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???????????????????????????????????????FDA???

????? ??????????????? ???????2021/2/27 13:10:22

 

????????????????????????FDA???Humira(??????????????????????)????????5?????????ж??????????????????(UC)??

?????????????????????????????3??????о?ENVISION I?????????о???????Humira???8????????Mayo????(PMS)???????????????????8???з????????У??????(52??)???????Mayo????(FMS)????????????????????????????PMS??FMSС??????2???????÷??????1??

????ENVISION I????????????????????3???о??????????Humira???????UC????(????4-17??)?е???Ч????????????????(?????FMS?6-12??????????÷??2-3??????????????????????)????????

????????8????????????????????0?????Humira 2.4 mg/kg(???160 mg)????2?????1.2 mg/kg(???80 mg)????4????6?????0.6 mg/kg(???40 mg)????????????1?????????2.4 mg/kg(???160 mg)?????????????8????52??????????????????????????ο????Humira 0.6 mg/kg(???40 mg)?????о????????????????8??????????????????????(??????????????2????????????????>1)????????52??????????????????????(?????Mayo?????2????????????????>1)????Mayo??????????????(?????Mayo?????2????????????????>1??)??

?????о???????????8?????????????????????Humira??????У???60%?????(28/47)????ξ???????????????????????????Humira??????У???43%?????(13/30)?????????????52??????8???PMS??????У?????????Humira?????????У?45%??????????FMS?в??黺??????????Humira?????????У???29%???????黺??????????ο???????????У???33%???????黺????????????С????ο?????????????????????

????Humira?????????????????????????????????

????????????18??????????????Humira???????????????????????????????????????????

??????ENVISION I?о??У???й??Humira???°??????????о??е??κ?Humira??????22.6%?????????????????????????????????????????(????????5%)?????????????????????????????????????о?δ???????????????????????ν??????????????

????2018??Humira????????????????????????????????????????2018????????????????200?????????????????2023????????????????????????????г???Humira??????????????????2018??????????????????????????????????????????????????????Bioepis????????Humira???????????????????????????

????2021??12????????????????????????UC???Rinvoq(upadacitinib)??3??????о?U-ACHIEVE??????????????????8??????????????????黺??????????????3??????о?U-ACCOMPLISH?????Rinvoq??????UC????????????????????????(?????Bioon.com)

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???????????400-693-1193
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???????: 8:00-21:00
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