2020年全球新药研发报告(Ⅰ)

A Report of New Drugs Research and Development in 2020(Ⅰ)

2020年因一场突如其来的疫情注定被载入史册,这场百年以来最严重的疫情以惊人的速度在全球迅速蔓延,影响了生活的方方面面。几乎2020年发生的所有事件或新闻报道在某种程度上均受到了新型冠状病毒肺炎(COVID-19)的影响。从这个角度看,2020年也在第一批新冠疫苗和COVID-19治疗药物获得紧急授权使用中高调地结束。尽管新冠疫情大流行占据了2020年的新闻头条,但从监管机构今年审评的产品数量来看,各治疗领域推出的新药均创下历史新高,较上一年增加了约50%。值得关注的成果包括:首款丁型肝炎治疗药物上市;预防和治疗埃博拉病毒病的生物制剂获得监管机构批准,该制剂在抗击2016—2018年刚果爆发的埃博拉病毒病方面发挥了作用;首款Hutchinson-Gilford早衰综合征(一种罕见的导致早熟型老化的遗传性疾病)药物获批;首款专门治疗甲状腺眼病(又称Graves眼病)的药物获批;首款非激素、按需用药、可调节阴道p H值的避孕药获批;首款针对花生过敏的口服过敏原免疫疗法获批。

2020 will go down in history as a year marked in every respect by the emergence and astonishingly rapid spread of the first major global viral pandemic in a century.It seems like nearly every event or story of the year was influenced in some way by COVID-19,and in that respect,the year ended on a high note with the authorization for emergency use of the first vaccines to prevent SARS-Co V-2 infection and drugs to treat COVID-19.Despite the pandemic’s dominance of the 2020 headlines,productivity was at a record high level across all therapeutic areas,as seen by the number of products in this year’s review:approximately 50%more than the previous year.Notable achievements include the launch of the first treatment for hepatitis D;regulatory decisions on a suite of biologics for the prevention and treatment of Ebola virus disease,fruit of the 2016-2018 outbreak in the Democratic Republic of Congo;the approval of the first-ever drug to treat Hutchinson–Gilford progeria syndrome,a rare genetic disorder that leads to premature aging;the first treatment developed specifically for thyroid eye disease,also known as Graves’ophthalmopathy;the first nonhormonal,on-demand,vaginal p H-regulating contraceptive;and the first oral allergen immunotherapy for peanut allergy.