On January 8 local time, Johnson & Johnson announced that its researchTau Monoclonal Antibody Posdinemab Granted Fast Track Designation by U.S. FDA, used for treatmentEarly Alzheimer'sDisease（AD）Patient.Previously, Johnson & Johnson's active immunotherapy JNJ-2056 targeting phosphorylated Tau protein was also granted Fast Track designation by the FDA.Posdinemab is a targetedMonoclonal antibodies targeting specific hyperphosphorylated epitopes in the middle region of Tau protein can delay or prevent the progression of AD by inhibiting the pathological deposition and spread of Tau protein. Currently,Posdinemab OpeningPhase IIb AuTonomy Clinical Study（NCT04619420）。AuTonomy is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical trial designed to evaluate the efficacy and safety of Posdinemab in patients with early AD. The study has enrolled 523 participants, and the primary endpoint isWeek 104 AD Composite Score Scale（iADRS）Change in Total Score from Baseline。In November 2021, Posdinemab was approved for clinical use in China for the first time to delay cognitive decline in patients diagnosed with prodromal AD and mild AD dementia. The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that Johnson & Johnson has completed a Phase I, open-label, single-dose study in Chinese healthy subjects to evaluate the pharmacokinetics, safety, and tolerability of Posdinemab.According to the Insight database, in recent years, the AD new drugs approved for marketing worldwide areEisai/Biogen's AducanumabAndLecanemab (Lunca Nai Monoclonal Antibody), and Eli Lilly'sDonanemab (Duanemab), are all Aβ monoclonal antibodies.Among them, Aducanumab has been abandoned by Eisai and Biogen due to ongoing controversies, while LecanemabExpectedFY 2024Total annual sales were 20 billion yuan.Donanemab has been on the market for less than half a year, and its market performance is worth looking forward to.Cover Source:Corporate Logo
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