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
The Global Offering comprised a total of 56,755,400 H Shares at an
Following the market open today, Alebund's shares show strong performance; as of the close, the share price rose 103.54%, closing at
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
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 itsChina -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 andTaiwan 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 inAustralia andChina , 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 andChina'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
Messages from Management
Dr.
Dr.
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: 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. 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.
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SOURCE Alebund Pharmaceuticals
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