Icatibant

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder. Patients suffer from recurrent subcutaneous and submucosal edema due to abnormally elevated bradykinin levels, and the edema can even be life-threatening if it involves the respiratory tract. Icatibant is a selective bradykinin B2 receptor antagonist. By competitively blocking the binding of bradykinin to its receptors, it directly inhibits bradykinin-mediated increases in vascular permeability, vasodilation and edema reactions. It is the world's first drug approved for the treatment of acute HAE attacks, and is indicated for on-demand treatment of acute attacks in adolescent patients aged 12 years and older and adult patients. It can rapidly relieve edema symptoms and greatly reduce the fatal risk of HAE attacks.

As a core product in the field of acute HAE treatment, the global market size of icatibant exceeded 700 million euros in 2023, with a compound annual growth rate of approximately 12% in the past five years. In terms of the domestic market, as icatibant was included in the medical insurance catalog in 2021, the payment threshold for patients has been significantly reduced, and the market size has expanded rapidly. The domestic sales revenue exceeded 300 million yuan in 2023, an increase of more than 400% compared with 2021. Currently, the original research product still dominates the domestic market, and 3 pharmaceutical companies have submitted marketing applications for generic drugs. With the successive launch of generic drugs in the next 3-5 years, the market accessibility will be further improved.

The original research enterprise of icatibant is Takeda Pharmaceutical, with the trade name Firazyr®. The expiration dates of its core compound patents in Europe and the United States are 2023 and 2024 respectively, and the compound patent in China expired in 2022. The dosage form approved for the original research product is injection, with the specification of 30mg/3ml. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, the icatibant active pharmaceutical ingredients (APIs) of 7 domestic enterprises have completed registration with the CDE, and the icatibant for injection of the original research enterprise and 2 domestic pharmaceutical enterprises have been approved for marketing. (The data is as of September 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of icatibant impurity reference standards. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most of the impurity reference standards are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day, which can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.