The China National Medical Products Administration (NMPA) has granted clearance for the IND application of Guangzhou Fermion Technology’s FZ007-119.
This is the company’s third successful IND approval since its founding and highlights the potential of FZ007-119 in the treatment of autoimmune ailments.
The company filed an application seeking IND approval for the tyrosine kinase 2 (TYK2) JH2 [a dual-specificity protein kinase] inhibitor in November 2023.
FZ007-119, 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.
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The company has more than five current pipelines in the autoimmune domain, targeting ailments including inflammatory bowel disease, psoriasis and rheumatoid arthritis.
FZ007-119 is the most rapidly progressing pipeline.
Fermion founder Dr Deco Deng stated: “While there are already multiple first and second-generation JAK inhibitors globally, possessing advantages in therapeutic effects and convenience, concerns persist among regulatory agencies, clinicians and patients regarding the safety of JAK inhibitors.
“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.”