Trientine

Wilson's disease, as a rare congenital disorder of copper metabolism, will lead to irreversible liver injury, neuropathy and even death if timely copper-eliminating treatment is not received. Trientine is an anti-Wilson's disease drug belonging to the class of metal chelating agents. It binds with free copper ions in the body to form stable soluble complexes, which are excreted from the body through urine to reduce the copper load in the body. It is mainly used for the long-term maintenance treatment of adult and pediatric Wilson's disease patients who are intolerant to penicillamine, and is the first-line alternative medication for penicillamine-intolerant populations. Compared with traditional treatment regimens, it has lower incidence rates of hepatotoxicity and skin adverse reactions, and can significantly improve patients' long-term medication compliance.

At present, the global patient population of Wilson's disease is approximately 100,000 to 150,000. As a core second-line therapeutic drug, trientine had a global market size of approximately USD 270 million in 2023, and it is expected to grow at a compound annual growth rate of 6.2% to USD 360 million by 2028. Affected by factors such as patent protection for rare disease drugs and high R&D thresholds, the original research products currently occupy the major share in the global market. The number of domestic generic drug enterprises that have obtained marketing approval is less than 5, and there is still a large clinical supply gap.

The original research enterprise of trientine is Bausch Health (formerly Valeant Pharmaceuticals), and the original research brand name is Syprine. Its core compound patent expired globally in 2006. The main dosage form of the original research marketed product is trientine hydrochloride capsules with a specification of 250mg, which has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (39th Batch)* in China. On the domestic front, the trientine hydrochloride APIs of more than 10 enterprises have obtained CDE registration numbers (status A) up to now, and 3 domestic trientine hydrochloride capsules have been approved for marketing and passed the consistency evaluation of generic drugs. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for trientine, most of which are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the testing requirements of different scenarios such as API R&D, quality research and consistency evaluation.