Here’s a polished English translation of the Chinese title: **”GenSci’s Fuxinqibai Monoclonal Antibody Injection Approved for Market: Greater Convenience and Nearly 90% Reduction in Gout Recurrence Risk Over Six Months”**

ShanghaiMay 7, 2026 /PRNewswire/ — Recently, the Fuxinqibai monoclonal antibody injection (aqueous solution) independently developed by Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”) officially received the “Drug Registration Certificate” approved by the National Medical Products Administration. It is approved for the treatment of acute gouty arthritis attacks in adult patients who are contraindicated, intolerant, or unresponsive to non-steroidal anti-inflammatory drugs and/or colchicine, as well as those unsuitable for repeated use of corticosteroids. Compared with the powder form, this upgraded aqueous solution formulation does not require reconstitution or preparation, making it more convenient to use and potentially improving patient compliance.

Fuxinqibai monoclonal antibody (brand name: Jinbeixin) is a novel fully human anti-interleukin-1β (IL-1β) monoclonal antibody drug independently developed by Jinsai Pharmaceutical. It is classified as a Class 1 new therapeutic biological product, capable of specifically binding to human IL-1β, blocking the production of inflammatory mediators induced by IL-1β, and thereby suppressing the acute inflammatory response of gouty arthritis at its source. The newly approved Fuxinqibai monoclonal antibody injection (aqueous solution) does not require reconstitution or preparation before clinical use, further simplifying procedures and offering a more convenient medication experience.

According to statistics, the number of hyperuricemia patients in China has exceeded 180 million, with over 30 million gout patients, and the trend is shifting toward younger demographics^[1]. Although traditional treatment regimens are widely used in clinical practice, nearly half of patients still experience inadequate relief from symptoms such as pain^[2], and approximately 60% of patients suffer recurrent attacks within one year^[3]. Particularly during the 3–6 months of urate-lowering therapy, about 12%–61% of patients may experience recurrent gout attacks. These recurrent episodes can affect patient compliance with urate-lowering treatment, leading to a vicious cycle of poor uric acid control, resulting in joint damage and potentially affecting multiple key organs such as the heart and kidneys^[4,5].

Results from the pivotal Phase III clinical trial of Fuxinqibai monoclonal antibody for injection showed that it rapidly takes effect within 6 hours of administration, with analgesic effects comparable to corticosteroids at 72 hours, reducing the risk of first recurrence by nearly 90% within 6 months, and demonstrating a favorable safety profile^[6]. As the first IL-1β monoclonal antibody in China, Fuxinqibai monoclonal antibody offers a novel treatment option for gout patients, leveraging its precise and long-lasting anti-inflammatory advantages.

In November 2025, the “Chinese Journal of Rheumatology” and the “Chinese Journal of Preventive Medicine” jointly published the world’s first guideline focusing on anti-inflammatory treatment for gout, the “Guidelines for Anti-Inflammatory Treatment of Gout (2025 Edition)”^[7,8]. This guideline introduces for the first time the concepts of long-term anti-inflammatory therapy and multi-organ protection in gout treatment, clearly establishing a full-course management requirement covering “acute gout attack—intercritical period—tophaceous stage,” emphasizing the importance of long-course anti-inflammatory therapy. This marks a shift from the traditional model of “urate-lowering alone” to a new era of “equal emphasis on anti-inflammation and urate-lowering, with comprehensive management.” The mechanism of Fuxinqibai monoclonal antibody, precisely targeting the IL-1β inflammatory pathway, not only rapidly controls acute attack symptoms but also significantly reduces the risk of long-term recurrence.

Beyond acute gouty arthritis attacks, Fuxinqibai monoclonal antibody has also achieved positive progress in other autoimmune disease areas. Previously, positive results from a Phase II clinical trial of Fuxinqibai monoclonal antibody for treating systemic juvenile idiopathic arthritis (sJIA) were officially published in the internationally renowned rheumatology journal “Rheumatology and Therapy”^[9], indicating recognition of its efficacy and safety by the international academic community. Additionally, clinical trials for Fuxinqibai monoclonal antibody injection have been approved for endometriosis and non-infectious uveitis; clinical trials for Fuxinqibai monoclonal antibody for injection have been approved for indications such as connective tissue disease-associated interstitial lung disease (CTD-ILD). Jinsai Pharmaceutical will continue to deepen its presence in the autoimmune and inflammatory disease fields, accelerating the development and launch of more innovative products.