Aidea Pharma: Phase I clinical trial approval granted for the investigational 2.2 class modified new drug AD108 injection

According to the Zhitong Finance APP, Aidea Pharma (688488.SH) announced that the company and its holding subsidiary, Nanjing Nanda Pharmaceutical Co., Ltd., received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration on March 12, 2025, allowing the company to conduct Phase I clinical trials for the investigational 2.2 category modified new drug AD108 injection.

It is reported that AD108 injection is a modified new drug (chemical drug category 2.2), with the active ingredient being human prekallikrein, specifically tissue-type kallikrein-1 (KLK-1), which is a serine protease secreted by the kidneys. It exerts biological effects in the human body through the kallikrein-kinin system (KKS), interacting and balancing with the renin-angiotensin system (RAS) to maintain the stability and function of the circulatory system. Numerous medical studies have proven that the decline in KKS system function is one of the important factors affecting the occurrence, development, and poor prognosis of cardiovascular and cerebrovascular diseases, making it a natural target for treating cardiovascular and cerebrovascular diseases, including stroke. There is evidence from evidence-based medicine that exogenous supplementation of KLK-1 can effectively improve neurological deficits in patients with acute ischemic stroke, reduce disability rates, and enhance the ability to perform daily activities. AD108 injection achieves sustained drug release in the patient's body through subcutaneous administration, maintaining steady-state blood drug concentration and drug effects, continuously exerting therapeutic effects, and avoiding the risk of blood pressure drop that may occur with intravenous administration