Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Sulfate Emmaxetine Tablets from the National Medical Products Administration, marking a significant step in expanding its product portfolio in the autoimmune disease treatment market [1][2]. Group 1: Drug Development and Clinical Trials - The clinical trial for Sulfate Emmaxetine Tablets in treating radiographic negative axial spondyloarthritis achieved its primary endpoint as planned by September 2025, demonstrating efficacy and safety in a multicenter, randomized, double-blind, placebo-controlled Phase III study involving 304 adult patients [1]. - The Emmaxetine group showed significant superiority over the placebo group in both primary and key secondary endpoints, with good safety and tolerability profiles compared to other JAK1 inhibitors, without new safety signals identified [1]. Group 2: Market Context and Competitive Landscape - Sulfate Emmaxetine Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe rheumatoid arthritis, among others [2]. - The drug is a highly selective JAK1 inhibitor, which exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [2]. - Currently, the only similar oral drug approved globally for radiographic negative axial spondyloarthritis is AbbVie's Upadacitinib (RINVOQ), which is projected to generate approximately $5.971 billion in global sales in 2024 [2]. - The total R&D investment for Sulfate Emmaxetine projects has reached approximately 1.091 billion yuan [2].