HONG KONG – South Korea's Chong Kun Dang (CKD) Pharmaceutical Corp. received approval for its novel erythropoiesis stimulating protein (NESP) biosimilar from Japan's Ministry of Health, Labour and Welfare (MHLW). The drug (CKD-11101) is world's first NESP biosimilar to treat anemia.

The company will sell the biosimilar in Japan through Mylan NV's Japanese operation, under a deal signed in April 2018. The Japanese subsidiary filed an application for drug manufacture and selling authorization from the MHLW last October. CKD will export finished pharmaceutical products, and Mylan will launch the drug around December this year after drug price registration.

CKD launched the biosimilar in Korea in September.

NESP is a protein with additional sialic acid compared with erythropoietin (EPO). It stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO), but it is biochemically distinct. Darbepoetin alfa, the drug's main ingredient, is used to treat anemia in patients with chronic kidney disease and those who are under chemotherapy. The original drug was developed by Amgen Inc., of Thousand Oaks, Calif., and Kyowa Hakko Kirin Co. Ltd., based in Tokyo.

The NESP patent is valid until this year in Japan and until 2024 in the U.S. It expired in 2015 in Korea.

CKD has patented the biosimilar in nine countries, including the U.S. and Japan since 2014. The Korean company plans to expand its biosimilar business throughout the world.

"The biosimilar is CKD's first biopharmaceutical product, and entering the Japanese market is a great milestone for us. We will accelerate our business expansion in the global biosimilar market, which is estimated around $3 billion," a spokesman at CKD told BioWorld.

Besides the NESP biosimilar, the Korean company is developing four more biopharmaceutical drug candidates.

Lucentis (ranibizumab) biosimilar CKD-701 is targeting macular degeneration and is in phase III testing at around 25 medical institutes in Korea. The company aims to finish the clinical trials by 2021 and launch it in the global market. The original Lucentis was developed by the Roche Holding AG subsidiary Genentech Inc., of South San Francisco, which holds commercial rights in the U.S. Swiss pharmaceutical company Novartis International AG, based in Basel, has exclusive commercial rights for the rest of the global market.

CKD-971, an interferon (IFN)-alpha Kinoid candidate targeting lupus, is in phase II trials. In 2015, the Korean company signed an agreement for exclusive distribution rights in Korea with Neovacs SA, of Paris. The French company is conducting phase II trials in some European countries, including France and Germany.

CKD-702, a bispecific antibody to treat cancer, is in preclinical studies and is expected to enter a domestic phase I trial by the end of this year.

Analysts predict the Korean company's annual sales will be around KRW1 trillion (US$833 million).

"For the second quarter this year, the company's sales reached $2,66.4 billion (YoY +12.3%) and operating profit reached KRW19 billion (YoY +2.2%), which met the consensus. Based on the performance so far, the company's yearly sales would be about KRW1 trillion in 2019," Mihwa Seo, analyst at Yuanta Securities Korea Co. Ltd., told BioWorld.

According to the U.S. research company Grand View Research Inc. in San Francisco, the global EPO drug market size was valued at $7.4 billion in 2016 and is expected to grow at a compound annual growth rate of 11.5% until the year 2025. Increasing incidences of chronic diseases such as renal diseases, cancer and HIV are expected to accelerate demand for EPO-stimulating agents.

There are other companies developing NESP biosimilars. Japan's Gene Techno Science Co. Ltd., of Tokyo, and Sanwa Kagaku Kenkyusho Co. Ltd., based in Nagoya, have jointly developed GBS-011 (darbepoetin alfa) since 2014, after Sanwa licensed rights to drug development and commercialization for Japan from Korean company Dong-A ST Co. Ltd. The biosimilar received manufacturing and marketing approval from the Japanese government in September.

Japan's Kissei Pharmaceuticals Co. Ltd., based in Matsumoto, along with Nagano and JCR Pharmaceuticals Co. Ltd., of Ashiya, Hyogo, finished JR-131's (darbepoetin alfa) phase III trial in January last year. The biosimilar is in the NDA process.

Korea pharmaceutical and health care company CJ Healthcare Corp., based in Seoul, has developed an NESP biosimilar, CJ-40001. It transferred the biosimilar technology to Japan's YL Biologics Ltd. in September 2017, and China's NCPC Genetech Biotechnology Development Co. Ltd., based in Shijiazhuang, in February 2018.

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