Taiwan drug seeking Food and Drug Administration permit for human testing


TAIPEI, CNA

An innovative drug for diabetic ulcers, developed by a Taiwanese biomedical research institution, is about to be submitted to the U.S. Food and Drug Administration (FDA) for a permit on human testing, academic sources disclosed yesterday.

If approved, they noted, it will mark a milestone in the nation’s pharmaceutical research and development.

The drug was developed by the government funded Development Center for Biotechnology (DCB) and has been transferred to a local pharmaceutical company, Microbio Biotechnology, to continue the R&D process.

All ingredients of the combo drug are extracted from natural herbs, and possess distinct curative effects for diabetic wounds but show none of the side-effects seen previously,making it an improvement on the only drug available on the market, according to the DCB.

Diabetic patients sometime suffer from persisting wounds which may become ulcers capable of disturbing or undermining the immune system if left untreated.

To date, Taiwan’s biomedical industry has spent most of its R&D funds on improving existing drugs, and there has been no previous case of developing a wholly new drug — a fact that makes this new drug even more remarkable, noted researchers on the both side.

If the drug is permitted to undergo human testing, it will be the first time that a Taiwanese-made drug has passed FDA reviews, and only the second time that a combo drug has been approved by the U.S. drug administration, they added.