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Zhejiang Hisun Pharmaceutical Receives US FDA Abbreviated New Drug Application Approval for Leukemia Injection

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Zhejiang Hisun Pharmaceutical (SHA:600267) received an abbreviated new drug application approval from the U.S. Food and Drug Administration for its fludarabine phosphate injection, according to a Saturday filing with the Shanghai bourse.

The injection is indicated for the treatment of adult B-cell chronic lymphocytic leukemia for patients unresponsive to at least one prior alkylating agent-containing therapy or whose disease has progressed during treatment.

Global sales of the injection reached $23.5 million in 2025, according to market data cited in the filing.

Hisun has invested 10 million yuan for research and development of the drug.

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