Nerandomilast

The recurrent attacks of chronic inflammatory diseases such as atopic dermatitis and asthma are closely related to the release of inflammatory factors caused by the overactivation of the Th2 pathway. For a long time, there has been a lack of targeted therapy options with both safety and oral convenience in clinical practice. Apremilast is an oral phosphodiesterase 4 (PDE4) inhibitor. It reduces the degradation of cyclic adenosine monophosphate by inhibiting the activity of PDE4, downregulates the expression of a variety of pro-inflammatory factors such as TNF-α, IL-4 and IL-13, and avoids the systemic adverse reactions caused by traditional hormone therapy. At present, the indications under global development cover moderate to severe atopic dermatitis, moderate to severe asthma, chronic obstructive pulmonary disease, etc., providing a new path for long-term maintenance treatment for people with allergic and inflammatory diseases.

At present, the global apremilast market is still in the early stage of commercialization, and the core growth driver comes from the increase in the penetration rate of atopic dermatitis indications. In 2023, the global market size of targeted drugs for atopic dermatitis has exceeded 20 billion US dollars, among which the compound annual growth rate of the oral PDE4 inhibitor segment exceeds 35%. Currently, only one apremilast preparation has been approved for marketing worldwide, and the original research product has not yet entered the mature stage of volume expansion. A number of pharmaceutical companies have laid out generic drug pipelines. With the future expiration of patents and the expansion of more indications, it is expected that the global market size of apremilast is expected to exceed 1.5 billion US dollars by 2030.

The original research enterprise of apremilast is Amgen Inc. in the United States, and the original research trade name is Otezla® (the former trade name of apremilast, and apremilast was its former translated name). The core compound patent will expire in 2028 in the United States, and the core compound patent in China will expire in 2027. The approved dosage form of the original research is tablet, with specifications including 10mg, 20mg and 30mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the China Catalog of Reference Preparations for Chemical Drugs. As of now, no apremilast API in China has obtained the A-status registration number. The original research preparation was approved for marketing by the NMPA in 2021, and a number of domestic enterprises have submitted clinical applications for apremilast generic drugs. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for apremilast API, covering intermediates, degradation impurities and enantiomers at each stage of the synthetic route. All products meet the requirements of Chinese Pharmacopoeia and relevant FDA regulations. Most products are in stock regularly, and orders placed before 16:00 can be shipped on the same day, fully meeting the reference substance needs of pharmaceutical enterprises in the stages of API R&D, quality research and declaration.