Alebund Pharmaceuticals Announces 2026 Interim Results

SHANGHAI, Aug. 26, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; stock code: 09637.HK), a renal-focused biopharmaceutical company, today announced its unaudited consolidated interim results for the six months ended June 30, 2026 (the "Reporting Period"). During the Reporting Period and up to the date of the interim results announcement, the Company made significant progress on four fronts: clinical development, external collaborations, commercialization in China, and the capital markets.

Highlights of the Reporting Period

Clinical Development

• AP301 — patient enrollment completed in the global Phase III pivotal multi-regional clinical trial; the New Drug Application in China accepted for review by the National Medical Products Administration of China (the "NMPA"). In May 2026, RESPOND-2, the global Phase III pivotal multi-regional clinical trial (the "MRCT") conducted in the United States and China, completed patient enrollment. On August 7, 2026, subsequent to the Reporting Period, the New Drug Application submitted by the Company for AP301 for the treatment of hyperphosphatemia in chronic kidney disease ("CKD") patients receiving maintenance dialysis was accepted for review by the NMPA as a Class 1 chemical drug in China.
• AP306 — the global Phase IIb multi-regional clinical trial has been initiated. The trial is co-sponsored by the Company and R1 Therapeutics, Inc. ("R1"), with the Company leading the conduct of the trial in the Chinese Mainland. The trial plans to enroll a total of approximately 168 participants with hyperphosphatemia receiving maintenance hemodialysis, and the first participant was randomized and dosed in July 2026, subsequent to the Reporting Period, as announced by the Company. The trial is expected to be completed in the second quarter of 2027, and the Company will announce topline results in due course.
• AP303 — the data from three completed Phase I/Ib clinical trials have been published in Kidney International Reports in August 2026, demonstrating that AP303 was safe and well tolerated; the expected dose-related hemodynamic effects were observed in healthy participants and patients with diabetic kidney disease (DKD).
• AP308 — preclinical results published in May 2026 in Kidney International. In humanized IgA (immunoglobulin A) nephropathy mouse models, AP308 reduced circulating human IgA1 by approximately 90% after a single dose, and eight weeks of treatment achieved near-complete clearance of glomerular IgA deposits with significant improvement in renal pathology and no treatment-related adverse effects; in a separate paired design, a single dose completely cleared established glomerular IgA and complement C3 deposits.

External Collaborations

• Licensing and equity agreements in respect of AP306 entered into with R1 Therapeutics. In March 2026, the Company announced that it had entered into licensing and equity agreements in respect of its product candidate AP306 with R1. The Company retains all rights to AP306 in Greater China and holds an equity interest in R1 as a principal shareholder, while R1 has obtained an exclusive license to develop, manufacture, and commercialize AP306 outside Greater China. R1's shareholders include DaVita (NYSE: DVA) and U.S. Renal Care, leading global kidney care providers. During the Reporting Period, the Company recognized licensing revenue of RMB79.3 million from the transaction.

Commercialization in China

• Sales revenue of Mircera® increased by approximately 105.0% year-on-year. During the Reporting Period, Mircera® generated sales revenue of RMB24.8 million (corresponding period of 2025: RMB12.1 million), representing a year-on-year increase of approximately 105.0%.

Capital Markets

• Listing of the H Shares on the Main Board of the Stock Exchange. The H Shares of the Company were listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Stock Exchange") on June 29, 2026 (stock code: 09637). Together with the full exercise of the Over-allotment Option under the Global Offering on July 24, 2026, subsequent to the Reporting Period, the aggregate net proceeds from the Global Offering amounted to approximately HK$1,355.8 million, of which approximately HK$184.7 million in additional net proceeds was attributable to the exercise of the Over-allotment Option.

Financial Overview

• Revenue growth with narrowing losses. Revenue for the first half of 2026 grew to RMB104.2 million from RMB12.1 million for the first half of 2025, representing an increase of RMB92.1 million, or 761.2%, primarily reflecting licensing revenue of RMB79.3 million recognized under the licensing and equity agreements entered into with R1 in respect of AP306, as well as sales revenue of RMB24.8 million from the commercialized product Mircera®; loss for the period was RMB162.6 million, narrowing by 22.5% year-on-year, and adjusted net loss for the period (non-International Financial Reporting Standards ("IFRS") measure) was RMB130.1 million, narrowing by 12.6% year-on-year. As of June 30, 2026, the aggregate balance of cash and cash equivalents, time deposits, and wealth management products was RMB1,392.8 million, representing an increase of RMB861.6 million.

Financial Summary

Product sales. During the Reporting Period, Mircera®, the Company's commercialized product, generated sales revenue of RMB24.8 million, representing an increase of approximately 105.0% from RMB12.1 million in the corresponding period of 2025; the gross profit of Mircera® was RMB11.7 million, representing an increase of RMB6.4 million, or 120.8%, from RMB5.3 million in the corresponding period of 2025, and the gross profit margin improved from 43.4% for the first half of 2025 to 47.3% for the first half of 2026.

Licensing value. In March 2026, the Company completed its performance obligations under the licensing and equity agreements entered into with R1 in respect of AP306 and recognized licensing revenue of RMB79.3 million; the consideration was received in the form of unlisted class B common shares of R1 as upfront, non-monetary, and non-refundable consideration. Together with the sales revenue of Mircera®, revenue for the first half of 2026 grew to RMB104.2 million from RMB12.1 million for the first half of 2025, representing an increase of RMB92.1 million, or 761.2%.

Narrowing of losses. Net loss for the first half of 2026 narrowed by RMB47.1 million, or 22.5%, to RMB162.6 million from RMB209.7 million for the first half of 2025. The narrowing was primarily driven by (i) the increase in licensing revenue during the Reporting Period and (ii) the termination, prior to the Listing, of the redemption liabilities in respect of certain shares of the Company (which is one-off in nature), following which no related interest was accrued during the Reporting Period. Adjusted net loss for the first half of 2026 was RMB130.1 million, a decrease of RMB18.8 million, or 12.6%, from RMB148.9 million for the first half of 2025, likewise primarily due to the increase in licensing revenue during the period.

R&D investment. Research and development (R&D) expenses increased by RMB31.3 million, or 28.4%, to RMB141.4 million for the first half of 2026 from RMB110.1 million for the first half of 2025. The increase primarily reflected progress across the R&D pipeline during the Reporting Period, including the completion of patient enrollment in the AP301 MRCT, the initiation of the global Phase IIb multi-regional clinical trial of AP306, and the continued advancement of preclinical and chemistry, manufacturing, and controls (CMC) studies of AP308.

Liquidity. As of June 30, 2026, the aggregate balance of cash and cash equivalents, time deposits, and wealth management products was RMB1,392.8 million, representing an increase of RMB861.6 million, or 162.2%, from December 31, 2025.

Business Progress

AP301: A Best-in-Class Oral Iron-Based Phosphate Binder for the Treatment of Hyperphosphatemia

AP301 is a best-in-class oral iron-based phosphate binder (registered as a Class 1 chemical drug in China), offering a very high phosphate-binding capacity, no need for chewing, minimal volume expansion in gastric fluid, and no systemic absorption. These characteristics help reduce the amount of medication patients need to take each day and lower the incidence of gastrointestinal adverse events such as nausea, vomiting, constipation, and intestinal obstruction, thereby delivering better safety and gastrointestinal tolerability and enhancing patients' long-term treatment adherence.

Global Phase III pivotal multi-regional clinical trial (RESPOND-2, NCT06933472) underway. The trial is a randomized, double-blind, global multi-regional Phase III clinical trial conducted in the United States and China. It planned to enroll 264 CKD patients aged 12 years and above with hyperphosphatemia receiving maintenance dialysis, and ultimately enrolled a total of 282 patients (138 in the United States and 144 in China). Based on the existing clinical data for AP301, the Company and the FDA have agreed that this global Phase III multi-regional clinical trial will serve as the single pivotal study to support the U.S. registration of AP301. The trial completed patient enrollment in May 2026.

Registration progress, catalysts and future milestones. On August 7, 2026, subsequent to the Reporting Period, the New Drug Application submitted by the Company for AP301 for the treatment of hyperphosphatemia in CKD patients receiving maintenance dialysis was accepted for review by the NMPA as a Class 1 chemical drug in China. The application is supported primarily by the results of RESPOND-1, the China pivotal Phase III clinical trial, together with other accumulated clinical data; the Company will actively cooperate with the NMPA's review and expects to obtain approval in 2027, subject to the progress of the regulatory review. The global Phase III multi-regional clinical trial is expected to be completed in the second quarter of 2027, following which the Company plans to submit a New Drug Application to the FDA.

AP306: First-in-Class Oral Pan-Phosphate Transporter Inhibitor with the Potential to Reshape the Treatment Landscape of Hyperphosphatemia

AP306 (formerly known as EOS789, originally discovered by Chugai) is an oral pan-phosphate transporter inhibitor that simultaneously inhibits three key sodium-dependent intestinal phosphate transporters: phosphate transporter type IIb (NaPi-IIb), phosphate transporter-1 (PiT-1), and phosphate transporter-2 (PiT-2). As of the Latest Practicable Date (August 20, 2026), AP306 is the world's first and only pan-phosphate transporter inhibitor to have entered clinical development — the only oral agent that simultaneously targets these three key intestinal phosphate transporters.

The global Phase IIb multi-regional clinical trial underway. The trial (NCT06712654) is a multicenter, randomized, double-blind, placebo-controlled, fixed-dose study conducted at multiple clinical sites in the United States and China and co-sponsored by the Company and R1, 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 placebo 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 phosphate control. The trial has been approved by the Office of Human Genetic Resources Administration of China. As announced by the Company on July 21, 2026, subsequent to the Reporting Period, the first participant in the trial was randomized and dosed.

Catalysts and future milestones. The global Phase IIb multi-regional clinical trial described above is expected to be completed in the second quarter of 2027, and the Company will announce topline results in due course. The Company also plans to initiate a global Phase III multi-regional clinical trial in the second half of 2027.

Regulatory designation. In June 2024, AP306 was granted Breakthrough Therapy Designation by the NMPA for the treatment of hyperphosphatemia in patients with chronic kidney disease.

AP303: A First-in-Class Oral Dual PPAR Agonist Intended to Delay or Halt the Progression of Chronic Kidney Disease

AP303 is a first-in-class oral small-molecule dual peroxisome proliferator-activated receptor (PPAR) α/γ agonist discovered and developed in-house, and the Company holds the global rights to develop, manufacture, and commercialize it. A differentiated disease-modifying agent, AP303 is intended to delay or halt the progression of chronic kidney disease, with target indications spanning multiple high-value therapeutic areas, including DKD, IgA nephropathy (IgAN), autosomal dominant polycystic kidney disease (ADPKD), and focal segmental glomerulosclerosis (FSGS).

Clinical development progress. AP303 has completed three Phase I clinical trials, which enrolled a total of 80 healthy participants and 18 DKD patients with impaired renal function and showed that AP303 was safe and well tolerated. The expected dose-related hemodynamic effects were observed in both healthy participants and patients with DKD. These Phase I results support the initiation of Phase II studies in patient populations. The Phase I/Ib clinical data were published in Kidney International Reports in August 2026.^[1]

Regulatory progress: Phase II clinical trial approvals obtained. In China, the Company submitted an Investigational New Drug application for the Phase II clinical trial to the NMPA and obtained approval for the pan-CKD indication, which can cover subsequent Phase II clinical trials in patients with DKD, IgAN, ADPKD, and FSGS. In the United States, the Company has communicated with the FDA regarding DKD, IgAN, ADPKD, and FSGS and received positive feedback. Among these, the ADPKD indication has been granted Orphan Drug Designation (ODD), and Phase II clinical trial approvals have been obtained for the DKD and IgAN indications.

Subsequent development plan. The Company expects to begin site selection for the Phase II basket trial in DKD and IgAN in the second half of 2026, while preparing in parallel for the initiation of the Phase II multi-regional clinical trials in ADPKD and FSGS and maintaining ongoing communication with the relevant regulatory authorities.

AP308: A First-in-Class Engineered Recombinant IgA Protease Aiming for Functional Cure of IgA Nephropathy

AP308 is an engineered recombinant IgA protease derived from Thomasclavelia ramosa, a human commensal bacterium, and specifically cleaves human IgA1 at a site upstream of the hinge region. Unlike existing therapies that reduce upstream IgA production by modulating B-cell pathways (such as APRIL/BAFF), AP308 acts by directly cleaving and clearing pathogenic IgA and IgA immune complexes that have already formed, including IgA deposited in the glomeruli.

Preclinical data. In the humanized mouse model of IgA nephropathy, a single dose reduced circulating human IgA1 by approximately 90% relative to controls, and circulating IgA1 remained low throughout the eight-week treatment period of weekly subcutaneous dosing; at the end of treatment, histological examination confirmed that glomerular IgA deposits were almost completely cleared, proteinuria decreased significantly, and kidney pathology improved markedly, while repeated dosing produced no treatment-related adverse reactions and no increase in anti-drug antibody titers. In a separate paired pre- and post-treatment design, a single dose completely cleared pre-existing glomerular IgA and complement C3 deposits. As of the Latest Practicable Date, no IgA protease drug candidate globally has entered the clinical stage. These results were published in May 2026 in Kidney International, the official journal of the International Society of Nephrology (ISN).^[2]

Development stage, catalysts and future milestones. As of the Latest Practicable Date, AP308 is at the preclinical stage. The Company plans to submit Investigational New Drug applications for AP308 to the NMPA and the FDA, respectively, in the second half of 2026, and will initiate the Phase I clinical trial of AP308 upon obtaining the relevant clearances.

External Collaboration

In March 2026, the Company announced that it had entered into licensing and equity agreements in respect of its product candidate AP306 with R1; the agreements were entered into in December 2025. The Company retains full rights and control over AP306 in Chinese Mainland, Hong Kong, Macau and Taiwan (collectively, "Greater China"), while R1 has obtained an exclusive license to develop, manufacture, and commercialize AP306 outside Greater China (the "R1 Territory"). R1 and the Company are co-sponsors of the global Phase IIb 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. During the Reporting Period, the Company recognized licensing revenue of RMB79.3 million from the transaction.

Commercialization in China: Mircera®

Mircera® (generic name: methoxy polyethylene glycol-epoetin beta) is a long-acting erythropoiesis-stimulating agent (ESA) of the continuous erythropoietin receptor activator (CERA) class and the world's first and only ESA approved for once-monthly administration. As of the Latest Practicable Date, no biosimilar of Mircera® has been approved or is under review anywhere in the world. In October 2023, the Company entered into a supply and marketing agreement with Roche Hong Kong, Ltd. ("Roche", a subsidiary of Roche Holding AG), obtaining the exclusive rights to sell, distribute, and otherwise commercialize Mircera® in the Chinese Mainland (excluding Hong Kong, Macau, and Taiwan); Roche is responsible for supply and for maintaining the drug registration certificate, while the Company is responsible for obtaining the permits required for promotion. Mircera® was included in the National Reimbursement Drug List (Category B) through the national medical insurance negotiations in 2023 and its listing was renewed in 2025 with no price reduction.

In the first half of 2026, revenue of Mircera® reached RMB24.8 million, an increase of approximately 105.0% from RMB12.1 million in the corresponding period of 2025, at a gross profit margin of approximately 47.3%. The Company has built a dedicated in-house nephrology sales team comprising 43 sales personnel as of the Latest Practicable Date to conduct academic promotion. The commercial availability of Mircera® has given the Company proven access channels to public hospitals, an established distribution network, and dedicated nephrology academic promotion capabilities ahead of the approval of AP301 — ready-made infrastructure for the commercialization of AP301 and subsequent products.

Integrated R&D, Manufacturing, and Commercialization Capabilities

Manufacturing capabilities. Construction of the Company's in-house manufacturing facility in Yangzhou is complete, and the facility has obtained a Drug Manufacturing License (Category B) issued by the Jiangsu Provincial Drug Administration. It has completed pilot-scale production and is preparing for scale-up, to support future commercial-scale production of product candidates such as AP301 and AP306.

Intellectual property. As of the Latest Practicable Date, the Company held 39 granted patents and 117 pending patent applications worldwide, spanning major jurisdictions including China, the United States, and Europe, and together covering the key inventions that underpin the Company's product pipeline. During the Reporting Period, the Company was granted 7 new patents and filed 22 new patent applications.

Outlook

The Company is committed to bringing better treatment options, covering the full course of disease, to patients with chronic kidney disease and related diseases worldwide.

In the treatment of complications in patients with end-stage renal disease, the New Drug Application for the Company's core product AP301 in China was accepted for review by the NMPA on August 7, 2026, subsequent to the Reporting Period. We will give the review process our full cooperation and, following completion of the global Phase III multi-regional clinical trial in the second quarter of 2027, will submit a New Drug Application to the FDA. In parallel, we will press ahead with capacity preparation at the Yangzhou manufacturing facility and continue building out our nephrology commercialization system, so that AP301 can benefit patients as soon as possible. For AP306, we will work with R1 to advance enrollment and execution of the global Phase IIb multi-regional clinical trial and will disclose topline results in due course.

In delaying the progression of CKD, we have now obtained all Phase II clinical trial approvals for AP303. In the second half of 2026, we will begin site selection for the Phase II basket trial in DKD and IgAN, prepare in parallel for initiation of the Phase II multi-regional clinical trials in ADPKD and FSGS, and map out the later-stage registration pathway for IgAN. For AP308, we will advance the submission of its Investigational New Drug applications and, once the relevant clearances are obtained, initiate the Phase I clinical trial. We will disclose these developments in due course.

In addition, we will continue to strengthen our integrated capabilities across R&D, manufacturing, and commercialization, advance capacity preparation at the Yangzhou manufacturing facility as planned, and continue to expand our product pipeline in kidney disease through a two-pronged approach of internal R&D and external collaboration.

References

[1] Perkovic V, et al. Randomized clinical trials of deutaleglitazar in healthy participants and in patients with diabetic kidney disease. Kidney Int Rep. Published online August 20, 2026. doi:10.1016/j.ekir.2026.107037

[2] Shen X, et al. Therapeutic efficacy and antigenicity of a novel PEGylated IgA protease in preclinical models of IgA nephropathy. Kidney Int. 2026;110:463–476. doi:10.1016/j.kint.2026.04.020

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, New Drug Application accepted for review by the NMPA in China, 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, has obtained a Drug Manufacturing License (Category B) issued by the Jiangsu Provincial Drug Administration, and has completed pilot-scale production and is preparing for scale-up. 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 Statements

This press release contains certain forward-looking statements relating to the Company's future plans, clinical development and registration progress, commercialization prospects and industry trends, among other matters. 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. For further details of the Company's 2026 interim results, please refer to the interim results announcement published on the websites of the Stock Exchange (www.hkexnews.hk) and the Company (www.alebund.com), and the interim report of the Company to be made available in due course.

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SOURCE Alebund Pharmaceuticals