Pidotimod

In the clinical application of immunomodulatory drugs, adjuvant therapy for recurrent infections has always been a key demand in pediatrics and respiratory departments. As a synthetic dipeptide immunostimulatory modulator, pidotimod exerts its effects through the dual mechanisms of promoting non-specific immune response, enhancing lymphocyte proliferation and cytokine secretion. It is mainly indicated for the adjuvant treatment of chronic or recurrent respiratory tract infections and urinary tract infections, covering high-risk groups with recurrent infections such as children and the elderly with low immunity. It can shorten the course of disease, reduce the frequency of attacks, and decrease the irrational use of antibiotics.

The global pidotimod market has maintained a stable growth trend in recent years, with the market size approaching USD 320 million in 2023, among which the Chinese market accounts for more than 45%, making it the largest application market in the world. Due to the clear clinical positioning of this drug, its penetration rate in pediatric prescriptions in primary medical institutions continues to rise, with a compound annual growth rate of 6.8% in the past three years. The competitive landscape is dominated by generic drugs. At present, there are more than 20 domestic manufacturers of approved pidotimod preparations, and the supply of API is mainly from local enterprises. Since the implementation of volume-based procurement in 2022, the price of preparations has dropped by more than 60%, further driving the market expansion.

The original developer of pidotimod is Italian company Poli Industria Chimica S.p.A, with the original brand name "Polimod". Its core compound patent expired globally in 2007. The main dosage form approved for the original drug is oral solution, with a specification of 400mg/7ml. This product has been included in the China Listed Drug Catalogue as a reference listed drug. In terms of domestic API registration, as of now, a total of 9 enterprises have had their pidotimod APIs publicized via CDE registration numbers (status A). The domestically approved preparations cover three categories: oral solution, granules and tablets, meeting the use needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of pidotimod, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the regulatory requirements of multiple regulations including Chinese Pharmacopoeia and FDA, and can effectively support enterprises in meeting the reference standard needs throughout the whole process of API associated declaration, preparation quality research and routine quality inspection.