[Economic Daily 2007/01/02]
Microbio was approved by FDA yesterday, for conducting phase II study of botanical new drug candidate MS-20. Last year, FDA had approved the first botanical drug for therapeutic purpose, thus, for Microbio's TCM drug to enter US market is no longer a dream.
CEO of Microbio Mr. William Lu also point out, US medical main stream had long resisted of TCM drug because of complexity and efficacy is hard to be analyze into single compound.
Under so many US-Chinese elites' efforts, FDA had announced [Draft for botanical substance regulation] in August 10th, 2000, and later in June 2004 had officially announce[Botanical drug inspection protocol]. Last year in November, FDA had finally approved Vergen TM as botanical drug extracted from green tea, which is produced by German company MediGene for therapeutic index in treatment of venereal disease related to Human Papilloma Virus, and the core technology was oriented from Japanese.
CEO Lu even stress out that the first botanical drug ever to be approved by FDA means those botanical substances which are widely practiced in US could also been recognizable by US pharmaceutical industry. US pharmaceutical market accounts 50% of the overall global market size, and the first botanical drug to be approved by FDA actually encourage those Chinese oriented TCM R&D companies for further motivation in TCM new drug discovery.
CEO Lu commended, in Harvard Business Review has foreseen that biotechonology, internet, modernization of TCM, and mobile communication will be the four most important industry for the next 20 years
Under National Medical Statistics report, PhytoPharm Consulting calculate, year 2002 botanical related product market size is about 22400 million USD; assuming with 10-12% of annual growth, last year's market size is about 35000 million USD
Partaking 4000 million USD market share
Microbio announced yesterday, new botanical drug candidate MS-20 has approved for FDA phase II study, and study will be undertaking in this year; once it is allowed to enter market officially, there will be an opportunity to partake 40000 million USD market share.
Beside of new drug R&D, Microbio also simultaneously developing functional food distribution and market channel, there are as many as 1,200 Lee Herb corporate stores been deployed. Further more, a newly established MLM company Mcirosoy is built to focused on health related business.
General manager Joey Chen expressed, MS-20 is very safe because it mainly derived from fermentation of ordinary soybean, Microbio's core technology derived from symbiotic fermentation, and acquired an active ingredient which can sooth the side effect induced by chemotherapy and improve patient's appetite.
Joey indicated, MS-20 has approved for 11 patents in manufacturing process and product, and stand beyond the CMC standard. Microbio had started development of MS-20 six years ago, in the meantime of submitting phase II study, conducting for Taiwan DOH phase II study is undertaking simultaneously in which over 3/4 of patients are enrolled, once the study is completed, it will be ready for Taiwan's market
Joey Cehn said, FDA has approved for MS-20 submission, Microbio will start clinical study on patient with hepatoma and submitted to DOH, this indication is set to be launched by year 2011 to partake 4,000 million USD global market.
According to FDA's revealed information, there have been as many as 200 botanical new drug NDA application filed, of which, 10 filing are from China and Taiwan, but MS-20 of Microbio is the only Taiwanese botanical new drug aim for cancer indication.