剂泰科技完成中国首个AI赋能管线三期临床研究

Core Insights - JieTai Technology announced that its 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][2] - MTS-004 is the first and currently the only drug in China to complete Phase III clinical trials for PBA (Pseudobulbar Affect), addressing a significant gap in the domestic treatment landscape for this condition [1][3] Summary by Sections Drug Development and Clinical Trials - MTS-004 is an innovative oral treatment candidate for PBA, designed as an orally disintegrating tablet (ODT) that dissolves quickly in the mouth without water, improving patient experience and adherence [1][3] - The AiTEM platform, powered by JieTai's proprietary AI nano-delivery platform NanoForge, significantly reduced the preclinical formulation optimization cycle from the industry average of 1-2 years to just 3 months [2] - The Phase III clinical trial involved 264 participants over 9.5 months, led by Professor Fan Dongsheng from Peking University Third Hospital, and included multiple centers across China [2] Clinical Efficacy and Safety - MTS-004 demonstrated good overall safety and clear efficacy in treating PBA secondary to neurological diseases, with statistically significant reductions in average attack frequency after 12 weeks of treatment [3] - The drug showed improvements in various assessments, including CNS-LS scores, CGI-C, PGI-C evaluations, and SF-36 mental health index, indicating enhanced emotional control and quality of life for patients [3] Future Prospects - JieTai plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for MTS-004 in 2026, with potential expansion into indications for swallowing disorders post-approval [3] - The CEO of JieTai emphasized the role of AI in accelerating clinical treatment and addressing unmet patient needs, highlighting the successful completion of the drug's development cycle as a foundation for future projects [4]