China biotech makes FDA 'breakthrough' for HIV drug

China's TaiMed Biologics has won the FDA's breakthrough drug title for its HIV therapy, ibalizumab (TMB-355), making it apparently the first Chinese med to get onto the list. TaiMed's manufacturing partner, Shanghai-based WuXi PharmaTech ($WX), put out word of the BTD win late last week, highlighting an antibody that belongs to a class of viral-entry drugs now in development. WuXi plans to partner on filing a rolling BLA in search of an approval for what the CRO says would be the first therapeutic with a made-in-China stamp that's launched in the U.S. market. A little under a year ago WuXi heralded the FDA's approval of a batch of ibalizumab manufactured in Shanghai for patients being treated under an IND. Story

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