Recently, the official website of the National Medical Products Administration (NMPA) announced that Jinbeixin (Fuxinqibaimab), a Class 1 innovative drug independently developed by Jinsai Pharmaceutical, has been officially approved for marketing. It is suitable for patients with acute attacks of gouty arthritis in adults who are contraindicated, intolerant or ineffective to non-steroidal anti-inflammatory drugs and/or colchicine, and who are not suitable for repeated use of steroid hormones. With the three major clinical advantages of " long-term control, rapid and effective, and safe and reliable ", Jinbeixin is expected to become the largest single product in the field of autoimmune disease treatment in China, meet huge market demand, and escort the majority of gout patients!
Gout is known as the "king of pain". According to the "2021 China Hyperuricemia and Gout Trend White Paper", there are approximately 177 million patients with hyperuricemia in China, and more than 14.66 million patients with gouty arthritis (GA), making it the second largest metabolic disease after diabetes [1] . Although traditional treatment options have been widely used in clinical practice, nearly half of patients still have not effectively relieved symptoms such as pain [2] , and approximately 60% of patients have recurrent attacks within a year [3]. In particular, within 3-6 months of uric acid-lowering treatment, approximately 12%-61% of patients may experience recurrent gout attacks. Recurrent gout attacks can affect patients' compliance with uric acid-lowering treatment, leading to a vicious cycle of poor uric acid control, leading to joint damage, and may also affect multiple key organs such as the heart and kidneys [4,5] . Studies have shown that the risk of myocardial infarction or stroke within 60 days of repeated gout attacks can increase by 89%; the risk of venous thrombosis within 30 days increases by 131%; the risk of chronic kidney disease (CKD) in gout patients increases by 4.61 times, and can reach 10 times with repeated attacks, and the risk of gout patients with CKD developing end-stage renal disease also increases by 57% [6-9] .
The reason behind the recurrent attacks of gout is the activation of the NOD-like receptor pyrin domain-related protein 3 (NLRP3) inflammasome in macrophages to release a large amount of interleukin 1β (IL-1β), triggering an inflammatory cascade reaction. The inflammation level is high both in the acute and intermittent stages of gout. Continuous inflammation will significantly increase the burden on the patient's heart and kidneys, causing long-term and serious health risks [10-12] . Therefore, long-term anti-inflammatory treatment is the cornerstone of gout treatment. At the same time, long-term anti-inflammatory treatment can reduce gout attacks, provide a better time window for uric acid-lowering treatment, and bring long-term benefits to the protection of target organs [13,14] . Traditional drugs have many hidden dangers, making it difficult to achieve the expected therapeutic effect, and are not conducive to long-term anti-inflammatory treatment for gout patients. Nonsteroidal anti-inflammatory drugs may cause serious adverse reactions such as gastrointestinal bleeding and cardiovascular disease [5] ; colchicine has a narrow therapeutic window, and improper use may lead to poisoning. Long-term use will cause adverse reactions in the digestive tract and liver and kidneys, seriously affecting the quality of life [5,15] . It is estimated that by 2030, the market size of gout drugs in China will reach RMB 10.8 billion [1] . Therefore, there is an urgent need for innovative treatment options that can control inflammation in the long term, reduce the frequency of attacks, and be safer.
Fuxinqibaimab works by precisely blocking IL-1β, which triggers gout inflammation. Clinical data show that fuxinqibaimab can take effect quickly after a single dose, with an analgesic effect comparable to that of hormones for 6-72 hours, and a 87% reduction in the risk of first recurrence within 6 months; no serious drug-related adverse reactions were found [16] .
The approval was based on the results of a Phase III clinical trial of fuxinqibaimab in patients with gouty arthritis. This multicenter, randomized, double-blind, positive-controlled clinical trial included 313 patients with acute gout attacks. The results showed [16] :
Primary endpoint: The improvement of 72-hour pain VAS score in the Fuxinqibaimab group was non-inferior to the betamethasone group . The difference between the two groups was -3.32mm (95% CI: -7.56, 0.91), and the upper limit of the 95% confidence interval was 0.91mm, which was less than the pre-set non-inferiority margin of 10mm, and the non-inferiority was established. Co-primary endpoints: Within 12 weeks of a single dose, the median time to the first acute gout recurrence was not reached and 45 days (95% CI: 28.00, 63.00) in the Fuxinqibaimab group and the betamethasone group, respectively; the risk of first recurrence in the Fuxinqibaimab group was reduced by 90% (HR=0.10, p<0.0001) compared with the betamethasone group.
Secondary study endpoint: Within 24 weeks of administration, the risk of first recurrence in the Fuxinqibaimab group was reduced by 87% (HR=0.13, p<0.0001) compared with the compound betamethasone group , and 85.3% of patients had no recurrence, setting a better record for similar drugs and establishing its potential position as a "Best-in-class" in the field of gout anti-inflammatory drugs.
In terms of safety, a total of 159 subjects (51.0%) experienced treatment-related adverse events, including 79 (50.6%) in the Fuxinqibaimab group and 80 (51.3%) in the compound betamethasone group. There were no treatment-related serious adverse events in the Fuxinqibaimab group , and a total of 3 patients in the compound betamethasone group reported treatment-related serious adverse events.
As the first IL-1β monoclonal antibody in China, the successful approval of Jinbeixin (Fuxinqibaimab) will quickly fill the gap in long-acting anti-inflammatory and precisely targeted treatment in the field of gout in China , bringing good news to the vast number of patients suffering from recurrent attacks of gouty arthritis.
In addition to gout, studies have shown that long-term anti-inflammatory treatment with IL-1β monoclonal antibodies can also bring additional benefits in cardiovascular, bone and joint, respiratory and other aspects, and it also has great therapeutic potential in the fields of metabolic diseases and tumors [17-20] .
About IL-1β Target
IL-1β is the main inflammatory factor in the IL-1 family that performs biological functions [19] . Urate crystals activate the NLRP3 inflammasome, promote the maturation and secretion of IL-1β, and ultimately lead to the occurrence and development of gout inflammatory response [21] . In addition, IL-1β is also involved in the pathogenic mechanism and progression of a variety of immune inflammatory diseases and chronic diseases, and also plays a role in metabolic diseases and tumor development [19,20] .
Fuxinqibaimab is a fully human monoclonal antibody against IL-1β, which can accurately bind to IL-1β and its receptor, blocking the inflammatory cascade. In addition to gouty arthritis, Fuxinqibaimab is actively expanding multiple indications, such as systemic juvenile idiopathic arthritis (sJIA), connective tissue disease-related interstitial lung disease (CTD-ILD), endometriosis (EM), etc., and we expect that it will meet more clinical needs in the future and provide new treatment options for patients.
About Gouty Arthritis
GA is a crystal-related arthritis caused by the deposition of monosodium urate in the joints. The incidence has been increasing in recent years and tends to be younger. GA can be divided into an acute attack phase, an inter-attack phase, and a chronic gouty arthritis phase. The typical manifestations of the acute attack phase are severe joint pain, a sudden onset, and progressively worsening pain [5] . For GA patients with frequent attacks, or contraindications, intolerance, and lack of efficacy of NSAIDs and/or colchicine, as well as those who are not suitable for repeated use of hormones, there is currently no suitable treatment drug for clinical selection in China. The launch of Fuxinqibaimab will bring a breakthrough treatment option to patients who have long been troubled by this disease.

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