April 23, 2024

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[THE INVESTOR] Chong Kun Dang Pharmaceutical said on April 27 it has been granted a patent covering the manufacturing process of its version of Kyowa Hakko Kirin and Amgen’s anemia drug Aranesp from the US Patent and Trademark Office.

The drug candidate -- CKD-11101 -- is a copycat of the red blood cell booster Aranesp, also known as Nesp in some Asian countries, which treats anemia in patients with chronic kidney disease. 

The patent was entitled “method for purifying erythropoietin analogs having lower isoelectric point,” its technology to remove contaminants from the drug’s active ingredient darbepoetin alfa, a Chong Kun Dang official told The Investor.

It represents another milestone in the firm’s commercial strategy, having already received patents in the European Union, Japan, Korea and five other countries.

“With the US patent, we will aggressively pursue an entry into the global Nesp market which is worth 2.8 trillion won (US$2.64 billion),” the Korean drug maker said in a statement.

In 2017, Aranesp generated some US$2 billion for Amgen and US$515.5 million for Kyowa Hakko Kirin, according to the firms’ financial reports.

Chong Kun Dang hopes to bring CKD-11101 to the domestic market next year as the world’s first Aranesp biosimilar as the med has been under review for marketing approval since December last year.

On April 16, the pharmaceutical firm said it signed a license agreement with a Japanese company, whose name was not disclosed, to supply CKD-11101.

The official said the company hasn’t initiate clinical trials in other major pharmaceutical markets like the US and the EU where it’s looking for partners for the anemia drug.

By Park Han-na (hnpark@heraldcorp.com)