Chong Kun Dang said Friday that it has acquired a patent regarding the formulation of CKD-11101 (Original: Nesp), an anemia treatment biosimilar, in the United States.
The patent is related to a differentiated method of refining pure darbepoetin alpha, the main component of CKD-11101. Darbepoetin alpha has a complicated structure making it hard to formulate.
Since 2014, Chong Kun Dang has patented CKD-11101 in nine countries, including Europe, Japan, and the U.S. Through the acquisition of the U.S. patent, the company plans to accelerate its entry into overseas markets.
CKD-11101 is an anemia biosimilar for chronic renal failure patients. The drug proved its safety and efficacy in regards to the original medication through a local phase 3 clinical trial last year. It is trying to receive sales approval in Korea. If approved, it will become the world's first NESP biosimilar.
“Through this patent, Chong Kun Dang has proved its biopharmaceutical manufacturing technology is at a world-class level,” a company official said. "We plan to accelerate our entry into the global Nesp market, which is worth 2.8 trillion won ($2.6 billion).”
To further expand their global reach, the company has recently signed a contract to export CKD-11101 with a Japanese corporation of global pharmaceutical companies and is preparing to enter the Japanese market worth 600 billion won.
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