New Drug R&D and Safety
Microbio acquired the first license in Taiwan for the new orally administered anti-cancer drug (MS-20 “Chemoyoung”) in 2011. MS-20 effectively improves fatigue and loss of appetite in patients who received chemotherapy through reconstruction of the intestinal ecosystem and restoration of immunity, thereby enhancing their quality of life. Microbio also acquired a license for “Herbiron” in 2013. This is the second autonomously developed new drug that successfully passed the registration process in Taiwan. Herbiron significantly improves menstrual discomfort and iron deficiency anemia. It won the first prize in the category of OTC drugs manufactured by domestic pharmaceutical companies of the National Biotechnology and Medical Care Quality Awards. The jury members highly lauded the R&D technologies and clinical efficacy of Herbiron. MB-6, a combination therapy drug for colorectal cancer, is ready to enter Phase 3 clinical trials. MB110 is a new orally administered anti-hepatitis C drug. Since other drugs for this indication have been marketed in succession in Taiwan and United States, the value of exploring this indication in Taiwanese and US markets has been greatly reduced. Therefore, Microbio will shift its R&D to the Chinese market, and Microbio (Shanghai), the subsidiary of Microbio, will be responsible for follow-up R&D, marketing, and sale of MB110 in China.
Moreover, Microbio has dedicated time to studying symbiotic bacteria fermentation-derived metabolites so long since. We have already detected over 450 metabolites capable of altering gut microbiomes and are currently expanding our drug library. On top of that, we rely on our world-leading technologies such as “the innovative commensal bacteria metabolite fermentation technology” and “intestinal immune modulation platform” to accelerate the selection of new drug candidates for the “gut micro-environment modulation.”
Last year, we successfully identified drug candidates for diabetes and inflammatory bowel disease. The development of new drugs for these two diseases currently represents the main focus of our R&D efforts. In line with their drug mechanisms of action, we have expanded clinical trials on indications. This has been a year of revolutionary breakthroughs in the development of microbiota drug/ medicine for Microbio. A total of six simultaneous clinical trials have been initiated to actively expand indications for the first-generation drug MS20. Manufacturers of next-generation micro-environment new drugs will take advantage of metabolite properties such as safety and edibility for their drug development strategies. Clinical studies have already been initiated for metabolite-based drug candidates selected this year. Once in vivo efficacy is verified, the strategy will result in significant cost reduction and time savings in the pre-clinical stage.
The Longtan Plant covers an area of 14,876 m2 (4,500 Pings). The deployment of hard- and software facilities in the plant has been completed, and it has been approved as a Chinese Medicine GMP Manufacturer by the Department of Chinese Medicine and Pharmacy of the Ministry of Health and Welfare. In addition, we have commissioned the Chinese Management Association to provide guidance in the ISO accreditation process for the whole plant to ensure drug safety. The plant has successfully acquired the ISO9001:2015 Quality Management System Certification, the ISO22000:2018 HACCP Food Safety Management System Certification, the OHSAS18001:2007 Occupational Health and Safety Assessment Series Certification, and the ISO14001:2015 Environmental Management System Certification.
