A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:
* Does AP301 lower blood phosphate levels?
* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?
* What discomfort or medical problem do the patients have when taking AP301?
* Does AP301 improve quality of life in Chinese patients?
The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.
In the study, the patients will experience the following stages in a chronicle order:
* Stop all using blood phosphate-lowering drugs,
* Take AP301 or the comparator three times a day for 8 weeks,
* Take AP301 three times a day for 24 weeks, and
* Take AP301 or the comparator three times a day for 3 weeks.
In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.
If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Start Date13 Jun 2025

Sponsor / Collaborator

Alebund Pharmaceuticals (Jiangsu) Co., Ltd.

[+1]

CTR20250674

/ CompletedPhase 1

一项在中国健康受试者中评估AP301与西那卡塞的药物-药物相互作用的研究

[Translation] A study evaluating drug-drug interactions between AP301 and cinacalcet in healthy Chinese subjects

主要目的：在健康男性和女性受试者中评估AP301（2.1g/次，每日3次）连续2日口服给药对西那卡塞（75 mg）单次口服给药的PK影响。次要目的：在健康男性和女性受试者中评估AP301和西那卡塞联合给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the PK effect of AP301 (2.1 g/time, 3 times daily) administered orally for 2 consecutive days on a single oral administration of cinacalcet (75 mg) in healthy male and female subjects. Secondary objective: To evaluate the safety and tolerability of AP301 and cinacalcet co-administered in healthy male and female subjects.

Start Date09 Apr 2025

Sponsor / Collaborator

Shanghai Alebund Pharmaceuticals Co., Ltd.

[+1]

CTR20250363

/ CompletedPhase 1

一项在中国健康参与者中评估AP301与罗沙司他的药物-药物相互作用的研究

[Translation] A study evaluating drug-drug interactions between AP301 and roxadustat in healthy Chinese participants

主要目的：在健康男性和女性参与者中评估AP301（2.1 g/次，每日3次）连续2日口服给药对罗沙司他（150 mg）单次口服给药的PK影响。次要目的：在健康男性和女性参与者中评估AP301和罗沙司他同时口服给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the PK effect of AP301 (2.1 g/time, 3 times daily) administered orally for 2 consecutive days on a single oral administration of roxadustat (150 mg) in healthy male and female participants. Secondary objective: To evaluate the safety and tolerability of AP301 and roxadustat administered orally simultaneously in healthy male and female participants.

Start Date03 Mar 2025

Sponsor / Collaborator

Shanghai Alebund Pharmaceuticals Co., Ltd.

[+1]

100 Clinical Results associated with VS-505

100 Translational Medicine associated with VS-505

100 Patents (Medical) associated with VS-505

Literatures (Medical) associated with VS-505

27 Sep 2024·Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis

Article

Author: Li, Kanghui ; Yuan, Weijie ; Liu, Bin ; Li, Yiwen ; Ye, Hong ; Peng, Ai ; Shi, Ming ; Zhang, Zhizheng ; Lin, Hongli ; Chen, Xiaolan ; Zheng, Huixiao ; Zhang, Weifeng ; Lu, Wei ; Zheng, Feng ; Wang, Song ; Gao, Qing ; Zuo, Li ; He, Qiang ; Liu, Yingxue Cathy ; Wang, Baoxing ; Long, Gang ; Luo, Yuan ; Wang, Lihua ; Luo, Ping ; Yang, Junwei ; Zhang, Shiying ; Liu, Tongqiang ; Liu, Changhua ; Zhuang, Bing ; Li, Xiaoling ; Gan, Liangying

ABSTRACT:

Background:

VS-505 (AP301), an acacia and ferric oxyhydroxide polymer, is a novel fiber-iron-based phosphate binder. This two-part Phase 2 study evaluated the tolerability, safety and efficacy of oral VS-505 administered three times daily with meals in treating hyperphosphatemia in chronic kidney disease (CKD) patients receiving maintenance hemodialysis (MHD).

Methods:

In Part 1, patients received dose-escalated treatment with VS-505 2.25, 4.50 and 9.00 g/day for 2 weeks each, guided by serum phosphorus levels. In Part 2, patients received randomized, open-label, fixed-dosage treatment with VS-505 (1.50, 2.25, 4.50 or 6.75 g/day) or sevelamer carbonate 4.80 g/day for 6 weeks. The primary efficacy endpoint was the change in serum phosphorus.

Results:

The study enrolled 158 patients (Part 1: 25; Part 2: 133), with 130 exposed to VS-505 in total. VS-505 was well tolerated. The most common adverse events were gastrointestinal disorders, mainly feces discolored (56%) and diarrhea (15%; generally during Weeks 1–2 of treatment). Most gastrointestinal disorders resolved without intervention, and none was serious. In Part 1, serum phosphorus significantly improved (mean change −2.0 mg/dL; 95% confidence interval −2.7, −1.4) after VS-505 dose escalation. In Part 2, serum phosphorus significantly and dose-dependently improved in all VS-505 arms, with clinically meaningful reductions with VS-505 4.50 and 6.75 g/day, and sevelamer carbonate 4.80 g/day [mean change −1.6 (−2.2, −1.0), −1.8 (−2.4, −1.2) and −1.4 (−2.2, −0.5) mg/dL, respectively]. In both parts, serum phosphorus reductions occurred within 1 week of VS-505 initiation, returning to baseline within 2 weeks of VS-505 discontinuation.

Conclusion:

VS-505, a novel phosphate binder, was well tolerated with a manageable safety profile, and effectively and dose-dependently reduced serum phosphorus in CKD patients with hyperphosphatemia receiving MHD.

Clinical Trial registration number:

NCT04551300

01 Jan 2022·Computational and structural biotechnology journal

Conformational ensemble of the TNF-derived peptide solnatide in solution

Article

Author: Eaton, Douglas C. ; Martin-Malpartida, Pau ; Macias, Maria J. ; Fischer, Bernhard ; Arrastia-Casado, Silvia ; Tzotzos, Susan ; Farrera-Sinfreu, Josep ; Lucas, Rudolf ; Fischer, Hendrik

Tumor necrosis factor (TNF) is a homotrimer that has two spatially distinct binding regions, three lectin-like domains (LLD) at the TIP of the protein and three basolaterally located receptor-binding sites, the latter of which are responsible for the inflammatory and cell death-inducing properties of the cytokine. Solnatide (a.k.a. TIP peptide, AP301) is a 17-mer cyclic peptide that mimics the LLD of human TNF which activates the amiloride-sensitive epithelial sodium channel (ENaC) and, as such, recapitulates the capacity of TNF to enhance alveolar fluid clearance, as demonstrated in numerous preclinical studies. TNF and solnatide interact with glycoproteins and these interactions are necessary for their trypanolytic and ENaC-activating activities. In view of the crucial role of ENaC in lung liquid clearance, solnatide is currently being evaluated as a novel therapeutic agent to treat pulmonary edema in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), as well as severe COVID-19 patients with ARDS. To facilitate the description of the functional properties of solnatide in detail, as well as to further target-docking studies, we have analyzed its folding properties by NMR. In solution, solnatide populates a set of conformations characterized by a small hydrophobic core and two electrostatically charged poles. Using the structural information determined here and also that available for the ENaC protein, we propose a model to describe solnatide interaction with the C-terminal domain of the ENaCα subunit. This model may serve to guide future experiments to validate specific interactions with ENaCα and the design of new solnatide analogs with unexplored functionalities.

01 Dec 2017·Critical care (London, England)Q1 · MEDICINE

Inhaled AP301 for treatment of pulmonary edema in mechanically ventilated patients with acute respiratory distress syndrome: a phase IIa randomized placebo-controlled trial

Q1 · MEDICINE

ArticleOA

Author: Krenn, Katharina ; Markstaller, Klaus ; Klein, Klaus Ulrich ; Ullrich, Roman ; Boehme, Stefan ; Croizé, Adrien ; Hermann, Robert ; Lucas, Rudolf

BACKGROUND:

High-permeability pulmonary edema is a hallmark of acute respiratory distress syndrome (ARDS) and is frequently accompanied by impaired alveolar fluid clearance (AFC). AP301 enhances AFC by activating epithelial sodium channels (ENaCs) on alveolar epithelial cells, and we investigated its effect on extravascular lung water index (EVLWI) in mechanically ventilated patients with ARDS.

METHODS:

Forty adult mechanically ventilated patients with ARDS were included in a randomized, double-blind, placebo-controlled trial for proof of concept. Patients were treated with inhaled AP301 (n = 20) or placebo (0.9% NaCl; n = 20) twice daily for 7 days. EVLWI was measured by thermodilution (PiCCO®), and treatment groups were compared using the nonparametric Mann-Whitney U test.

RESULTS:

AP301 inhalation was well tolerated. No differences in mean baseline-adjusted change in EVLWI from screening to day 7 were found between the AP301 and placebo group (p = 0.196). There was no difference in the PaO₂/FiO₂ ratio, ventilation pressures, Murray lung injury score, or 28-day mortality between the treatment groups. An exploratory subgroup analysis according to severity of illness showed reductions in EVLWI (p = 0.04) and ventilation pressures (p < 0.05) over 7 days in patients with initial sequential organ failure assessment (SOFA) scores ≥11 inhaling AP301 versus placebo, but not in patients with SOFA scores ≤10.

CONCLUSIONS:

There was no difference in mean baseline-adjusted EVLWI between the AP301 and placebo group. An exploratory post-hoc subgroup analysis indicated reduced EVLWI in patients with SOFA scores ≥11 receiving AP301. These results suggest further confirmation in future clinical trials of inhaled AP301 for treatment of pulmonary edema in patients with ARDS.

TRIAL REGISTRATION:

The study was prospectively registered at clinicaltrials.gov, NCT01627613 . Registered 20 June 2012.

News (Medical) associated with VS-505

07 Aug 2026

·www.prnewswire.com

Alebund's AP301 NDA Accepted for Review by China's NMPA

SHANGHAI, Aug. 7, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; HKEX: 09637), a renal-focused biopharmaceutical company, today announced that the New Drug Application (NDA) for AP301 capsules, a novel oral iron-based phosphate binder, for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) receiving maintenance dialysis, is formally accepted for review by China's National Medical Products Administration (NMPA) today. The NDA is supported primarily by the results of RESPOND-1, the pivotal Phase III clinical trial of AP301 completed in China, together with other accumulated clinical data. AP301 is a novel fiber-iron-based phosphate binder that offers high phosphate-binding capability, does not require chewing before swallowing, does not expand in volume when exposed to gastric fluid, and is not systemically absorbed. These features contribute to a reduced pill burden, improved tolerability, and enhanced patient adherence. AP301 China Pivotal Phase III Trial (RESPOND-1) RESPOND-1 was a randomized, open-label, active-controlled, multicenter pivotal Phase III clinical trial conducted at 50 sites in China and led by Professor Li Zuo, Director of the Department of Nephrology at Peking University People's Hospital. A total of 474 patients with hyperphosphatemia receiving maintenance dialysis were randomized in a 3:1 ratio to AP301 (355 patients) or sevelamer carbonate (119 patients) for a 52-week treatment period, with doses in both groups titrated to the same serum phosphate target.[4] The trial met both of its pre-specified primary efficacy endpoints. The AP301 maintenance dose demonstrated clinically and statistically significant superiority over the ineffective low dose in reducing serum phosphate levels, and the efficacy of AP301 was robust and sustained throughout the entire 52-week treatment period, meeting the endpoint of non-inferiority to sevelamer carbonate in reducing serum phosphate levels as designed in the trial. AP301 was safe and well tolerated. The most common adverse events were discolored feces and diarrhea. Diarrhea generally occurred early in treatment and resolved without any change to treatment. At Week 12, the AP301 group was non-inferior to the active comparator sevelamer carbonate group in reducing serum phosphate levels least-squares mean reductions from baseline of 0.72 mmol/L ([2.22 mg/dL] vs. 0.70 mmol/L [2.22 mg/dL] vs. 0.70 mmol/L [2.17 mg/dL], respectively); the upper bound of the 95% confidence interval (CI) for the between-group difference (0.06 mmol/L [0.20 mg/dL]) was below the pre-defined non-inferiority margin of 0.19 mmol/L (0.59 mg/dL), demonstrating that AP301 met the pre-specified non-inferiority criterion. During the low-dose control period (from the end of Week 24 to the end of Week 27), among AP301 responders (serum phosphate <1.78 mmol/L [5.5 mg/dL] at the end of Week 20) who were re-randomized 1:1, serum phosphate control in the AP301 maintenance-dose group (94 patients) was superior to that in the AP301 ineffective low-dose control group (93 patients), with a between-group difference of -0.58 mmol/L (-1.8 mg/dL) (P<0.001), which was both clinically and statistically meaningful. At Week 52, the AP301 group showed a greater mean reduction in serum phosphate level from baseline than the sevelamer carbonate group (0.76 mmol/L [2.35 mg/dL] vs. 0.72 mmol/L [2.22 mg/dL]), a higher serum phosphate target attainment rate (66.7% vs. 58.6%), and a lower mean daily dose exposure (AP301 6.52 g/day vs. sevelamer carbonate 7.56 g/day). AP301 achieved a robust and sustained reduction in serum phosphate levels throughout the 52-week treatment period[4]. AP301 was generally safe and well tolerated over the 52-week treatment period. The most common adverse events were discolored feces and diarrhea. Diarrhea generally occurred early in treatment and resolved without any change to treatment. In addition, no notable iron-overload risk signal was observed during the 52-week treatment period. Results from RESPOND-1 were presented at the American Society of Nephrology (ASN) Kidney Week 2025.[4] Further details of the trial are available at clinicaltrials.gov under identifier NCT07030595, or at under registration number CTR20231624. Hyperphosphatemia and Unmet Medical Need Hyperphosphatemia is a common complication in patients with CKD receiving dialysis, affecting approximately 95% of patients with end-stage renal disease ("ESRD") on dialysis.[1] Chronically elevated serum phosphate is associated with vascular calcification, secondary hyperparathyroidism and renal osteodystrophy, as well as increased risks of cardiovascular events and all-cause mortality.[2] Regular dialysis and dietary phosphorus restriction are generally insufficient to adequately control the phosphate burden, and patients often require long-term pharmacological treatment. Despite the widespread use of phosphate binders, according to data from China Insights Consultancy, approximately 76% of dialysis patients in China fail to achieve the target serum phosphate range of 1.13–1.78 mmol/L [3.5–5.5 mg/dL];[1] separately, according to 2021 data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), approximately 52% and 39% of hemodialysis patients in the United States and Japan, respectively, had serum phosphate levels above 1.78 mmol/L [5.5 mg/dL].[3] Existing therapies continue to face challenges in gastrointestinal tolerability, pill burden and long-term treatment adherence, and innovative treatment options that combine efficacy, tolerability and dosing convenience remain to be further developed.[1-3] Dr. Gavin Guoyao Xia, Co-founder, Chairman of the Board, and Chief Executive Officer of Alebund Pharmaceuticals, said: "The NMPA's acceptance of the NDA for AP301 marks a key step in advancing Alebund's proprietary products from clinical development toward commercialization, and an important milestone in our global strategy. Hyperphosphatemia requires long-term management, yet reconciling efficacy, safety and adherence remains a core challenge in clinical care today. As a potential best-in-class oral phosphate binder, AP301 can genuinely offer patients with chronic kidney disease on dialysis a long-term treatment option that brings together efficacy, tolerability and dosing convenience. Building on this acceptance, we will actively support the review process and, drawing on our manufacturing base in Yangzhou, accelerate our preparations for launch. We look forward to bringing this innovation from China to patients with kidney diseases around the world." Jin Tian, M.D., Co-founder and Chief Medical Officer of Alebund Pharmaceuticals, commented: "Achieving the sustained serum phosphate control within the target range over the long term remains a major challenge for patients with chronic kidney disease on dialysis. Results from the AP301 China Phase III pivotal study confirmed that this novel iron-based phosphate binder effectively lowers phosphorus, is safe, and well tolerated. We will work closely throughout the review process and continue to advance the global clinical development of AP301, with the goal of making a new phosphate lowering product available to patients as soon as possible." 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, 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 . 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 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 2NDA

21 Jul 2026

·www.prnewswire.com

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 . Media and Investor Inquiries Media and Investor Relations: [email protected] Website: 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 21% more press release views with Request a Demo

Phase 2License out/inBreakthrough TherapyClinical ResultPhase 3

29 Jun 2026

·www.prnewswire.com

Alebund Pharmaceuticals (09637.HK) Debuts on the HKEx Main Board

Deepening Its Commitment to Kidney Disease and Accelerating Toward Becoming a Global Leader in Renal Innovation SHANGHAI, June 29, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; stock code: 09637.HK), a biopharmaceutical company focused on kidney disease, with the broadest pipeline by renal indication coverage, today listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Stock Exchange"). The Global Offering marks Alebund's entry into the international capital markets, positioning the Company as a scarce, innovation-driven renal-focused asset in Hong Kong's capital market. Continue Reading Alebund Pharmaceuticals lists on the Main Board of The Stock Exchange of Hong Kong Limited The Global Offering comprised a total of 56,755,400 H Shares at an Offer Price of HK$22.60 per Offer Share, consisting of 5,675,600 H Shares under the Hong Kong Public Offering and 51,079,800 H Shares under the International Offering. Without taking into account any exercise of the Over-allotment Option (the "Greenshoe"), total gross proceeds amounted to approximately HK$1.283 billion (approximately US$164 million). If the Over-allotment Option (up to 8,513,300 H Shares) is exercised in full, the total gross proceeds will increase to approximately HK$1.475 billion (approximately US$189 million). After deducting offering expenses, the Company estimates that the net proceeds from the Global Offering will be approximately HK$1.181 billion. Following the market open today, Alebund's shares show strong performance; as of the close, the share price rose 103.54%, closing at HK$46.0 per share. The Global Offering attracted a strong line-up of cornerstone investors, including GIC, Loomis Sayles, RTW, SymBiosis, Tencent, Cormorant, Dymon Asia, GF Fund, China Universal, E Fund and Loyal Valley Capital, among other renowned institutions. The cornerstone investors subscribed for a total of approximately US$81.5 million (approximately HK$639 million), representing approximately 49.78% of the shares offered under the Global Offering. The International Offering was approximately 19.77 times oversubscribed, and the Hong Kong Public Offering was approximately 963.56 times oversubscribed, reflecting enthusiastic demand. The strong cornerstone line-up and robust market response fully demonstrate the global capital markets' high recognition of the scarcity value of Alebund's innovative renal pipeline, as well as their firm confidence in the Company's core value and long-term development potential. A Broad and Well-Balanced Renal Innovation Pipeline Alebund has built the industry's broadest pipeline in terms of kidney disease indication coverage: AP301 is a best-in-class oral phosphate binder for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, with its registrational Phase III trial in China having met the primary endpoint, a New Drug Application (NDA) to the National Medical Products Administration (NMPA) planned for the near future, and its China-U.S. Phase III multi-regional clinical trial (MRCT) having completed enrollment. AP306 is a first-in-class pan-phosphate transporter inhibitor that has received Breakthrough Therapy Designation (BTD) from the NMPA and whose rights outside Chinese Mainland, Hong Kong, Macau and Taiwan have been licensed to R1 Therapeutics. China Phase II data demonstrated monotherapy reducing mean serum phosphate by 2.51 mg/dL from baseline and approximately 95% of patients achieving serum phosphate below 5.5 mg/dL by Week 7-8 (versus approximately 50% for the active control, sevelamer carbonate, in the same trial). AP303 is a first-in-class, differentiated dual PPAR agonist designed to delay or halt the progression of CKD across potential indications including diabetic kidney disease (DKD) and IgA nephropathy (IgAN), and has received Orphan Drug Designation (ODD) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) from the U.S. FDA. In the completed Phase I trials in Australia and China, AP303 demonstrated favorable safety and was well tolerated in healthy volunteers as well as in patients with DKD, and there was a clear and robust dose-dependent pharmacodynamic ("PD") signal. Alebund has received IND clearance from the NMPA and the FDA for AP303, and expects to conduct a basket Phase II clinical trial in DKD and IgAN patients in the second half of 2026. AP308 is a first-in-class engineered recombinant IgA protease aiming for a functional cure of IgAN. The Company plans to submit an IND to the U.S. FDA and China's NMPA in the third quarter of 2026 and to enter the clinical development stage. The Company's commercialized renal anemia product Mircera®, a long-acting ESA (erythropoiesis-stimulating agent), continues to gain traction, marking Alebund's accelerating transition from biotech to biopharma. Focusing on the "Silent Majority" and Addressing Vast Unmet Needs Kidney disease is a long-underestimated field with vast unmet clinical needs. There are more than 800 million people living with chronic kidney disease worldwide, including nearly 124 million patients in China. Taking hyperphosphatemia as an example, approximately 76% of dialysis patients in China have uncontrolled serum phosphate levels — far higher than in the United States (52%) and Japan (39%) — reflecting a treatment need that is real, long-term and structural. Alebund firmly focuses on kidney disease, the "silent majority," committed to providing higher-quality and more accessible treatment options for kidney disease patients worldwide. Messages from Management Dr. Gavin Xia, Co-founder, Chief Executive Officer and Chairman of the Board of Alebund, said: "Listing on the Main Board of The Stock Exchange of Hong Kong Limited is an important milestone in Alebund's journey. Alebund's rapid growth and successful listing on the Hong Kong Stock Exchange would not have been possible without the relentless efforts of our team, nor without the support of government authorities at all levels, our investors, and partners across all sectors. From this new starting point, Alebund will continue to accelerate the clinical and commercialization progress of its product pipeline, further upgrade its globally competitive integrated kidney disease platform, reward shareholders and partners with even stronger performance, and safeguard patients worldwide with higher-quality kidney disease treatment solutions." Dr. Jin Tian, Co-founder and Chief Medical Officer of Alebund, said: "Alebund is dedicated to overcoming the persistent therapeutic challenges associated with chronic kidney disease and has established a highly differentiated and innovative product pipeline. Our lead asset, AP301, has successfully completed a Phase III registrational trial in China and is on track for New Drug Application (NDA) submission, which we expect to provide a better option for the management of hyperphosphatemia in patients receiving dialysis. In parallel, we are rapidly advancing the clinical development of our follow-up pipeline candidates, striving to bring next-generation therapies to patients with renal disease as quickly as possible." About Alebund Pharmaceuticals Alebund Pharmaceuticals (09637.HK) was established in Shanghai, China in early 2018. It is a biopharmaceutical company focused on kidney disease and related chronic diseases, with the broadest pipeline in terms of renal indication coverage, principally engaged in the discovery, development, manufacturing and commercialization of innovative drugs in these areas, with the aim of providing better clinical treatment solutions for patients with chronic kidney disease and related diseases worldwide. Alebund has established a rich and well-balanced pipeline of innovative kidney disease drugs, including seven product candidates and one commercialized product (Mircera®), with indications spanning hyperphosphatemia, renal anemia, IgA nephropathy (IgAN), diabetic kidney disease (DKD), focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD), among others. The Company has built and commenced operations at a manufacturing facility in Yangzhou, Jiangsu, which has obtained a Drug Manufacturing License (Category B) issued by the Jiangsu Provincial Drug Administration, to support the future commercialization of AP301 and other pipeline products. The Company has also established a specialized nephrology sales team responsible for the commercialization of related products in China. Company website: 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. This press release does not constitute an offer to sell or a solicitation of an offer to purchase any securities. For complete information on the Global Offering, please refer to the prospectus published by the Company. SOURCE Alebund Pharmaceuticals 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 2Orphan DrugBreakthrough Therapy

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	Phase 3	China	Alebund Pharmaceuticals (Jiangsu) Co., Ltd.	12 Jun 2023
Kidney Failure, Chronic	Phase 3	China	Alebund Pharmaceuticals (Jiangsu) Co., Ltd.	12 Jun 2023
Chronic Kidney Diseases	Phase 2	China	Shanghai Alebund Pharmaceuticals Co., Ltd.	13 Oct 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07030595 (RESPOND-1, ASN2025 \| Company_Website)	Phase 3	Hyperphosphatemia	474	AP301	aczcuhwhff(bepllcelni) = qaxwfvsggq sxexokqcdw (bdocwrgkgo )	Non-inferior	06 Nov 2025
				AP301	aczcuhwhff(bepllcelni) = zofpigjpzb sxexokqcdw (bdocwrgkgo )
NCT07030595 \| CTR20231624 (PRNewswire) Manual	Phase 3	Hyperphosphatemia	474	AP301	oqdekxaxqo(cjodslmwdm) = The trial met its primary endpoint deihhvxbio (nmfhoajyqu ) Met	Positive	26 Jun 2025
				sevelamer carbonate active contro
NCT04551300 (Pubmed) Manual	Phase 2	Hyperphosphatemia Maintenance	130	VS-505 2.25 g/day	jdtsobsqhf(qscforecwe) = umpjjnlikl efkphcjdvt (gmmsibwnlv, -2.7 to -1.4)	Positive	07 Mar 2024
				VS-505 4.50 g/day	jdtsobsqhf(qscforecwe) = wxxojknstg efkphcjdvt (gmmsibwnlv )
NCT02469467 (VS-505, ASN2018)	Phase 1/2	-	-	VS-505	yithihtbdo(jtkudukepw) = no change of Ca levels jicvgrujea (menqdsyfwv ) View more	Positive	23 Oct 2018
				Sevelamer

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