A New Monoclonal Antibody-Based Biosimilar GnRH Antagonist

Gregory M. Lee
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Abstract

GHR106 is a monoclonal antibody generated against an oligopeptide corresponding to that in the extra cellular domains of human GnRH receptor. The humanized forms of GHR106 exhibit almost identical biological properties to those of decapeptide GnRH antagonists such as Antide and Cetrorelix. The Fc region of humanized GHR106 has been replaced with IgG4 subtype to eliminate activities of effector function. Therefore, the newly humanized GHR106-IgG4Fc can be used clinically as biosimilar GnRH antagonists of higher molecular size, and longer half-life (hrs. vs. days) for therapeutic treatments of fertility-related health conditions without complications arising from the effector functions of immunoglobulins.
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一种新的基于单克隆抗体的GnRH生物类似药拮抗剂
GHR106是一种单克隆抗体,产生的寡肽与人GnRH受体细胞外结构域的寡肽相对应。人源化的GHR106表现出与十肽型GnRH拮抗剂(如Antide和Cetrorelix)几乎相同的生物学特性。人源化GHR106的Fc区被IgG4亚型取代,以消除效应功能的活性。因此,新人源化的GHR106-IgG4Fc可作为更高分子大小、更长的半衰期(hrs)的GnRH拮抗剂生物类似药用于临床。(Vs. days)用于治疗与生育有关的健康状况,而不会因免疫球蛋白的效应功能引起并发症。
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