Delamanid

The clinical treatment of drug-resistant tuberculosis has long been plagued by the dilemmas of limited optional drugs and low conversion rate. The advent of delamanid has filled an important treatment gap for people with multidrug-resistant tuberculosis. As a new dihydroimidazooxazole class of anti-mycobacterial drug, it exerts a bactericidal effect by inhibiting the production of methoxymycolic acid and ketomycolic acid, which are key components in the synthesis of mycobacterial cell walls, thus destroying the structural integrity of Mycobacterium tuberculosis cell walls. At present, it is mainly used in combination with other anti-tuberculosis drugs globally for the treatment of adult patients with multidrug-resistant tuberculosis, and its indication for children with multidrug-resistant tuberculosis has been approved and expanded in some regions.

Public data show that the existing stock of patients with multidrug-resistant tuberculosis worldwide is about 500,000 cases, with more than 100,000 new cases every year. As a core therapeutic drug for multidrug-resistant tuberculosis recommended by the WHO, the global market size of delamanid had exceeded USD 120 million in 2023, with a compound annual growth rate of around 8% in the past three years. Due to the public health attribute of anti-tuberculosis drugs, the current market is dominated by the supply of the original research drug, and no generic drug has been approved in China yet, resulting in a relatively high concentration of the overall market supply. With the improvement of the diagnosis and treatment rate of drug-resistant tuberculosis in China, the clinical demand for this variety is still in a steady upward channel.

The original research enterprise of delamanid is Otsuka Pharmaceutical, with the original brand name Deltyba. The core compound patent of delamanid will expire in 2027 in major markets such as Europe and the United States, and the compound patent in China will expire in 2026. At present, the main dosage form approved for the original research drug is tablet, with a specification of 50 mg per tablet. The original research tablet has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed in the FDA Reference Preparation Catalogue. Up to now, no delamanid preparation product has been approved for marketing in China, and no valid A-state delamanid API registration number under evaluation or publicized has been found on the CDE API Registration Platform. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the research, development and quality control needs of delamanid, CATO can provide a full set of impurity reference standards for this API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the impurity research needs of pharmaceutical enterprises at all stages from research and development to declaration.