NEWS

NEWARK, CA • SEPTEMBER 7, 2022

AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for AL01211 as a treatment for Fabry disease. “Receiving an FDA Orphan Drug Designation further validates AL01211 as a novel, once-daily orally administered GCS inhibitor as a potential treatment to improve the quality of life of patients suffering from Fabry disease,” said Marvin Garovoy, M.D., Chief Medical Officer of AceLink Therapeutics. “AL01211 was selected based on its unique properties, including high potency and inability to cross the blood-brain barrier, to more effectively treat the peripheral organs affected by Fabry disease.”

NEWARK, CA & SUZHOU, CHINA • MARCH 4, 2022

AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases and rare genetic diseases, announced today that the IND application of company’s lead compound AL01211 was approved by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). 

NEWARK, CA & SUZHOU, CHINA • DECEMBER 10, 2021

AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases, announced today that the IND application of company’s lead compound AL01211 was accepted by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). Dr. Jerry Shen, Chairman, CEO and co-founder of the company said, “this is a big milestone for our young and growing company. AL01211 is a highly specific and potent glucosylceramide synthase inhibitor that is suitable for various non-CNS indications. We are very looking forward to having the clearance and approval from Center for Drug Evaluation (CDE) of NMPA so we can advance to clinical trials in China.”

NEWARK, CA • OCTOBER 29, 2021

Acelink Therapeutics would like to congratulate our team member Jessica Nario for winning the Bronze or third-place award for The PharmaTimes Clinical Researcher of the Year – The Americas (PTCROY) in 2021. Jessica Nario is Associate Director of Clinical Operations, leading several aspects of clinical study conduct including strategic organization and vendor partnerships, clinical study start-up, execution, and closure for Acelink’s lead molecule AL01211 which is now in clinical development within Australia and USA with a potential expansion in Europe. Jessica is an integral member of the team.

NEWARK, CA & SUZHOU, CHINA • AUGUST 10, 2021

AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases, announced today that it has established AceLink Therapeutics China subsidiary at Suzhou Industry Park, China. Dr. Jerry Shen, Chairman, CEO and co-founder of the company said, “we are very excited to have our China company established. This new entity will allow us to interact closely with our local partners, conduct clinical trials in China and recruit local talents to advance our research and development programs. Our mission is to bring products to China market to help Chinese patients with unmet medical needs and to bring the drug candidates developed in China to the global market”. 

NEWARK, CA • JULY 6, 2021

AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for kidney diseases, today announced dosing the first human subject in its Phase I clinical trial evaluating AL01211, a novel small molecule glucosylceramide synthase (GCS) inhibitor.

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