· Canada’s largest CGT CDMO facility, supporting projects from early clinical stages to commercialization
· Strengthened partnerships and business development with global pharmaceutical and biotech firms in North America, accelerated by the advancement of CARTISTEM^®‘s U.S. Phase 3 trial preparations

MEDIPOST (CEO Wonil Oh) announced on the 21st that its affiliate, OmniaBio Inc., a Canada-based Contract Development and Manufacturing Organization (CDMO) in Cell and Gene Therapy (CGT), has completed construction and opened its new CGT CDMO facility. In May 2022, MEDIPOST had previously invested CAD 90 million (KRW 90 billion) in OmniaoBio through a convertible bond acquisition to support the launch of CARTISTEM^®, its knee osteoarthritis treatment, in the North American market.

The ceremony was attended by MEDIPOST representatives and many industry professionals including Michael May, Chairman of OmniaBio’s Board of Directors, and Doug Ford, Premier of Ontario.

The new 7,500-square-meter facility, which began construction in October 2022, is located in McMaster Innovation Park in Hamilton, Ontario. With the addition of this site to its existing 3,700-square-meter facility in Toronto, OmniaBio now boasts a total production space of 11,200 square meters, solidifying its position as Canada’s largest CGT CDMO.

With over a decade of accumulated expertise in CGT manufacturing, development, and analytics, OmniaBio aims to establish the new production facility as a leading innovation hub in North America, enhancing accessibility and cost-effectiveness for advanced medical therapies across the region.

OmniaBio’s first initiative at the new facility will be the development and manufacturing of MEDIPOST’s CARTISTEM^® for Phase 3 clinical trials in the U.S., with plans to scale up production for broader distribution across the North American market. CARTISTEM^® is an allogeneic umbilical cord blood-derived mesenchymal stem cell product used to treat knee cartilage defects caused by degenerative osteoarthritis or repeated traumas

At the ceremony, Michael May, Chairman of OmniaBio’s Board of Directors, highlighted the significance of the new facility, stating, “Our new facility significantly enhances our competitiveness in regenerative medicine, including CGT.” He continued, “Using our strategic location near the US border and Canada’s largest international airport, combined with cutting-edge technologies such as robotics, biosensors, and AI, we aim to position OmniaBio as a global CDMO, attracting international pharmaceutical and biotech companies as well as Canada’s most innovative enterprises.”

Antonio Seung Jin Lee, Head of MEDIPOST’s Global Business Division and CEO of its U.S. and Japanese subsidiaries, stated: “Over the past 20 years, MEDIPOST has successfully advanced umbilical cord blood stem cell therapies from foundational research to full commercialization.” e added, “With the completion of patient enrollment for CARTISTEM^®‘s Phase 3 clinical trials in Japan and ongoing plans for U.S. Phase 3 clinical trials, we are excited to drive MEDIPOST’s global expansion and establish our presence in international markets.”

With the expansion of OmniaBio’s production facility, MEDIPOST plans to complete the manufacturing of clinical trial materials and other key preparations for entering U.S. Phase 3 clinical trials, accelerating its business development and partnerships with global pharmaceutical and biotech firms in North America. Additionally, MEDIPOST anticipates that the expected rise in commercial orders and production will drive sustained mid- and long-term revenue growth.