Bedaquiline

The clinical treatment of drug-resistant tuberculosis has long been faced with the dilemmas of limited optional drugs, frequent adverse reactions and long treatment courses. The advent of bedaquiline has filled the gap in this field. As the world's first diarylquinoline anti-mycobacterial drug, it exerts a bactericidal effect by specifically inhibiting the proton pump activity of ATP synthase of Mycobacterium tuberculosis and blocking the energy synthesis of Mycobacterium tuberculosis. At present, this drug is recommended by WHO as the core component of the combination treatment regimen for multidrug-resistant pulmonary tuberculosis and extensively drug-resistant pulmonary tuberculosis. It is suitable for adult and pediatric (≥5 years old) patients with drug-resistant tuberculosis, and can significantly improve the treatment success rate of patients and reduce the risk of death.

The large base of drug-resistant tuberculosis patients worldwide drives the continuous expansion of the bedaquiline market size. In 2023, the global market size has exceeded 1.2 billion US dollars, with a compound annual growth rate of around 18%. China is one of the countries with a high burden of drug-resistant tuberculosis in the world. The growth rate of its domestic market in recent years is significantly higher than the global average, and the market size exceeded 1.2 billion yuan in 2023. The current market is still dominated by the original research product. With the expiration of the patent, a number of domestic enterprises have laid out the R&D of generic drugs, and the future price drop will further improve the accessibility of the drug.

The original research enterprise of bedaquiline is Johnson & Johnson, with the trade name Sirturo®. Its compound patent in China expired in 2027. The dosage form approved for the original research product is tablet, with a specification of 100mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the FDA Reference Preparations Catalogue. Up to now, the bedaquiline APIs of a number of enterprises in China have obtained A status through the registration with the Center for Drug Evaluation (CDE). The original research product and a number of domestic generic drug preparations have been approved for marketing in China and included in the National Medical Insurance Catalogue. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for bedaquiline API. Most products are available in stock. Orders for in-stock products paid before 16:00 can be shipped on the same day. All products comply with the pharmacopoeia of the People's Republic of China, FDA and other pharmaceutical regulatory requirements of various countries, and can fully meet the demands of enterprises for impurity reference standards in the process of drug R&D, quality research and production.