On the evening of July 2nd, Changchun High tech announced that its subsidiary Jinsai Pharmaceutical, which is controlled by the company, has obtained approval from the National Medical Products Administration for the injection of Fuxinqibai monoclonal antibody (formerly known as Jinna monoclonal antibody for injection). This drug is the first domestically approved IL-1 inhibitor for the treatment of acute attacks of gouty arthritis, and its precise and long-lasting anti-inflammatory advantages will bring new treatment options for gout patients.

It is reported that Fuxinqibai monoclonal antibody for injection is a new type of fully human anti-IL-1 β monoclonal antibody drug developed by the company. It belongs to the first class of therapeutic biological products and can specifically bind to human IL-1 β, block the production of inflammatory mediators induced by IL-1 β. It is suitable for acute attacks of gouty arthritis in adults who are contraindicated, intolerant or lack efficacy of nonsteroidal anti-inflammatory drugs and/or colchicine, as well as those who are not suitable for repeated use of steroid hormones.

Gouty arthritis is a crystal related joint disease caused by the deposition of monosodium urate salts in the joints. Some patients have ineffective, poor tolerance, or contraindications to traditional treatment drugs, leading to poor gout control. IL-1 inhibitors are recommended by both domestic and international guidelines for the treatment of the above-mentioned patients, but there have been no approved indications for gout treatment in China before.

The key clinical trial "Randomized, double-blind, double-blind, double-blind, positive control, multicenter phase III clinical trial evaluating the effectiveness and safety of injectable kinumab in the treatment of gouty arthritis" has been completed. The results show that Fuxinqibai monoclonal antibody can quickly take effect within 6 hours, and its analgesic effect is comparable to hormones within 72 hours. The risk of first recurrence within 6 months is reduced by nearly 90%, and its safety is good.

Changchun High tech stated that the approval of this product is beneficial for enriching the company's product layout in the field of adult self exemption and enhancing the company's competitiveness in the pharmaceutical market. The company will actively organize the marketing, production, and sales of related products, promote their widespread application in the market, and provide patients with more treatment options.