Nintedanib

Idiopathic pulmonary fibrosis, as a chronic and progressive interstitial lung disease, has a median survival of only 2-3 years after diagnosis, and there has been a long-term lack of effective clinical intervention methods. Nintedanib is a multi-target tyrosine kinase inhibitor, which can simultaneously inhibit the kinase activity of platelet-derived growth factor receptor, fibroblast growth factor receptor and vascular endothelial growth factor receptor, and delay the annual decline rate of lung function by blocking the signaling pathways of fibroblast proliferation, migration and transformation. At present, this drug has been approved for three major indications: idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and chronic fibrosing interstitial lung disease with progressive phenotype, covering adult patients with fibrosing lung disease of all age groups, and it is one of the core therapeutic drugs in the field of interstitial lung disease.

The global market size of nintedanib was close to 3.5 billion US dollars in 2023, with a compound annual growth rate of 8.2% from 2019 to 2023, and the growth momentum mainly comes from the continuous expansion of fibrosing lung disease indications. The sales of nintedanib in the Chinese market exceeded 1.8 billion yuan in 2023, with a compound annual growth rate of more than 22% in the past three years, which is higher than the global average. In terms of competitive landscape, the original research product still occupies a dominant position. As of 2024, 3 domestic enterprises have been approved for generic drug preparations of this variety, and this variety has been included in the seventh batch of national centralized drug procurement. The selected price has been reduced by more than 70% at most compared with the original research drug, and the accessibility for patients has been greatly improved.

The original research enterprise of nintedanib is Boehringer Ingelheim, and the original trade name is Ofev®. Its core compound patent will expire in China in June 2024, and the crystal form patent will expire in 2030. The original research dosage form approved in China is oral capsule, with two specifications of 100mg and 150mg, which has been included in the *Catalogue of Marketed Drugs in China* as the reference listed drug. In terms of API registration, as of the retrieval time, more than 10 nintedanib API registration numbers including the original research one can be queried on CDE, among which 9 have been publicly approved for use in marketed preparations; on the preparation side, in addition to the original research drug, a number of domestic generic drugs have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for nintedanib API, covering all categories such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.