Anagyrine

The pathogenesis of autoimmune diseases is closely related to the overactivation of pro-inflammatory factors such as IL-1. As a recombinant human interleukin-1 receptor antagonist, anakinra competitively binds to IL-1 receptors to block IL-1-mediated inflammatory signal transduction, and belongs to the IL-1 inhibitor class of biological agents. It is clinically mainly used for the treatment of rheumatoid arthritis and cryopyrin-associated periodic syndrome (CAPS) in adults and children over 4 years old, and can also be used for the treatment of indications such as adult-onset Still's disease and acute gout attacks, providing a targeted intervention option for patients with autoinflammatory diseases who do not respond well to conventional treatment.

As the world's first approved IL-1 receptor antagonist, the global market size of anakinra exceeded USD 1.2 billion in 2023, with a compound annual growth rate of around 7% in the past five years. The growth momentum mainly comes from the expansion of indications for rare autoinflammatory diseases. At present, the global market is dominated by the original research product, with few generic product layouts. In China, it is still in the clinical development stage and has not yet been included in the medical insurance centralized procurement catalog, leaving a relatively high market gap.

The original research enterprise of this product is Swedish Orphan Biovitrum AB (Sobi), with the original brand name Kineret. The core compound patent expired in 2017 in major markets such as the European Union and the United States, and the compound patent in China also expired in 2017. The original marketed dosage form is a prefilled injection with a specification of 100mg/0.67ml, which has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese *Catalog of Reference Preparations for Chemical Drugs*. As of the retrieval time point, there is no anakinra preparation approved for marketing in China, and there is no relevant registration number with A status or I status on the CDE API registration platform. (Data as of September 2024, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for anakinra. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. Meanwhile, they can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, providing stable reference material support for the generic drug R&D, quality research and declaration processes of this product.