Mesna

In response to the urinary tract toxicity risk caused by chemotherapy with high-dose alkylating agents such as cyclophosphamide and ifosfamide, mesna, as a urinary system protective agent, plays an irreplaceable role in clinical practice. It belongs to the sulfhydryl compound class of mucosal protective agents. After entering the body, it can bind to acrolein, a toxic product produced by the metabolism of chemotherapeutic drugs, forming a non-toxic stable adduct that is excreted with urine. Meanwhile, it can reduce the degradation rate of 4-hydroxy metabolites, effectively preventing urinary tract injuries such as hemorrhagic cystitis without affecting the chemotherapeutic effect. It is an essential adjuvant drug for patients with malignant tumors receiving high-dose alkylating agent chemotherapy and people undergoing hematopoietic stem cell transplantation pretreatment.

At present, the global mesna market size is approximately USD 320 million, with an annual compound growth rate maintained at around 4.7%. The growth momentum mainly comes from the rising incidence of malignant tumors and the expansion of clinical demand brought by the popularization of autologous stem cell transplantation. Driven by the centralized procurement policy, the generic drug substitution process in the domestic market has accelerated. In 2023, the terminal sales of public medical institutions exceeded RMB 900 million. The competitive landscape is dominated by generic drug manufacturers, and the API supply is concentrated in China and India. Leading enterprises occupy the main market share by virtue of compliant production capacity.

The original research enterprise of mesna is Baxter Oncology GmbH in Germany, with the original research trade name Uromitexan®. Its core compound patent expired globally in 1999. The original research dosage forms include injection and oral dosage forms. The injection specifications cover 2ml:0.2g and 4ml:0.4g, which have been included in the Reference Listed Drug Catalog of the China Listed Drug Catalog, and are also included in the FDA Reference Preparation Catalog. At present, more than 20 domestic enterprises have obtained approval for the marketing of mesna preparations. The CDE API Registration Platform shows that there are 11 mesna API registration numbers with A status, which can meet the compliant supply demand of domestic preparation production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of mesna impurity reference standards, covering the whole chain research needs of starting materials, intermediates, degradation impurities, etc. Most products are in stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research, consistency evaluation and other links.