Fonte : liberoquotidiano di 13 set 2024

Stapokibart Was Granted Marketing Approval From National Medical Products Administration For The Treatment Of Moderate-to-severe Atopic Dermatitis in Adults

Stapokibart Was Granted Marketing Approval From National Medical Products Administration For The Treatment Of Moderate-to-severe Atopic Dermatitis in Adults (Di venerdì 13 settembre 2024) CHENGDU, China, Sept. 12, 2024 /PRNewswire/

Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the new drug application for Stapokibart (anti-IL-4R? monoclonal antibody, trade name: Kangyueda (???), for the indication of Moderate-to-severe Atopic Dermatitis in Adults. The Marketing Approval of Stapokibart is based on a multi-center, randomized, double-blind, placebo-controlled Phase III study, with the co-primary endpoints being the achievement of at least a 75% improvement in Eczema Area and Severity Index (EASI-75) From baseline and an Investigator's Global Assessment (IGA) score of 0 or 1 with a reduction of ?2 points From baseline at week 16.
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