Clinical Trial Failure Risk: Drug development is a lengthy and uncertain process, and many investigational products fail to demonstrate efficacy or safety in clinical trials, leading to significant financial losses and delays.

Regulatory Approval Uncertainty Risk: Even if clinical trials are successful, obtaining necessary regulatory approvals from health authorities worldwide is not guaranteed and can be subject to lengthy reviews, additional data requests, or outright rejection.

Intense Competition Risk: The pharmaceutical industry is highly competitive, and Ascentage Pharma's product candidates may face competition from existing therapies or new products developed by larger, more established companies with greater resources.