Iguratimod

In response to the clinical pain points of poor response to traditional disease-modifying antirheumatic drugs for rheumatoid arthritis (RA) and high incidence of adverse reactions with long-term medication, iguratimod, the world's first marketed small molecule innovative antirheumatic drug, has a dual mechanism of action of both anti-inflammation and bone protection. It can reduce the release of inflammatory factors by inhibiting the activation of the nuclear factor-κB (NF-κB) pathway, while inhibiting osteoclast differentiation and promoting osteoblast function. It can not only rapidly relieve the symptoms of joint swelling and pain in RA patients, but also delay the progression of joint structural damage when used for a long time. It is suitable for adult patients with active RA, especially for people who cannot tolerate traditional drugs such as methotrexate.

Currently, the number of people suffering from rheumatoid arthritis worldwide exceeds 20 million, and the number of patients in China exceeds 5 million, driving the continuous expansion of the iguratimod market size. In 2023, the terminal sales of iguratimod in China's public medical institutions exceeded 2.2 billion yuan, with a compound annual growth rate of more than 18% in the past three years. At present, the domestic market has formed a pattern of joint competition between the original research drug and generic drugs. Generic preparations from 4 enterprises have passed the consistency evaluation, and this variety has been included in the National Medical Insurance Catalogue, with the medical insurance payment scope covering the indication of active rheumatoid arthritis. With the advancement of hierarchical diagnosis and treatment, there is still considerable room for improvement in the penetration rate of the primary market.

The original research enterprise of iguratimod is Toyama Chemical Co., Ltd. of Japan, with the original brand name "Ailamulin". Its Chinese compound patent expired in 2023. The dosage form of the original research drug approved in China is tablet, with a specification of 25mg, which has been included in the China Listed Drug Catalogue as a reference preparation. At present, there are more than 10 registration numbers of iguratimod active pharmaceutical ingredients (APIs) on the platform of the Center for Drug Evaluation (CDE) of China, among which the API status of multiple enterprises is "A" (approved for use in marketed preparations). Multiple domestic enterprises have obtained marketing approval for iguratimod tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of iguratimod impurity reference standards. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference substance use needs in the processes of API R&D, quality research and consistency evaluation.