GNT Pharma Obtains European Patent for Manufacturing ZedaCure's Key Ingredient, a Novel Drug for Canine Dementia

On April 20, GNT Pharma, a new drug development company, announced that it has obtained a European patent for the manufacturing process of "Crisdesalazine," a new drug candidate for treating degenerative brain diseases such as Alzheimer's dementia and Lou Gehrig's disease. With this patent, GNT Pharma has established a mass production system to enable the global rollout of "ZedaCure," its novel drug for canine cognitive dysfunction syndrome (dementia).

The newly registered European patent covers core process technology that enables the stable production of high-purity and high-yield active pharmaceutical ingredient (API) for Crisdesalazine. Existing synthesis methods suffered from low stability of intermediates and difficulty in removing impurities, resulting in chemical, manufacturing, and quality control (CMC) risks such as quality fluctuations during large-scale production.

원본보기 아이콘

The GNT Pharma research team addressed these issues by introducing a new strategy that incorporates a specific protecting group. Through an innovative "three-step synthesis method" involving intermediate protection, condensation reactions, and hydrolysis, they effectively blocked the formation of isomer and disubstituted impurities. As a result, the company secured industrial-scale production suitability, enabling the stable mass production of raw materials at a high purity level of 99.9%, with almost no detectable impurities.

"ZedaCure," which contains Crisdesalazine as its active ingredient, is a synthetic veterinary drug that was the first of its kind to be approved in Korea in February 2021, having demonstrated efficacy and safety in dogs suffering from cognitive dysfunction similar to Alzheimer's disease in humans. It is currently prescribed at over 2,000 animal hospitals across Korea.

Clinical trials and post-marketing surveillance (PMS) for ZedaCure have shown that dogs with cognitive dysfunction at all stages, from early to late, experience improvements in memory to near-normal levels, as well as fundamental therapeutic effects, garnering significant attention within the veterinary community.

With the acquisition of this high-quality mass production technology patent, GNT Pharma is accelerating its efforts to expand ZedaCure into the global market. Previously, the company signed an agreement with Chanelle Pharma, Ireland's largest animal pharmaceutical contract development and manufacturing organization (CDMO), for cGMP production and technology transfer.

Chanelle Pharma plans to complete global-standard cGMP production of ZedaCure by the second quarter of next year, based on this newly patented process. GNT Pharma intends to launch a full-scale global market entry starting in the second half of 2027.

Considering the current sales trend of ZedaCure in Korea and the aging trend among pet dogs, the global market for canine cognitive dysfunction treatments is expected to exceed 500 billion won annually starting next year.

Byung-Joo Kwak, CEO of GNT Pharma, stated, "This European patent registration demonstrates that our technology for producing ZedaCure's key raw materials at the highest global quality standards is now internationally recognized. Through close collaboration with Chanelle Pharma, we aim to successfully launch globally by 2027, delivering hope to senior dogs and their owners around the world."

Meanwhile, GNT Pharma is also accelerating clinical research to develop treatments for human Alzheimer's dementia and Lou Gehrig's disease based on Crisdesalazine. In particular, as canine dementia and Alzheimer's dementia in humans share common pathological mechanisms such as amyloid, tau, and neuronal cell death, there is growing interest in whether therapeutic effects can also be demonstrated in future human clinical trials.

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.