Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

- Dong-A building a foundation for expanding its biosimilar business through license-out and supply agreements to Türkiye, Brazil and Mexico - Creating a synergy effect with STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings SEOUL, South Korea--(BUSINESS WIRE)-- Dong-A ST (Min Young Kim, President and CEO) (KRX: 170900) announced that they signed an exclusive license-out and supply agreement on November 4, 2022, with Polifarma (Mehmet Asri, CEO) for NESP® biosimilar DA-3880. According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico to Polifarma. Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. Meanwhile, Polifarma will be responsible for the development and commercialization in Türkiye, Brazil, and Mexico. The details of the upfront, milestone payments, and supply profit structure remain undisclosed as per the consensus between both parties. “DA-3880” is an ARANESP®/NESP® biosimilar for the treatment of anemic patients with chronic renal failure or those undergoing chemotherapy. Dong-A ST signed a license-out agreement with Sanwa Kagaku Kenkyusho in 2014 for the development and commercialization of DA-3880 in Japan. After regulatory approval from PMDA (Pharmaceuticals and Medical Devices Agency, Japan) in 2019, DA-3880 has been successfully commercialized in the Japanese market, making it one of the bestsellers among darbepoetin alfa biosimilar products. Polifarma is a Türkiye pharmaceutical company with 100% domestic capital and 36 years of experience. It has established actual export records of 586 drugs to over 70 countries, including the US, Europe, Brazil, and Mexico. As the most well-known, and most preferred, hospital products brand in Türkiye, Polifarma’s goal is to maintain its lead in the Türkiye market and become one of the biggest global leaders by sustaining its quality and technological superiority. Jae Hong Park (President and CSO of Dong-A ST) said, “This agreement provides an opportunity for Dong-A ST to introduce DA-3880 beyond the Japanese market and into the global biosimilar market including Türkiye and South & Central America. Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities.”