Lynk Pharmaceuticals Announces FDA IND Approval of Its Allosteric TYK2 Inhibitor LNK01006

HANGZHOU, China and SHANGHAI and BOSTON, Dec. 2, 2025 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on developing innovative therapies for immune and inflammatory diseases, today announced that its innovative TYK2 allosteric inhibitor, LNK01006, has been approved by U.S. Food and Drug Administration (FDA) for human clinical trials.

LNK01006 is a highly brain-penetrant, potent, and selective oral TYK2 allosteric inhibitor targeting the JH2 domain. TYK2 is a key regulator of the IL-12 and IL-23 signaling pathways, which promote Th1 and Th17 cell differentiation. Th1/Th17 cells play a central role in central nervous system (CNS) inflammatory diseases such as multiple sclerosis (MS). Inhibiting TYK2 reduces the activation of pro-inflammatory T cells, thus lowering CNS inflammation. LNK01006 demonstrated high brain penetration in preclinical species and promising efficacy in treating and preventing multiple sclerosis in MS disease models, presenting a great potential for treating neuroinflammatory diseases. 

Dr. Michael Lawrence Vazquez, Co-founder and Executive Vice President of Lynk Pharmaceuticals, said, "Obtaining FDA IND approval for LNK01006 marks a key milestone in our pursuit of innovative TYK2 allosteric mechanisms. Our CNS penetrant TYK2 inhibitor was specifically designed to cross the BBB (blood brain barrier) and afford high CNS exposure. We leveraged medicinal chemistry principles and molecular design to optimize the physical properties, potency and selectivity. Allosteric TYK2 inhibitors (binding the pseudokinase domain) can achieve high specificity, avoiding cross‑inhibition of JAK1/2/3, thus a selective TYK2 inhibitor could dampen pathogenic immune signaling without broadly suppressing other JAK pathways. We look forward to advancing this promising molecule into human clinical trials and bringing new therapeutic options to treat patients suffering from neurodegenerative diseases."

Dr. Jun Wang, Co-founder and Chief Scientific Officer of Lynk Pharmaceuticals, said, "LNK01006 is a novel brain-penetrant allosteric TYK2 inhibitor designed to modulate CNS-relevant inflammatory pathways, including type I interferons and IL-12/IL-23 signaling. Supported by strong evidence from human genetics and patient gene-expression studies and by robust efficacy in preclinical neuroinflammation models, LNK01006 represents a promising new therapeutic approach for CNS diseases with significant unmet need. We look forward to advancing its clinical validation."

About Lynk Pharmaceuticals

Lynk Pharmaceuticals, a clinical stage company, was founded by senior drug R&D experts and executives from Pfizer, Merck, and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. We thrive to provide differentiated innovative therapies to benefit patients globally. To date, Lynk Pharmaceuticals has independently developed several innovative new drug candidates and successfully completed a number of clinical studies.

SOURCE Lynk Pharmaceuticals Co., Ltd.