Recently, the official website of the National Medical Products Administration (NMPA) showed that Yangtze River Pharmaceutical's Aguratimod tablets, which were applied for as a generic 4 drug, were officially approved for marketing, becoming the second company in China to have its generic drug approved and pass the consistency evaluation. This progress not only marks a further breakthrough for Yangtze River Pharmaceutical in the field of anti-rheumatic diseases, but also provides more treatment options for domestic patients with rheumatoid arthritis.

Eguratimod tablets are a new type of disease-modifying antirheumatic drug (DMARDs) that has both anti-inflammatory and immunomodulatory mechanisms. It can inhibit the production of inflammatory factors such as IL-6 and TNF-α, while delaying bone erosion and promoting bone formation. Clinical data show that it can be effective in 2-4 weeks when used in combination with methotrexate, with a patient remission rate of over 60%, and significantly lower liver toxicity and infection risks than traditional drugs, with better long-term tolerance.

In 2011, Eguratimod tablets developed by Innovent Biologics were approved for the first time as a domestically produced Class 1.1 new drug (trade name "Edixin"). After being included in the national medical insurance catalogue in 2017, the market share increased rapidly. According to Yaozhi data, the market sales volume of Elamide tablets will exceed 1.1 billion yuan in 2023. Its clinical efficacy and safety advantages have made it recommended as a first-line drug for rheumatoid arthritis (RA) in guidelines from many countries.
After Yangtze River Pharmaceutical's approval, the domestic Eguratimod tablet market will be dominated by three local companies (Innovent Biologics, CP Qingjiang, and Yangtze River Pharmaceutical). Previously, Zhengda Qingjiang had won the first imitation and the first review in June 2024, and Yangtze River followed closely to become the second. At present, more than a dozen companies including Huahai Pharmaceutical and Kelun Pharmaceutical have also submitted applications for generic drugs, and market competition will intensify in the future.
The approval of Yangtze River Pharmaceutical's Eguratimod tablets is not only a reflection of the company's R&D strength, but also provides a new model for domestic generic drugs to replace original research. Driven by both policy support and market demand, the anti-rheumatic drug market will usher in more intense competition and innovation, ultimately benefiting a large number of patients.