Catalyst Event
Simcere Pharmaceutical Group (2096) · Other
From Akros SCHK HK-Global Genomics Index (ASHGGENM)
4/29/2026, 12:00:00 AM
Announced that the resubmitted New Drug Application (NDA) for Rademikibart was accepted by China's NMPA on April 29, 2026. Medium importance as NDA acceptance is a key regulatory milestone likely causing >5% price impact.
Korean Translation
아토피 피부염 치료제 라데미키바트에 대해 재제출된 신약 허가 신청(NDA)이 2026년 4월 29일 중국 국가약품감독관리국(NMPA)에 의해 접수됨. NDA 접수는 주요 규제 마일스톤으로 5% 이상의 주가 변동을 초래할 것으로 예상되어 'Medium'으로 분류함.
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