中国首个！申万投资已投企业德睿智药AI创新药MDR-001进入Ⅲ期临床

Core Viewpoint - The article highlights the significant milestone of Hangzhou Derui Zhiyao Technology Co., Ltd. (Derui Zhiyao) as its AI-assisted small molecule GLP-1 receptor agonist MDR-001 enters Phase III clinical trials in China, marking it as the first AI-designed drug to reach this stage in the country [1][2]. Group 1: Clinical Development - MDR-001 is set to recruit approximately 750 overweight or obese participants for a 52-week study to systematically evaluate the drug's efficacy and safety [1]. - Since 2021, Derui Zhiyao has developed over 10 independent research pipelines and nominated 7 clinical candidates, with two receiving clinical trial approvals [2]. - The Phase III study aims to further explore and confirm the differentiated advantages of MDR-001 [2]. Group 2: Efficacy and Safety - In a previous Phase IIb trial involving 317 participants with a baseline weight of 90 kg, MDR-001 demonstrated a weight reduction of 10.3% after 24 weeks, significantly exceeding the 5% threshold commonly used as an early response benchmark [2]. - MDR-001 exhibited exceptional safety, with no serious adverse events reported during the Phase II trial and a treatment discontinuation rate due to adverse events of only 0.8% [3]. - Compared to other small molecule GLP-1 drugs, such as Eli Lilly's Orforglipron, which showed increasing discontinuation rates due to adverse events, MDR-001's safety profile is notably superior [3]. Group 3: Investment and Strategic Focus - Shenwan Hongyuan Investment Co., Ltd. has invested in Derui Zhiyao as part of its commitment to the central financial work conference's directives and as a strategic move into AI-related sectors [4]. - The company plans to continue tracking cutting-edge AI technologies and explore their applications in innovative drug development, focusing on unmet clinical needs and investing in key areas such as innovative medical devices, IVD and precision medicine, biomedicine and life sciences, and smart healthcare [4].