Nanjing King-Friend Biochemical Pharmaceutical (603707.SH) subsidiary obtains US FDA registration approval for additional manufacturing site for amikacin sulfate injection

Nanjing King-Friend Biochemical Pharmaceutical (603707.SH) announced that its subsidiary Meitheal Pharmaceuticals Inc. recently received approval from the U.S. Food and Drug Administration (FDA) for an additional manufacturing site for Amikacin Sulfate Injection (500mg/2mL (250mg/mL) and 1g/4mL (250mg/mL)), approving manufacturing at the site of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. It is reported that this drug is indicated for the short-term treatment of serious infections caused by susceptible Gram-negative bacteria, such as septicemia, respiratory tract, bone and joint, central nervous system, skin and soft tissue, intra-abdominal, burn, postoperative, and complicated urinary tract infections; it is also effective against some gentamicin/tobramycin-resistant bacteria and Staphylococcus. The newly approved product further enriches the company's international product pipeline and strengthens the company's international market layout. If subsequent launch and sales in the U.S. market are, it is expected to have a positive impact on the company's operating performance.