Plerixafor

For patients with hematological malignancies such as non-Hodgkin's lymphoma and multiple myeloma, hematopoietic stem cell transplantation is the core solution to prolong survival and achieve clinical cure, and efficient mobilization of hematopoietic stem cells is the prerequisite for successful transplantation. As a specific blocker of the chemokine receptor CXCR4, plerixafor can block the binding of CXCR4 to stromal cell-derived factor SDF-1α, thereby promoting the rapid release of hematopoietic stem cells from the bone marrow into the peripheral blood. When used in combination with granulocyte colony-stimulating factor, it can significantly increase the success rate of hematopoietic stem cell collection, and is especially suitable for high-risk patients who do not respond well to traditional mobilization regimens. It is currently a key targeted drug in the field of clinical hematopoietic stem cell mobilization.

At present, the global plerixafor market size has exceeded 800 million US dollars, with a compound annual growth rate of around 7%. The growth drivers mainly come from the rising prevalence of hematological tumors, the expansion of autologous transplantation indications, and the standardized popularization of mobilization regimens in developing countries. The growth rate of the Chinese market in recent years is significantly higher than the global average, with a compound annual growth rate of more than 15%. The current market presents a pattern of coexistence of original research drugs and generic drugs: since 2018, generic drugs from a number of domestic pharmaceutical companies have been approved for marketing. After the implementation of centralized procurement, the terminal price has dropped by more than 80%, which has greatly improved the accessibility for patients and also driven the continuous increase in demand for active pharmaceutical ingredients.

The original research enterprise of plerixafor is Sanofi, with the trade name Mozobil. Its core compound patent expired in the United States in 2023, and the compound patent in China expired in 2022. The main dosage form approved for the original research drug is injection, with the specification of 1.2ml:24mg. It has been included in the *Catalogue of Chemical Reference Preparations* issued by the NMPA, and is also included in the FDA reference preparation catalogue. In terms of domestic API registration, as of now, the plerixafor APIs of a number of enterprises have been registered with the CDE with the status of A, which can be used for associated declaration by preparation manufacturers. A number of generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for plerixafor API. Most of the products are in sufficient stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple countries including the Chinese Pharmacopoeia and the FDA. The structures of the impurities have been fully confirmed, and they can be directly used for API quality research, stability study and registration declaration, fully meeting the compliance requirements of pharmaceutical enterprises in the whole process of R&D and production.