Tafamidis

Transthyretin amyloidosis (ATTR) is a rare progressive disease involving multiple organs. Previously, there was no targeted clinical treatment available, and the prognosis of patients was generally poor. As the world's first approved transthyretin stabilizer, tafamidis selectively binds to the tetramer binding site of transthyretin, stabilizes the tetramer structure and inhibits its dissociation, thereby blocking the formation of amyloid fibrils from the origin of pathogenesis. At present, this drug has been approved for the treatment of adult transthyretin amyloid cardiomyopathy (ATTR-CM) and transthyretin amyloid polyneuropathy (ATTR-PN), providing a core treatment option for patients with such rare diseases to delay disease progression.

The global market size of tafamidis exceeded US$2.1 billion in 2023, with a compound annual growth rate of 27% in the past 5 years. The core growth driver comes from the improvement of the diagnosis rate of rare diseases worldwide and the coverage of ATTR therapeutic drugs by medical insurance policies in many regions. The current market is still dominated by the original research product, and no approved generic preparation has appeared in the domestic market for the time being. Since ATTR is a rare disease, the patient population is stable and there are very few clinical alternatives, so there is a relatively rigid market demand for this API for a long time.

The original research enterprise of tafamidis is Pfizer, and the original research trade names are Vyndaqel and Vyndamax. The core compound patent of tafamidis will expire in China in 2027. The approved dosage forms of the original research include oral capsules with specifications of 20 mg and 61 mg respectively, which have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also reference preparations recognized by the FDA. Up to now, the domestic CDE API registration platform has not yet announced the approved API registration number of tafamidis, and all domestic marketed preparations are original imported products. (Data as of August 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of tafamidis impurity reference standards. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for relevant pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.