Many Taiwan's botanical drug approved for clinical study
Joey Chen, general manager and spokesman for Microbio expressed today, according to sufficient information from FDA, there are as many as six botanical drug from Taiwan approved for FDA clinical study, and Microbio's cancer regimen is the first to be approved by FDA for clinical trial.
Joey Chen indicated, according to FDA's information, there are over 200 filing for HIND, both China and Taiwan.
IND filings from Taiwan: BMEC-101 (aim for hepatitis B) and MNEC-1217B (aim for asthma) from Biotech Center, PDC-339 (for peptic ulcer) from PDC, STA-2 (for cardiovascular disease) from Sinphar,TCM-700C (for hepatitis C) from Taigen, and MS-20 (for cancer) from Microbio.
He mentioned, upon receiving notice, he realized that MS-20 not only the sixth FDA approval for HIND but also the first botanical drug under cancer therapeutic indication which shows that global pharmaceutical regulation is starting to accept botanical substance's complexity instead of single compound.
He said, Microbio's MS-20 derived from soybean fermentation, approved by Taiwan's DOH phase III study submission and aim for lessen chemotherapy side effect as indication.
Both Microbio and Sinphar are official nominated and approved botanical R&D center. Microbio's investment capital is 740 million NT dollars and allocate 300 million NTD for this project; it went IPO by June 9th,2006 and in the same year filing HIND to submit under FDA
