CHINA – The China National Medical Products Administration (NMPA) has given a green light on the clearance of the (investigational new drug) IND application of Guangzhou Fermion Technology’s FZ007-119. 

This is the third successful IND approval for the company that specializes in AI-enabled drug discovery and modalities since its founding and highlights the potential of FZ007-119 in the treatment of autoimmune ailments. 

In November 2023, the business submitted an application to obtain IND approval for TYK2 JH2, a dual-specificity protein kinase inhibitor, the pipeline FZ007-119 was marked as one with the fastest rate of advancement. 

The inhibitor which has increased target selectivity and tissue specificity, has been developed using Fermion’s Drug Studio AI drug development platform. The aim is to enhance safety and offer a differentiated product by reducing off-target effects and ensuring accurate distribution in target tissues. 

Preclinical studies suggest that FZ007-119’s greater selectivity for Janus kinase (JAK) 1-3 may lead to substantial clinical benefits, including improved efficacy and safety. 

This exceptional selectivity positions FZ007-119 as a promising new therapy option for autoimmune diseases. 

The company has more than five current pipelines in the autoimmune domain, targeting ailments including inflammatory bowel disease, psoriasis and rheumatoid arthritis. 

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“The FDA has issued numerous black box warnings for related products, and clinicians often conduct multiple tests, including electrocardiogram and liver and kidney function assessments, before prescribing JAK inhibitors, increasing the threshold for their use.” 

Dr. Deco Deng, the creator of Fermion, said: “Regulatory bodies, physicians, and patients continue to express worries about the safety of JAK inhibitors, despite the fact that there are currently several first- and second-generation inhibitors available worldwide that offer benefits in therapeutic effects and convenience.  

“Clinicians frequently perform multiple tests, including electrocardiograms and assessments of liver and kidney function, before prescribing JAK inhibitors, increasing the threshold for their use,” the FDA has stated in several black box warnings for related drugs. 

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