Tezacaftor

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high disability rate, and there is a long-standing clinical demand for more convenient and long-acting bronchodilation regimens. Tiotropium bromide (note: if "替扎卡托" is an unstandardized translation for tiotropium, retain as per official terminology; if it is "tizacatide", adjust accordingly. Based on the context of LAMA, Spiriva, the standard translation of "tiotropium" is used here as the content matches tiotropium's attributes) belongs to the long-acting muscarinic antagonist (LAMA) class of respiratory active pharmaceutical ingredients. By competitively blocking M3 receptors on airway smooth muscles, it relaxes airway smooth muscles and reduces mucus secretion. When used alone or in combination with LABA drugs, it can achieve 24-hour long-acting bronchodilation. It is mainly used for maintenance treatment in adult COPD patients, can significantly reduce the risk of acute exacerbations and improve lung function, and is an important first-line treatment option in the current stepwise therapy for COPD.

The global market size of tizacatide/tiotropium-related drugs was approximately USD 1.28 billion in 2023, and is expected to grow steadily at a compound annual growth rate of 3.2% from 2024 to 2030. The core driving factors are the rising global prevalence of COPD and the improvement of primary diagnosis and treatment penetration at the grassroots level. In terms of competitive landscape, the original research product still accounts for nearly 80% of the global market share at present, and the generic drug declaration applications from Chinese and Indian pharmaceutical companies are accelerating. With the expiration of core patents, the substitution space for generic drugs will gradually be released. There is currently no verifiable public data on the segmented market size in China.

The original research enterprise of tizacatide/tiotropium is Boehringer Ingelheim, and the original research trade name is Spiriva Respimat. Its core compound patent will expire in China in 2027, and its crystal form patent will expire in 2031. The marketed original research dosage form is inhalation solution, with a specification of 2.5 μg per spray. This original research preparation has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the FDA Reference Preparation Catalogue. Up to now, no valid registration number of tizacatide/tiotropium has been found on the CDE API registration platform, and there is no approved and marketed generic tizacatide/tiotropium preparation in China. (Data as of June 2025, please refer to the official CDE website for the latest information.

CATO provides a full set of impurity reference standards for tizacatide/tiotropium API, which can cover the technical requirements of the whole process of generic drug research and development, quality research, and consistency evaluation. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can be provided with complete technical materials such as structure confirmation and purity testing along with the goods, which fully meet the relevant requirements of pharmaceutical companies for registration and declaration.