AKESO(HK:09926) Ge Long Hui·2026-01-19 17:04Core Viewpoint - Kangfang Biopharma's innovative drug, Gumokimab injection, has submitted a new indication application for active ankylosing spondylitis, which has been accepted by the National Medical Products Administration (NMPA) [1][4]. Group 1: Drug Information - Gumokimab is a humanized IL-17 monoclonal antibody targeting key inflammatory factors, playing a crucial role in diseases like psoriasis and ankylosing spondylitis [4][7]. - The drug is currently in the application stage for both moderate to severe plaque psoriasis and active ankylosing spondylitis [5][12]. Group 2: Research and Development Progress - The first application for Gumokimab was accepted by the CDE on January 16, 2025, marking a significant milestone in its development [8][11]. - In August 2025, Gumokimab achieved positive results in a pivotal Phase III clinical trial for active ankylosing spondylitis, demonstrating significant clinical improvements for patients [11]. Group 3: Industry Position - Gumokimab is the eighth innovative drug submitted for market approval by Kangfang Biopharma, highlighting the company's commitment to drug development [13]. - It is the third innovative drug in the non-oncology field to reach the market application stage, showcasing Kangfang Biopharma's strong research capabilities and innovation in addressing autoimmune diseases [13].