Medigen Biotechnology Corp. (hereinafter as MBC) was founded in Taiwan in December 1999, with a primary focus on the development of new therapeutics for liver diseases and cancers. MBC is a public company currently listed as Emerging Stock Market of Taiwan, with an estimated market value of US$90M~100M. Major shareholders of MBC include several distinguished publicly listed companies in Taiwan, such as Everspring Industry Co., Ltd., Tatung Co., Taching Holding Co., and Lucky Cement Corporation.

In June 2010, MBC licensed the global commercialization rights of PI-88 from Progen Pharmaceuticals of Australia, with whom MBC has had a decade long collaboration history. The phase II study demonstrated that PI-88 has good safety profiles and a promising effect in reducing tumor recurrence after surgical resection of early hepatocellular carcinoma (HCC). The phase III (PATRON) study has integrated key findings of the phase II trial and is randomized, double-blind and placebo controlled in design. The PATRON phase III protocol has received official approval by the TFDA (Taiwan FDA), and is pursuing further approval in China, Korea, Hong Kong and several Western countries. Active recruitment of study subjects is expected soon. 

Telomelysin (OBP-301) is a novel oncolytic virotherapy for head and neck cancers and HCC treatment. In collaboration with Oncolys BioPharma of Japan, MBC’s joint project to validate the efficacy of Telomelysin for treating various cancers is among MBC’s development pipeline. OBP-301 has shown a good safety profile in the phase I study conducted in USA. Currently, MBC has received the green-light from the USFDA and the Taiwan FDA for a phase I/II study of intra-tumoral injection of OBP-301 for the treatment of locally advanced HCC (a mid-stage liver cancer). MBC will pursue further development of OBP-301 together with the Japanese partner in due course. 

In addition to the drug development platform, MBC established a second business entity for the development/production and marketing of Nucleic Acid Tests (NAT) in 2005. Facilitated by the in-house molecular diagnostic technologies, MBC launched its first benchmark Morgan™ HLA typing kits to the global market in 2007 through an efficient vertical integration of product design, development, manufacturing, clinical studies, certification and marketing. Up to this date, MBC has been selling HLA products to 22 countries including USA and EU countries. MBC’s subsidiary in China (Shanghai Haoyuan Biotech Co., Ltd) on the other hand, focuses primarily on the blood screening market for HIV/HBV/HCV testing. With the recent approval of Haoyuan’s proprietary 5-channel, 3 in 1 screening kit by the SFDA, Haoyuan anticipates a market penetration of up to 25% of blood banks and blood products manufacturers in China in 3 years. The implementation of China’s 5-year National Medical Reform Plans (2011~2015) is expected to augment business opportunities and sales revenue of Haoyuan’s NAT products. MBC is working closely with Haoyuan to expand the NAT product portfolio with synchronized automatic devices for pathogen detection and other clinical uses. 

In 2009, MBC initiated a technology platform for the mass production of cell-based vaccines. The quality and efficiency of this high density cell production system have been validated through the confirmation of several batches of H1N1/H5N1 virion antigen, produced by certified MDCK cell line at a semi-industrial scale production (60~500L). MBC is in negotiation with several potential collaborators to co-develop a series of prophylactic or therapeutic vaccine projects, which will significantly diminish public concerns of emerging infectious diseases in the Asia-Pacific region.