Tranilast

As a classic anti-allergic drug targeting chronic allergic and fibrotic diseases, tranilast is different from conventional antihistamines that relieve symptoms对症. It can stabilize the cell membranes of mast cells and basophils, inhibit the release of allergic mediators such as histamine and leukotriene, and down-regulate the expression of transforming growth factor-β (TGF-β) to slow down the progression of fibrosis. In clinical practice, in addition to the long-term prevention and treatment of allergic diseases such as bronchial asthma, allergic rhinitis and atopic dermatitis, it is also expanded to be used for the intervention of fibrosis-related diseases such as keloid, hypertrophic scar and systemic sclerosis. The applicable population covers adults and pediatric patients over 5 years old, and it is a chronic disease management drug with both preventive and therapeutic values.

At present, the global market size of tranilast is approximately USD 120 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at 3.7%. The growth momentum mainly comes from the expanding demand for indications of dermatological fibrotic diseases. In terms of the domestic market, oral preparations have been included in the local medical insurance catalogs of multiple provinces. The annual growth rate of in-hospital sales has maintained at around 8% in the past 3 years. The competitive landscape is dominated by generic drugs, with 16 existing preparation approvals. No imported original research preparations have been launched, and the localization rate of API has reached 92%, with only a small amount of API for high-end preparations relying on imports.

The original research enterprise of tranilast is Kissei Pharmaceutical Co., Ltd. of Japan, with the original research brand name "Tranilast". Its core compound patent expired globally in 1999. The main dosage forms approved by the original research include 100mg oral tablets and 1% topical ointment. Among them, the oral tablet is listed as the reference preparation in the Japanese Orange Book, and the original research preparation has not been introduced in China. In terms of domestic API registration, 6 enterprises have obtained A-status registration numbers for tranilast API after passing the review of the Center for Drug Evaluation (CDE), and the corresponding approved preparation varieties cover three dosage forms: ordinary tablets, capsules and granules. (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 tranilast API, most of which are in stock. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of the whole process of API R&D, quality research and declaration.