Guangzhou Fermion Technology Co., Ltd. (Fermion), an AI drug discovery company focused on drug development for autoimmune diseases and pain management, is pleased to announce investigational new drug (IND) approval for its TYK2 JH2 inhibitor, FZ007-119, by the Chinese agency NMPA, the China National Medical Products Administration. This is Fermion's third IND approval since its inception.
FZ007-119 is a third-generation JAK inhibitor targeting TYK2 JH2, developed using Fermion's Drug Studio AI drug development platform.
Preclinical studies of FZ007-119 demonstrated high selectivity for JAK1-3, indicating significant potential for clinical benefits, such as improved clinical efficacy and increased safety of use. Its exceptional selectivity positions FZ007-119 as a potential first-class candidate in its category, known as a BIC (“ Best in Class ”) candidate.
Since its establishment in 2019, Fermion has been dedicated to developing differentiated BIC/FIC products in the central nervous system (CNS) and autoimmune areas as an AI and data-driven innovative drug development company. In the autoimmune space, Fermion has already established more than five pipelines, targeting indications such as psoriasis, inflammatory bowel disease and rheumatoid arthritis. The approved TYK2 JH2 inhibitor, FZ007-119, represents the most rapidly advancing pipeline in this area.
Dr. Deco Deng, Founder and CEO of Fermion, said: “While several first- and second-generation JAK inhibitors are available worldwide, concerns regarding the safety of JAK inhibitors persist among regulatory authorities, clinicians and researchers. patients. FZ007-119, a third-generation JAK inhibitor targeting TYK2 JH2, presents a potential BIC option due to its superior selectivity, more than a thousand times higher than that of deucravacitinib, the first drug targeting this receptor. Deucravacitinib was approved for the treatment of moderate to severe plaque psoriasis without a boxed warning (or black box warning), but with a relatively narrow therapeutic window. Signs of safety were still observed in clinical studies, probably related to its insufficient selectivity for JAK1-3. The selectivity of FZ007-119 for JAK1-3 greatly exceeds that of deucravacitinib, enabling it to become a first-in-class TYK2 JH2 inhibitor. »
The groundbreaking IND approval for Fermion's FZ007-119 marks an important milestone in the company's commitment to developing innovative and differentiated therapies in the autoimmune space. With its rapid progress and focus on safety and effectiveness, Fermion continues to demonstrate its leadership in the development of new treatments for autoimmune diseases.
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