Jiangsu Hengrui Pharmaceuticals (600276.SH) has obtained approval for the listing of type 1 new drug SHR0302, for the treatment of ankylosing spondylitis.

On March 21st, the latest announcement on the official website of the National Medical Products Administration (NMPA) of China stated that Jiangsu Hengrui Pharmaceuticals (600276.SH) has received approval for the market application of a Class 1 new drug, SHR0302 (Imexonib sulfate tablets). This drug is suitable for adult patients with active ankylosing spondylitis who have ineffective or intolerant responses to one or more TNF inhibitors. According to public information from Jiangsu Hengrui Pharmaceuticals, this is a JAK1 inhibitor developed independently by the company. Ankylosing spondylitis (AS) is an autoimmune disease characterized by chronic inflammation in the axial joints without a clear cause. AS mainly affects the sacroiliac joints, spinal accessory joints, adjacent soft tissues of the spine, and peripheral joints. In severe cases, spinal deformities and stiffness can occur. Nonsteroidal anti-inflammatory drugs (NSAIDs) are first-line drugs for treating AS. For AS patients who still have active symptoms or cannot tolerate NSAIDs, biologic drugs are recommended. However, some active AS patients still have poor treatment outcomes. JAK inhibitors can block the JAK-STAT signaling pathway, directly or indirectly blocking the signaling of various cytokines related to AS, thereby suppressing inflammation and relieving the disease. They are considered effective treatment methods for AS in recent years. JAK1 inhibitors have higher selectivity, so they have fewer potential side effects and are more effective. Imexonib is a highly selective JAK1 inhibitor developed independently by Jiangsu Hengrui Pharmaceuticals. It can inhibit JAK1 signaling, exerting biological effects that have anti-inflammatory and immunosuppressive effects, and reducing side effects such as anemia caused by JAK2 inhibition.