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

Start Date21 Jan 2025

Sponsor / Collaborator

Incepta Pharmaceuticals Ltd.

[+1]

TCTR20190718006

/ RecruitingPhase 4IIT

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

Start Date19 Mar 2019

Sponsor / Collaborator-

NCT03552393

/ CompletedPhase 2

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.

Start Date03 Aug 2018

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Methoxy Polyethylene Glycol-Epoetin Beta

100 Translational Medicine associated with Methoxy Polyethylene Glycol-Epoetin Beta

100 Patents (Medical) associated with Methoxy Polyethylene Glycol-Epoetin Beta

514

Literatures (Medical) associated with Methoxy Polyethylene Glycol-Epoetin Beta

01 Feb 2026·PHARMACEUTICAL RESEARCH

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

Article

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

01 Feb 2026·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.

01 Jan 2026·TALANTA

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

Article

Author: 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.

News (Medical) associated with Methoxy Polyethylene Glycol-Epoetin Beta

17 Mar 2026

·www.prnewswire.com

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

Phase 2License out/inOrphan DrugPhase 3Clinical Result

17 Mar 2026

·www.biospace.com

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

Phase 2

09 Jan 2026

·healthcare-digital.com

Nestlé & Novo Nordisk: This Week's Top Healthcare Stories

Korab Zuka, Global Head of Social Impact & Chief Sustainability Officer, Novartis This week's top healthcare stories include Nestlé's product recalls, Novo Nordisk's 2026 predictions and Cera's AI agent for healthcare professionals Nestlé Recalls SMA Formula Over Cereulide Toxin Risk Nestlé has initiated a voluntary recall of certain batches of its SMA Infant Formula and Follow-On Formula in the UK and Ireland due to a potential presence of the toxin cereulide. The company is offering full refunds for returned products. “There have been no confirmed reports of any illness associated with consumption of the products concerned,” Nestlé states. “Nevertheless, out of an abundance of caution, Nestlé has decided to perform this voluntary product recall in line with our strict product quality and safety protocols.” What Does 2026 Have in Store for Novo Nordisk? Mike Doustdar, CEO of Novo Nordisk For global pharmaceutical company Novo Nordisk , 2026 holds a lot of potential. As it works on bouncing back from last year’s setbacks, it aims to grow its presence in the US weight loss market. Novo Nordisk’s CEO, Mike Doustdar, reflected on the year on LinkedIn and shared the company’s plans for the future, including improving its performance and building trust with patients, partners and investors. How Can Cera’s Healthcare AI Aid Nurses, Hospitals & Carers? Cera , the home healthcare innovator, is developing a suite of AI care agents. The agents are designed to automate time-consuming tasks, make decisions based on information they gather and act on them by using reasoning, planning and memory. Cera is set to introduce almost 1,000 agents across its 10,000-strong workforce, speeding up recruitment of carers, organising replacement cover and continuously reviewing and improving patient care quality and compliance. Korab Zuka: Leading Sustainability at Novartis Novartis, one of the world’s largest pharmaceutical companies, has sharpened its sustainability focus under the leadership of Korab Zuka, who took the role of Global Head of Social Impact and Chief Sustainability Officer at the end of 2024. Korab, who joined Novartis a year ago, brings a career shaped by social impact work in both the public and private sectors. His role unites sustainability, access to medicine and the company’s philanthropic foundations under one strategy. For Korab, sustainability is about more than environmental targets. It is intrinsically tied to human health and to Novartis’ mission of widening access to its scientific breakthroughs. As he puts it: “In order for people to have healthy lives, you have to have a healthy planet.” Fujitsu and Nvidia: Harnessing AI to Transform Healthcare Japan's ageing population crisis has inspired an ambitious partnership between Fujitsu and Nvidia, aimed at revolutionising healthcare delivery through artificial intelligence. The collaboration centres on developing a healthcare orchestrator platform that coordinates multiple AI agents to streamline administrative tasks, allowing medical professionals to focus on patient care. With Japan having the world's highest percentage of people over 65, the healthcare system faces mounting pressure on resources and staff. Fujitsu, generating approximately US$24.64bn in revenue last fiscal year with a global workforce of 113,000, has identified healthcare AI as a critical growth sector within its broader strategy to address societal challenges. Company portals Cera Fujitsu Nestlé Novartis Novo Nordisk NVIDIA Executives Dr. Ben Maruthappu Founder & CEO Jensen Huang Founder and CEO Korab Zuka Global Head of Social Impact and Chief Sustainability Officer Maziar Mike Doustdar President and CEO Philipp Navratil Chief Executive Officer

Executive Change

100 Deals associated with Methoxy Polyethylene Glycol-Epoetin Beta

External Link

KEGG	Wiki	ATC	Drug Bank
-	Methoxy Polyethylene Glycol-Epoetin Beta	B03XA03	DB09107

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	China	Roche Pharma (Schweiz) AG	28 Apr 2018
Anemia of renal disease	Japan	Chugai Pharmaceutical Co., Ltd.	22 Apr 2011
Anemia in chronic kidney disease	Australia	Roche Products Pty Ltd.	28 Jul 2009
chronic renal failure anemia	European Union	Roche Registration GmbH	20 Jul 2007
chronic renal failure anemia	Iceland	Roche Registration GmbH	20 Jul 2007
chronic renal failure anemia	Liechtenstein	Roche Registration GmbH	20 Jul 2007
chronic renal failure anemia	Norway	Roche Registration GmbH	20 Jul 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic kidney disease, Stage V	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Mar 2007
Peritoneal dialysis complication	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	01 Feb 2007
Nephrosis	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	01 Jan 2007
Chronic Kidney Diseases	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	Brazil	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	Canada	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	Czechia	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	France	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	Germany	Hoffmann-La Roche, Inc.	01 Feb 2004
Chronic Kidney Diseases	Phase 3	Greece	Hoffmann-La Roche, Inc.	01 Feb 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERA2022	Not Applicable	Anemia in chronic kidney disease	229	C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Peritoneal Dialysis (PD))	cokjsrbzsd(rsyjdjetzv) = 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. jcrodrkjfy (ifnfhfxlwt ) View more	Positive	03 May 2022
				C.E.R.A. (Continuous Erythropoietin Receptor Activator—Methoxy Polyethylene Glycol Epoetin Beta) (Hemodialysis (HD))
NCT03552393 (SKIPPER, ERA2022)	Phase 2	Anemia in chronic kidney disease Maintenance	-	C.E.R.A. SC every 4 weeks	ipcwocogif(mnlyaryqpe) = emwprgltsf ytswdiriyu (glhslfgchg, 1.03) View more	Positive	03 May 2022
NCT03552393 (SKIPPER, CTgov)	Phase 2	Anemia \| chronic renal failure anemia \| Chronic Kidney Diseases	40	Mircera	aqazxdloiz(orhuzdfqiv) = ogbmxgswpm sryosbdquf (nzhqbebzmf, 0.51) View more	-	07 Mar 2022
NCT00773513 (Pubmed \| Clin J Am Soc Nephrol)	Phase 4	Anemia in chronic kidney disease	2,818	Methoxy Polyethylene Glycol-Epoetin Beta	cfpxdbumfv(qiuidefaoq): HR = 1.06 (95% CI, 0.94 - 1.19) View more	-	06 Dec 2019
				Reference Erythropoiesis-Stimulating Agents
NCT01519947 (ALTITUD \| ALTITUDE, CTgov)	Phase 4	chronic renal failure anemia	87	Methoxy polyethylene glycol-epoetin beta (Pre-dialysis, Sea Level)	izirjfdyth(fvwaqsdynw) = kdwyvbguds wdngumgfjq (xtduwblwtb, 69.0) View more	-	27 Dec 2018
				Methoxy polyethylene glycol-epoetin beta (Dialysis, Sea Level)	izirjfdyth(fvwaqsdynw) = giiblsdmju wdngumgfjq (xtduwblwtb, 214.2) View more
NCT00773513 (CTgov)	Phase 4	Cardiovascular Diseases \| chronic renal failure anemia	2,825	methoxy polyethylene glycol-epoetin beta+Epoetin Beta+Darbepoetin Alfa (Erythropoiesis Stimulating Agents)	pbgqhagexo(htgqbccefz) = dfxdldnqjt bdtnizgidz (xxqossawug, vsgqdufbqa - tyjxeqxumr) View more	-	15 Aug 2018
				methoxy polyethylene glycol-epoetin beta+Epoetin Alfa+Darbepoetin Alfa (Methoxy Polyethylene Glycol-Epoetin Beta)	pbgqhagexo(htgqbccefz) = gqdiuucusn bdtnizgidz (xxqossawug, vqoahbljuo - afknmsrjck) View more
NCT00717366 (Pubmed \| Clin J Am Soc Nephrol) Manual	Phase 2	Chronic Kidney Diseases	64	methoxy polyethylene glycol-epoetin beta	rpxxkebdrg(yulztogfws) = qplnxfofbj gqchdjgguc (ntnbkatvbu, -0.45 to 0.26) View more	Positive	06 Jan 2018
NCT00717366 (NH19707, CTgov)	Phase 2	Anemia of renal disease \| chronic renal failure anemia \| Chronic Kidney Diseases	64	Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA Group 1: Intermediate-Conversion-Factor Group)	zulzroitsc(entlzlbzed) = mfrlpwkwnd ryexdojuxt (njzmjqoafx, 0.496) View more	-	08 Sep 2017
				Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA Group 2: High-Conversion-Factor Group)	zulzroitsc(entlzlbzed) = auqjwkmsgu ryexdojuxt (njzmjqoafx, 0.493) View more
NCT01194154 (Pubmed \| Nephrol Dial Transplant) Manual	Phase 2	Chronic Kidney Diseases	235	erythropoiesis-stimulating agents	swabvgwaae(fcokvvqkpn) = vedttlmoit rktwcgswyz (itvouhvkdm, -2.2 to 3.8) View more	Negative	01 Feb 2017
				Placebo	swabvgwaae(fcokvvqkpn) = dobowhbniy rktwcgswyz (itvouhvkdm, -2.0 to 3.2) View more
NCT00394953 (CTgov)	Phase 3	Anemia \| chronic renal failure anemia \| Chronic Kidney Diseases	490	methoxy polyethylene glycol-epoetin beta [Mircera] (MIRCERA)	hagoltwlta = yjxttltcpj doiyghljwj (quxzkdsfmz, jlvztoxikz - yvzaxbyxqm) View more	-	20 Jan 2017
				Darbepoetin alfa (Darbepoetin Alfa)	hagoltwlta = goqkglejzq doiyghljwj (quxzkdsfmz, xrsiyrcyet - erojfncogj) View more

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