A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects. - NIL

开始日期2025-01-21

申办/合作机构

Incepta Pharmaceuticals Ltd.

[+1]

TCTR20190718006

/ Recruiting临床4期IIT

A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS

开始日期2019-03-19

申办/合作机构-

NCT03552393

/ Completed临床2期

An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

开始日期2018-08-03

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与甲氧聚二醇重组人促红素相关的临床结果

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100 项与甲氧聚二醇重组人促红素相关的转化医学

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100 项与甲氧聚二醇重组人促红素相关的专利（医药）

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465

项与甲氧聚二醇重组人促红素相关的文献（医药）

2026-02-01·Clinical and Experimental Nephrology

Erythropoiesis-stimulating agent hyporesponsiveness and malignancy development in patients with non-dialysis chronic kidney disease: a prospective cohort study

Article

Abstract:

Background:

Erythropoiesis-stimulating agents (ESA) hyporesponsiveness may be linked to malignancy, but studies examining this association are limited. We investigated whether initial ESA hyporesponsiveness and changes in responsiveness may serve as clinical markers reflecting undiagnosed malignancy in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Methods:

We used data from the BRIGHTEN, a prospective study of NDD-CKD patients with anemia. Initial ESA responsiveness was assessed using the erythropoietin resistance index (ERI-1B), calculated as the ratio of darbepoetin-alfa dose (μg) to hemoglobin concentration (g/dL) at 12 weeks after darbepoetin-alfa initiation. ESA responsiveness trends after 12 weeks were analyzed using a joint latent class model (JLCM). The associations of both initial ESA responsiveness and ESA responsiveness trends after 12 weeks with malignancy development were analyzed using a Cox proportional hazards model.

Results:

Of the 1641 patients analyzed, 44 developed new malignancies. Patients with poor ESA response at 12 weeks (ERI-1B > 3.8 μg/g/dL) had a higher incidence of malignancy compared to those with better ESA response (adjusted hazard ratio [HR]: 2.07; 95% confidence interval [CI]: 1.07–4.00). Furthermore, based on the JLCM, patients in the poor response group, characterized by a faster decline in ESA responsiveness after 12 weeks, had a higher risk of malignancy than the good response group (adjusted HR: 2.01; 95% CI: 1.08–3.72).

Conclusion:

Both initial ESA hyporesponsiveness and subsequent declines in responsiveness were significantly associated with the development of malignancy in patients with NDD-CKD. ESA hyporesponsiveness may serve as a clinical marker that reflects an increased risk of undiagnosed malignancy.

2026-02-01·PHARMACEUTICAL RESEARCH

Forecasting the Biological Effect of PEGylated-rHuEPO Candidates in Chronic Kidney Disease Patients using a Middle-out Translation Approach

Article

作者: Amaro, Daniel ; Duconge, Jorge ; Azeredo, Francine Johansson ; Troconiz, Iñaki F ; Mangas-Sanjuan, Victor ; Vozmediano, Valvanera ; Reynaldo-Fernandez, Gledys ; Solozábal, Joaquin ; Rodriguez-Vera, Leyanis

BACKGROUND:

Anemia is a common and debilitating complication in patients with chronic kidney disease (CKD), often managed with erythropoiesis-stimulating agents. While PEGylation extends drug half-life, it may alter pharmacodynamics, requiring careful dose optimization. This study applies a middle-out translational pharmacokinetic/pharmacodynamic modeling approach, aligned with Model-Informed Drug Development principles, to evaluate two pegylated recombinant human erythropoietin candidates (PEG-EPO 32 kDa and PEG-EPO 40 kDa) and guide dose selection for CKD patients.

METHODS:

A semi-mechanistic pharmacokinetic/pharmacodynamic model developed in rabbits was extrapolated to humans using allometric scaling for pharmacokinetics and physiological adaptation for pharmacodynamics. The model was verified using intravenous data from Mircera®. Simulations were conducted in virtual CKD stage 4 and 5 populations to predict hemoglobin (Hb) trajectories over 90 days of dosing. Clinical thresholds were applied to assess efficacy and safety.

RESULTS:

Simulations with 0.6 µg/kg Q2W reproduced Mircera® profiles but showed higher proportions of patients exceeding Hb safety thresholds (> 11 g/dL in stage 4, > 9 g/dL in stage 5) for both PEG-EPOs. Dose reduction to 0.4 µg/kg Q2W aligned Hb responses with Mircera®, reducing the risk of excessive Hb elevation.

CONCLUSIONS:

Middle-out modeling successfully predicted clinical performance of PEG-EPO candidates and identified 0.4 µg/kg Q2W as optimal starting dose for clinical trials. PEG-EPO 32 kDa and 40 kDa emerges as a promising candidate for further development. This study exemplifies the value of MIDD in optimizing dose selection, enhancing translational relevance, and de-risking early clinical evaluation of long-acting erythropoiesis-stimulating agents in CKD.

2026-01-01·TALANTA

Selection, characterization and the application of the RNA aptamer in the capture assay of Erythropoietin (EPO)

Article

作者: Gopinath, Subash C B ; Citartan, Marimuthu ; Shuid, Ahmad Naqib ; Tang, Thean-Hock

Erythropoietin (EPO) is an erythropoietic growth factor that induces the production of red blood cells. However, this protein is also extensively manipulated by athletes to illegally enhance their performance, a phenomenon known as doping. Generating a feasible molecular recognition element against EPO would be beneficial for doping detection. In this study, we have successfully isolated an RNA aptamer against EPO using SELEX. Termed REPORA-6, this RNA aptamer has an estimated binding affinity of 25 ± 1 nM. REPORA-6 RNA aptamer also retains its binding against degylosylated EPO and interacts with both Epoetin Beta and Mircera, suggesting that this aptamer binds to the protein domain of the recombinant EPO despite the variation in the glycosylation side chains. Ethylnitrosourea mapping, in-line probing assay and docking revealed important nucleotides for interaction with EPO. Capitalizing these findings, a truncated RNA aptamer was derived, REPORA-6b RNA. This aptamer has an improved binding affinity of 22 ± 2 nM. We have incorporated this aptamer into a capture assay and found out that the limit of detection achieved was 19.6 pM. REPORA-6b RNA has an immense potential in applications involving doping detection of EPO.

项与甲氧聚二醇重组人促红素相关的新闻（医药）

2026-03-19

·乙酰水杨酸投研

罗氏制药主要药品销售收入分析（2001年至2025年）

罗氏制药介绍及公司历史罗氏（Roche）成立于1896年，总部位于瑞士巴塞尔，是全球领先的制药公司和体外诊断的领导者，领先的工业化生产原研药的企业之一。 F. Hofmann-La Roche & Co于1896年10月1日在瑞士巴塞尔成立。创始人弗里兹·霍夫曼 (Fritz Hoffmann)，在创立罗氏之前，创立了F.Hofmann-La Roche & Co.。创立罗氏时福里兹霍夫曼才28岁。药剂师Carl Schaerges，罗氏首个研究负责人，和化学家Emil C. Barell一起证明了甲状腺提取物中碘的存在。推出了罗氏的第一个专利和在杂志上出版的研究论文。Aiodin的推出标志着罗氏最早的一系列甲状腺制剂。罗氏推出了由Hoffmann， Traub & Co.最初开发的伤口杀菌剂Airol。 1897年至1914年期间，罗氏制药实现了国际化扩张。1914年时，罗氏在米兰、纽约、圣匹兹堡、伦敦均设立了办公室。罗氏制药于1898年推出了Sirolin，为非处方止咳糖浆，包含活性成分Thiocol，此橙色的止咳糖浆在未来超过60年仍风靡市场。 1920年，Markus Guggenheim发表了关于生物氨基酸的论文，氨基酸、多肽、蛋白质、强心苷、维生素、荷尔蒙均为罗氏制药内部研发的物质。1927年，Guggenheim开始研究维生素B1，从米糠中提取研究，其研究为罗氏未来维生素B1的开发奠定了基础。 1920年，罗氏引进Allonal，推出首个化学合成的镇痛催眠制剂。 1928年至1944年，罗氏基于其维生素的生产，使得公司经历了前所未有的增长，公司实现了向美国市场的扩张。Tadeusz Reichstein为罗氏提供了维生素C的合成方法，首次生产了50kg维生素C。首个维生素C产品Redoxon随即推出。罗氏陆续成为维生素A，B1，B2，E和K1的供应商。直到1938年，罗氏的主要产品包括Benerva（维生素B1）、Nestrovit（多种维生素）、Beflavin（维生素B2）以及Ephynal（维生素E）。 1945年至1964年期间，罗氏不断扩张其研发工作，试图多样化其产品。1945年，罗氏成立了Pantene Corporation以及附属化妆品公司。19世纪50年代中期，镇静安定药引入临床使用。罗氏开发了Librium（氯氮卓，利勃龙），苯二氮卓类药物。1962年，罗氏推出了首个抗肿瘤药物，氟尿嘧啶，奠定了罗氏在化疗药物领域的基础。1963年，罗氏推出了Valium（地西泮，即安定） 1968年，罗氏成立诊断部门，进入新的领域，除了开发新的诊断测试和自动化分析仪以外，还包括成立服务实验室，为医院以及一些医生诊所提供临床分析。 1974年，罗氏的抗帕金森药Madopar获得了Galien奖。 1980年，罗氏分子生物学研究所分离纯化了干扰素α，罗氏Nutley和基因泰克，就生产基因工程产品达成合作协议。 1982年，罗氏推出了Rocephin，头孢菌素类抗生素，1987年，Rocephin的销售收入超过了罗氏其他产品。诊断部门推出了Cobas Bio/Mira 生物化学分析仪器。Roferon-A，罗氏的首个基因工程药物上市。 1991年，罗氏自Cetus Corporation收购了PCR的市场化权利，可在数分钟内检测基因物质。 20世纪90年代，罗氏推出了系列的抗癌药物，包括Herceptin，用于转移性乳腺癌，为阻断HER2作用的人源单抗。MabThera延长了白血病患者的无进展生存期。1999年，推出了Invirase，首个HIV蛋白酶抑制剂，获得了Galien奖。推出了Valcyte和Fuzeon，首个用于HIV的融合抑制剂。Fuzeon阻断病毒进入人类免疫细胞，阻止HIV复制。 20世纪90年代中期，罗氏诊断部门推出了系列的产品，包括Cobas Integra，临床化学和免疫化学分析仪；Cobas Amplicor，基于PCR技术的分析仪；Accutrend和Accu-Chek，用于糖尿病管理和无痛检测的分析仪器。 1999年，罗氏推出Tamiflu（奥司他韦），属于神经氨酸酶类药物，用于预防和治疗流感。 1994年，罗氏收购了Syntex Corporation，强化了其在国际和美国市场的地位。 1998年，罗氏收购了德国宝灵曼公司Boehringer Mannheim，成为体外诊断领域的全球领导者及糖尿病护理领域的大型企业。1991年，收购了Nicholas，非处方药生产商，强化了罗氏OTC领域的发展，Nicholas构成了罗氏消费健康部分的一部分。罗氏分别于1999年、2002年剥离了香水与香精业务及维生素与精细化学品业务，以进一步发展和专注于公司的制药和诊断部门。 2004年，罗氏成为世界首个在中国上海张江高科技园区建立研发中心的国际医药公司。 2002年，罗氏和中外制药结成联盟，在日本建立一家研究驱动型制药公司。新公司名为日本中外制药株式会社Chugai Pharmaceutical Co., Ltd.，是由罗氏日本与中外制药合并而成。该公司专注于处方药业务，并在生物技术方面具有优势。 Avastin是首个用于治疗转移性结直肠癌的药物。2004年推出，通过阻止新血管的形成发挥抗癌作用。Tarceva主要通过抑制酪氨酸激酶发挥作用，酪氨酸激酶属于人表皮生长因子受体的一部分，作为癌症形成和生长的重要信号通路。 2005年，罗氏收购了GlycArt Biotechnology，专注于抗体领域研究。2007年和2008年分别收购了BioVeris，扩张了公司免疫化学检测业务，收购了NimbleGen，获得了DNA微阵列，在制药领域广泛用于开发和研究的工具。收购了454 Life Sciences，获得了未来测序产品，2008年收购了Ventana Inc.，获得基于组织器官的诊断技术。继1990年收购基因泰克60%的股份后，罗氏于2009年收购其剩余股份，两大制药巨头正式合并。 2009年在美国等地区推出了Actemra/RoActemra，为人源抗-IL-6受体抗体，用于成人类风湿关节炎。2009年，推出了cobas 8000诊断系统，模块组件可以通过多种方式组合，形成多种测试产品线。 2011年，罗氏推出了Zelboraf，主要用于BRAF V600突变的皮肤癌，此产品和相关基因检测BRAF V600突变同时推出。罗氏还推出了HPV测试用于检测宫颈癌。 2012年和2013年，罗氏推出了系列创新抗肿瘤药物，包括Erivedge，新的信号通路抑制剂，用于基底细胞癌；Gazyva用于慢性淋巴细胞白血病；Perjeta和Kadcyla，为罗氏开发的首批抗体偶联药物，用于HER2阳性乳腺癌。罗氏同时还推出了多个创新检测，包括CINtec Plus全自动化的基于细胞的宫颈癌筛查细胞学测试等。 2018年，罗氏收购了临床数据处理领域的领导者Flatiron Health，以及拥有全球最大的癌症基因组数据库之一的基因组分析专家Foundation Medicine。这些收购让罗氏进一步了解精准医疗，使罗氏更加接近个体化医疗的承诺。 2019年，罗氏收购了总部位于费城的Spark Therapeutics公司，该公司成立的目的是挑战遗传疾病的必然性。两家公司携手合作，将进一步加深对人类基因组和基因异常的了解，针对遗传疾病的根本原因，为特定遗传疾病患者开发出量身定制的突破性疗法。 2021年，罗氏收购了GenMark Diagnostics, Inc以及TIB Molbiol Group，丰富了公司的诊断业务。 2023年，罗氏收购了Telavant Holdings, Inc，获得了其3期靶向TL1A炎症性肠病管线。 2024年1月26日，完成Carmot Therapeutics, Inc.的收购，获得用于肥胖和糖尿病的3个临床阶段管线以及临床前管线，收购价格29亿美元，以及4亿美元的或有付款安排。2024年7月26日，完成对LumiraDx Limited子公司的收购，获得多种诊断模块，收购价4亿美元。2024年7月26日，完成对AntlerA Therapeutics, Inc.的收购，获得了眼科临床前Wnt激动剂抗体，首付款2亿美元。2024年3月20日，与Lonza Group AG签署协议，将其Vacaville工厂、质量和仓储设施以12亿美元转让给Lonza。2024年收购了Regor Pharmaceuticals下一代CDK抑制剂，用于乳腺癌的管线资产。 2025年1月8日，罗氏制药收购了Poseida Therapeutics, Inc.100%股权。交易价格10亿美元，加上里程碑付款总计约15亿美元，通过收购，罗氏获得了Poseida的临床前和临床阶段的CAR-T疗法管线。罗氏制药2025年主要动向 2025年罗氏制药实现总营业收入633.56亿瑞士法郎，相比去年增长1.54%。其中，制药部门实现销售收入476.69亿瑞士法郎，占总营业收入的75%；诊断部门实现138.47亿瑞士法郎，占总营业收入的22%，合作授权等收入为18.40亿瑞士法郎，占总营业收入的3%。重要产品近期专利到期及各市场首个仿制药推出情况如下表。MabThera/Rituxan已于2017年市场上推出首仿产品。Herceptin于2018年市场上推出首仿产品，Avastin于2019年中市场上推出首仿产品。Esbriet和Lucentis均于2022年市场上推出首仿产品。Actemra/RoActemra于2023年市场上推出首仿产品。Xolair和Perjeta专利将于2025年到期，预计市场将于2026年推出首仿产品。仿制品种的推出将使得相应产品的销售收入出现明显下降。罗氏制药2025年主要动向罗氏制药在2025年的国际审批动态如下：罗氏制药在2025年发生的合作授权及收并购交易如下表，2025年达成与Zealand Pharma关于petrelintide的合作，petrelintide为胰淀素类似物，开发用于减重。罗氏也达成了与Broad Clinical Labs关于下一代测序技术的合作。收并购交易包括对Poseida Therapeutics和对89bio, Inc.的收购，收购Poseida获得了异体细胞疗法用于实体瘤，收购89bio, Inc.获得了pegozafermin，开发用于脂肪肝。罗氏制药总体营业收入情况罗氏制药的营业收入情况如下图所示。罗氏制药在2001年至2025年期间有制药、诊断和维生素及精细化工部门。2025年营收达633.56亿瑞士法郎。2003年完成了维生素和精细化工部门的剥离。2002年罗氏日本公司与日本中外制药合并，1990年收购基因泰克的60%，2009年收购了基因泰克全部股份。制药部门在2001年至2025年期间营业收入占总营业收入的比例为64%~77%。罗氏制药分类销售收入情况根据2001年至2025年的年报披露的药品品种营收数据，罗氏制药各分类药品的销售收入如下图，未单独披露销售收入的品种数据归入其他。从图中可见，有披露数据的药品销售收入之和占据整个制药部门销售收入的68%~96%。前期肿瘤、免疫、血液和抗病毒药物为主要品类，后期肿瘤药物逐年增长，至2020年又逐步下降，神经及罕见病药物逐年增长，2019年以后，肿瘤、神经、免疫、罕见病、眼科、血液为主要品类。披露的药品销售收入情况根据每年罗氏制药披露的单品销售收入情况整理的各品种销售收入变迁见下图。可见，罗氏制药在2020年前的大品种包括Herceptin、Mabthera/Rituxan、Avastin，这三大品种较长时间为罗氏药品销售收入的三驾马车，另外还有CellCept、NeoRecormon、Tamflu、Lucentis等品种。在2010年开始，新品种逐步推出，随着销量的增长，以及三驾马车由于竞争的原因销售收入逐渐减少，近年来，新品种Ocrevus、Hemlibra、Vabysmo、Tecentriq、Perjeta、Actemra、Xolair、Kadcyla、Phesgo等已替代了三驾马车成为罗氏制药的主要品种。罗氏制药2025年分类销售收入情况根据2025年披露的各药品销售收入数据，将各药品分类，未披露销售收入数据的药品全部归入其他类。各分类的销售收入如下图所示。罗氏制药的制药部门2025年实现销售收入476.69亿瑞士法郎，包括肿瘤、神经、免疫、罕见病、眼科、血液及其他几个品类。肿瘤品类销售收入占制药部门总收入的39%，仍为第一大品类。罗氏制药2025年各品种销售收入如下表。前10大品种销售收入占制药部门全部销售收入约72%。之前的三驾马车，Herceptin、Mabthera/Rituxan和Avastin销售收入已退出罗氏销售收入前十大品种之列。披露的肿瘤药品销售收入情况根据每年罗氏制药披露的销售收入数据整理的罗氏肿瘤药物各单品销售收入变迁情况见下图。根据每年罗氏制药披露的销售收入数据整理，罗氏肿瘤药物有披露销售数据的有以上16个品种，罗氏肿瘤药物2025年实现销售收入188.21亿瑞士法郎，占制药部门全部销售收入的39%。从品种推出的最早年限进行划分，2005年以前推出的品种包括：Herceptin（赫赛汀，曲妥珠单抗），1998年获批、 Mabthera/Rituxan（美罗华，利妥昔单抗），1997年获批、Avastin（安维汀，贝伐珠单抗），2004年获批、Tarceva（特罗凯，厄罗替尼），2004年获批、Xeloda（希罗达，卡培他滨），1998年获批、以及Furtulon（去氧氟尿苷）。赫赛汀、美罗华和安维汀为罗氏2020年前销售收入的三驾马车。赫赛汀为最早1998年上市的HER2单抗，针对乳腺癌，2017年达到峰值销售额70亿瑞士法郎，由于2018年之后陆续出现生物仿制药，销售收入迅速下滑。2025年销售收入已下滑至约10亿瑞士法郎。美罗华为最早1997年上市的CD20单抗，针对淋巴瘤，2017年达到峰值销售额74亿瑞士法郎，由于2017年之后陆续出现生物仿制药，销售收入迅速下滑。2025年销售收入已下滑至约13亿瑞士法郎。安维汀为最早2004年上市的EGFR单抗，针对多种实体瘤，2018年达到峰值销售额71亿瑞士法郎，由于2019年之后陆续出现生物仿制药，销售收入迅速下滑。2025年销售收入已下滑至约10亿瑞士法郎。这三个品种在21世纪10年代期间为罗氏制药贡献了大部分收入，三个品种高于50亿瑞士法郎销售收入的年份保持了超过十年，2020年3个品种各自的销售收入才开始低于50亿瑞士法郎。希罗达和特罗凯为比较老的小分子药。希罗达和特罗凯的销售生命周期均比较平缓，峰值销售额在2012年和2013年，分别为15亿瑞士法郎和13亿瑞士法郎。希罗达为抗代谢药，用于结直肠癌、胃癌、乳腺癌等实体瘤。特罗凯为EGFR小分子抑制剂，用于非小细胞肺癌、胰腺癌等实体瘤。2025年两个品种的销售收入已跌至前二十几个品种之外，因此罗氏制药未予披露这两个品种2025年的销售收入。其余品种均为2010年以后上市的药物，自上市以来销售收入增长较快的品种包括：Perjeta（帕捷特，帕妥珠单抗）、Tecentriq（泰圣奇，阿替利珠单抗）、Kadcyla（赫赛莱，恩美曲妥珠单抗）、Alcensa（安圣莎，阿来替尼）、Phesgo（赫双妥，帕妥珠单抗+曲妥珠单抗）、 Polivy（优罗华，维泊妥珠单抗）以及 Gazyva/Gazyvaro（伽罗华，奥妥珠单抗）。帕捷特为最早2012年上市的HER2单抗，针对乳腺癌，其在2022年峰值销售额为41亿瑞士法郎，预计2026年出现仿制药。泰圣奇为最早2016年上市的PD-L1单抗，针对多种实体瘤，销售收入连年增长，2023年销售收入达38亿瑞士法郎。赫赛莱为最早2013年上市的HER2与DM1连接的ADC药物，2022年峰值销售额达21亿瑞士法郎，可能还有一定的增长潜力。安圣莎为最早2015年上市的小分子ALK酪氨酸激酶抑制剂，2025年销售收入约16亿瑞士法郎。赫双妥为帕妥珠和曲妥珠单抗的复方制剂，2020年获批上市，有一定的增长潜力，2025年销售收入约24亿瑞士法郎。优罗华为CD79b与MMAE的ADC药物，2019年上市，2025年销售收入增至约15亿瑞士法郎。伽罗华为CD20单抗，2013年上市，2025年销售收入增至约10亿瑞士法郎，两者均用于血癌。最近新上市的品种Columvi（高罗华，格菲妥单抗），为CD20/CD3双抗，用于弥漫性大B细胞淋巴瘤，2023年获批，2025年销售收入约3亿瑞士法郎。另外还包括2个不太出彩的品种，Erivedge（维莫德吉），为Hedgehog信号通路阻断剂，用于晚期基底细胞癌，2012年获批。Zelboraf（佐博伏，维莫非尼），为BRAF抑制剂，用于黑色素瘤，2011年获批。综上可见，肿瘤品类的销售收入由于三驾马车的推出，繁荣了十年之久，2017年以后开始出现下滑趋势。随后罗氏制药推出的系列新品，虽然未能挽回肿瘤品类的销售收入下降颓势，但也为肿瘤品类提供了有力的支撑。目前Phesgo（赫双妥）、Polivy（优罗华）、Gazyva/Gazyvaro（佳罗华）均处于快速增长阶段。披露的神经/免疫/罕见病药品销售收入情况根据每年罗氏制药披露的销售收入数据整理的神经/免疫/罕见病各单品销售收入变迁情况见下图。根据每年罗氏制药披露的销售收入数据，罗氏神经/免疫/罕见病药物有披露销售数据的有15个品种。其中，神经品类有7个品种，2025年实现销售收入约95亿瑞士法郎，占制药部门总销售收入的20%。免疫品类有6个品种，2025年实现销售收入约64亿瑞士法郎，占制药部门总销售收入的13%。罕见病品类有2个品种，2025年实现销售收入约51亿瑞士法郎，占制药部门总销售收入的11%。神经品类包括： Ocrevus（奥瑞利珠单抗）、Evrysdi（艾满欣，利司扑兰）、Madopar（左旋多巴/苄丝肼）、Enspryng（安适平，萨特利珠单抗）、Lexotan（溴西泮）、Dormicum/Versed（咪达唑仑）以及Rivotril（氯硝西泮）。左旋多巴/苄丝肼、溴西泮、咪达唑仑、氯硝西泮均是耳熟能详的老药。左旋多巴/苄丝肼用于帕金森病，属于多巴胺补充剂和外周脱羧酶抑制剂的联合制剂。溴西泮用于焦虑、紧张，通过强化γ-氨基丁酸抑制性神经递质作用而发挥疗效。咪达唑仑属于麻醉镇静药，氯硝西泮属于抗癫痫药。神经类药物处于增长阶段的药物奥瑞利珠单抗的表现比较亮眼，为针对多发性硬化症的CD20单抗，2017年获批，自上市以来销售收入逐年增长，2025年销售收入约70亿瑞士法郎，是罗氏又一个销售收入超过50亿瑞士法郎的大品种。销售收入还有上涨的空间。艾满欣为2020年获批的品种，为脊髓性肌萎缩症的运动神经元2（SMN2）剪接修饰子，为靶向mRNA的小分子药物，2025年销售收入约18亿瑞士法郎，未来还有很大的增长空间。安适平为2020年获批的IL-6单抗，用于抗水通道蛋白-4抗体阳性的视神经脊髓炎谱系障碍，2025年销售收入约4亿瑞士法郎。免疫类品种包括： Actemra/RoActemra（雅美罗，托珠单抗）、Xolair（茁乐，奥马珠单抗）、Pulmozyme（阿法脱氧核糖核酸酶）、CellCept（骁悉，吗替麦考酚酯）、Neutrogin（来格司亭）以及Neupogen（非格司亭）。来格司亭和非格司亭属于重组人粒细胞集落刺激因子，用于中性粒细胞减少症。吗替麦考酚酯（骁悉）为用于移植排斥反应的老药，1995年获批，2008年达峰值销售额约21亿瑞士法郎。阿法脱氧核糖核酸酶也是用于肺囊性纤维化的老药，1993年获批，2019年峰值销售额约7.5亿瑞士法郎。免疫类品种处于增长阶段的品种雅美罗，为针对类风湿等免疫疾病的IL-6单抗，2009年获批，2021年达峰值销售额36亿瑞士法郎，2023年有生物仿制药获批，销售已有明显下降，未来还将受到一定影响。茁乐为2003年获批的IgE单抗，用于过敏性哮喘、荨麻疹、鼻炎等，上市以来销售收入一直处于上升阶段，2025年实现销售收入约31亿瑞士法郎，销售生命周期平缓且较长，预计2026年会推出生物仿制药。罕见病类品种包括：Hemlibra（舒友立乐，艾美赛珠单抗）和Elevidys，舒友立乐为针对血友病A的因子IXa和因子X的人源单抗，2017年上市以来销售收入迅猛增长，2025年销售收入约48亿瑞士法郎，还有上涨的空间。Elevidys是2023年推出的新品，用于杜氏肌营养不良症，为腺相关病毒载体的基因疗法，2025年销售收入约3亿瑞士法郎。综上，神经和罕见病品类均为近年来新开发的品类，由于奥瑞丽珠单抗、舒友立乐等大单品的推出使得其销售收入近年来连年上升，未来仍有很大的增长空间。免疫品类虽为罗氏的传统品类，雅美罗、茁乐的推出也推动了销售收入的迅速增长。披露的眼科/血液/抗病毒药品销售收入情况根据每年罗氏制药披露的销售收入数据整理的眼科/血液/抗病毒单品销售收入变迁情况见下图。根据每年罗氏制药披露的销售收入数据整理，罗氏眼科/血液/抗病毒类有披露销售数据的药物有14个品种。眼科包括2个品种，2025年销售收入约41亿瑞士法郎，占制药部门销售收入的9%。血液品类包含3个品种，2025年销售收入约15亿瑞士法郎，占制药部门销售收入的3%。抗病毒品类包含9个品种。眼科品种主要包括： Vabysmo（罗视佳，法瑞西单抗）和Lucentis（诺适得，雷珠单抗）。诺适得为针对眼科疾病的血管内皮生长因子A（VEGF-A）单抗，2006年获批上市，销售收入稳步增长，至2019年达峰值销售额约18亿瑞士法郎。诺适得仿制药已于2022年推出。罗视佳为针对眼科疾病的血管内皮生长因子A（VEGF-A）和血管生成素2（Ang-2）单抗，2022年刚获批上市，上市后销售收入迅猛增长，2025年销售收入约41亿瑞士法郎，未来有很大增长潜力。血液类品种包括： Activase, TNKase（阿替普酶、替奈普酶）、 Mircera（美信罗，甲氧聚二醇重组人促血红素）以及NeoRecormon，Epogin（罗克曼，倍他依泊汀）。这三种均为较老的药物。Activase, TNKase（阿替普酶、替奈普酶）自2000年上市后销售收入增长缓慢，但近年来销售收入快速增长，2019年达到峰值销售额13亿瑞士法郎。为重组人组织型纤溶酶原激活物，用于心肌梗死等。罗克曼为人促红细胞生成素，用于贫血。1997年获批上市，2005年达峰值销售额23亿瑞士法郎。美信罗为修饰的促血红素，也用于贫血，为NeoRecormon，Epogin下一代产品，2007年获批上市，销售收入增长缓慢，2019年达峰值销售额6亿瑞士法郎。抗病毒类品种包括： Ronapreve（卡西瑞单抗+伊德单抗）、Cymevene/Cytovene, Valcyte（万赛维，更昔洛韦，缬更昔洛韦）、 Tamiflu（达菲，奥司他韦）、 Pegasys（派罗欣，聚乙二醇干扰素α-2a）、Copegus（利巴韦林）、Pegasys+Copegus、Viracept（甲磺酸奈非那韦）、Roferon-A（干扰素α-2a）以及Invirase, Fortovase（沙奎那韦）。除Ronapreve以外，均为上市多年的老药。万赛维用于巨细胞病毒感染，最早1989年获批，2014年峰值销售额为7.3亿瑞士法郎。达菲为1999年上市的抗流感病毒药物，随着两次流感爆发销售收入经历了剧增又骤降的过程，2009年达峰值销售额32亿瑞士法郎，属于抗病毒药中销售收入很高的品种。派罗欣为聚乙二醇干扰素α-2a很早便在市场上推出，用于乙肝、丙肝等病毒性感染，2009年峰值销售额约17亿瑞士法郎。Roferon-A为派罗欣的上一代产品，干扰素α-2a。利巴韦林为鸟苷类似物，用于丙肝流行性出血热等，可以和派罗欣共同使用，2002年获批。甲磺酸奈非那韦和沙奎那韦均用于HIV感染，均为1997年获批品种。抗病毒类品种中最近推出的Ronapreve为用于治疗新冠病毒感染药物，2021年获批，2022年峰值销售额约17亿瑞士法郎，随着新冠病毒感染的退潮，此药物销售收入最近也迅速降低。2024年销售收入仅约300万瑞士法郎。总体来看，罗氏制药的眼科品种在推出诺适得后销售收入逐年增长，但近年来已销售收入迅速下滑，随后又推出了新产品罗视佳，继承了眼科药品的销售增长趋势，未来仍有很大的增长空间。罗氏的血液类以及抗病毒类均为较老的品类，未来增长不明显。披露的其他药品销售收入情况根据每年罗氏制药披露的销售收入数据整理的其他各单品销售收入变迁情况见下图。根据每年罗氏制药披露的销售收入数据整理，罗氏其他有披露销售数据药物有12个品种。其他类药品基本均为已上市多年的老药。呼吸系统药物Esbriet（吡非尼酮），为2011年上市的小分子药物，针对特发性纤维化疾病，上市后销售收入平缓增长，2019年达峰值销售额11亿瑞士法郎。吡非尼酮已于2022年推出仿制药。抗菌药包括老药Rocephin（罗氏芬，头孢曲松），为1984年获批上市，销售收入一度达到几十亿瑞士法郎，目前我们选取的研究期间里，自2001年开始罗氏芬的销售生命周期已经进入了下降区间，仿制药也已经推出，2001年销售收入也还比较高，达17亿瑞士法郎。内分泌类品种包括：Nutropin, Protropin（生长激素）以及Evista（雷洛昔芬）。罗氏生长激素产品于1993年获批，在研究期间里，2006年达峰值销售额约5亿瑞士法郎。雷洛昔芬为雌激素受体调节剂，用于抑制乳腺上皮和子宫内膜增生，预防骨丢失，1997年获批。骨科品种包括：Bonviva/Boniva（邦罗力，伊班膦酸）以及Rocaltrol（罗盖全，骨化三醇）。邦罗力于2003年上市，用于绝经后骨质疏松，2008年峰值销售额达11亿瑞士法郎。罗盖全可激活维生素D受体，增加肠道对钙的吸收，用于骨质疏松，1978年获批。心血管代谢类品种包括：Xenical（赛尼可，奥利司他）、Dilatrend（卡维地洛）、Inhibace（西拉普利）以及Torem（托拉塞米）。奥利司他阻断胃肠道脂肪酶，用于体重管理，1998年获批。卡维地洛为β受体拮抗剂，用于心衰、高血压及心绞痛等，西拉普利为血管紧张素转换酶抑制剂，用于高血压。托拉塞米为袢利尿剂，用于高血压。消化系统药物包括：Kytril（格拉司琼），为5-HT3受体拮抗剂，用于放化疗引起的恶心和呕吐，1993年获批，研究期间于2005年达峰值销售额约5亿瑞士法郎。皮肤科药物包括Roaccutane/Accutane（异维A酸），用于重度痤疮，1982年获批。其他还有很多老药，在我们的研究期间里，销售生命周期已经进入尾声。罗氏制药2025年各单品销售收入增长情况 2025年相比2024年罗氏制药部门各药物单品销售收入变动情况如下表。可见销售收入增长金额贡献最大的品种为Phesgo，相比2024年，销售收入增加了7亿瑞士法郎，为2020年新推出的帕妥珠单抗+曲妥珠单抗双联制剂，未来还有很大增长空间。Xolair在2025年销售收入增长了约6亿瑞士法郎，为2003年推出，目前仍处于增长阶段。Polivy、Ocrevus、Hemlibra销售收入依次增长了约3亿瑞士法郎。Perjeta的销售收入在2025年降低了约6.5亿瑞斯和法郎，于2022年销售收入达峰。Herceptin销售收入下降了约3.5亿瑞士法郎，Avastin下降了约3亿瑞士法郎。总体来看，2025年罗氏制药部门的销售收入相比2024年增长了约15亿瑞士法郎，实现3.24%的增长。总体来看，三驾马车仿制药竞争导致的销量下降风险已充分释放。Xolair、Perjeta预计2026年推出仿制药，可能对销售收入有一定的影响，但近年来其他新品种的增长一定程度上应该可以抵御仿制药带来的销售收入下滑。总结根据每年罗氏制药披露的销售收入数据整理，罗氏有披露销售收入数据的这57个品种，抗癌药是罗氏制药产品组合的重头戏。不论是21世纪10年代的三架马车（美罗华、赫赛汀及安维汀），以及近期新推出的帕捷特、泰圣奇、赫赛莱、安圣莎等，销售收入的表现均较好，且未来也有很大的增长潜力。但近年来，由于三驾马车的生物仿制药的陆续推出，销售收入呈现明显的下滑，虽然新品种已经开始接棒三驾马车，但也未能达到之前三驾马车的辉煌业绩，因此，新品的推出仍未能挽回肿瘤品类销售收入的下降颓势。但随着新品的逐步发力，可以再行观察其未来情况。神经药物（如奥瑞利珠单抗）、免疫类药物（雅美罗）、血友病（舒友立乐）及眼科药物（诺适得、罗视佳）是近年来新开发的增长较快的品种，未来有很大的潜力。2017年上市的奥瑞利珠单抗2025年销售额已经超过70亿瑞士法郎。2017年上市的舒友立乐2025年销售额超过47亿瑞士法郎。但雅美罗由于仿制药的出现对销售收入的侵袭，峰值销售额未超过40亿瑞士法郎。诺适得上市较早（2006年），但罗视佳是最近推出接替的新品，在2025年销售收入约41亿瑞士法郎，还有很大的增长空间。可见罗氏制药的未来增长很大程度上集中在神经、血友病及眼科品类。罗氏制药的抗病毒药近年来发展稍缓慢，除了推出新冠感染药物以外，抗感染品种的销售收入在逐年收缩。从大趋势上看，罗氏制药这二十几年来完成了从2000年以前的化学小分子药物，向生物大分子、抗体药物的转型。这也主要得益于对日本中外制药以及基因泰克的收购。两家公司在生物制剂上有了迅猛的发展，尤其是日本中外制药，在并入罗氏后，在单抗、双抗药物的发现和开发方面有了快速的成长。借助于两家公司的技术，罗氏制药的产品组合也很早就转向了抗体生物大分子药物。未来还将在生物大分子、抗体等抗癌药方面继续发力。近年来由于重要品种纷纷受到仿制药的冲击，销售收入有所下降，但新推出的品种销售放量，一定程度上应该可以抵御仿制药的冲击。罗氏制药2001年至2025年主要品种全球销售收入数据可见B站（阿司匹林投研）小店及T宝（阿司匹林投研），加入知识星球（阿司匹林投研）还可获得本文的可编辑图表excel文件

2026-03-17

·PRNewswire

Alebund Pharmaceuticals Announces Collaboration and License Agreement with R1 Therapeutics for AP306

AP306 is a first-in-class pan-phosphate transporter inhibitor in development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) receiving dialysis Alebund grants exclusive rights to develop, manufacture, and commercialize AP306 outside Greater China to R1 Therapeutics, a newly launched company backed by leading global kidney care providers and life sciences strategic and venture capital investors The collaboration includes potential milestone payments of up to low triple-digit millions of U.S. dollars and tiered royalties in the low double-digit percentage range based on net sales of AP306 in the licensed territory Alebund holds a substantial non-dilutive equity interest in R1, with the opportunity to participate in future commercial upside through dividends SHANGHAI, March 17, 2026 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), a leading renal-focused biopharmaceutical company, today announced that it has entered into licensing and equity agreements (the "Agreements") with R1 Therapeutics, Inc. ("R1"). R1 is a newly launched clinical-stage biotechnology company that recently completed an oversubscribed Series A financing of $77.5M. R1 is backed by major global kidney care providers, DaVita, one of the largest kidney care providers globally, and U.S. Renal Care, the largest privately held dialysis provider in the United States and a syndicate of leading global venture capital investors. Under the Agreements, Alebund has granted R1 an exclusive license to develop, manufacture, and commercialize AP306 outside Greater China (the "R1 Territory"). As part of the transaction, the aggregate financial terms include development, regulatory and commercial milestone payments of up to low triple-digit millions of U.S. dollars, and Alebund will share in the economics of AP306's success in the R1 Territory through tiered royalty payments in the low double-digit percentage range on net sales. In addition, Alebund holds a substantial non-dilutive equity interest in R1, with the opportunity to participate in future commercial upside through dividends. R1 will fund and lead the global clinical development of AP306, with Alebund as a collaborative development partner, including a global Phase 2b multi-regional clinical trial ("MRCT") in the U.S. and China planned to initiate later this year. Alebund and R1 will work together to accelerate the global development of AP306. Gavin Xia, Ph.D., Co-Founder and CEO of Alebund Pharmaceuticals, commented: "This collaboration validates the global potential of AP306 and represents an important milestone for Alebund. By partnering with R1, global kidney care providers, and financial investors, we can accelerate AP306's global development. With the support of R1, DaVita and U.S. Renal Care, we are well-positioned to capture the significant market potential in the United States. We look forward to working with the R1 team to bring this potentially transformative therapy to patients worldwide." Krishna Polu, M.D., Co-Founder, President and CEO of R1 Therapeutics, commented: "We are thrilled to launch R1 with the backing of world-class investors who share our conviction in the potential of AP306 to fundamentally change how hyperphosphatemia is managed. AP306 represents a new mechanistic approach - blocking the active transport of phosphorus rather than relying on traditional phosphate binding - and the Phase 2a data published in Kidney International Reports demonstrate compelling efficacy and tolerability. We look forward to advancing the global Phase 2b program in collaboration with Alebund and bringing AP306 to patients around the world." About AP306 AP306 is a first-in-class pan-phosphate transporter inhibitor in development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) receiving dialysis. Unlike conventional phosphate binders, AP306 works by inhibiting the active transport of phosphorus through three key phosphate transporters (NaPi-IIb, PiT-1, and PiT-2) in the gastrointestinal tract, representing a fundamentally new mechanism of action for managing hyperphosphatemia. AP306 was originally discovered by Chugai Pharmaceuticals Co., Ltd. and subsequently licensed to Alebund Pharmaceuticals, which has conducted clinical development of the compound, including a completed Phase 2a study in hemodialysis patients. Results published in Kidney International Reports demonstrated significant reduction in serum phosphate levels with good safety and tolerability. Data from the Phase 2a study has also been presented at the 61st European Renal Association (ERA) Annual Congress. About R1 Therapeutics R1 Therapeutics is a clinical-stage biopharmaceutical company focused on the development of first-in-class therapies for patients with kidney disease. Its lead program, AP306, targets hyperphosphatemia in patients with chronic kidney disease on dialysis, a condition associated with serious bone and cardiovascular complications and poorer outcomes when phosphate remains uncontrolled. AP306 is a first-in-class pan-phosphate active transport inhibitor designed to block three key phosphate transporters in the gut, with the potential to deliver rapid and effective phosphate lowering with a significantly reduced treatment burden. R1 has licensed exclusive global rights outside Greater China to AP306 from Alebund Pharmaceuticals and is advancing a global Phase 2b development program. R1 launched with an oversubscribed $77.5 million Series A financing in March 2026 co-led by Abingworth, DaVita Venture Group, and F-Prime, with participation from Curie.Bio, SymBiosis, and U.S. Renal Care. For more information, visit and follow R1 on LinkedIn. About Alebund Pharmaceuticals Alebund Pharmaceuticals is a global leading renal-focused biopharmaceutical company with a vertically integrated platform encompassing R&D, manufacturing, and commercialization. The Company possesses the most comprehensive innovative renal portfolio in terms of indication coverage, with seven drug candidates and one commercialized product (Mircera®) targeting a broad range of renal indications including CKD complications (hyperphosphatemia, renal anemia), IgA nephropathy, diabetic kidney disease, FSGS, and ADPKD. Alebund holds global rights for its core pipeline assets, including AP301 (a best-in-class oral phosphate binder currently in global Phase 3), AP306, AP303 (a first-in-class dual PPAR agonist with FDA Orphan Drug Designation for ADPKD), and AP308 (a first-in-class IgA protease). The Company has completed construction of its manufacturing facility in Yangzhou, China, and has established a dedicated in-house commercialization team in China. About DaVita DaVita (NYSE: DVA) is a health care provider focused on transforming care delivery to improve quality of life for patients globally. As a comprehensive kidney care provider, DaVita has been a leader in clinical quality and innovation for more than 25 years. DaVita cares for patients at every stage and setting along their kidney health journey-from slowing the progression of kidney disease to helping support transplantation. This includes ensuring they are supported at home, in dialysis centers, in the hospital and in skilled nursing facilities. As of December 31, 2025, DaVita served approximately 295,000 patients at 3,242 outpatient dialysis centers, of which 2,657 centers were located in the United States and 585 centers were located in 14 other countries worldwide. DaVita has reduced hospitalizations, improved mortality, helped improve health access and worked collaboratively to propel the kidney care community to adopt a higher quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About. About U.S. Renal Care U.S. Renal Care, the largest privately held and fastest-growing dialysis provider in the nation, partners with nephrologists to care for more than 37,000 people living with kidney disease across 32 states in the U.S. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence - delivering the best experience and outcomes for its patients. Visit USRenalCare.com to learn more. Investor & Media Contact: Alebund Pharmaceuticals [email protected] SOURCE Alebund Pharmaceuticals 21% more press release views with Request a Demo

临床2期引进/卖出孤儿药临床3期临床结果

2026-03-17

·BioSpace

R1 Therapeutics launches with oversubscribed $77.5 million Series A financing to advance first-in-class treatment for hyperphosphatemia in patients with chronic kidney disease

Series A co-led by Abingworth, DaVita Venture Group, and F-Prime with participation from Curie.Bio, SymBiosis, and U.S. Renal Care Partnership with Alebund Pharmaceuticals to gain exclusive global development and commercial rights outside of Greater China for AP306, a differentiated pan phosphate transporter inhibitor, the only agent blocking the active transport of phosphate Advancing Phase 2b clinical development of AP306 as a monotherapy for hyperphosphatemia in patients with chronic kidney disease on dialysis REDWOOD CITY, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- R1 Therapeutics, Inc (“R1”), a clinical-stage biopharmaceutical company focused on the development of first-in-class therapies for patients with kidney disease, today announced its launch with an oversubscribed $77.5 million Series A financing, along with the exclusive global license to develop and commercialize AP306 outside of Greater China from China-based Alebund Pharmaceuticals, Ltd. (“Alebund”). The financing was co-led by Abingworth, F-Prime, and DaVita Venture Group, part of DaVita Inc. (NYSE: DVA), with participation from Curie.Bio, SymBiosis, and U.S. Renal Care. Proceeds from the Series A financing will fund R1's global development program of AP306 in partnership with Alebund, including a Phase 2b study planned to start later this year. AP306 is a first-in-class, pan phosphate transporter inhibitor in development as a monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). Whereas currently available approved phosphate lowering therapies work by inhibiting “passive” transport of phosphate through binding phosphate and other mechanisms, AP306 is distinguished as being the only agent that blocks the “active” transport of phosphate for the treatment of CKD. The treatment of hyperphosphatemia is an important component in managing CKD patients, especially those on dialysis, yet it represents a high unmet need. More than 500,000 patients in the United States 1 and four million worldwide receive dialysis, 2 however more than 40% of US patients fail to achieve treatment targets. 3 Uncontrolled hyperphosphatemia contributes to bone and cardiovascular disease, leading to significant risk of morbidity and mortality. 4 Current phosphate binders, which have been the standard of care for 60 years, are limited by low binding capacity, high pill burden and poor gastrointestinal tolerability, contributing to poor adherence and limiting the effectiveness of these therapies. 5 AP306 has been evaluated in a Phase 2a study in dialysis patients, with results published in Kidney International Reports 6 demonstrating significant reduction in serum phosphate levels with good safety and tolerability. R1 is led by Co-Founder, President and CEO Krishna Polu, M.D., a nephrologist with more than 20 years of experience in the biopharmaceutical industry and a track record of pipeline advancement and company creation. Joining Dr. Polu is fellow Co-Founder, biotech veteran, and former Chief Development Officer at SpringWorks Therapeutics, L. Mary Smith, Ph.D., who will serve as Chief Operating Officer and lead R1’s development activities. “We are excited to be launching R1 Therapeutics in partnership with Alebund and with support from a strong, experienced syndicate including DaVita and U.S. Renal Care, recognized global providers transforming kidney care. This backing, plus a differentiated clinical-stage asset, positions us to address one of the most persistent challenges in managing patients with chronic kidney disease,” said Krishna Polu, M.D., Co-Founder, President and CEO of R1 Therapeutics . “AP306 represents a fundamentally new approach to treating hyperphosphatemia. By blocking the active transport of phosphate through three different phosphate transporters in the GI tract, initial clinical studies suggest AP306 has the potential to deliver superior efficacy with substantially lower pill burden compared to current phosphate binder therapies. If successful, AP306 should redefine the class of phosphate lowering therapies and become the treatment of choice for the management of hyperphosphatemia.” “R1 Therapeutics brings together an exceptional leadership team with deep nephrology expertise and a clear vision for advancing AP306,” said Gavin Xia, CEO of Alebund Pharmaceuticals. “This asset addresses a significant unmet need in a large, underserved patient population. We are delighted to partner with R1 Therapeutics to develop AP306 globally and improve outcomes for the millions of CKD patients struggling with inadequate phosphate control.” R1’s Board of Directors will be comprised of Andrew Sinclair, Ph.D., Managing Director at Abingworth; Tom Musgrave, Vice President, Pharma Strategy at DaVita Venture Group; Chong Xu, Ph.D., Partner at F-Prime; Ben Auspitz, Managing Partner at Curie.Bio; Steve Landau, M.D., Independent Director; and Krishna Polu, M.D., Co-Founder, President and CEO of R1. AP306 (previously known as EOS789) was originally discovered and developed by Chugai Pharmaceutical Co., Ltd. and subsequently licensed to Alebund Pharmaceuticals. Investigational New Drug (IND) applications to support AP306’s clinical development are open in both the United States and China. About R1 Therapeutics R1 Therapeutics is a clinical-stage biopharmaceutical company focusing on the development of first-in-class therapies for patients with kidney disease. Its lead program, AP306, targets hyperphosphatemia in patients with chronic kidney disease on dialysis, a condition associated with serious bone and cardiovascular complications and poorer outcomes when phosphate remains uncontrolled. AP306 is a first-in-class pan phosphate active transport inhibitor designed to block three key phosphate transporters in the gut, with the potential to deliver rapid and effective phosphate lowering with a significantly reduced treatment burden. R1 has licensed exclusive global rights outside of Greater China to AP306 from Alebund Pharmaceuticals and is advancing a global Phase 2b development program. R1 launched with an oversubscribed $77.5 million Series A financing in March 2026 co-led by Abingworth, DaVita Venture Group, and F-Prime, with participation from Curie.Bio, SymBiosis, and U.S. Renal Care. For more information, visit and follow R1 on LinkedIn . About Alebund Pharmaceuticals Alebund was founded in Shanghai in 2018. The Company focuses on the discovery, development, manufacturing, and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring better therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of seven drug candidates and one commercialized product (Mircera®) targeting a broad range of renal indications, including chronic kidney disease (CKD) and CKD complications, such as hyperphosphatemia, renal anemia, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site in Yangzhou that will supply both drug substance and drug products of its product candidates upon commercial launch. Alebund has also established a dedicated in-house commercialization team in China responsible for promoting the renal products. About Abingworth Abingworth is a leading transatlantic life sciences investment firm and part of the global investment firm Carlyle. Abingworth helps transform cutting-edge science into novel medicines by providing capital and expertise to top calibre management teams building world-class companies. Since 1973, Abingworth has invested in approximately 200 life science companies, leading to over 50 mergers and acquisitions and more than 75 IPOs. Abingworth’s therapeutics-focused investments fall into three categories: seed and early-stage, development stage, and clinical co-development. Abingworth supports its portfolio companies with a team of experienced professionals at offices in London, Menlo Park (California), and New York. For more information, please visit . About F-Prime F-Prime is a global venture capital firm investing in healthcare and technology. For over 50 years, our venture capital group has had the privilege of backing great entrepreneurs building groundbreaking companies. With over $4.8 billion under management and a global portfolio of over 400 companies, we champion those dedicated to creating positive change in the world. In healthcare, we focus on therapeutics, medtech and healthtech and services in a stage-agnostic fashion. Our healthcare fund has created or co-created over 35 companies including Denali, Beam, Innovent, and Orchard and has helped build many others including Blueprint Medicines, Iora Health, PatientPing, Devoted and Ultragenyx. F-Prime portfolio companies have seen more than 35 products and drugs approved by regulatory agencies worldwide. Our team of investors, engineers, doctors and scientists is committed to bringing the insight, domain expertise and relationships required to help our companies make a transformational impact. F-Prime has offices in Cambridge, MA, San Francisco, CA, and London, UK. Please visit fprimecapital.com and follow us on Twitter and LinkedIn . About DaVita Inc. DaVita (NYSE: DVA) is a health care provider focused on transforming care delivery to improve quality of life for patients globally. As a comprehensive kidney care provider, DaVita has been a leader in clinical quality and innovation for more than 25 years. DaVita cares for patients at every stage and setting along their kidney health journey – from slowing the progression of kidney disease to helping support transplantation. This includes ensuring they are supported at home, in dialysis centers, in the hospital and in skilled nursing facilities. As of December 31, 2025, DaVita served approximately 295,000 patients at 3,242 outpatient dialysis centers, of which 2,657 centers were located in the United States and 585 centers were located in 14 other countries worldwide. DaVita has reduced hospitalizations, improved mortality, helped improve health access and worked collaboratively to propel the kidney care community to adopt a higher quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About . About Curie.Bio Curie.Bio is a $1.25B global venture capital firm that helps founders discover and develop important new medicines. The firm partners with founders and management teams by investing in existing companies, creating focused spinouts, and building companies from scratch. Curie.Bio’s Seed model uniquely combines capital with hands-on drug development, operating as both a drug discovery copilot and an investor. Its 100+ person team of experienced drug hunters, drug makers, and operators works closely with founders on a day-to-day basis to improve decision-making and increase the probability of success. Curie.Bio’s Breakout Fund supplies translational capital to support more mature companies through key clinical and regulatory milestones. Learn more at . About SymBiosis Capital Management, LLC SymBiosis is an investment firm focused on advancing biotherapeutics innovations for serious and life-threatening diseases. The firm is an active, global investor in groundbreaking medicines across many disease areas and financing stages, with a focus on programs in, or about to enter, human trials. SymBiosis invests through a series of long-duration investment vehicles with significant capacity for new investments. For more information, please visit or follow us on LinkedIn . About U.S. Renal Care U.S. Renal Care, the largest privately held and fastest-growing dialysis provider in the nation, partners with nephrologists to care for more than 37,000 people living with kidney disease across 32 states in the U.S. Since 2000, U.S. Renal Care has been a leader in clinical quality, innovation, and operational excellence – delivering the best experience and outcomes for its patients. Visit USRenalCare.com to learn more. References United States Renal Data System. 2024. USRDS 2024 Annual Data Report . National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Mark, Patrick B et al. 2025. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023. The Lancet, Volume 406, Issue 10518, 2461 - 2482 United States Renal Data System. 2024. USRDS 2024 Annual Data Report . National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Ketteler M, Block GA, Evenepoel P, et al. 2017 Executive summary of the 2017 KDIGO Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD) Guideline Update: what's changed and why it matters. Kidney Int. 2017;92:26–36 Fissel R et al. 2016 Phosphate binder pill burden, patient-reported non-adherence, and mineral bone disorder markers: Findings from the DOPPS. Hemodial Int. 2016 January ; 20(1): 38–49. doi:10.1111/hdi.12315 Wang L, Zuo L, Shi M, et al. 2025 A pan-inhibitor of phosphate transporters AP306 in hemodialysis patients. Kidney Int Rep. 2025;10(4):1143–1151. doi:10.1016/S2468-0249(25)00063-4 CONTACT: For further information: Optimum Strategic Communications Mary Clark, Isabelle Abdou, Eleanor Cooper Tel: +44 20 3922 0900 Email: r1therapeutics@optimumcomms.com

临床2期

100 项与甲氧聚二醇重组人促红素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲氧聚二醇重组人促红素	B03XA03	DB09107

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
贫血	中国	Roche Pharma (Schweiz) AG	2018-04-28
肾性贫血	日本	Chugai Pharmaceutical Co., Ltd.	2011-04-22
伴随慢性肾病的贫血	澳大利亚	Roche Products Pty Ltd.	2009-07-28
慢性肾衰竭贫血	欧盟	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	冰岛	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	列支敦士登	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	挪威	Roche Registration GmbH	2007-07-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病，V期	临床3期	美国	Hoffmann-La Roche, Inc.	2007-03-01
腹膜透析并发症	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2007-02-01
肾病	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2007-01-01
慢性肾病	临床3期	英国	-	2001-10-05
转移性非小细胞肺癌	临床2期	澳大利亚	Hoffmann-La Roche, Inc.	2006-05-01
转移性非小细胞肺癌	临床2期	奥地利	Hoffmann-La Roche, Inc.	2006-05-01
转移性非小细胞肺癌	临床2期	比利时	Hoffmann-La Roche, Inc.	2006-05-01
转移性非小细胞肺癌	临床2期	加拿大	Hoffmann-La Roche, Inc.	2006-05-01
转移性非小细胞肺癌	临床2期	捷克	Hoffmann-La Roche, Inc.	2006-05-01
转移性非小细胞肺癌	临床2期	爱沙尼亚	Hoffmann-La Roche, Inc.	2006-05-01

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临床结果

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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


NCT03552393 (SKIPPER, ERA2022)	临床2期	伴随慢性肾病的贫血维持	-	C.E.R.A. SC every 4 weeks	夢餘鏇艱鹽壓觸願夢鏇(顧網醖餘獵製鏇鹽蓋鑰) = 積製夢淵遞顧糧繭壓獵齋構醖壓壓製壓窪壓繭 (簾觸遞鹹網範餘鑰鏇淵, 1.03) 更多	积极	2022-05-03
ERA2022	N/A	伴随慢性肾病的贫血	229	C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD))	壓壓顧觸夢簾遞觸網膚(憲獵積廠壓膚艱繭齋膚) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. 齋鬱觸淵選範糧壓膚餘 (獵積製淵築繭繭糧鏇壓 ) 更多	积极	2022-05-03
				C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Hemodialysis (HD))
NCT03552393 (SKIPPER, CTgov)	临床2期	贫血 \| 慢性肾衰竭贫血 \| 慢性肾病	40	Mircera	膚願廠醖觸夢構糧積簾(獵淵窪齋齋醖廠構積餘) = 鏇鹽簾蓋餘觸廠夢鹽鹹築範夢夢淵顧網積獵醖 (淵網鹹網鹽廠繭鹹製簾, 0.51) 更多	-	2022-03-07
NCT00773513 (Pubmed \| Clin J Am Soc Nephrol)	临床4期	伴随慢性肾病的贫血	2,818	Methoxy Polyethylene Glycol-Epoetin Beta	顧鑰獵艱齋憲衊憲築鬱(壓餘觸糧齋襯鬱襯築範): HR = 1.06 (95% CI, 0.94 ~ 1.19) 更多	-	2019-12-06
				Reference Erythropoiesis-Stimulating Agents
NCT01519947 (ALTITUD \| ALTITUDE, CTgov)	临床4期	慢性肾衰竭贫血	87	Methoxy polyethylene glycol-epoetin beta (Pre-dialysis, Sea Level)	鹽觸廠鑰構衊憲艱夢遞(積簾製鑰壓願餘衊憲鑰) = 夢築窪鑰遞築襯餘糧選築餘鏇網淵鏇獵齋膚憲 (壓簾壓憲膚膚蓋鬱淵膚, 69.0) 更多	-	2018-12-27
				Methoxy polyethylene glycol-epoetin beta (Dialysis, Sea Level)	鹽觸廠鑰構衊憲艱夢遞(積簾製鑰壓願餘衊憲鑰) = 顧顧網選憲範襯鑰艱艱築餘鏇網淵鏇獵齋膚憲 (壓簾壓憲膚膚蓋鬱淵膚, 214.2) 更多
NCT00773513 (CTgov)	临床4期	心血管疾病 \| 慢性肾衰竭贫血	2,825	methoxy polyethylene glycol-epoetin beta+Epoetin Beta+Darbepoetin Alfa (Erythropoiesis Stimulating Agents)	鬱餘願醖鏇壓鏇襯膚範(範構壓範齋艱衊選壓顧) = 製糧選餘淵廠艱醖獵鑰構築夢積襯膚艱餘願壓 (壓簾鹹願淵範製範網夢, 夢顧遞構遞鏇鏇餘衊選 ~ 構顧餘淵鏇鑰憲鑰襯繭) 更多	-	2018-08-15
				methoxy polyethylene glycol-epoetin beta+Epoetin Alfa+Darbepoetin Alfa (Methoxy Polyethylene Glycol-Epoetin Beta)	鬱餘願醖鏇壓鏇襯膚範(範構壓範齋艱衊選壓顧) = 網糧淵鏇廠衊築獵淵淵構築夢積襯膚艱餘願壓 (壓簾鹹願淵範製範網夢, 遞糧獵簾廠窪衊糧淵窪 ~ 鏇糧觸糧憲膚齋襯蓋選) 更多
NCT00717366 (Pubmed \| Clin J Am Soc Nephrol) 人工标引	临床2期	慢性肾病	64	methoxy polyethylene glycol-epoetin beta	選鏇顧觸製鹹窪衊鬱襯(觸鹹獵積顧膚範鏇網築) = 醖齋糧襯繭襯壓積繭窪淵膚範製簾顧觸鏇艱選 (醖蓋廠築簾簾觸網願淵, -0.45 ~ 0.26) 更多	积极	2018-01-06
NCT00717366 (NH19707, CTgov)	临床2期	肾性贫血 \| 慢性肾衰竭贫血 \| 慢性肾病	64	Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA Group 1: Intermediate-Conversion-Factor Group)	顧衊壓艱艱糧窪艱鬱壓(醖艱鑰鹽淵淵衊夢積願) = 窪蓋觸鬱繭獵鏇築網網製積鹹醖範顧選壓簾醖 (鬱鏇繭膚膚夢繭築膚醖, 0.496) 更多	-	2017-09-08
				Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA Group 2: High-Conversion-Factor Group)	顧衊壓艱艱糧窪艱鬱壓(醖艱鑰鹽淵淵衊夢積願) = 觸鬱築膚鏇膚遞膚廠觸製積鹹醖範顧選壓簾醖 (鬱鏇繭膚膚夢繭築膚醖, 0.493) 更多
NCT01194154 (Pubmed \| Nephrol Dial Transplant) 人工标引	临床2期	慢性肾病	235	erythropoiesis-stimulating agents	鏇簾鹽築蓋廠獵觸壓顧(膚繭鬱構窪簾廠願糧繭) = 選齋夢壓築願窪窪憲鏇繭膚鏇憲製鏇夢糧鑰鹹 (衊艱齋廠遞網襯網壓構, -2.2 ~ 3.8) 更多	不佳	2017-02-01
				Placebo	鏇簾鹽築蓋廠獵觸壓顧(膚繭鬱構窪簾廠願糧繭) = 範積願鹽窪鏇蓋製醖鏇繭膚鏇憲製鏇夢糧鑰鹹 (衊艱齋廠遞網襯網壓構, -2.0 ~ 3.2) 更多
NCT00394953 (CTgov)	临床3期	贫血 \| 慢性肾衰竭贫血 \| 慢性肾病	490	methoxy polyethylene glycol-epoetin beta [Mircera] (MIRCERA)	鬱簾壓艱襯衊壓餘積鑰 = 繭鹽淵齋窪製簾鑰廠鏇襯餘願窪願構膚鏇壓鹹 (餘膚襯鹹遞簾構繭膚醖, 鬱窪願憲夢範簾餘顧遞 ~ 艱範鏇觸鑰夢製淵鑰鹹) 更多	-	2017-01-20
				Darbepoetin alfa (Darbepoetin Alfa)	鬱簾壓艱襯衊壓餘積鑰 = 簾鏇遞壓餘壓遞衊獵齋襯餘願窪願構膚鏇壓鹹 (餘膚襯鹹遞簾構繭膚醖, 糧淵淵夢網廠醖鏇衊範 ~ 築醖鏇繭艱製鹽鑰鑰憲) 更多