China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of cyclophosphamide, marketed as Endoxan by UK firm Hikma Pharmaceuticals USA Inc. The approval allows Hengrui to market its capsules for the treatment of a wide range of cancers, including malignant lymphoma, Hodgkin’s lymphoma, multiple myeloma, leukemia, ovarian adenocarcinoma, and breast cancer, among others.
Therapeutic Indications and Mechanism
Cyclophosphamide is a chemotherapeutic agent involved in the cross-linking of tumor cell DNA. It is primarily bio-transformed into active alkylated metabolites in the liver through the mixed-functional microsomal oxidase system. These metabolites interfere with the growth of sensitive and rapidly proliferating malignant cells, making cyclophosphamide effective both as a standalone treatment and in combination with other anti-tumor drugs. The drug is indicated for the treatment of various cancers, including those in advanced stages where other treatments may be less effective.
Market Landscape and Hengrui’s Position
According to Fineline Info & Tech, cyclophosphamide is currently available in China only in the form of injection powder and tablets. Hengrui’s introduction of the 25mg capsule formulation represents a significant addition to the market. The company’s cyclophosphamide capsules received priority review status from the NMPA in October 2021, highlighting the urgency and importance of this approval. Globally, the product generated USD 325 million in sales in 2021, underscoring its market potential and therapeutic value.
Future Outlook
The approval of Hengrui’s generic cyclophosphamide capsules marks a significant milestone in expanding treatment options for patients with various cancers. With its broad therapeutic indications and proven efficacy, the drug is poised to make a meaningful impact on patient outcomes. Hengrui’s entry into this market segment further solidifies its position as a leading pharmaceutical company in China, committed to delivering high-quality generic medications.-Fineline Info & Tech
