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 Arbormed and Penmix Apply for U.S. FDA Approval of Complex Generic ‘Sugammadex’ Arbormed (Co-CEOs Park Kyo-jin and Im Weonbin), a developer of treatments for rare and intractable diseases, announced on the 9th that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for the complex generic ‘Sugammadex’ injection on the 5th, in collaboration with Penmix, a domestic specialist in finished drug CDMO services. Through this cooperation, the two companies strategize to solidify their position in the global high-difficulty injectable market, which has high entry barriers. 

 Sugammadex is a neuromuscular blockade reversal agent. In this project, Penmix is in charge of product development, manufacturing, and supply, while Arbormed exclusively performs the U.S. FDA application (ANDA) and commercialization (marketing and distribution). The two companies aim for FDA approval by the end of 2026. Additionally, they plan to continue close cooperation for the development and commercialization of Ferric Carboxymaltose, a treatment for iron deficiency anemia, with the goal of applying for U.S. FDA approval in 2027. 

 Penmix obtained EU-GMP in 2022 and received Sugammadex approval from the European EMA. Arbormed plans to meet U.S. FDA approval requirements based on the manufacturing process data and quality control standards secured by Penmix. Penmix is also pursuing the acquisition of U.S. cGMP by 2026. 

 As a agent that quickly recovers patients from anesthesia after surgery, demand for Sugammadex is increasing in the North American market. The company plans to expand its business portfolio by securing additional high-difficulty complex generic pipelines and simultaneously strengthen its stable profit structure and future growth engines. 

 Following its recently signed 230 billion KRW European technology transfer agreement (ARBM-101), Arbormed is achieving results in both R&D and commercialization through the FDA approval process for complex generics. The company believes that expanding this revenue base will serve as a core competitive advantage in the technical evaluation for its KOSDAQ listing scheduled for 2027. 

 CEO Park Kyo-jin stated, “Through cooperation with Penmix, which possesses world-class production technology, we have established a clear bridgehead for entering the U.S. market. We will complete the successful launch of Sugammadex in 2026 and the approval application for Ferric Carboxymaltose in 2027 without a hitch, and use this as a stepping stone to accelerate Pre-IPO investment attraction and IPO preparations to maximize corporate value.”