Penicillamine

Hepatolenticular degeneration is a rare congenital disorder of copper metabolism, and there has been a long-term lack of highly effective and safe copper-eliminating treatment options in clinical practice. The advent of penicillamine has filled the core demand in this field. As a heavy metal detoxifying complexing agent, its mechanism of action is to bind with heavy metal ions such as copper and iron through sulfhydryl groups to form soluble complexes, which are then excreted from the body via urine. In addition to being a first-line treatment drug for hepatolenticular degeneration, it can also be used for the treatment of severe active rheumatoid arthritis, cystinuria with cystine stones, and the rescue of heavy metal poisoning such as lead and mercury poisoning. The applicable population covers children and adult patients who meet the indications, and it is a basic drug in the treatment pathways of the above-mentioned diseases.

At present, the global market size of penicillamine is approximately USD 180 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the improvement of rare disease drug security policies and the increasing clinical demand for heavy metal poisoning treatment. Driven by the expansion of the rare disease drug catalog and the centralized procurement policy in the domestic market, the generic drug substitution rate has increased to more than 85%, and the overall market size is approximately RMB 210 million. The production side is dominated by domestic generic drug enterprises, and the market share of original research products is less than 10%.

The original research enterprise of penicillamine is Merck KGaA, Germany, with the original brand name Cuprimine. Its core compound patent expired globally in 1982. At present, the mainstream marketed dosage form is tablet, with the core specification of 250 mg. The original research product has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (9th Batch)* of China. In terms of domestic API registration, 3 enterprises have obtained A-status registration numbers for penicillamine APIs, and multiple domestic enterprises have obtained marketing approval for penicillamine tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the drug quality control needs related to penicillamine, CATO can provide a full set of impurity reference standards for this API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable supply guarantee for the impurity reference standard needs of pharmaceutical enterprises in the whole process of R&D and production.