国内首款AI赋能制剂新药完成三期临床

Core Insights - The company, JieTai Technology, announced that its self-developed AI-driven small molecule formulation optimization platform, AITEM, has successfully reached the primary endpoint of Phase III clinical trials for the candidate drug MTS-004, making it the first AI-enabled formulation new drug to complete Phase III trials in China [1] - MTS-004 is also the first and currently the only drug to complete Phase III clinical trials for Pseudobulbar Affect (PBA) in China, addressing a significant gap in the domestic treatment landscape for PBA [1] Company Overview - AITEM utilizes JieTai Technology's self-developed AI nano-delivery platform, NanoForge, as its technical engine, employing proprietary algorithms for drug formulation design and optimization [2] - The platform leverages quantum chemistry and molecular dynamics simulations to predict interactions between drugs and excipients, generating nano-level formulation optimization solutions to enhance drug solubility and bioavailability [2] Development Efficiency - In the MTS-004 project, AITEM significantly reduced the preclinical formulation optimization cycle from the industry average of 1-2 years to within 3 months [2] - The timeline from project initiation to the completion of Phase III clinical trials for MTS-004 was only 38 months, representing a substantial improvement in drug development efficiency compared to industry standards [2]