Pretomanid

As a breakthrough innovative drug in the global anti-tuberculosis treatment field in the past 40 years, Pretomanid is a dihydroimidazooxazole class of anti-mycobacterial drugs. Its mechanism of action is different from that of traditional anti-tuberculosis drugs: it inhibits dihydrofolate reductase of mycobacteria and blocks the folic acid synthesis pathway, thereby effectively killing Mycobacterium tuberculosis. This drug is mainly combined with bedaquiline and linezolid to form the BPaL regimen, which is used for the treatment of adult extensively drug-resistant tuberculosis (XDR-TB) and multidrug-resistant tuberculosis (MDR-TB) that is intolerant or non-responsive to treatment. It greatly shortens the treatment cycle of multidrug-resistant tuberculosis and provides a new possibility of cure for drug-resistant tuberculosis patients who have no available drugs.

Globally, there are approximately 150,000 new cases of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis each year, and the treatment success rate of previous clinical regimens is less than 40%. The clinical cure rate of the Pretomanid-containing combination regimen can be increased to more than 80%, driving the relevant market size to grow from USD 80 million in 2020 to USD 320 million in 2023, with a compound annual growth rate of more than 58%. At present, only the original research manufacturer has realized large-scale production of this API, and the supply is highly concentrated. With the advancement of policies on the accessibility of anti-tuberculosis drugs in low- and middle-income countries, the market demand will continue to maintain a rapid growth trend.

The original research manufacturer of Pretomanid is Johnson & Johnson of the United States, and the original brand name is Sirturo. The expiration date of its core compound patent in China is 2027. The currently approved main dosage form is oral tablet, with a specification of 100 mg per tablet. The original research preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs*. As of now, no generic Pretomanid preparation has been approved for marketing in China. No publicized domestic Pretomanid API registration information has been found on the CDE API registration platform, and only the original research manufacturer holds the relevant registration number for imported APIs. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of Pretomanid impurity reference standards, which meet the full-process requirements of API R&D, quality research and consistency evaluation. Most impurity products are regularly kept in stock. Spot orders paid before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeia regulations of multiple countries including the Chinese Pharmacopoeia and FDA, and can be directly used for the submission of application materials.