China-based Shanghai Shyndec Pharmaceutical Co., Ltd (SHA: 600420) has announced that its generic version of Pfizer’s (NYSE: PFE) Cytosar-U (cytarabine) has obtained marketing approval in China. This marks the first generic to pass the generic quality consistency evaluation among similar products in the country.
Product Profile and Market Context
Cytarabine for injection is an antimetabolic drug, primarily used for the induced remission and maintenance treatment of adult and child acute nonlymphocytic leukemia. The product is listed in China as potentially suffering from supply shortages, and Shyndec received priority review status for its version. In 2021, the molecule generated USD 129 million in global sales, with sample hospital sales at RMB 138 million (USD 19.74 million) in China.
Future Prospects and Strategic Implications
The marketing approval positions Shyndec to address significant unmet medical needs and improve patient access to this essential medication. By leveraging its generic version of Cytosar-U, Shyndec aims to contribute to the stability of the drug supply and enhance its market presence in the oncology space.-Fineline Info & Tech
