Last update 09 Dec 2025

AA001(ZHIYUAN)

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
AA001
Target
APP
Action
inhibitors
Mechanism
APP inhibitors(Beta amyloid A4 protein inhibitors)
Therapeutic Areas
Nervous System DiseasesOther Diseases
Active Indication
Alzheimer DiseaseMild cognitive disorder
Inactive Indication-
Originator Organization
Bei Jing Zhi Yuan Hong Sheng Sheng Wu Yi Yao You Xian Gong Si
Active Organization
Bei Jing Zhi Yuan Hong Sheng Sheng Wu Yi Yao You Xian Gong Si
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Related

2
Clinical Trials associated with AA001(ZHIYUAN)
CTR20254815
/ Not yet recruitingPhase 1
评价AA001单抗在中国阿尔茨海默病源性轻度认知障碍和轻度阿尔茨海默病患者中安全性、耐受性和初步有效性的随机、双盲、安慰剂对照、剂量递增的Ⅰb期临床试验
[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase Ib clinical trial evaluating the safety, tolerability, and preliminary efficacy of AA001 monoclonal antibody in Chinese patients with Alzheimer's disease-related mild cognitive impairment and mild Alzheimer's disease.
CTR20250571
/ Not yet recruitingPhase 1
评价AA001单抗在中国健康成年参与者中单次给药的安全性、耐受性及药代动力学的单中心、随机、双盲、安慰剂对照、剂量递增的Ⅰa期临床试验
[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalating Phase Ia clinical trial to evaluate the safety, tolerability, and pharmacokinetics of a single dose of AA001 in healthy Chinese adult participants
100 Clinical Results associated with AA001(ZHIYUAN)
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100 Translational Medicine associated with AA001(ZHIYUAN)
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100 Patents (Medical) associated with AA001(ZHIYUAN)
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100 Deals associated with AA001(ZHIYUAN)
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Alzheimer DiseasePhase 1
China
Bei Jing Zhi Yuan Hong Sheng Sheng Wu Yi Yao You Xian Gong Si
28 Feb 2025
Mild cognitive disorderPhase 1
China
Bei Jing Zhi Yuan Hong Sheng Sheng Wu Yi Yao You Xian Gong Si
28 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Phase
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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