Abrocitinib

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API lub npe Qhov taw qhia Innovator Patent Expiry Date (Tebchaws Asmeskas)
Abrocitinib Atopic dermatitis Pfizer Peb 11, 2034


Product Detail

Khoom cim npe

KHOOM PLIG

Abrocitinib yog ib qho ntawm qhov ncauj, me me molecule, Janus kinase (JAK) 1 inhibitor hauv kev loj hlob rau kev kho mob ntawm cov neeg laus thiab cov tub ntxhais hluas uas muaj mob atopic dermatitis.

Abrocitinib tab tom tshawb nrhiav hauv kev sim tshuaj NCT03796676 (JAK1 Inhibitor Nrog Tshuaj Kho Mob hauv Cov Hluas Nrog Atopic Dermatitis).

Abrocitinib tam sim no tau tsim los ntawm Pfizer rau kev kho mob atopic dermatitis (eczema).Nws yog ib qho kev tshawb nrhiav qhov ncauj ib zaug ib hnub Janus kinase 1 (JAK1) inhibitor.

Atopic dermatitis (AD) yog ib qho nyuaj, mob ntev, kab mob ntawm daim tawv nqaij uas tshwm sim los ntawm pruritic, khaus khaus, thiab eczematous lesions cuam tshuam txog 25% ntawm cov menyuam yaus thiab 2% mus rau 3% ntawm cov neeg laus thoob ntiaj teb.Abrocitinib yog ib qho kev xaiv inhibitor ntawm Janus kinase-1 (JAK1) enzyme inhibiting txheej txheem inflammatory.Yog li ntawd, peb tsom mus ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm abrocitinib rau nruab nrab-rau-hnyav AD.

Abrocitinib nyob rau hauv koob tshuaj 100 mg lossis 200 mg yog ib qho tshuaj zoo, muaj txiaj ntsig zoo, thiab muaj txiaj ntsig zoo hauv kev kho cov neeg mob uas muaj mob atopic dermatitis.Txawm li cas los xij, kev tsom xam pom zoo rau kev ua tau zoo ntawm abrocitinib 200 mg tshaj 100 mg, tab sis cov kev mob tshwm sim xws li xeev siab thiab mob taub hau yuav tshwm sim ntau dua nrog 200 mg.

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Tswv yim18Quality Consistency Evaluation tej yaam num uas tau pom zoo4, thiab6tej yaam num raug tso cai.

Quality management2

Advanced thoob ntiaj teb kev tswj hwm qhov system tau tso lub hauv paus ruaj khov rau kev muag khoom.

Quality management3

Kev saib xyuas zoo ua haujlwm los ntawm tag nrho lub neej voj voog ntawm cov khoom kom ntseeg tau tias qhov zoo thiab kho cov nyhuv.

Quality management4

Pab Pawg Kev Tswj Xyuas Kev Tswj Xyuas Kev Ua Haujlwm txhawb nqa qhov kev xav tau zoo thaum lub sijhawm thov thiab tso npe.

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