Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer (TAYLOR-003)

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to standard neoadjuvant chemotherapy combined with HER2-targeted therapy prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and reduce unnecessary chemotherapy exposure.

开始日期2026-05-20

申办/合作机构

浙江大学医学院附属第二医院（浙江省第二医院）

NCT06620731

/ Completed临床1期

Single-dose, Parallel, Open-label Pharmacokinetic Study of FCN-437c Capsule in Subjects With Impaired Liver Function

To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.

开始日期2023-09-04

申办/合作机构

锦州奥鸿药业有限责任公司

NCT06290466

/ Completed临床1期

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Design to Evaluate the Pharmacokinetics and Effects on QT Interval of a Single Oral Dose of FCN-437c Capsule in Healthy Subjects.

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.
This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.
This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.

开始日期2022-11-11

申办/合作机构

锦州奥鸿药业有限责任公司

100 项与枸橼酸伏维西利相关的临床结果

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100 项与枸橼酸伏维西利相关的转化医学

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100 项与枸橼酸伏维西利相关的专利（医药）

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项与枸橼酸伏维西利相关的文献（医药）

2026-08-01·JAMA Oncology

Fovinaciclib for First-Line Therapy of Advanced Breast Cancer

Article

作者: Yang, Xiaoran ; Wang, Xujuan ; Shen, Kunwei ; Ouyang, Zhong ; Zhang, Fenglin ; Pan, Yueyin ; Zhong, Yahua ; Yi, Tienan ; Zhang, Mingjuan ; Wang, Xingli ; Tong, Zhongsheng ; Miao, Jidong ; Ge, Yang ; Deng, Chao ; Zhao, Weihong ; Teng, Yue’e ; Huang, Zhen ; Xu, Binghe ; Tang, Xiaojiang ; Yin, Yongmei ; Wang, Guihua ; Peng, Yuhui ; Liu, Yunjiang ; Shan, Jinlu ; Sheng, Yuan ; Li, Jianhui ; Li, Huiping ; Shu, Guijun ; Zhang, Lili ; Sun, Meili ; Cheng, Jing ; Yang, Xiuli ; Zhong, Jincai ; Du, Yingying ; Cang, Shundong ; Zhou, Enxiang ; Jiang, Aimei ; Guo, Hongqiang ; Li, Xiaoyan ; Li, Taolang ; Xiong, Qiuyun ; Zong, Hong ; Tao, Weiping ; Li, Xuesong ; Jia, Hongyan ; Zheng, Ke ; Liu, Jian ; Xu, Jingwei ; Liu, Hu ; Yuan, Peng ; Li, Youhuai ; Li, Wei ; Lu, Ying ; Wang, Mopei ; Xiong, Huihua ; Tian, Fuguo ; Chen, Ru ; Yang, Hua ; Li, Kai ; Li, Liang ; Li, Huihui ; Wang, Xinshuai ; Li, Hongtao ; Ma, Lixia ; Wang, Shouman ; Meng, Xuli ; Sun, Tao ; Ding, Sijuan ; Wang, Kun ; Wu, Jinsheng ; Wang, Shusen ; Li, Lize ; Lu, Ping ; Wang, Jingfen

Importance:

Approximately 70% of patients with breast cancer (BC) have hormone receptor–positive, human epidermal growth factor receptor 2 ( ERBB2 ; formerly HER2 )–negative disease.

Objective:

To evaluate the efficacy and safety of fovinaciclib plus an aromatase inhibitor as first-line treatment for hormone receptor–positive, ERBB2 -negative advanced BC.

Design, Setting, and Participants:

This double-blind, phase 3 randomized clinical trial enrolled patients from March 2, 2022, to June 28, 2023, from 63 centers in China. Eligible patients were adult women with hormone receptor–positive, ERBB2 -negative advanced BC and no history of systemic therapy for advanced disease. The data cutoff date was June 25, 2024. Data were analyzed from September to October 2024.

Intervention:

Patients were randomized (1:1) to receive fovinaciclib, 200 mg (orally once daily on days 1 to 21), or placebo plus letrozole, 2.5 mg, or anastrozole, 1 mg (orally once daily on days 1 to 28), in 28-day cycles. Premenopausal or perimenopausal patients also received goserelin, 3.6 mg (subcutaneously on day 1).

Main Outcomes and Measures:

The primary end point was progression-free survival (PFS) per blinded independent central review (BICR). Secondary end points included other efficacy end points and safety. Exploratory end points included overall survival (OS) and quality of life.

Results:

Of 417 randomized female patients, the median (range) age was 57.0 (32-84) years. A total of 208 were randomized to the fovinaciclib arm and 209 to the placebo arm. At prespecified interim analysis (median [range] follow-up, 16.6 [0.3-27.8] months), a significantly prolonged median PFS was observed with fovinaciclib compared with placebo (not reached vs 20.2 months [95% CI, 16.4 months to not evaluable]; hazard ratio, 0.55; 95% CI, 0.38-0.77; 1-sided P &lt; .001) per BICR assessments. Consistent PFS benefit was observed in most patient subgroups. Fovinaciclib was also favored across secondary efficacy end points. OS data were immature, with only 40 events (9.6%). The most common treatment-emergent adverse events were hematologic toxic effects, none of which led to serious adverse events or study drug discontinuation. Incidence of discontinuation due to treatment-emergent adverse events was only 1.4% in both arms (3 of 208 receiving fovinaciclib and 3 of 209 receiving placebo). Longitudinal changes in global health status, function domains, and symptom domains of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 were similar between the 2 arms.

Conclusions and Relevance:

In this randomized clinical trial, adding fovinaciclib to first-line aromatase inhibitor conferred significant and clinically meaningful PFS benefit and consistent improvements in other efficacy outcomes, along with manageable safety and unaffected quality of life.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05439499

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetics, mass balance, and metabolism of [14C]FCN-437c, a selective and potent CDK4/6 inhibitor in humans

Article

作者: Diao, Xingxing ; Yan, Shu ; Gao, Lei ; Li, Lize ; Zhang, Hua ; Miao, Liyan ; Ma, Sheng ; Yang, Xiaoran ; Diao, Lei ; Tian, Ling

This study investigated the pharmacokinetics, mass balance, and metabolism of [¹⁴C]FCN-437c, a selective and potent CDK4/6 inhibitor, in humans. Six healthy male Chinese subjects were administered a single oral dose of 200 mg [¹⁴C]FCN-437c (120 µCi), and plasma, urine, and feces samples were collected up to 456 h post-dose. The geometric mean C_max of radioactivity in plasma and blood were 706 and 557 ng eq./mL, respectively, with a median T_max of 5.0 h and a geometric mean t_1/2 of 56.5 h in plasma. The primary route of elimination was fecal excretion, accounting for a mean of 77.16% of the dose, whereas urinary excretion constituted a mean of 19.19% of the administered radioactivity. UHPLC-HRMS analysis identified 12 metabolites in human plasma, urine, and feces, with 8 of them being phase I metabolites, and the major metabolic pathways were mono-oxidation and O-dealkylation. Additionally, 4 phase II metabolites were identified, including two glucuronides, one glutathione conjugate, and one cysteine conjugate. The study provides insights into the metabolic stability and clearance mechanisms of FCN-437c in human, which are essential for its further clinical development and dosing regimens.

2025-08-01·INVESTIGATIONAL NEW DRUGS

Safety and pharmacokinetics of FCN-437c, a novel cyclin-dependent kinase 4/6 inhibitor, in Chinese patients with hepatic impairment

Article

作者: Yanhua Ding ; Jia Xu ; Yunjie Fu ; Yi Sun ; Xiaoran Yang ; Jingrui Liu

This study explored the impact of hepatic impairment on the safety and pharmacokinetics (PK) of FCN-437c, a novel dual CDK4/6 inhibitor for potential breast cancer treatment. In an open-label trial, 25 subjects (8 with mild hepatic impairment, 8 with moderate hepatic impairment, and 8 healthy controls matched for age, sex, and body weight) received a single 200-mg dose of FCN-437c. Results showed that FCN-437c was generally well-tolerated, with no serious adverse events. In mild hepatic impairment group, total FCN-437c C_max increased by 9.5%, while AUC_0-t and AUC_0-∞ decreased by 4.8%. Free drug exposure increased by 24.7%, 8.4%, and 8.4%. In moderate hepatic impairment group, total FCN-437c C_max, AUC_0-t, and AUC_0-∞ decreased by 16.7%, 17.1%, and 15.7%, and free drug exposure increased by 47.8%, 47.0%, and 49.6%. Overall, no clinically relevant differences in FCN-437c exposure were found between subjects with mild or moderate hepatic impairment and normal controls, but moderate hepatic impairment increased free drug exposure. Thus, no dose adjustment is needed for patients with mild hepatic impairment, but a reduced dose may be necessary for those with moderate hepatic impairment. Trial Registration: www.clinicaltrials.gov identifier NCT06620731 (retrospectively registered).

301

项与枸橼酸伏维西利相关的新闻（医药）

2026-08-25

·QQ浏览器

复星医药2026年中报：营收及归母扣非净利润双增创新兑现及全球化构筑增长破局点

2026 年上半年，国内医药行业处在转型升级关键周期，医保控费、集采常态化、汇率波动多重因素交织，行业整体经营承压，药企普遍面临增长考验。在此背景下，复星医药（600196.SH；02196.HK）交出一份韧性十足的中期成绩单：报告期实现营业收入 204.42 亿元，同比增长 4.75%，恒定汇率口径下营收同比增长 7.17%；归母扣非净利润 11.44 亿元，同比增长 19.09%，利润增速显著跑赢营收增速，盈利质量持续改善；经营活动产生的现金流量净额 24.24 亿元，同比增长 13.59%，主业现金流稳健夯实企业持续研发与扩张的底盘。拆解这份业绩，创新产品进入集中兑现周期、全球化布局成效显著，成为公司穿越行业周期的两大核心驱动力。创新药层面，公司持续加码研发投入，2026 年上半年研发总投入 32.47 亿元，同比增长 25.66%；其中创新药品相关研发投入达 26.50 亿元，占集团研发总投入 81.61%，资源重点向肿瘤、免疫炎症、神经退行性疾病三大核心治疗领域倾斜，同步布局 CVRM、抗感染、罕见病赛道，夯实抗体 ADC、新一代小分子，拓展核药、小核酸等前沿技术平台。投入迎来密集产出，报告期复星医药创新药品步入密集收获期，共有7 个创新药品合计 20 项适应症于境内外获批上市，多款产品实现临床空白填补。H药汉斯状®（斯鲁利单抗注射液）国内新增胃癌围术期适应症，填补全球临床空白；欧盟一次性获批一线治疗三项肺癌适应症，截至目前该产品已经登陆全球50个国家和地区，纳入12个国家医保或公共支付体系。汉倍优®帕妥珠单抗）在中国、欧盟两地同步获批上市，与汉曲优®、汉奈佳®、复妥宁®构建起乳腺癌领域产品矩阵；复迈宁®（芦沃美替尼片）新增2岁及以上儿童青少年朗格汉斯细胞组织细胞增生症适应症，补齐国内该领域治疗缺口，成人 I 型神经纤维瘤病适应症上市申请获受理并纳入优先审评。与此同时，ALK 抑制剂丁二酸复瑞替尼胶囊、BCMA×CD3 双特异性抗体纬利妥米单抗（GR1803）等多款创新药上市申请获国家药监局受理；HLX43、HLX22 等重点管线高效推进国际多中心临床研究，覆盖中美欧澳日等国家及地区，其中 PDL1 ADC候选药物 HLX43 展现“高效、低毒”初步临床疗效。报告期内，公司3项在研管线入选2026 ASCO年会口头报告、10项研究入选壁报展示，高质量临床数据为产品全球注册、商业化拓展提供学术支撑。从经营数据看，创新业务拉动效应持续放大。2026上半年，复星医药创新药品收入49.11亿元，同比增长13.84%，占制药业务收入比重达33.21%，较上年同期提升2.17个百分点。全球化布局成为对冲国内行业压力、打造第二增长引擎的关键抓手，公司正从 “产品出海”向着研发、注册、生产、商业化一体化的体系出海升级。2026 年上半年，中国大陆以外地区业务收入63.79亿元，同比增长16.45%，占总营收比重达31.21%，同比提升3.14 个百分点，海外业务已经成为稳定增长极。双向 BD 合作持续落地，验证自研创新资产的全球价值。对外授权方面，复宏汉霖将斯鲁利单抗注射液分别授予卫材日本区域开发商业化权益、授予雅培亚洲、中东、非洲、东欧合计42个国家和地区独家商业化权益。许可引进方面，复星医药与 AriBio 达成阿尔茨海默病在研药物AR1001全球独家选择权合作，该药国际多中心III期临床试验已完成最后一例受试者的最后一次访视，顶线数据预计2026年内公布；同时引进BCMA×CD3双特异性抗体纬利妥米单抗（GR1803）、偌考奇拜单抗（抗IL-17A单抗）等高价值管线，补强血液瘤、免疫炎症领域布局，构建 “自主研发+双向BD”的开放式创新生态。全球制造供应链底座持续加固。生物药基地建成总产能84000升，商业化运行产能48000升，实现全球多区域常态化供货；2026年8月初，控股子公司Gland Pharma宣布与全球领先药企达成55个SKU无菌注射剂战略供应协议，进一步印证了其在高壁垒复杂制剂领域的技术积淀与客户黏性。复星医药董事长陈玉卿表示：“2026 年上半年，面对充满挑战的行业变局，复星医药以战略聚焦应对外部不确定性，业绩实现稳健增长。我们坚定践行创新与国际化，聚焦肿瘤、免疫炎症、神经退行性疾病核心领域，依托 BD 双向赋能，锻造商业化能力。中国创新药全球化机遇当前，我们蓄力长远，坚定迈向高质量发展。”

2026-08-25

·复星医药

复星医药2026年中期业绩：营收净利同比齐增全球化加速创新药品价值兑现

（2026年8月25日，中国上海）8月25日，复星医药（600196.SH；02196.HK）公布2026年中期业绩。2026年上半年，复星医药营收人民币204.42亿元，同比增长4.75%，按恒定汇率口径计算，营业收入同比增长7.17%；归母扣非净利润11.44亿元、同比增长19.09%，利润增速持续优于营收表现，盈利质量持续优化。经营活动产生的现金流量净额为24.24亿元，同比增长13.59%。创新与国际化成为驱动业绩增长的核心引擎：创新药品收入49.11亿元、同比增长13.84%，占制药业务收入比重达33.21%、同比提升2.17个百分点；中国大陆以外地区和其他国家业务收入63.79亿元，同比增长16.45%，占营业收入比重达31.21%、同比提升3.14个百分点，收入结构持续优化。聚焦核心治疗领域加速创新药临床转化复星医药坚持以临床价值为导向，聚焦肿瘤、免疫炎症、神经退行性疾病三大核心治疗领域，并同步拓展CVRM(心血管、肾及代谢)、抗感染、罕见病等领域，通过自主研发、合作开发、许可引进、基金孵化、产业投资等开放式创新体系，加速临床转化，持续推进创新转型。 2026年上半年，复星医药研发总投入32.47亿元，同比增长25.66%；其中，创新药品相关研发投入占研发总投入的81.61%，主要投入HLX43、HLX22、GR1803、FXR0906等管线，以及新一代小分子药物、核药等前沿技术平台。报告期内，复星医药创新药品进入密集获批兑现期，共有7个创新药品共20项适应症于境内外获批上市，在肺癌、乳腺癌、消化道肿瘤等实体瘤领域，多产品协同、全球商业化已形成差异化竞争优势。汉利康®（利妥昔单抗）、汉曲优®（曲妥珠单抗）、奥康泽®等产品稳居细分市场领先地位，持续贡献稳定现金流。 2026年上半年，H药汉斯状®（斯鲁利单抗）于中国境内新增胃癌围术期适应症，填补了全球临床空白；于欧盟新增获批一线治疗鳞状非小细胞肺癌、食管鳞癌、非鳞状非小细胞肺癌三项适应症；截至目前，H药已在全球约50个国家和地区上市，并被纳入英国、德国、意大利、西班牙和瑞典等12个国家医保或公共支付体系。汉倍优（帕妥珠单抗）接连在欧盟、中国获批上市，与汉曲优®、汉奈佳®、复妥宁®等乳腺癌领域创新产品协同放量。复迈宁®（芦沃美替尼片）新增获批2岁及2岁以上经系统治疗后复发/难治的朗格汉斯细胞组织细胞增生症（LCH）儿童及青少年适应症，填补国内临床空白。与此同时，公司多款创新药品上市申请获受理，高效推进重点管线的国际多中心临床研究，为后续商业化增长持续注入动力。ALK抑制剂SAF-189（丁二酸复瑞替尼胶囊）用于非小细胞肺癌的上市申请已获国家药监局受理；复迈宁®治疗丛状神经纤维瘤的I型神经纤维瘤病成人适应症上市申请获国家药监局受理并纳入优先审评；BCMA×CD3双特异性抗体纬利妥米单抗（GR1803）用于多发性骨髓瘤的上市申请已获受理。重点在研资产HLX43、HLX22国际多中心研究同步推进，覆盖中美欧澳日等多个国家和地区，其中，HLX43作为潜在同类最优的广谱抗肿瘤PD-L1ADC，在非小细胞肺癌等多个实体瘤中已展现出“高效、低毒”的初步临床疗效。在免疫炎症领域，公司加强自研的同时通过BD合作持续丰富管线，获授予偌考奇拜单抗（抗IL-17A单抗）于中国境内及港澳台地区的开发、生产及商业化权利；补体抑制剂 FXS6837用于治疗IgA肾病等补体异常激活相关肾小球疾病于中国境内启动IIb期临床试验；DPP1抑制剂FXS7553针对非囊性纤维化支气管扩张症及慢阻肺的两项适应症于中国境内均处于II期临床阶段。神经退行性疾病领域诊疗一体化布局不断夯实。甘露特钠胶囊于中国境内的上市后确证性临床稳步推进，截至2026年7月31日累计入组超1,000例，超过计划入组例数的50%。帕金森病在研药物HT001已在澳大利亚启动I期临床。与此同时，“磁波刀”临床应用与相关诊断试剂的研发有序推进。复星医药坚持以循证医学为导向，报告期内，复星医药的3个在研创新药管线的临床研究成果入选2026 ASCO年会口头报告，包括复迈宁®NF1成人III期研究、斯鲁利单抗注射液胃癌围术期III期研究及HLX43非小细胞肺癌临床研究；另有10项研究入选2026 ASCO年会壁报展示，其中包括复妥宁®两项Ⅲ期研究数据、HLX43在鼻咽癌中的研究等。在《柳叶刀》《自然医学》等全球顶级期刊及全球行业学术会议持续输出高质量临床成果，为产品的国际注册与商业拓展提供坚实学术支撑。深度国际化全球化能力加速创新价值兑现作为国内较早实现全球化布局的制药企业，复星医药正从“产品出海”向“体系出海”持续升级，在研发、注册、生产、商业化等维度持续深化国际化能力，加速创新药品在全球商业化的价值兑现。对外授权方面，控股子公司复宏汉霖就斯鲁利单抗注射液先后与卫材、雅培达成战略合作：授予卫材在日本及约定领域的开发、生产及独家商业化权利；授予雅培在亚洲、中东、非洲及东欧共42个国家和地区的独家商业化许可，加速自主创新成果的全球化落地，惠及广大患者。许可引进方面，复星医药与AriBio就阿尔茨海默病在研药物AR1001达成全球独家选择权合作，在原有中国及东南亚区域权益基础上，有权进一步拓展至美国、欧洲、日本等全球核心市场，并将作为该产品对应区域的上市许可持有人。目前AR1001用于治疗早期阿尔茨海默病的国际多中心III期临床试验已完成最后一位患者的最后一次访视，顶线数据将于2026年内公布。复星医药依托多年全球合规生产经验，持续推进国际化战略。生物药生产基地已实现全球市场供货常态化，供货范围覆盖中国、欧洲、加拿大、拉丁美洲、东南亚、印度等市场。截至报告期末，已建成84,000升产能，其中已商业化运行的产能为48,000升。复星医药控股子公司Gland Pharma作为印度首家获美国FDA批准的注射剂生产企业，具备西林瓶、冻干、安瓿、预充式注射器等复杂剂型的一站式开发与制造能力。近期与全球领先药企达成55个SKU无菌注射剂战略供应协议，进一步印证了其在高壁垒复杂制剂领域的技术积淀与客户黏性。这一平台也为复星医药的全球化布局提供了不可多得的战略性资源，在出海进程中形成了独具差异化的竞争优势。凭借创新与全球化的核心竞争力，复星医药持续巩固行业领先地位，MSCI ESG评级提升至AAA级[1]。在国内，连续八年稳居工信部 “中国医药工业百强榜单”前十；在全球，创新管线规模进入全球第一梯队，入选Citeline“全球TOP25管线规模制药企业”前20。陈玉卿复星医药董事长 “ 2026年上半年，面对充满挑战的行业变局，复星医药以战略聚焦应对外部不确定性，业绩稳健增长。我们坚定践行创新与国际化，聚焦肿瘤、免疫炎症、神经退行性疾病核心领域，依托全球化布局与BD双向赋能，锻造商业化能力。中国创新药全球化机遇当前，我们蓄力长远，坚定迈向高质量发展。 ” [1] 本文中对MSCI Solutions LLC或相关实体（“MSCI”）数据、标识、商标、服务标志或指数名称的使用，不构成MSCI对本集团的赞助、认可、推荐或推广。MSCI的服务和数据归MSCI或其信息提供者所有，按现有状态提供，不作任何保证。MSCI的名称和标识是MSCI的商标或服务标志 Fosun Pharma Announces 2026 Interim Results Globalization Accelerates Value Realization of Innovative Drugs (August 25, 2026, Shanghai, China) — On August 25, Fosun Pharma (“the Company”, stock code: 600196.SH; 02196.HK) announced its interim results for 2026. In the first half of 2026 (“the Reporting Period”, or 1H2026), the Company recorded revenue of RMB 20.442 billion, a year‑on‑year increase of 4.75%, or 7.17% at constant exchange rates. Profit attributable to shareholders of the listed company, net of non‑recurring gains and losses, stood at RMB 1.144 billion, up 19.09% year‑on‑year. Profit growth outpaced revenue growth, reflecting sustained improvement in earnings quality. Net cash generated from operating activities reached RMB 2.424 billion, rising 13.59% year‑on‑year. Innovation and globalization stand as the dual core engines driving business performance. Revenue from Innovative Drugs hit RMB 4.911 billion, representing a 13.84% year‑on‑year increase and accounting for 33.21% of pharmaceutical‑segment revenue, 2.17 percentage points higher than the same period last year. Business revenue from regions outside Chinese mainland and other countries totaled RMB 6.379 billion, growing 16.45% year‑on‑year and making up 31.21% of total revenue, a year‑on‑year uplift of 3.14 percentage points. The Group’s revenue mix continues to improve. Focusing on Core Therapeutic Areas and Accelerating Clinical Translation of Innovative Drugs Guided by clinical‑value‑driven innovation, Fosun Pharma prioritises three core therapeutic areas: oncology, immunology and inflammation, and neurodegenerative diseases. It also expands into CVRM (cardiovascular, renal and metabolic), anti‑infectives, rare diseases and other segments. Leveraging an open‑innovation framework that combines in‑house R&D, two‑way licensing and fund‑incubation models, the Company accelerates clinical translation and pushes forward its innovation‑led transformation. In 1H2026, Fosun Pharma's total R&D investment amounted to RMB 3.247 billion, up 25.66% year-on-year. Among this, R&D investment related to Innovative Drugs accounted for 81.61% of total R&D investment, primarily directed towards pipelines such as HLX43, HLX22, GR1803, FXR0906, as well as next-generation small molecule drugs, radiopharmaceuticals, and other cutting-edge technology platforms. During the reporting period, Fosun Pharma's Innovative Drugs entered a period of intensive approvals and value realization, with a total of 20 indications of 7 Innovative Drugs were approved for launch both domestically and overseas. In solid tumor areas including lung cancer, breast cancer, and gastrointestinal tumors, the Company has established differentiated competitive advantages through multi-product synergy and global commercialization. Han Li Kang (Rituximab), Han Qu You (trastuzumab), and Akynzeo® continue to maintain leading positions in their respective market segments, consistently contributing stable cash flow. During H1 2026, Han Si Zhuang (Serplulimab) gained approval in China for the perioperative treatment of gastric cancer, filling a global unmet clinical need. In the EU, it obtained three additional first‑line approvals for squamous non‑small‑cell lung cancer, esophageal squamous‑cell carcinoma and non‑squamous non‑small‑cell lung cancer. To date, serplulimab has been launched in approximately 50 countries and regions worldwide and is reimbursed under national health‑insurance or public‑reimbursement schemes in 12 markets including the United Kingdom, Germany, Italy, Spain and Sweden. Han Bei You (Pertuzumab) received successive marketing approvals in the EU and China. It works in synergy with breast‑cancer portfolio assets including Han Qu You, Han Nai Jia and Fu Tuo Ning to drive commercial uptake. Fu Mai Ning (luvometinib tablets) secured a new indication for pediatric and adolescent patients aged two years and older with relapsed/refractory Langerhans‑cell histiocytosis (LCH) following systemic therapy, addressing an unmet clinical need in China. With regulatory applications accepted for multiple innovative drugs and international multi-center clinical trials for key pipelines moving forward efficiently, Fosun Pharma continues to fuel its long-term commercial growth. ‑ The NDA for SAF‑189 (foritinib succinate capsules), an ALK inhibitor for non‑small‑cell lung cancer, has been accepted by the NMPA. ‑ The NDA of Fu Mai Ning for adult patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) has been accepted and granted priority review by the NMPA. ‑ The NDA for Velinotamig (GR1803), a BCMA × CD3 bispecific antibody for multiple myeloma, has been accepted. Lead pipeline candidates HLX43 and HLX22 are progressing in international multi‑center trials across China, the US, Europe, Australia, Japan and other geographies. As a potential best‑in‑class pan‑tumor PD‑L1‑targeting ADC, HLX43 has demonstrated promising preliminary clinical efficacy featuring high potency and favorable safety profiles across multiple solidtumors types including non‑small‑cell lung cancer. In the immunology and inflammation field, the Company strengthened its in-house R&D while continuously enriching its pipeline through BD collaborations, obtaining the rights to develop, manufacture, and commercialize roconkibart (anti-IL-17A monoclonal antibody) in Chinese mainland, Hong Kong SAR, Macau SAR, and Taiwan region. The complement inhibitor FXS6837 for the treatment of IgA nephropathy and other glomerular diseases associated with complement dysregulation initiated Phase 2b clinical trials in Chinese Mainland. The DPP1 inhibitor FXS7553 is in Phase 2 clinical stage in Chinese Mainland for two indications: non-cystic fibrosis bronchiectasis and COPD. In the neurodegenerative diseases field, the integrated diagnosis and treatment layout continues to strengthen. The post-marketing confirmatory clinical trial for Sodium Oligomannate Capsules in Chinese mainland is progressing steadily; as of July 31, 2026, cumulative enrollment exceeded 1,000 cases, reaching over 50% of the planned enrollment target. HT001, an investigational drug for Parkinson’s disease, has initiated Phase 1 clinical trials in Australia. Parallel work is underway on the clinical deployment of magnetic‑resonance‑guided focused‑ultrasound therapy and the R&D of companion diagnostic reagents. Rooted in evidence‑based medicine, Fosun Pharma presented three oral abstracts at the 2026 ASCO Annual Meeting, including the Phase 3 study of Fu Mai Ning in adult NF1 patients, the Phase 3 study of serplulimab injection in the perioperative setting for gastric cancer, and the clinical study of HLX43 in non-small cell lung cancer. 10 studies were selected for poster presentations at the 2026 ASCO Annual Meeting, including data from two Phase 3 studies of Fu Tuo Ning and a study of HLX43 in nasopharyngeal carcinoma. The Company continues to deliver high-quality clinical outcomes in top-tier global journals such as The Lancet and Nature Medicine, as well as at global industry academic conferences, providing solid academic support for international registration and commercial expansion of its products. Deep Globalization: Global Capabilities Accelerate Value Delivery of Innovation Among China’s early‑movers in global pharmaceutical expansion, Fosun Pharma is evolving from mere product exports toward system‑level global deployment. It strengthens cross‑border capabilities across R&D, regulatory affairs, manufacturing and commercialization to maximize the global value of its innovative assets. In terms of out-licensing, Shanghai Henlius, a subsidiary of Fosun Pharma, has entered strategic partnerships with Eisai and Abbott for serplulimab. Eisai obtains development, manufacturing and exclusive commercialization rights for Japan and agreed territories. Abbott receives exclusive commercial‑license rights covering 42 countries and regions across Asia, the Middle East, Africa and Eastern Europe. These collaborations accelerate global roll‑out of home‑grown innovations for patients worldwide. In terms of in-licensing, Fosun Pharma entered into a global exclusive option agreement with AriBio for AR1001, an investigational drug for Alzheimer's disease. Building on the existing rights in China and Southeast Asia, Fosun Pharma is entitled to further expand its right to global core markets including the US, Europe, and Japan, with the Company serving as the marketing authorization holder for the product in the corresponding territories. The international multi-center Phase 3 clinical trial of AR1001 for the treatment of early Alzheimer's disease has completed the last patient's last visit, with top-line results to be announced within 2026. Drawing on years of global GMP‑compliant manufacturing experience, Fosun Pharma presses ahead with its internationalization drive. Its biotech manufacturing site supplies products routinely to global markets including China, Europe, Canada, Latin America, Southeast Asia and India. As of period‑end, installed biologic capacity totaled 84,000 liters, of which 48,000 liters are commercially operational. Fosun Pharma's subsidiary Gland Pharma, as the first injectable manufacturer in India to receive U.S. FDA approval, possesses one-stop development and manufacturing capabilities for complex dosage forms including vials, lyophilized products, ampoules, and pre-filled syringes. Gland Pharma recently entered into a strategic supply agreement with a global leading pharmaceutical company for 55 SKUs of sterile injectable, further validating its technological expertise and customer stickiness in the high-barrier complex formulation segment. This platform also provides Fosun Pharma with a unique strategic resource for its globalization layout, creating a differentiated competitive advantage in the process of going global. Bolstered by its innovation and globalization strengths, Fosun Pharma keeps elevating its industry standing and has achieved an MSCI ESG rating upgrade to AAA[1]. Domestically, it has ranked among the top 10 of MIIT’s China Top 100 Pharmaceutical Enterprises for eight consecutive years. Globally, its innovative‑pipeline scale places it within the world’s top tier, ranking top 20 in Citeline's Global Top 25 Pipeline Scale Pharmaceutical Companies. “Amidst challenging industry dynamics, Fosun Pharma responded to external uncertainties with strategic focus, achieving steady revenue growth.” Chen Yuqing, Chairman of Fosun Pharma, said, “We stay firmly committed to innovation and globalization. Concentrating on oncology, immuno-inflammation and neurodegenerative diseases, we leverage our global footprint and two‑way BD synergies to build stronger commercial capabilities. Amid global‑expansion opportunities for China’s innovative drugs, we take a long‑term view and advance resolutely toward high‑quality development.” [1] The use by Fosun Pharma of any MSCI Solutions LLC and related entities (“MSCI”) data, and the use of MSCI logos, trademarks, service marks or product names, do not constitute a sponsorship, endorsement, recommendation, or promotion of Fosun Pharma by MSCI. MSCI ESG Ratings are solely the opinion of MSCI Solutions. MSCI services and data are the property of MSCI or its information providers, are provided ‘as-is’ and without warranty, and MSCI disclaims all liability, including for any damages. 联系方式媒体：pr@fosunpharma.com 投资人：ir@fosunpharma.com

2026-08-24

·GBIHealth

23亿美元！基因泰克获韩美药品新型减肥药权利

企业动态 No.1 /复宏汉霖2026H1财报：产品海外销售增长159.4% 2026年8月21日，复宏汉霖（2696.HK）发布2026年上半年财报。报告期内，公司实现营收人民币35.882亿元，同比增长27.3%；净利润4.304亿元，同比增长10.3%。 2026年上半年，公司聚焦乳腺癌、肺癌、消化道肿瘤等优势治疗领域，全球产品销售收入达到29.386亿元，同比增长14.9%，海外产品销售收入同比大幅提升159.4%至1.053亿元，海外产品利润0.595亿元，为去年同期的4倍以上，全球商业化变现能力进一步增强。乳腺癌领域收入16.983亿元，四款上市产品协同放量，汉曲优（曲妥珠单抗，美国商品名：HERCESSI，欧洲商品名：Zercepac）销售额14.844亿元，汉倍优（帕妥珠单抗，美国及欧洲商品名：POHERDY）销售额770万元、汉奈佳（奈拉替尼）销售额1.955亿元、复妥宁（伏维西利）销售额1070万元。在肺癌、消化道肿瘤等实体瘤领域，多产品协同增长，汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）上半年全球销售额5.975亿元，汉贝泰（贝伐珠单抗）上半年实现收入2.182亿元，同比增长87.6％，其在美国的上市申请也有望于今年下半年获得批准。成熟产品汉利康（利妥昔单抗）与汉达远（阿达木单抗）等持续在血液肿瘤和自身免疫领域贡献稳健现金流，分别基于与合作伙伴的约定实现销售及授权许可收入3.357亿元与3040万元；HLX14（地舒单抗）双规格BILDYOS（60mg/mL）和BILPREVDA（120mg/1.7mL）于2025年下半年相继在美国、欧盟和英国获批，报告期内实现销售收入及授权许可收入7310万元。在临床与注册端，公司在欧美日澳均设有自有团队，在近30个国家和地区同步开展临床研究，合作临床研究中心超1000家。报告期内，公司在全球新增获得32项临床试验申请批准及25项上市注册批件，覆盖近50个国家和地区。在生产与供应端，交付能力持续升级。截至目前，公司累计完成GMP商业化生产批次超1400批，公司顺利通过全球各国药监机构及国际合作方超百项实地核查与审计，核查通过率100%，期内成功完成9次药品首发及18次海外批量发货。 ->点击文末阅读原文，解锁完整双语新闻 No.2 /先声药业2026H1财报：创新药收入增长34.1% 2026年8月20日，先声药业（2096.HK）发布2026年上半年公司财务业绩。公司收入45.8亿元，同比增长27.8%。创新药业务收入38.87亿元，同比增长34.1%，占总收入的84.9%。归属公司权益股东的利润为8.29亿元，同比增长37.9%。集团收入主要来自业务聚焦的治疗领域。其中，神经科学领域收入20.09亿元，占总收入的43.9%，同比增长60.9%；抗肿瘤领域收入9.25亿元，占总收入的20.2%，同比增长5.8%；自身免疫领域收入12.10亿元，占总收入的26.4%，同比增长37.8%；其他领域收入4.36亿元，占总收入的9.5%，同比下降25.2%。集团重点聚焦神经科学、抗肿瘤、自身免疫及抗感染领域，在聚焦领域内共有10款创新药获批上市，截至2026年6月30日，集团有多种产品进入100多个政府机构或权威专业学会发布的指南和路径，超过45个产品被纳入国家医保药品目录。集团已就五项自主研发创新药物与艾伯维、勃林格殷格翰、益普生等国际领先制药企业达成海外权益授权合作，交易总金额超过46亿美元。 ->点击文末阅读原文，解锁完整双语新闻 No.2 /23亿美元！基因泰克获韩美药品新型减肥药权利 2026年8月24日，韩美药品宣布，已与罗氏（SIX：RO，ROP；OTCQX：RHHBY）子公司基因泰克达成一项独家许可协议。基因泰克将获得韩美用于治疗肥胖症及其相关并发症（如2型糖尿病和心血管疾病）的创新代谢治疗候选药物HM17321（UCN2）在全球范围内的开发、制造和商业化权利（韩国市场除外）。 HM17321是一款专有的UCN2（尿促肾上腺皮质素-2）类似物，具有非肠促胰岛素（non-incretin）作用机制，是一款旨在同时促进减重并保留瘦体重（肌肉质量）的潜在同类首创（first-in-class）疗法。相比之下，现有的基于GLP-1的肠促胰岛素疗法虽然展现出了显著的减重效果，但往往伴随着瘦体重的减少。根据协议条款，韩美将获得1.9亿美元的首付款。包括开发、监管和商业化里程碑付款在内，交易总额最高可达约23亿美元。此外，产品商业化后，韩美还有资格根据未来的产品销售额获得阶梯式特许权使用费。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

100 项与枸橼酸伏维西利相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	锦州奥鸿药业有限责任公司	2025-05-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床3期	中国	锦州奥鸿药业有限责任公司	2022-01-18
ER阳性/HER2阴性乳腺癌	临床2期	中国	锦州奥鸿药业有限责任公司	2020-06-30
肝功能不全	临床1期	中国	上海复尚慧创医药研究有限公司	2023-09-04
肝损伤	临床1期	中国	锦州奥鸿药业有限责任公司	2023-09-04
晚期恶性实体瘤	临床1期	美国	重庆复创医药研究有限公司	2019-06-25

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05439499 (Pubmed \| JAMA Oncol)	临床3期	晚期乳腺癌一线 hormone receptor-positive \| ERBB2-negative	417	Fovinaciclib + letrozole/anastrozole	憲艱夢觸餘積觸鬱鹹獵(遞醖鹽獵廠鬱簾製糧鹽) = 遞糧醖糧範鏇蓋襯蓋膚鹹醖獵夢製鹹鏇繭衊鹽 (襯繭膚夢廠積壓遞獵網 ) 更多	积极	2026-06-01
				Placebo + letrozole/anastrozole	憲艱夢觸餘積觸鬱鹹獵(遞醖鹽獵廠鬱簾製糧鹽) = 網糧範願餘範顧獵遞淵鹹醖獵夢製鹹鏇繭衊鹽 (襯繭膚夢廠積壓遞獵網, 16.4 ~ NE) 更多
NCT05439499 (ASCO2026)	临床3期	晚期乳腺癌一线 HR-positive \| HER2-negative	417	Fovinaciclib	淵範膚製選鏇壓糧壓鬱(窪窪蓋鏇範願鏇衊餘廠) = 醖顧齋壓鑰夢廠齋憲簾夢憲願艱鏇膚夢醖齋積 (壓鑰選網獵餘醖繭觸窪, 16.4 ~ NE) 更多	积极	2026-05-29
				Placebo	淵範膚製選鏇壓糧壓鬱(窪窪蓋鏇範願鏇衊餘廠) = 糧窪遞膚遞鹹醖築鹹顧夢憲願艱鏇膚夢醖齋積 (壓鑰選網獵餘醖繭觸窪, 16.4 ~ NE) 更多
NCT06620731 (Pubmed \| Invest New Drugs)	临床1期	肝功能不全	25	FCN-437c 200 mg (mild hepatic impairment)	鹽壓窪觸網製遞壓選鹹(選鹹鬱鑰築製醖獵餘顧) = 繭鬱齋獵顧鑰鹽獵餘選願築範築獵積觸淵網築 (遞積鏇築齋繭襯範艱鹽 )	积极	2025-08-01
NCT05004142 (SABCS2023) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌二线 \| 一线 \| 三线 HR Positive \| HER2 Negative	67	FCN-437c 200 mgFCN-437c 200 mg + fulvestrantfulvestrant 500 mg (Cohort 1)	膚鑰鑰網憲鬱製網廠選(廠窪艱膚膚簾製餘築醖) = 積蓋選齋淵蓋願繭壓淵蓋築夢夢鏇艱蓋鬱網獵 (網鹹壓製製鹽繭簾鹽鏇, 16.9 ~ 49.3) 更多	积极	2023-03-01
				FCN-437c 200 mgFCN-437c 200 mg + letrozoleletrozole 2.5 mg + goserelin 3.6 mggoserelin 3.6 mg (Cohort 2)	膚鑰鑰網憲鬱製網廠選(廠窪艱膚膚簾製餘築醖) = 鑰窪遞膚鹹蓋醖構構齋蓋築夢夢鏇艱蓋鬱網獵 (網鹹壓製製鹽繭簾鹽鏇, 33.1 ~ 69.9) 更多
NCT04488107 (ASCO2022) 人工标引	临床1期	HR阳性/HER2阴性乳腺癌一线 HR Positive \| HER2 Negative	29	FCN-437c 200 mg+letrozole 2.5 mg	餘築遞鏇鑰襯鏇構構積(築遞齋廠鹽襯製願積齋) = 衊網獵糧製憲鑰鑰醖夢範膚艱壓膚繭壓衊鏇觸 (觸積鹽憲糧觸鏇選鹹遞 ) 更多	积极	2022-06-02
				FCN-437c 300 mg+Letrozole 2.5 mg	遞願製願鹹範遞繭築糧(簾鏇衊廠鹽積遞鑰衊壓) = 蓋膚網鬱膚簾選鹽淵蓋遞鏇衊膚網醖醖製簾選 (築鑰糧夢願選淵蓋鑰積, 47.82 ~ 100) 更多
AACR2021	临床1期	晚期乳腺癌	17	FCN-437c	醖壓鹽齋鹽糧鬱鏇積範(襯廠鏇壓廠獵製製構鹹) = 餘網獵鹹衊淵選蓋願憲衊鏇艱鏇艱淵衊顧選糧 (衊鏇廠網壓積醖繭鬱襯 ) 更多	-	2021-07-01
NCT04488107 (Pubmed \| Invest New Drugs)	临床1期	晚期乳腺癌	-	FCN-437c 50 mg	簾淵醖鹽遞鹽膚鏇鑰齋(觸夢簾簾製齋積獵壓壓) = 壓鏇網選遞願窪選觸選願遞襯築膚鬱蓋憲壓觸 (製製蓋鏇膚鹽襯鏇網鹹 ) 更多	-	2021-06-09
				FCN-437c 100 mg	簾淵醖鹽遞鹽膚鏇鑰齋(觸夢簾簾製齋積獵壓壓) = 願憲艱艱願獵觸範壓鬱願遞襯築膚鬱蓋憲壓觸 (製製蓋鏇膚鹽襯鏇網鹹 ) 更多