Core Viewpoint - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the injection of Fushen Qibai monoclonal antibody (trade name: Jinbeixin), which is indicated for acute attacks of gouty arthritis in adults who are intolerant to or have contraindications for non-steroidal anti-inflammatory drugs and/or colchicine, as well as those unsuitable for repeated use of steroid hormones [1] Group 1 - The newly developed Fushen Qibai monoclonal antibody is a fully human anti-IL-1β monoclonal antibody that specifically binds to human IL-1β, blocking the production of inflammatory mediators induced by IL-1β [1] - Key clinical trial results indicate that Fushen Qibai can take effect within 6 hours, with pain relief comparable to steroids at 72 hours, and a nearly 90% reduction in the risk of first recurrence within 6 months, demonstrating good safety [1] - The approval of this product is expected to enrich the company's product portfolio in the adult autoimmune field and enhance its competitiveness in the pharmaceutical market [1]
长春高新:子公司注射用伏欣奇拜单抗获批上市