Zelgen(SH:688266) Shang Hai Zheng Quan Bao·2025-10-20 19:33Core Viewpoint - Suzhou Zejing Biopharmaceutical Co., Ltd. announced that its self-developed drug, JAK inhibitor Jikaxitinib (previously known as JAK inhibitor Jackitinib), has achieved the primary efficacy endpoint in a Phase III clinical trial for treating active ankylosing spondylitis, demonstrating statistical significance (p < 0.0001) [2][3] Group 1: Drug and Clinical Trial Information - The Phase III clinical trial, titled "Efficacy and Safety of Jikaxitinib in Patients with Active Ankylosing Spondylitis," was conducted at 31 hospitals, enrolling 265 patients who were randomly assigned to either the Jikaxitinib 100mg BID group or the placebo group [3] - The primary efficacy endpoint was the percentage of patients achieving the ASAS 40 response criteria after 16 weeks of treatment, with the Jikaxitinib group significantly outperforming the placebo group [3] - The safety and tolerability of Jikaxitinib in treating active ankylosing spondylitis were reported to be good, with detailed data to be presented at upcoming academic conferences [3] Group 2: Future Development and Regulatory Process - The company plans to expedite the market application process for Jikaxitinib for the treatment of active ankylosing spondylitis following the successful trial [2][3] - The company is also conducting an extended Phase III trial (protocol number ZGJAK030) for Jikaxitinib in this indication [4] - Previous Phase II trial results for Jikaxitinib were published in the international journal "RMD Open" on January 2, 2025 [4] Group 3: Drug Background and Market Context - Jikaxitinib is a novel dual inhibitor of JAK and ACVR1, classified as a first-class new drug, with the company holding independent intellectual property rights [5] - The NDA application for Jikaxitinib to treat myelofibrosis has been approved, making it the first domestic JAK inhibitor approved for this indication [5] - The drug is also under investigation for other indications, including moderate to severe atopic dermatitis and non-segmental vitiligo in adolescents and adults [6] Group 4: Disease Context - Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the sacroiliac joints and spine, with a prevalence rate in China estimated at 0.3%, affecting approximately 4 million people [7] - Current treatment options for AS include NSAIDs, biological DMARDs, and JAK inhibitors, with JAK inhibitors providing a new oral treatment option for patients who do not respond to or cannot tolerate biological DMARDs [7] - Currently, only three JAK inhibitors have been approved in China for treating active ankylosing spondylitis: Tofacitinib, Upadacitinib, and Ivarmacitinib [7]