Multiple AI-Designed Drugs Enter Phase III Trials, Marking the Dawn of Commercial Value Realization in AI-Driven Drug Discovery

　　【Pharmaceutical Network Industry Dynamics】As the AI pharmaceuticals industry continues to advance, new drug development is gradually moving from early research to clinical validation. In 2025, Jingtai Technology, MindRank, and U.S.-based Generate Biomedicines have successively announced that products designed by AI have entered Phase III clinical trials.
 

In October 2025, JiTai Technology announced that its self-developed AI drug MTS-004 has successfully reached the primary endpoint of Phase III clinical research. According to the company, MTS-004 is a novel PBA oral treatment candidate drug, utilizing JiTai Technology's self-developed AiTEM orally disintegrating tablet (ODT) formulation design. This formulation addresses the common issue of swallowing difficulties in PBA patients, as it dissolves rapidly in the mouth without the need for water, significantly improving the patient's medication experience and treatment adherence.
 

MTS-004 is the first drug in China to complete Phase III clinical trials for the treatment of PBA (Pseudobulbar Affect). Study results show that MTS-004 has overall good safety and demonstrates clear efficacy and good tolerability in treating PBA secondary to neurological diseases.
 

On December 22, 2025, Hangzhou MindRank Ltd. announced that the company has officially launched the Phase III clinical trial in China for its self-developed AI-assisted designed small molecule GLP-1 receptor agonist, MDR-001. According to reports, this pivotal study plans to recruit approximately 750 overweight or obese subjects and will systematically evaluate the drug's efficacy and safety over a 52-week period.
 

From the project initiation to advancing into Phase III clinical trials, MindRank took only about four and a half years. If all goes well, the drug is expected to be launched by the end of 2028 or in 2029.
 

December 2nd, news: Biotech company Generate: Biomedicines announced that its AI-engineered drug GB-0895 will initiate two Phase III clinical trials, SOLAIRIA-1 and SOLAIRIA-2, to evaluate the efficacy of GB-0895 in approximately 1,600 adult and adolescent patients with severe asthma whose current treatments are inadequately controlled.
 

Multiple AI-Driven Drugs Have Entered Phase III Clinical Trials, Reflecting the Flourishing Development of the AI Pharmaceutical Industry. Incomplete statistics show that, as of December 24, 2025, there are over 350 AI pharmaceutical companies globally. Among them, China has at least 100, most of which are in the start-up stage, with more than 10 in the growth and maturity stages, including XtalPi, Insilico Medicine, Taimei Medical, and Kangyun Biotech. The therapeutic areas cover multiple key fields such as oncology, infectious diseases, immunomodulation, dermatology, gastrointestinal system, and ophthalmology.
 

Moreover, last year there were nearly 80 global AI pharmaceutical-related investment and financing events. Among them, at least 31 occurred in China. This scale is comparable to the 32 cases in 2021 and 33 cases in 2022, demonstrating the capital market's long-term confidence in this sector.
 

The industry believes that the entry of AI drugs into Phase III clinical trials in 2025 will be a milestone for the industry’s transition from concept to validation. Against the backdrop of high global pharmaceutical R&D costs and low success rates, AI is rapidly integrating into the pharmaceutical industry. By 2026, the industry is expected to witness a critical year of "clinical breakthroughs + accelerated commercialization," driving the pharmaceutical industry to transform from "high investment, long cycle, low return" to "precise, efficient, and low cost," and accelerating the emergence of First-in-Class/Best-in-Class drugs.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.