Core Viewpoint - Green Leaf Pharmaceutical (02186) has seen a stock increase of over 3% following the announcement of FDA approval for clinical trials of its new drug LY03017, aimed at treating various psychiatric disorders associated with Alzheimer's and Parkinson's diseases [1] Company Summary - Green Leaf Pharmaceutical's LY03017 is a new generation 5-HT2AR agonist and 5-HT2CR antagonist, which has received FDA permission to initiate clinical trials [1] - The drug is intended for the treatment of Alzheimer's Disease Psychosis (ADP), Parkinson's Disease Psychosis (PDP), and Negative Symptoms of Schizophrenia (NSS) [1] - The FDA has waived the single ascending dose (SAD) trial phase for the Phase I clinical trial, allowing the company to proceed directly to multiple ascending dose (MAD) trials and subsequent clinical phases [1] - LY03017 is developed based on the company's new molecular entity/novel therapeutic entity technology platform and is being developed simultaneously in China and the U.S. [1] - Currently, LY03017 is in Phase I clinical trials in China [1] Industry Summary - There is only one drug globally approved by the FDA for the treatment of PDP, which has not yet been approved in China [1] - No drugs have been approved for the treatment of ADP either domestically or internationally [1] - Only a few drugs have shown efficacy for NSS, but their effectiveness is considered inadequate, indicating a significant unmet medical need in these therapeutic areas [1]
绿叶制药涨超3% 新药LY03017在美国获准开展临床试验 拟用于治疗PDP等