King-Friend subsidiary gets FDA nod for daunorubicin production

Nanjing King-Friend Biochemical Pharmaceutical (SSE:603707) announced that its subsidiary, Meitheal Pharmaceuticals, Inc., secured FDA approval to transfer the production site of its Daunorubicin Hydrochloride Injection, 20 mg/4 mL. The approval covers the single-dose product (ANDA No. 065035) and allows production at Jianjin Pharmaceutical Co., Ltd., another subsidiary of King-Friend. The drug is indicated for the treatment of acute non-lymphocytic leukemia in adults and acute lymphocytic leukemia in children and adults. The company has invested approximately CNY830,800 in the production site transfer project. King-Friend expects this approval to positively impact the company's operating performance as it prepares to launch the product in the U.S. market.