Melphalan

As a classic alkylating antineoplastic agent, melphalan exerts cytotoxic effects by cross-linking with DNA to inhibit DNA synthesis and replication in tumor cells. It is clinically mainly used for first-line induction and maintenance treatment of multiple myeloma, and is also indicated for the treatment of malignant tumors such as ovarian cancer, malignant lymphoma, chronic lymphocytic leukemia and breast cancer. It is also a commonly used basic drug in hematopoietic stem cell transplantation conditioning regimens, and the applicable population covers adults and some pediatric hematological tumor patients who meet the indications.

The global melphalan market size was approximately USD 210 million in 2022, and it is expected to grow steadily at a compound annual growth rate of 3.2% from 2024 to 2030. In terms of the domestic market, the sales volume at public hospital terminals exceeded RMB 320 million in 2023. As melphalan is a basic drug for the treatment of multiple myeloma, its clinical demand is rigid and stable, the current competitive landscape is relatively concentrated, and the generic drug substitution rate has exceeded 70%. Only 3 domestic enterprises have been approved to produce melphalan preparations, which have not yet been included in the national centralized procurement catalog.

The original research enterprise of melphalan is GlaxoSmithKline, with the original brand name Alkeran. Its core compound patent expired globally in 1992, and the preparation patent in China expired in 2017. Currently, the main dosage forms of the original research product on the market include 2mg tablets and 50mg powder for injection. The original research preparation has been included in the China Listed Drug Catalog, and is a domestically recognized reference listed drug. As of now, a total of 3 enterprises in China have obtained CDE registration numbers for melphalan APIs, among which 2 are in A status and can support the marketing application of preparations. There are 5 marketing authorizations for melphalan preparations in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for melphalan API, and the vast majority of products are available from stock. Stock orders paid before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of drug regulatory authorities of multiple countries such as the Chinese Pharmacopoeia and FDA. The structure and purity of impurities have undergone strict structural confirmation and calibration, which can fully meet the full-process R&D requirements such as API registration and declaration, quality research, and stability study.