环孢菌素

Rejection after organ transplantation is the core obstacle affecting the long-term survival of patients, and the emergence of calcineurin inhibitors has completely rewritten the development path of transplantation medicine. As the first-generation calcineurin inhibitor, cyclosporine can specifically inhibit the activation and proliferation of T lymphocytes. By blocking the transcription of immune-related cytokines such as interleukin-2, it achieves targeted immunosuppression without significantly damaging innate immunity. Its clinical application covers anti-rejection therapy for solid organ and hematopoietic stem cell transplantation including kidney, liver, heart and bone marrow, and can also be used for the third-line treatment of autoimmune diseases such as severe psoriasis, rheumatoid arthritis and systemic lupus erythematosus. It is an indispensable basic drug in the fields of transplantation and rheumatology immunology.

The global cyclosporine market size has stabilized at around USD 2.5 billion in recent years, among which generic drugs account for more than 70%. The domestic market size is about RMB 1.8 billion, with an annual growth rate remaining in the range of 3%-5%. As the compound patent has long expired, the global competitive landscape is dominated by generic drugs. Domestic manufacturers are concentrated in North China and East China. At present, more than 20 enterprises have obtained preparation approvals, and more than 10 enterprises have completed the registration of active pharmaceutical ingredients. This variety has been included in multiple batches of national centralized procurement, and the winning price has dropped by more than 80% compared with the original research drug, and the clinical accessibility has been greatly improved.

The original research enterprise of cyclosporine is Novartis, and the original research trade name is Neoral. Its core compound patent expired globally in 1995. The main dosage forms of the original research marketed products include soft capsules, oral solutions and injections. The specifications of soft capsules are 10mg, 25mg and 50mg, the specification of oral solution is 50ml:5g, and the specification of injection is 5ml:250mg. This original research product has been included in the NMPA Chemical Drug Reference Preparation Catalog and the FDA Reference Preparation Catalog. At present, there are more than 30 A-status registration numbers for cyclosporine APIs in China, and generic drugs of multiple dosage forms such as soft capsules, oral solutions and injections have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demand for quality research and compliance declaration of cyclosporine, CATO can provide a full set of impurity reference standards for this API. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality control and declaration and registration work of API and preparation enterprises.