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 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]

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]