Recently, the Class 1 innovative drugBrAD-R13tablet for treating Alzheimer's disease (AD, commonly known as "senile dementia"), led and developed byDean and Chair Professor Ye Keqiang of the Faculty of Life and Health Sciences at Shenzhen University of Advanced Technologyteam, successfully completedPhase I clinical trialat Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. This achievement not only marks a key breakthrough in China's innovative drug development for Alzheimer's disease but also brings new treatment hope to global Alzheimer's patients.

Breaking Traditional Paths

Achieving Target Innovation: Leap from "0 to 1"

In China's brain science field, especially the central nervous system (CNS) innovative drug development, there have long been many industry pain points such as unclear disease mechanisms, high R&D costs, long cycles, difficult clinical trial design, and low blood-brain barrier penetration rates for drugs.

Facing this dilemma, Ye Keqiang's team took a different approach, abandoning the traditional "symptomatic relief" R&D thinking and focusing on the more fundamental "disease-modifying" direction. The team continuously tackled around the new target TrkB receptor, through long-term dedicated research and repeated trials, successfully developing the world's first oral TrkB receptor agonist to enter the clinical stage—BrAD-R13 tablet, achieving an original breakthrough "from 0 to 1" in this field.

The core competitiveness of this innovative drug lies in its unique and efficient mechanism of action:

1,Possessing excellent blood-brain barrier permeability, able to precisely reach the target site;

2,By activating the brain-derived neurotrophic factor (BDNF)-TrkB signaling pathway, it can exert neuroprotective effects, improve patients' cognitive function, downregulate the activity of the key enzyme AEP in Alzheimer's disease pathogenesis, reduce the production of pathogenic proteins from the root, and lower their neurotoxic damage to neurons;

3,Can effectively regulate neuroinflammation, thereby achieving the core goal of "disease-modifying therapy."

In addition, the team's innovative drug screening methods and efficient R&D processes have significantly improved R&D efficiency and substantially shortened the cycle from laboratory results to clinically usable drugs.

Previously, BrAD-R13 tablet has successively obtained clinical implied permissions from the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA), and with its new target and unique mechanism, has become the world's first oral TrkB receptor agonist to enter the clinical stage.

Phase I Clinical Results Impressive

Laying a Solid Foundation for Follow-up Research

This Phase I clinical trial of BrAD-R13 tablet adopted an internationally recognized rigorous design scheme, covering single ascending dose (SAD), multiple ascending dose (MAD), and food effect (FE) three studies. The trial results showed that BrAD-R13 tablet exhibited good tolerability in the subjects, and combined with pharmacokinetic (PK) parameter analysis, confirmed its high safety; the food effect study further clarified the drug's PK characteristics, providing key data support for the optimization of subsequent clinical dosing regimens.

This is the first time BrAD-R13 tablet has verified the drug's safety and pharmacokinetic properties in subjects, providing key dosing basis for subsequent clinical studies and laying a solid foundation for the upcoming Phase II clinical trial.

Ye Keqiang, Dean and Chair Professor of the Faculty of Life and Health Sciences at Shenzhen University of Advanced Technology

"Shenzhen University of Advanced Technology has provided the research team with a high-quality innovation platform and all-round support." Ye Keqiang stated that in the future, the team will continue to deepen cooperation with Braegen Pharmaceutical and Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,scientifically and efficiently advancing the subsequent clinical trials of BrAD-R13 tablet while accelerating the R&D progress of the pipeline in development."We firmly believe that in the near future, we will surely bring new dawn to the treatment of neurodegenerative diseases.”

From target innovation to clinical breakthroughs, from therapeutic drugs to diagnostic reagents, Ye Keqiang's team has always taken conquering neurodegenerative diseases as its mission, practicing the commitment of "contributing to human health" with practical actions.

Let us look forward together to Shenzhen University of Advanced Technology

Bringing more world-class breakthroughs in the research field!