SHANGHAI, Oct. 23, 2026 /PRNewswire/ — Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; HKEX: 09637), a renal-focused biopharmaceutical company, today announced that its partner, R1 Therapeutics, Inc. ("R1"), presented a trial-in-progress poster outlining the design of the ongoing global Phase IIb multi-regional clinical trial of AP306, a first-in-class oral pan-phosphate transporter inhibitor, in patients with hyperphosphatemia receiving maintenance hemodialysis (NCT06712654) on October 22, 2026 (local time) at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado. The global Phase IIb multi-regional clinical trial is co-sponsored by Alebund and R1 and is being conducted at multiple clinical sites across the United States and China.
The global Phase IIb multi-regional clinical trial (NCT06712654) is a multicenter, randomized, double-blind, placebo-controlled, fixed-dose study designed to evaluate the safety, tolerability, and serum phosphate-lowering effect of AP306. The trial plans to enroll approximately 168 participants with hyperphosphatemia receiving maintenance hemodialysis, randomized across six fixed-dose AP306 regimens and a placebo group over an eight-week treatment period; the primary endpoint is the change in serum phosphate level from baseline to the end of treatment, and the secondary endpoints include the proportion of participants reaching the target phosphate range and the time to the first occurrence of phosphate control. Employing a multi-dose parallel-group design, the study is intended to systematically characterize the dose-response relationship of AP306 and evaluate its efficacy, safety, and tolerability profiles across both twice-daily (BID) and three-times-daily (TID) dosing regimens, with the aim of optimizing the dosing schedule to further reduce daily medication burden, enhance long-term treatment adherence for dialysis patients, and inform dose and regimen selection for subsequent clinical development. Peking University People’s Hospital is the lead site of the Phase IIb Trial in China, which is being conducted at seven clinical sites in total and has been approved by the Office of Human Genetic Resources Administration of China; the Company announced on July 21, 2026 that the first participant in the trial was randomized and dosed. Participant enrollment is currently ongoing at clinical sites in the United States and China, with trial completion expected in the second quarter of 2027 and topline results to be announced in due coure.
AP306 (formerly known as EOS789) is a first-in-class oral pan-phosphate transporter inhibitor originally discovered by Chugai Pharmaceutical Co., Ltd. ("Chugai") and subsequently licensed to Alebund, which obtained the exclusive global rights to develop, manufacture, and commercialize AP306. Unlike conventional phosphate binders that passively bind phosphate in the gut lumen, AP306 simultaneously inhibits three key sodium-dependent intestinal phosphate transporters — sodium-dependent phosphate transporter type IIb (NaPi-IIb), phosphate transporter-1 (PiT-1), and phosphate transporter-2 (PiT-2) — to actively block intestinal phosphate transport. As the world’s first and only pan-phosphate transporter inhibitor to have entered clinical development and the only oral candidate that simultaneously targets these three key intestinal phosphate transporters, AP306 has the potential to deliver effective phosphate lowering while substantially reducing daily medication burden, offering a differentiated approach to the management of hyperphosphatemia.
Unmet Medical Need
Hyperphosphatemia is a common and serious complication in patients with chronic kidney disease (CKD) receiving dialysis, affecting approximately 95% of dialysis-dependent CKD patients.[1-3] Elevated serum phosphate levels are associated with vascular calcification, secondary hyperparathyroidism, renal osteodystrophy, and increased risks of cardiovascular events and all-cause mortality.[1-3] Regular dialysis and dietary phosphate restriction are often insufficient to effectively control phosphate burden, requiring patients to undergo long-term pharmacological treatment. Even with the widespread use of phosphate binders, approximately 76% of dialysis patients in China still fail to achieve the target serum phosphate range of 1.13–1.78 mmol/L (3.5–5.5 mg/dL).[4] Separately, according to a Dialysis Outcomes and Practice Patterns Study (DOPPS) report, in 2021 approximately 52% of in-center hemodialysis patients in the United States and approximately 39% in Japan had serum phosphate levels above 1.78 mmol/L (5.5 mg/dL) (reflecting distinct study populations, years, and endpoint definitions).[5] The dialysis patient population in China is expected to grow from approximately 1.3 million in 2025 to approximately 3.4 million by 2035, representing a compound annual growth rate (CAGR) of approximately 10.1% and a continuously expanding unmet medical need.[6] Existing phosphate binder therapies continue to face challenges including high pill burden, gastrointestinal tolerability, and suboptimal long-term adherence, underscoring the need for innovative treatment options that balance efficacy, tolerability, and dosing convenience.[1-3, 7]
References
|
[1] Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2017;7(1):1–59. |
|
[2] Block GA, Klassen PS, Lazarus JM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004;15(8):2208–2218. |
|
[3] Tentori F, Blayney MJ, Albert JM, et al. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2008;52(3):519–530. |
|
[4] China Insights Consultancy (CIC). Global and Chinese Hyperphosphatemia Drug Industry Blue Book. 2023. |
|
[5] Guedes M, Bieber B, Dasgupta I, et al. Serum phosphorus levels and treatment practices among hemodialysis patients: a DOPPS special report. Kidney Med. 2023;5(2):100584. doi: 10.1016/j.xkme.2022.100584. |
|
[6] Prospectus of Alebund Pharmaceuticals (Jiangsu) Limited, dated June 18, 2026. |
|
[7] Fissell RB, Karaboyas A, Bieber BA, et al. Phosphate binder pill burden, patient-reported non-adherence, and mineral bone disorder markers: Findings from the DOPPS. Hemodial Int. 2016;20(1):38–49. doi:10.1111/hdi.12315. |
Collaboration with R1 Therapeutics
R1 Therapeutics is a newly established clinical-stage biotechnology company focused on the research, development, and commercialization of innovative biopharmaceutical products for kidney diseases and related complications. In December 2025, Alebund and R1 Therapeutics entered into licensing and equity agreements in respect of AP306. Under these agreements, Alebund retains full rights and control over AP306 in Chinese Mainland, Hong Kong, Macau, and Taiwan (collectively, "Greater China"), while R1 Therapeutics obtained an exclusive license to develop, manufacture, and commercialize AP306 outside Greater China. Alebund and R1 Therapeutics are co-sponsors of the global Phase IIb multi-regional clinical trial; each party is responsible for clinical trial execution and regulatory submissions in its respective territory and provides the other party with relevant data and support required for regulatory purposes.
About Alebund Pharmaceuticals
Alebund Pharmaceuticals (09637.HK) is a biopharmaceutical company focused on kidney disease and related chronic conditions, aiming to bring better therapies to patients worldwide. It has one of the broadest renal-focused pipelines and an integrated platform spanning R&D, manufacturing and commercialization. Its portfolio comprises seven investigational drug candidates and one commercialized product, Mircera®. Three of the candidates are at the clinical stage: AP301 (Phase III; China pivotal Phase III trial completed and NDA accepted, global MRCT ongoing), AP306 (Phase II) and AP303 (Phase I). The U.S. Food and Drug Administration (FDA) has also cleared the Investigational New Drug (IND) application for AP308. Together they address chronic kidney disease (CKD) and its complications, including hyperphosphatemia, renal anemia, IgA nephropathy, diabetic kidney disease, FSGS and ADPKD. Alebund has built a manufacturing site in Yangzhou, Jiangsu to support the future commercial manufacturing of AP301 and other pipeline products and has obtained a Drug Manufacturing License (Category B) issued by the Jiangsu Provincial Drug Administration. The Company has also established a dedicated nephrology sales team responsible for the commercialization of relevant products in China. For more information, visit www.alebund.com.
Forward-Looking Statement
This press release contains certain forward-looking statements, including, but not limited to, statements relating to the Company’s future plans, clinical development and registration progress, expected timing of data, clinical potential of product candidates, commercialization prospects, and industry trends. These statements are based on the Company’s judgments and assumptions as of the date of this press release and are subject to various risks and uncertainties; actual results may differ materially from such forward-looking statements. This press release does not constitute an offer to sell or a solicitation of an offer to purchase any securities.
