Abstract Biotechnology is one of the five strategic emphases in the next 15 years in China. As one of the most important application fields of biotechnology, pharmaceutical biotechnology is its front technique and the hotspot of its R&D, as well as the most important technical impetus for the development of pharmaceutical industry. This article analyzed and summarized the strategic opportunities and six challenges of Chinese pharmaceutical biotechnology and its industry. The strategic opportunities included building an innovative nation, constructing a harmonious society, and adjusting the economic structure. The challenges included lack of innovative abilities, smallness of industry size, insufficient of capital investment, incorrectness of R&D main body, low of patent quality and IPR consciousness, and faultiness of standard system.
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