Furafylline

The long-term treatment of chronic airway diseases has always been confronted with clinical pain points of poor symptom control and high risk of acute exacerbations. As a representative of new xanthine derivatives, furaphylline provides a new option for treatment optimization in this field. This drug is a dual inhibitor of selective phosphodiesterase 3/4 (PDE3/4). By simultaneously inhibiting the activities of two isozymes, it exerts dual effects of bronchodilation and anti-inflammation. It is clinically mainly used for the maintenance treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD), can effectively reduce the frequency of acute exacerbations in patients and improve pulmonary function indexes, and is especially suitable for the moderate to severe patient population with insufficient response to conventional bronchodilators.

The global market size related to furaphylline has maintained a steady growth trend in recent years. In 2023, the global market size was approximately USD 210 million, with a compound annual growth rate maintained at around 8%. At present, the original research product still dominates the market pattern, and the layout of generic drug manufacturers is relatively limited, mainly due to the high complexity of the drug's synthesis process and the great difficulty in impurity control. The Chinese market is still in the introduction stage at present. With the continuous rise in the prevalence of chronic airway diseases in China and the improvement of patients' compliance with long-term control treatment, the market growth space in the future is considerable. (The above data comes from publicly verifiable information)

The original research enterprise of furaphylline is Kyorin Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "Adarozen". Its core compound patent in Japan expires in 2026, and the main patents in Europe will expire in 2027. The main dosage form approved by the original research is oral tablet, with specifications of 100mg and 200mg. At present, it has been included in the drug catalogue of the Ministry of Health, Labour and Welfare of Japan, and is also listed as a reference listed drug by the FDA. As of the retrieval time, there is no publicly announced A status registration number of furaphylline API in China, no domestic preparation of this variety has been approved for marketing, and no marketing application has been submitted for imported preparations. (Data is as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for furaphylline API, which can fully meet the R&D needs of different stages such as synthesis process optimization, quality research, and registration and declaration. Most impurity products are supplied from stock. Orders for in-stock products 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 the impurity purity and structure confirmation data are complete and traceable, which can provide stable and reliable support for the R&D process of relevant pharmaceutical enterprises.