Alebund’s Innovative Investigational Drug AP306 Receives NMPA’s Breakthrough Therapy Designation (BTD) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease (CKD)

June 25, 2024, Shanghai, China—Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to AP306 for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).

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Alebund Presents Phase 2 Trial Results of AP306 at the 61st European Renal Association (ERA) Congress

  • In the completed phase 2 study (NCT05764590), AP306 monotherapy significantly reduced serum phosphate and substantially improved the serum phosphate control rate in hemodialysis patients with hyperphosphatemia. AP306 was safe and well-tolerated.
  • Alebund is actively advancing further clinical development of AP306.

May 27, 2024, Shanghai, China—Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, presented the phase 2 study results of AP306 in hemodialysis patients with hyperphosphatemia through the Focused Oral at the 61st European Renal Association (ERA) Congress in Stockholm, Sweden.

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Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

March 29, 2024, Shanghai, China – Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

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Alebund Reports Update for AP306 (EOS789), a First-in-Class Pan-inhibitor of Sodium-dependent Phosphate Transporters, from a Completed Phase 2 Clinical Trial in Patients with Hyperphosphatemia on Hemodialysis

December 13, 2023, Shanghai, China—Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced phase II proof-of-concept study results for the investigational drug, AP306, a first-in-class, pan-inhibitor of sodium-dependent phosphate transporters, which was discovered by Chugai Pharmaceutical Co., Ltd., and previously referred by EOS789.

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Alebund Reached Cooperation with Roche to Commercialize MIRCERA® In China

October 19 2023, Shanghai, China — Roche Pharmaceutical (hereinafter referred to as “Roche”) and Alebund Pharmaceuticals (hereinafter referred to as “Alebund”) entered a supply and marketing agreement, under which Alebund will exclusively promote Roche’s MIRCERA® (methoxy polyethylene glycol-epoetin beta) in mainland China.

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Alebund Achieved First Patient Enrolment for AP301 Pivotal Phase 3 Clinical Trial and Successfully Held Investigator Meeting in Beijing

July 17 2023, Shanghai, China — Alebund Pharmaceuticals (“Alebund” or the “Company”), a biopharmaceutical company dedicated to developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced that the first patient was enrolled and dosed on June 30 in its phase 3 trial “a randomized, open-label, multicenter phase 3 study to evaluate the efficacy and safety of AP301 on serum phosphorus control in dialysis patients with hyperphosphatemia ”(AP301-HP-02 Phase 3 Clinical Trial). Clinical trial information is available at www.chinadrugtrials.org.cn with identifier CTR20231624. Professor Li ZUO, Director of Department of Nephrology at Peking University People’s Hospital, acts as the leading investigator of the AP301 pivotal phase 3 clinical trial. The trial will be conducted in 50 sites and plan to enroll 472 hyperphosphatemia patients, among which 90% on hemodialysis and 10% on peritoneal dialysis.

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Alebund Pharmaceuticals Closes Nearly RMB 200 Million Pre-C Round Financing and Secures RMB 800 Million Syndicated Loan Credit

Shanghai, China, April 12th, 2023—Alebund Pharmaceuticals (“Alebund” or the “Company”) announced that it has closed its Pre-C round financing, with close to RMB 200 million. Participants in this round include Yangzhou Guojin Investment, Jiangsu Dingxin Capital, Yangzhou Longchuan Holdings a leading international sovereign fund, Lilly Asia Venture, Quan Capital, 3H Health, Octagon Capital, and Verition Fund.

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China’s NMPA Clears Phase 3 IND Application for Alebund Pharmaceutical’s AP301, a New-generation Iron-based Phosphate Binder, to Treat Hyperphosphatemia in Dialysis Patients

March 17, 2023, Shanghai, China—Alebund Pharmaceuticals (“Alebund” or the “Company”) announced that China’s National Medical Products Administration (NMPA) has granted approval for the company’s IND application for a phase 3 study of AP301 to treat hyperphosphatemia in dialysis patients.

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Alebund Pharmaceuticals and Peking University First Hospital enter into a strategic partnership to develop a novel and specific treatment for IgA Nephropathy (IgAN)

SHANGHAI/BEIJING, CHINA, June 30, 2022 — Alebund Pharmaceuticals, a biopharmaceutical company dedicated to developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced a strategic partnership between its subsidiary Alezyme and Peking University First Hospital, to discover, develop and commercialize PKU308/AP308, a potential innovative and specific therapeutic for IgAN. Designed and developed by Peking University First Hospital, this compound has a completely innovative mechanism of action (MOA) as compared to currently available treatment options.

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Alebund Pharmaceuticals Holds Groundbreaking Ceremony for Yangzhou Research and Production Base

Yangzhou, China, Dec. 7, 2021 – Alebund Pharmaceuticals (“Alebund” or the “Company”), a biopharmaceutical company dedicated to developing innovative therapies for the treatment of renal diseases and related chronic conditions, held today a groundbreaking ceremony for its research and production plant in Jiangsu province’s Yangzhou city.

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