Nanjing King-Friend subsidiary wins US FDA approval for Dalbavancin

Nanjing King-Friend Biochemical Pharmaceutical (SSE:603707) announced its subsidiary, King-Friend Pharmaceutical Co., Ltd., received US FDA approval for its Dalbavancin for injection, 500 mg/vial. The drug is indicated for acute bacterial skin and skin structure infections in adult and pediatric patients. The reference product for Dalbavancin for injection, 500 mg/vial, is held by AbbVie Inc.

As of the announcement, two other generic versions of Dalbavancin for injection are approved in the US, held by Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC. Nanjing King-Friend has invested approximately CNY 1,853,080.00 in the Dalbavancin for injection project.

The newly approved product is expected to launch in the US market soon, potentially having a positive impact on the company's operating performance. However, the company cautioned investors about potential risks, including market sales not meeting expectations due to national policies, market conditions, and other uncertainties.