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China NMPA Approves LEQEMBI Autoinjector: A Signal for Drug-Device Combination Products
This episode examines the September 3, 2026, approval of the LEQEMBI (lecanemab) subcutaneous autoinjector by China's NMPA. We explore how this shift from bi-weekly IV infusions to once-weekly at-home administration impacts Alzheimer's treatment and what the NMPA's use of the Priority Review pathway signals to manufacturers of innovative drug-device combination products seeking access to the Chinese market. Key Questions: - What are the key differences between the new subcutaneous LEQEMBI formulation and the previous intravenous version? - Why did the NMPA grant this application a Priority…
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