Today, Highlightll Pharma announced that the results of its Phase III clinical study evaluating its proprietary, world-leading, highly selective dual JAK1/TYK2 inhibitor, girocitinib (TLL-018), for the treatment of active rheumatoid arthritis ("RA"), have been selected for a late-breaking oral presentation at the 2026 American College of Rheumatology Annual Meeting (ACR Convergence 2026).
ACR Convergence 2026, the world’s largest in-person academic conference in rheumatology, will take place from November 6 to 11, 2026, in Orlando, Florida, USA. As the premier academic indicator in global rheumatology and immunology, the 2026 ACR Annual Meeting received nearly 3,000 abstract submissions and will convene more than 15,000 rheumatology clinicians, translational scientists, and pharmaceutical R&D professionals from over 100 countries, making it the largest academic event in the global rheumatology field.
Selected for the late-breaking oral presentation at ACR Convergence 2026 are the primary efficacy endpoint analysis results from the Phase III head-to-head study comparing girocitinib with tofacitinib in patients with active rheumatoid arthritis. Principal Investigator Professor Xiaofeng Zeng from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, stated: "ACR Convergence is a top-tier international academic meeting in rheumatology and immunology. The selection of our study for a late-breaking oral presentation fully demonstrates the international peer recognition of these results. The trial has now been successfully completed, and we look forward to engaging in in-depth exchanges with experts worldwide at the conference, while actively promoting the translation and clinical application of these findings to bring benefits to patients as quickly as possible."
About girocitinib
Girocitinib is a world-leading, highly selective dual JAK1/TYK2 inhibitor with therapeutical potential across a wide range of autoimmune diseases. Leveraged by its proprietary kinase inhibitor platform, girocitinib achieved a major breakthrough by demonstrating over 200-fold greater selectivity for TYK2 and JAK1 compared to JAK2 and JAK3.
In the field of rheumatoid arthritis, girocitinib has completed a Phase III registrational clinical trial in China, reading out positive top-line data in April 2026 and receiving Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) in July 2026. In the field of chronic spontaneous urticaria, girocitinib has also completed a Phase III registrational clinical trial, reading out positive top-line data in January 2026.
About Highlightll Pharma
Highlightll Pharma is a clinical-stage biopharmaceutical company focused on treatments for peripheral and central nervous system (CNS) autoimmune and inflammatory diseases, dedicated to developing innovative medicines with major clinical value.
The company's core asset, girocitinib (TLL-018), is a highly potent, highly selective dual inhibitor of JAK1 and TYK2. It has completed Phase III clinical trials for chronic spontaneous urticaria (CSU) and rheumatoid arthritis (RA), achieving positive efficacy and safety results.
The company has validated its CNS drug development capabilities through the TLL-041 project. TLL-041 is a brain-penetrant JAK1/TYK2 inhibitor that was out-licensed to Biohaven in 2023 and has now advanced into global Phase II/III pivotal clinical trials for Parkinson's disease (BHV-8000/TLL-041).
NLRP3 represents the company’s second major R&D platform, under which it is developing HL-400 for central nervous system/neurodegenerative diseases and HL-450 for peripheral diseases.
