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).

中国广州，2024年2月5日/新华社/--广州费米昂科技有限公司（Fermion），一家临床阶段人工智能药物发现公司，专门开发用于自身免疫性疾病和疼痛管理的药物，很高兴宣布批准研究性新药（IND）的TYK2 JH2抑制剂FZ007-119，由中国国家医药产品管理局（NMPA）提供。

This marks Fermion's third successful IND approval since its establishment..

这标志着费米子公司自成立以来第三次成功获得IND批准。。

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

FZ007-119是针对TYK2 JH2的第三代JAK抑制剂，使用费米子专有的Drug Studio AI药物开发平台开发。

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..

FZ007-119的临床前研究表明对JAK1-3具有高选择性，表明具有显着的临床益处潜力，例如改善的临床疗效和增强的使用安全性。其出色的选择性使FZ007-119成为其类别中潜在的同类最佳（BIC）候选人。。

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.

自2019年成立以来，费米子一直致力于开发中枢神经系统（CNS）和自身免疫领域的差异化BIC/FIC产品，作为一家人工智能和数据驱动的创新药物开发公司。在自身免疫领域，费米子已经建立了五条以上的管道，针对包括牛皮癣，炎症性肠病和类风湿性关节炎在内的适应症。

The approved TYK2 JH2 inhibitor, FZ007-119, represents the most rapidly advancing pipeline in this field..

批准的TYK2 JH2抑制剂FZ007-119代表了该领域发展最快的管道。。

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.

费米子公司创始人兼首席执行官Deco Deng博士评论道，“虽然全球有多种第一代和第二代JAK抑制剂可用，但监管机构，临床医生和患者仍然担心JAK抑制剂的安全性。FZ007-119是一种靶向TYK2 JH2的第三代JAK抑制剂，由于其比第一种靶向该受体的药物Deucravacitinib具有更高的选择性，因此具有潜在的同类最佳选择。

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.'.

Deucravacitinib已被批准用于治疗中度至重度斑块状牛皮癣，没有黑匣子警告，但治疗窗口相对狭窄。在临床研究中仍观察到安全信号，可能与其对JAK1-3的选择性不足有关。FZ007-119对JAK1-3的选择性大大超过了Deucravacitinib，因此有可能成为同类最佳的TYK2 JH2抑制剂。

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..

费米昂对FZ007-119的开创性IND批准标志着该公司致力于在自身免疫领域开发创新的差异化疗法的重要里程碑。随着其快速发展以及对安全性和有效性的关注，费米子继续在开发自身免疫性疾病的新型治疗方法方面发挥着领导作用。。

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SOURCE Guangzhou Fermion Technology Co., Ltd.

来源：广州费米子科技有限公司。