Zhejiang Hisun Pharmaceutical Subsidiary Obtains US FDA Clearance for Generic Cancer Drug Injection

Stock News07-24

Zhejiang Hisun Pharmaceutical Co.,Ltd. (600267.SH) has announced that its wholly-owned subsidiary, Hisun Pharmaceutical (Hangzhou) Co., Ltd., has received notification from the U.S. Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection.

The ANDA has been formally approved, which authorizes the Hangzhou subsidiary to market and sell this product within the United States market.

Fludarabine Phosphate Injection is a nucleoside metabolic inhibitor. Its approved indications include use as a component of combination therapy for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL). Additionally, it is indicated for adult B-cell CLL patients who have not responded to, or whose disease has progressed during, at least one prior treatment regimen containing an alkylating agent.

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