生物技术衍生疗法的商业发展考量

Commercial development considerations for biotechnology-derived therapeutics.

作者信息

Marafino B J, Pugsley M K

机构信息

Department of Comparative Medicine, XOMA (US) LLC, Berkeley, CA 94710, USA.

出版信息

Cardiovasc Toxicol. 2003;3(1):5-12. doi: 10.1385/ct:3:1:5.

DOI:10.1385/ct:3:1:5

PMID:12668886

Abstract

Although it seems unlikely, it has only been 20 years since the US Food and Drug Administration (FDA) approved the first recombinant protein as a therapeutic modality. Unbelievably, an average of slightly more than two approvals per year of monoclonal antibodies (MAbs) and other human protein therapeutics has been achieved by this burgeoning industry 43 recombinant protein therapeutics in the two decades since 1982 (see Table 1), and the pace is increasing.

摘要

尽管看起来不太可能，但自美国食品药品监督管理局（FDA）批准第一种重组蛋白作为治疗手段至今，仅仅过去了20年。令人难以置信的是，自1982年以来的二十年里，这个蓬勃发展的行业平均每年批准的单克隆抗体（MAb）和其他人类蛋白治疗药物略多于两种（见1982年以来已有43种重组蛋白治疗药物获批），而且这一速度还在加快。