AceLink Therapeutics Received the IND Clearance for AL01211 from Chinese NMPA

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). Dr. Jerry Shen, Chairman, CEO and co-founder of the company said, “AL01211 is a new-generation glucosylceramide synthase inhibitor with favorable drug-like properties.  It adds a new tool to the arsenal for the treatment of Fabry disease and several other disease indications.  Now with the IND clearance, we are very excited to initiate the clinical programs in China as planned.” Dr. Jianhong Zheng, General Manager of AceLink China also commented, “ The IND approval of AL01211 as a Class One innovative drug by CDE/NMPA marks an important milestone for AceLink and allows the clinical development of AL01211 in China to address critical unmet medical needs and brings hope to patients around the world”.

About AceLink Therapeutics, Inc.

Founded in 2018, AceLink Therapeutics is an innovative biopharma startup focusing on developing safe and effective medicines to address kidney diseases and rare genetic diseases with high unmet needs. The company’s initial focus is to develop AL01211 for the treatment of Fabry disease, a disease that causes multi-organ disorders including dysfunction of the kidneys.

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About AL01211

AL01211 is a proprietary GCS inhibitor with excellent potency and great selectivity against a broad range of therapeutic targets.  It possesses favorable drug properties and is intended for once-daily oral administration. 

About GCS inhibitor

GCS (glucosylceramide synthase) catalyzes the first step in the synthesis of glycosphingolipids, a group of bioactive molecules that play important roles in various cellular processes.  A GCS inhibitor reduces the production of glycosphingolipids, thereby exerting beneficial effects to diseases such as Fabry Disease.

Contact Information:

Jerry Shen, Ph.D.

CEO and President

Phone: (925) 262-3145


Jianhong Zheng, Ph.D.

General Manager, AceLink Therapeutics, China

Phone: 15821372802


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