METiS BioTech Announces China’s First AI-Enabled Formulation Drug Candidate to Complete Phase III Clinical Trial

MTS-004, developed by METiS BioTech, is China's first AI-designed drug candidate to complete Phase III clinical trials, representing a significant national milestone in AI-driven drug development123.

The drug is specifically formulated to treat Pseudobulbar Affect (PBA), a neurological condition causing involuntary emotional episodes, and is the first therapy for PBA in China to reach this stage23.

MTS-004 is an orally disintegrating tablet (ODT) designed for patients with swallowing difficulties, dissolving rapidly in the mouth without water, and is intended to improve adherence and patient experience23.

Development leveraged METiS BioTech's proprietary AiTEM platform and NanoForge AI nanodelivery system, which apply advanced algorithms, quantum chemistry, and molecular dynamics simulations to accelerate formulation optimization—reducing the preclinical timeframe from 1–2 years to under 3 months23.

The Phase III trial was a randomized, double-blind, placebo-controlled, multicenter study led by Peking University Third Hospital, enrolling 264 patients at 48 leading hospitals across China to evaluate MTS-004's efficacy and safety in PBA secondary to ALS, MS, stroke, traumatic brain injury, or Parkinson's disease23.

MTS-004 is expected to file for New Drug Application (NDA) with China's National Medical Products Administration (NMPA) in 2026, with post-marketing studies planned for broader indications such as dysphagia3.

The drug's development cycle—from concept to Phase III completion—was completed in approximately 38 months, reflecting an accelerated pathway achieved through AI integration3.

Sources:

1. https://third-news.com/article/2a855284-b01d-11f0-a4be-9ca3ba0a67df

2. https://www.prnewswire.com/news-releases/metis-biotech-announces-chinas-first-ai-enabled-formulation-drug-candidate-to-complete-phase-iii-clinical-trial-302592862.html

3. https://www.morningstar.com/news/pr-newswire/20251023cn05479/metis-biotech-announces-chinas-first-ai-enabled-formulation-drug-candidate-to-complete-phase-iii-clinical-trial