On October 31, DM Bio (Co Presidents Min Byung-jo and Kawasaki Yoshikuni) announced that it had signed an MOU with Alteogen (President Park Soon-jae) for the production and supply of biosimilars.
Under the terms of the MOU, DM Bio and Alteogen will cooperate with each other on the production and supply of commercial products after DM Bio finishes developing clinical samples of the Eylea biosimilar ALT-L9, which is being developed by Alteogen, for the global phase III clinical study.
Eylea is a biopharmaceutical developed by Bayer, Germany, for treating macular degeneration. Macular degeneration is a disease in which the macular tissue, located in the central retina of the eye, is impaired due to aging, genetic factors, toxicity, and inflammation. The global market amounted to about USD 6.5 billion (7.6 trillion KRW) last year.
The clinical study of ALT-L9 is now under way as the MFDS approved Alteogen for the phase I domestic clinical study of ALT-L9 in May of this year. Alteogen is currently preparing for the phase III global clinical study. The phase I samples were also produced and supplied by DM Bio.
DM Bio is a biosimilar company founded by Dong-A Socio Group in cooperation with Meiji Seika Pharma. It is equipped with biopharmaceutical production facilities with the capacity to manufacture 8,000L of cGMP-level antibodies per year, and recently received GMP compliance approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. DM Bio not only produces biosimilars jointly developed by the two companies but also conducts a CDMO business that provides such services as contract manufacturing and process development.
To expand the CDMO business, the company recently received consulting from Lachman, USA on the US FDA standards for the GMP system (Quality Material, Production, Laboratory, Microbiology, Computerized System, Facility & Engineering) and established a research center.
President Min Byung-jo of DM Bio said, “DM Bio is expanding its biopharmaceutical CDMO business based on its excellent cGMP-class production facilities.” “We will serve as a forward base that helps biopharmaceutical developers at home and abroad to enter the global market by producing and supplying high-quality biopharmaceutical products that are suitable for advanced markets like the US, Europe, and Japan,” he added.