The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Alebund Pharmaceuticals (Jiangsu) Limited 禮邦醫藥(江蘇)股份有限公司 (the "Company") (A joint stock company incorporated in the ...

Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][12] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, both containing the active ingredient tenapanor [12] Product Information - XPHOZAH (tenapanor) is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. FDA for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis [2][11] - It is indicated as add-on therapy for patients who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy [11] - XPHOZAH operates through a unique mechanism that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily [2][6] Clinical Study Insights - The OPTIMIZE Study was a randomized, open-label trial involving 330 patients with CKD on dialysis and hyperphosphatemia, aimed at evaluating methods for initiating XPHOZAH to optimize phosphorus management [3] - A post-hoc analysis of this study has been accepted for presentation at the National Kidney Foundation Spring Clinical Meetings [1][4] Safety and Efficacy - Diarrhea was the most common side effect reported in clinical trials, occurring in 43-53% of patients, with severe diarrhea reported in 5% of patients [10] - The majority of diarrhea events were mild-to-moderate and typically resolved over time or with dose reduction [10] Industry Context - Hyperphosphatemia is a serious condition affecting the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [7] - The KDIGO treatment guidelines recommend lowering elevated phosphate levels toward the normal range of 2.5-4.5 mg/dL [7]