Ciclosporin

The long-term survival challenge in the field of organ transplantation relies to a large extent on the optimization of immunosuppressive regimens. As a representative immunosuppressant of calcineurin inhibitors, cyclosporine specifically inhibits the activation and proliferation of T lymphocytes, reduces the release of cytokines such as interleukin-2, and achieves targeted immune regulation without significantly impairing the hematopoietic function of bone marrow. In clinical practice, in addition to being used for the prevention of rejection in solid organ transplants such as kidney, liver and heart transplants, it can also be used for the treatment of autoimmune diseases such as severe aplastic anemia, refractory autoimmune hemolytic anemia and psoriasis. It is one of the basic drugs in multiple fields including transplantation, hematology and dermatology.

The global cyclosporine market size is approximately USD 1.6 billion. Driven by the growth in the number of transplantation surgeries and the improvement in the diagnosis rate of autoimmune diseases in recent years, its compound annual growth rate has remained at around 3.2%. In the domestic market, the annual sales at the terminal of public medical institutions have exceeded RMB 2 billion. Among them, the proportion of original research drugs and generic drugs in the preparation market is approximately 4:6, and the localization rate of APIs has exceeded 85%. Major domestic compliant manufacturers are concentrated in North China and East China. As the eighth batch of nationally organized drug centralized procurement included oral cyclosporine dosage forms, the demand of downstream preparation enterprises for cost-effective and compliant APIs has further increased.

The original research enterprise of cyclosporine is Novartis, with the original brand name Sandimmune Neoral. The core compound patent expired around 2000 in major global markets, and the preparation patent in China also expired in 2014. The current mainstream dosage forms include soft capsules, oral solutions and injections. Common specifications cover 10mg, 25mg, 50mg soft capsules, 100mg/ml oral solution, etc. The original research preparations have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, more than 20 domestic enterprises have obtained CDE registration for cyclosporine APIs, among which there are more than 15 A status registration numbers. The approved domestic cyclosporine preparation varieties cover all mainstream dosage forms. (Data as of April 2025, please refer to the official CDE website for the latest information)

In response to the quality research needs of cyclosporine APIs and preparations, CATO provides a full set of impurity reference standards for this API, which can fully meet the qualitative and quantitative research requirements of synthetic pathway impurities and degradation impurities. Most products are in stock. In-stock products ordered before 16:00 will 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 support the whole-process research scenarios such as R&D declaration and quality release.