER2antibody HLX22,oral selective estrogen receptor modulator(SERM)lasofoxifene(HLX78),KAT6A/B inhibitor HLX97,LIV-1-targeting ADC HLX41,HER2×HER2bispecific epitope ADC HLX49and HER2ADC HLX87through 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.