Alebund Pharmaceuticals Announces First Participant Randomized and Dosed in Global Phase IIb Multi-Regional Clinical Trial of AP306 for Hyperphosphatemia

SHANGHAI, July 21, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; HKEX: 09637), a renal-focused biopharmaceutical company, today announced that the first participant has been randomized and dosed in the global Phase IIb multi-regional clinical trial of AP306 in patients with hyperphosphatemia receiving maintenance hemodialysis (NCT06712654). The trial is being conducted at multiple clinical sites in the United States and China and is co-sponsored by Alebund and R1 Therapeutics, Inc. ("R1").

AP306 (formerly known as EOS789) is a first-in-class oral pan-phosphate transporter inhibitor. AP306 was originally discovered and developed by Chugai Pharmaceutical Co., Ltd. ("Chugai") and was subsequently licensed to the Company, which has obtained the global rights to develop, manufacture and commercialize AP306. Unlike conventional phosphate binders that bind phosphate in the gut lumen, AP306 broadly inhibits three key intestinal phosphate transporters — NaPi-IIb, PiT-1 and PiT-2 — to reduce active intestinal phosphate transport, offering a differentiated approach to the management of hyperphosphatemia. The randomization and dosing of the first participant marks a new stage in the multicenter clinical execution of AP306's global development program in the United States and China.

Trial Design

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study that plans to enroll approximately 168 participants with hyperphosphatemia receiving maintenance hemodialysis. Participants will be randomized across six fixed-dose AP306 regimens or placebo over an eight-week treatment period. The study is designed to evaluate the safety, tolerability and serum phosphate-lowering effect of fixed-dose AP306.

The primary endpoint is the change in serum phosphate from baseline to the end of treatment. Secondary endpoints include the proportion of participants reaching the target phosphate range and the time to phosphate control. Topline results are expected in the first half of 2027.

The trial has obtained approval from the Human Genetic Resources Administration of China (HGRAC). Peking University People's Hospital, the China leading site, was recently activated, and participant enrollment is in progress.

Unmet Medical Need

Hyperphosphatemia is a common and important complication in patients with chronic kidney disease (CKD) receiving dialysis, affecting approximately 95% of dialysis-dependent CKD patients. Persistently elevated serum phosphate is 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 control phosphate burden, meaning patients frequently require 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 3.5–5.5 mg/dL, which is significantly higher than that in the U.S. (approx. 52%) and Japan (approx. 39%). [4-5] The number of dialysis patients in China is expected to grow from approximately 1.3 million in 2025 to about 3.4 million by 2035 (a CAGR of approx. 10.1%),  [6] representing a continuously expanding unmet medical need. Existing therapies still face challenges such as gastrointestinal tolerability, pill burden, and long-term adherence. Innovative treatment options that balance efficacy, tolerability, and convenience remain to be further developed.

Prior Phase II Study of AP306 in China

In a completed Phase II clinical trial in China (NCT05764590), AP306 monotherapy demonstrated a mean serum phosphate reduction from baseline of 2.51 mg/dL, compared with 1.08 mg/dL for the active comparator sevelamer carbonate. At Weeks 7 to 8, nearly 95% of patients in the AP306 group had serum phosphate levels below 5.5 mg/dL, compared with approximately 50% in the sevelamer carbonate group in the trial.

The most common adverse events were gastrointestinal disorders, mainly diarrhea; all diarrhea events were Grade 1 or 2 and mostly resolved within two weeks. No serious adverse event was reported in the AP306 group, and the discontinuation rate due to adverse events was below 5%. Results were published in Kidney International Reports. [7]

Based on AP306's innovative mechanism and clinical results, the National Medical Products Administration granted Breakthrough Therapy Designation to AP306 for the treatment of hyperphosphatemia in patients with chronic kidney disease in June 2024.

Collaboration with R1

R1 is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for patients with kidney disease. In December 2025, Alebund and R1 entered into licensing and equity arrangements. Under the collaboration and license agreement forming part of these arrangements, Alebund granted R1 an exclusive license to develop, manufacture and commercialize AP306 outside Chinese Mainland, Hong Kong, Macau and Taiwan, while retaining full rights and control in those four markets. The parties are co-sponsors of the Phase IIb 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 registrational Phase III trial completed, global MRCT ongoing), AP306 (Phase II) and AP303 (Phase I). 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.

Media and Investor Inquiries

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Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding clinical development plans, expected timing of data, product potential and future development. 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.

SOURCE Alebund Pharmaceuticals