China prüft Biogens Antrag auf subkutane LEQEMBI-Formulierung im beschleunigten Verfahren

Reuters
Yesterday
China prüft Biogens Antrag auf subkutane LEQEMBI-Formulierung im beschleunigten Verfahren

Die chinesische Arzneimittelbehörde National Medical Products Administration (NMPA) hat den Antrag auf Marktzulassung für die subkutane Formulierung von LEQEMBI® (Lecanemab), entwickelt von Eisai Co., Ltd. und Biogen Inc., im Januar 2026 angenommen und als vorrangiges Prüfverfahren eingestuft. LEQEMBI® ist zur Behandlung des frühen Alzheimer-Stadiums vorgesehen. Eisai übernimmt die führende Rolle bei der Entwicklung und den Zulassungsanträgen weltweit.

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