Development of 2nd-generation continuous EPO manufacturing technology

Chong Kun Dang Pharmaceutical Corp. (Yeo-wook Gho , Head of Bio Research Center)
https://korean-products.com/inquiryWhile companies all over the world are more actively striving to find future growth engines, there is fierce competition in the biomedicine field, which comprises the largest sector of the bio-industry. Chong Kun Dang, which has concentrated on the pharmaceutical field only for 70 years since its establishment even in such a competitive environment, established a central research center in 1972 for the first time in the pharmaceutical industry and opened new horizons in pharmaceutical study. Of its valuable achievements, the company succeeded in the technical development of 2nd-generation EPO darbepoetin-alpha, which is being used in anemia treatment for patients suffering from chronic renal insufficiency. Thereby, the company is expected to contribute greatly to the advancement of Korea’s biomedicine industry, along with its full-scale growth as a biomedicine manufacturer.

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Success in the localization of 2n d-generation continuous
EPO manufacturing technology

This successful technical development by Chong Kun Dang that evolved under the goal of ‘”Realizing disease-free human society” is mainly considered attributable to the potential of Chong Kun Dang, which has quietly focused on one thing and chairman Janghan Lee’s insight by providing active support and investment despite the risks and uncertainty in the biomedicine industry.
Moreover, adding wholehearted support and confidence from management added impetus to the technical development. As a result, Chong Kun Dang can settle into its new role as a biomedicine manufacturer from synthetic drug manufacturer, and accumulate its ability and performance including 2nd-generation EPO bio-similar development for the first time in the country in 2015.
In this regard, Yeo-woo Goh who led this technical development as head of the bio-research center said that “The numbers of patients suffering from chronic renal insufficiency are increasing persistently all over the world. While the market of EPO used to treat anemia for those patients is also growing, the market expanding speed becomes faster for 2nd-generation EPO that can provide equivalent medicinal effects with once a week or once in two weeks injection due to better blood half-life compared to 1st-generation EPO (erythropoietin) that needs to be injected with hypodermic or intravenous injection three times per week.” He added that “However, other than original foreign products, 1st- generation EPO has been developed and sold by several domestic pharmaceutical companies, whereas only foreign original products are monopolizing domestic supply for 2nd-generation continuous EPO. In this situation, success in developing 2nd-generation continuous EPO manufacturing technology that can substitute for expensive original products has great significance, because it sets the foundation of entering global 2nd-generation EPO market that has a value of 2,500 billion won as well as provides import-substituting effect.”

Overcoming high-tech barriers with self-developed
technical power

According, it is necessary to understand the cause of monopolistic supply of foreign original products for 2ndgeneration continuous EPO darbepoetin-alpha. The 2ndgeneration EPO has a very complicated glycoprotein structure, where two sugar chains are added to 1st-generation EPO. Adding sugar chains is a core technique to improve blood half-life in EPO, and three-times longer blood half-life than 1st-generation EPO can be achieved by adding sugar chains. Due to such additional sugar chains, 2nd-generation EPO has longer blood half-life but it is produced in isomer with dozens of various structures.
On this account, the following core techniques are required to produce the medicine in the same quality as 2nd-generation EPO darbepoetin-alpha: the first core technique is separating and purifying only a few isomers having suitable blood half-life and medical effects from dozens of various isomers; and the second core technique is manufacturing technique having the same sugar structure as unique sugar chain of darbepoetin-alpha as much as possible.

Because of such complicated and difficult techniques, foreign original products dominated the domestic market. Therefore, this independent development by Chong Kun Dang for protein pure separation and purification technology and technology to control sugar structure in glycoprotein is well appreciated as the company succeeded in developing manufacturing technology for 2nd-generation EPO that has appropriate effects. In addition, the company secured analysis skill, preclinical and clinical assessment skill through its unique technical power to evaluate the structure, physicochemical characteristics, immunological characteristics, purity, and medical effects of 2nd-generation EPO, so the considerable effort and time invested by the company resulted in a splendid achievement.

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Promoting global competitiveness expansion by entering
global market

Chong Kun Dang secured the high production cultivation technique and the high purity separate purification technique of 2nd-generation continuous EPO with investment in technical development and research infrastructure for the past seven years, and built a Bio-GMP factory to secure commercial production scales of manufacturing infrastructure. Also, the company is now in the 3rd-phase clinical stage of 2nd-generation continuous EPO product development, thus sales maximization according to market preoccupancy would be possible.
Consequently, after completing domestic 3-phase clinical tests, it is expected that 2nd-generation continuous EPO from Chong Kun Dang will capture about KRW20 billion of the domestic 2nd-generation EPO market through the nation’s first production around 2018 as a substitute product for the original product. As there is a very big market worth KRW600 billion per year, income through exports to Japan is also expected to rise due to Chong Kun Dang’s association contract with Fuji Pharmaceutical Ind.
concluded in December 2015. Moreover, it is known that industrialization review and preparation is in progressing actively to enter advanced markets in Europe.
About future plans, Yeo-wook Gho, head of the bioresearch center, declared that “As I mentioned earlier, equivalence of movement and effects on the body of Chong Kun Dang’s 2ndgeneration continuous EPO were already confirmed through preclinical and 1st-phase clinical tests, and 3rd phase is ongoing domestically as the final stage. This is rated as the most advanced development stage. After completing the 3rd-phase clinical tests, overseas clinical tests are also planned to enter market in developing countries and advanced countries including Japan and Europe as well as the domestic market. Through this, we will raise our 2nd-generation continuous EPO to a global bio-product.”
Also, Yeo-wook Gho, head of the bioresearch center, said that “Through technical power and know-how, facility, and equipment accumulated from this technical development course, we plan to make a greater effort to develop biomedicine for other diseases that can improve patients’ lives practically, furthermore helping to improve human life quality.”

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