Recently, Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. （hereinafter referred to as "NKF") received a notice from the US FDA. The Dalbavancin for Injection, independently developed by its Chengdu subsidiary, Kindos Pharmaceutical Co., LTD., has officially been approved by the US Food and Drug Administration (FDA) and is allowed to be sold in the US market. The first batch of products arrived in the United States under controlled conditions in early November, marking a crucial step forward in our international layout.
Dalbavancin for Injection is mainly used to treat acute bacterial skin and skin structure infections in adult and pediatric patients. According to the data, the market size of this drug in the United States will exceed 250 million US dollars in 2024, while no similar products have been approved in the Chinese market so far. This approval not only further enriches our product pipeline in the US market, but also makes Kindos Pharmaceutical the first domestic enterprise to obtain international approval for this variety.
Dalbavancin is a semi-synthetic lipopeptide antibacterial drug composed of five closely related active homologues. Its quality research involves methodological studies and precise control of multiple key quality attributes. The team of Kindos Pharmaceutical, a subsidiary of the company, relying on the full-process quality compliance control system and through continuous technological breakthroughs, has fully guaranteed the purity and safety of the products. Meanwhile, the related research and development technology of this variety has been granted domestic patent authorization, and international patents are also being actively laid out.
Facing the current complex and volatile international trade environment, we have always taken technological innovation and compliant operation as the core, and continuously advanced the "dual circulation at home and abroad" strategy. The successful overseas expansion of Dalbavancin for Injection this time fully demonstrates our international registration capabilities, high-standard compliance system and commercialization implementation strength.
In the future, NKF will continue to leverage its comprehensive advantages of an international compliance system, a global commercialization network, and full industrial chain integration to promote more high-end sterile preparations made in China to the world. It will persistently build itself into a "bridgehead" for the internationalization of biopharmaceutical achievements, providing more high-quality treatment options for patients worldwide.
