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]

Core Insights - The company JieTai Technology announced that its AI-driven small molecule formulation optimization platform AiTEM has successfully achieved 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 Pseudobulbar Affect (PBA), addressing a significant gap in the domestic treatment landscape for PBA [1][3] Company Overview - MTS-004 is a novel oral treatment candidate for PBA, designed as an orally disintegrating tablet (ODT) that dissolves quickly in the mouth without the need for water, improving patient experience and adherence to treatment [1][2] - The AiTEM platform utilizes JieTai's proprietary AI nano-delivery platform NanoForge, employing specialized algorithms for drug formulation design and optimization, significantly reducing the preclinical formulation optimization cycle from the industry average of 1-2 years to just 3 months [2] Clinical Trial Details - The Phase III clinical trial was led by Dr. Fan Dongsheng, a renowned expert in neurodegenerative diseases, and involved a double-blind, randomized, placebo-controlled multi-center study assessing the efficacy and safety of MTS-004 in PBA patients secondary to various neurological conditions [2] - A total of 264 participants were enrolled over a period of 9.5 months, with the trial conducted across 48 clinical centers, including prestigious hospitals such as Peking University Third Hospital and Xuanwu Hospital [2] Efficacy and Safety - MTS-004 demonstrated good overall safety and clear efficacy in treating PBA secondary to neurological diseases, significantly reducing the average frequency of PBA episodes after 12 weeks of treatment, with statistically significant differences observed [3] - The treatment effects were noted as early as the second week, with improvements in emotional control and quality of life measured by various scales, including CNS-LS scores and SF-36 mental health index [3] Future Plans - The company plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for MTS-004 for PBA indications in 2026, with intentions to explore potential expansion into swallowing disorder treatments post-approval [3]

Core Insights - The company, Jitai Technology, has launched the world's first AI-driven nano delivery platform, NanoForge, which integrates quantum chemistry and molecular dynamics simulations for drug delivery optimization [1][2] - NanoForge enables a closed-loop process from molecular generation to formulation design, leveraging a large-scale library of over 10 million LNP lipid structures [1][2] - Jitai Technology has developed three major solutions based on NanoForge: AiLNP, AiRNA, and AiTEM, focusing on nucleic acid delivery, mRNA sequence design, and small molecule formulation design respectively [1][2] Company Developments - Jitai Technology has identified LNP targeted delivery for eight organs or tissues, with over 100 authorized and filed patent applications [2] - The company has successfully developed more than 10 pipeline projects, producing 7 preclinical candidates and advancing 4 clinical projects, with the fastest pipeline reaching the pre-NDA stage [2] - The CEO of Jitai Technology emphasized the shift from biotechnology to tech-driven biology, highlighting the efficiency and technological breakthroughs achieved through the integration of large model innovations and iterative experiments [2] Financial and Strategic Moves - In August, Jitai Technology completed a Series D financing round, raising a total of 400 million yuan, led by the Beijing Pharmaceutical Health Industry Investment Fund and the Daxing District Industrial Investment Fund [2] - The funds raised will accelerate the company's strategic initiatives, including platform automation upgrades, advancement of self-developed product pipelines, deepening international collaborations, and attracting high-end talent [2]