With the continuous improvement of living standards, the incidence rate of gout also rises, and presents a younger trend. According to data, by 2024, there will be approximately 221 million patients with hyperuricemia and 25.3 million patients with gout in China. Behind the huge patient population is a huge and long-term unmet clinical demand, which has also driven domestic pharmaceutical companies to continue to deepen their involvement in the gout field. A number of domestically produced innovative drugs have been approved for market, and pipeline research and development has brought new choices for gout treatment.
In the field of innovative drugs for gout, domestic innovative drugs have achieved breakthroughs in two major technological directions: one focuses on the IL-1 β target and specializes in anti-inflammatory measures for acute gout attacks; The other type is the new generation of URAT1 inhibitors, which focus on long-term uric acid reduction and form a dual line layout of acute phase control and chronic disease management.
On the IL-1 β target, San Sheng Guojian's Class 1 innovative drug Anfeichita monoclonal antibody injection was approved for market in August this year. It is suitable for acute attacks of gouty arthritis in adults who are contraindicated, intolerant, or lack efficacy against nonsteroidal anti-inflammatory drugs and/or colchicine, as well as those who are not suitable for repeated use of steroid hormones.
Data shows that Anfeichita monoclonal antibody is a recombinant humanized monoclonal antibody against IL-1 β, which targets the core inflammatory mediator IL-1 β in acute gout attacks, inhibits the inflammatory cascade reaction from the source, and has a precise mechanism of action. It is specifically designed for patients with limited conventional treatment, further expanding the clinical treatment toolbox for acute gout.
The Fuxinqibai monoclonal antibody developed by Jinsai Pharmaceutical has been approved for market in 2025, making it the first domestically produced IL-1 β monoclonal antibody for gout indication. According to the data, Fuxinqibai monoclonal antibody is a new type of fully human anti interleukin-1 β (IL-1 β) monoclonal antibody drug independently developed by Jinsai Pharmaceutical. 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, and inhibit the acute inflammatory response of gouty arthritis from the source.
In terms of URAT1 inhibitors, Hengrui Pharmaceutical's Ruxinor Sodium Tablets were officially approved for market by the National Medical Products Administration in May of this year. This product is the first independently developed new generation highly selective URAT1 inhibitor in China, suitable for patients with gout and hyperuricemia. It is reported that URAT1 is specifically expressed in renal tubular epithelial cells, and by selectively inhibiting the transport of uric acid by URAT1, ruxostat sodium can inhibit the reabsorption of uric acid and promote its excretion, achieving the goal of reducing blood uric acid concentration.
In addition to the launch of new drugs, good news has also come from the clinical pipeline. On September 3rd, Yifeng announced that the Phase III clinical trial of the innovative gout drug AR882 for the treatment of gout patients with hyperuricemia has reached its primary endpoint. AR882 is a Class 1 innovative drug under development for poinsettia, which is a globally competitive next-generation highly selective uric acid transporter (URAT1) inhibitor. It aims to promote the excretion of uric acid salts from the kidneys by inhibiting uric acid reabsorption, thereby reducing blood uric acid (sUA) levels, and is used for the treatment of gout and gouty tophi in patients. AR882 overcomes the shortcomings of remifentanil and benzbromarone, and can bind to uric acid transporters for a long time, prolonging the inhibitory effect. Clinical results show that its efficacy can last up to 24 hours. Moreover, blocking the reabsorption of uric acid around the clock will not increase renal burden, which can avoid nephrotoxicity and effectively eliminate uric acid in the body, achieving the goal of dissolving gouty stones.
Gout is a chronic disease that requires long-term standardized management, which is divided into two stages: acute attack period for pain relief and anti-inflammatory treatment, and stable period for continuous uric acid lowering. In the past, there was a shortage of new drugs for gout in China, and patients had limited options for treatment. Nowadays, domestic innovative drugs have achieved breakthroughs in two treatment pathways, multiple products have been approved successively, and potential drugs such as AR882 are in the late clinical stage. The matrix of domestic gout innovative drugs is accelerating its formation. The concentrated breakthrough of domestically produced innovative gout drugs has brought new hope for treatment to millions of patients, and also marks the continuous improvement of China's innovative research and development capabilities in metabolic diseases. In the future, it will continue to provide patients with better and more affordable treatment plans.