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.”

“We are very excited to achieve this regulatory milestone. AL01211 is the first drug candidate in our development pipeline. From proof of concept, to preclinical and CMC IND enabling, the NMPA IND acceptance is a testament to our team’s strong scientific and technical strength in translational medicine, and vision and commitment in bringing innovative therapeutics to patients in disease areas with urgent medical needs,” said Jianhong Zheng, General Manager of AceLink China. “We will start our planned China clinical program once we get IND clearance, and look forward to joining the global phase 2 study in 2022”.

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 with high unmet needs. The company’s initial focus is to develop novel therapeutics for genetically associated kidney disorders, such as Fabry disease. For more information, please visit www.acelinktherapeutics.com.

About AL01211

AL01211 is a proprietary GCS inhibitor with excellent potency (single-digit nanomolar IC₅₀) 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

Email: [email protected]

Jianhong Zheng, Ph.D.

General Manager, AceLink Therapeutics, China

Phone: 15821372802

Email: [email protected]