Fermion's TYK2 JH2 Inhibitor FZ007-119 Granted IND Approval by China NMPA

GUANGZHOU, China, Feb. 5, 2024 /PRNewswire/ -- Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain management, is pleased to announce the approval of the Investigational New Drug (IND) for its TYK2 JH2 inhibitor, FZ007-119, by the China National Medical Products Administration (NMPA). This marks Fermion's third successful IND approval since its establishment.

FZ007-119 is a third-generation JAK inhibitor targeting TYK2 JH2, developed using Fermion's proprietary Drug Studio AI drug development platform. 

Preclinical studies of FZ007-119 have demonstrated high selectivity for JAK1-3, indicating significant potential for clinical benefits, such as improved clinical efficacy and enhanced safety of use. Its exceptional selectivity positions FZ007-119 as a potential Best in Class (BIC) candidate within its category.

Since its inception in 2019, Fermion has been dedicated to developing differentiated BIC/FIC products in the central nervous system (CNS) and autoimmune fields as an AI and data-driven innovative drug development company. In the autoimmune field, Fermion has already established over five pipelines, targeting indications including psoriasis, inflammatory bowel disease, and rheumatoid arthritis. The approved TYK2 JH2 inhibitor, FZ007-119, represents the most rapidly advancing pipeline in this field.

Dr. Deco Deng, Founder and CEO of Fermion, commented, "While multiple first and second-generation JAK inhibitors are available globally, concerns about the safety of JAK inhibitors persist among regulatory authorities, clinicians, and patients. FZ007-119, a third-generation JAK inhibitor targeting TYK2 JH2, presents a potential Best in Class option due to its superior selectivity over a thousand times greater than Deucravacitinib, the first drug targeting this receptor. Deucravacitinib has been approved for the treatment of moderate to severe plaque psoriasis without black box warnings but with a relatively narrow therapeutic window. Safety signals have still been observed in clinical studies, possibly related to its insufficient selectivity for JAK1-3. FZ007-119's selectivity for JAK1-3 exceeds that of Deucravacitinib by a wide margin, thus holding the potential to become a Best in Class TYK2 JH2 inhibitor."

Fermion's groundbreaking IND approval for FZ007-119 marks a significant milestone in the company's commitment to developing innovative, differentiated therapies in the autoimmune field. With its rapid progress and focus on safety and efficacy, Fermion continues to demonstrate its leadership in the development of novel treatments for autoimmune diseases.

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