2.1。Problem statement ............................................................................................. 9 2.1.1.Disease or condition......................................................................................... 9 2.1.2.Epidemiology .................................................................................................. 9 2.1.3.Biologic features ............................................................................................ 10 2.1.4.临床表现，诊断和阶段/预后................................................................................................. 10 2.1.5。Management ................................................................................................. 10 2.2.Quality aspects ................................................................................................ 11 2.2.1.Introduction ................................................................................................. 11 2.2.2.活性物质..................................................................................................................................................................................................................................................................................................................................................................................................................... 11 2.2.3。Finished Medicinal Product .............................................................................. 14 2.2.4.讨论化学，药物和生物学方面的讨论................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................. 19 2.2.5。关于化学，药物和生物学方面的结论........................................................................................................................................................................................................................... 19 2.2.6。Recommendation(s) for future quality development ............................................ 19 2.3.非临床方面............................................................................................................................................................................................................................................................................................................................................. 19 2.3.1。简介..................................................................................................................................................................................................................................................................................................................................................................................... 19 2.3.2。Pharmacology ............................................................................................... 20 2.3.3.Pharmacokinetics .......................................................................................... 25 2.3.4.Toxicology .................................................................................................... 28