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 www.chinadrugtrials.org.cn 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." References [1] CIC, Global and Chinese Hyperphosphatemia Drug Industry Blue Book, 2023. [2] KDIGO 2017 Clinical Practice Guideline Update. Kidney Int Suppl. 2017;7(1):1–59. [3] Guedes M, et al. Kidney Med. 2023;5(2):100584. doi:10.1016/j.xkme.2022.100584. [4] Zuo L, et al. J Am Soc Nephrol. 2025;36(10S):TH-PO1200. doi:10.1681/ASN.202556bnmcy8. 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 www.alebund.com . 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.
2026-08-07 10:40:00
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