Chan Ye Xin Xi Wang·2025-07-22 01:14Core Viewpoint - The article discusses the growth and significance of International Multi-Center Clinical Trials (MRCT) in the pharmaceutical industry, highlighting the shift towards biological drugs and the increasing participation of domestic companies in MRCTs [1][9][21]. Group 1: Overview of MRCT - MRCT refers to clinical trials conducted simultaneously at multiple centers across different regions to evaluate the efficacy, safety, and applicability of new drugs or treatments [2][3]. - MRCT has gained global recognition in the pharmaceutical and medical device industries, becoming a primary source of clinical trial data for product registration in multiple countries [9][21]. Group 2: Current Status of MRCT in China - The number of MRCTs in China peaked in 2021, saw a decline, and is projected to reach a new high of 336 in 2024, representing a 15% year-on-year increase [9][11]. - The transition from small molecule chemical drugs to large molecule biological drugs is evident, with biological trials surpassing chemical trials for the first time in 2023 [11][21]. - In 2024, 55.4% of MRCTs will be biological trials (186 trials), while chemical trials will account for 150 trials [11][13]. Group 3: MRCT Phases and Trends - The majority of MRCTs in China are Phase III trials, maintaining over 55% of the total, followed by Phase II (21.1%) and Phase I (17.0%) trials [13][21]. - The increase in Phase I trials is attributed to improved review and approval efficiency, allowing for faster market entry of drugs based on early clinical data [13][21]. Group 4: Company Landscape in MRCT - Foreign companies like AstraZeneca, Sanofi, and Merck dominate MRCTs in China, holding the top positions in trial numbers [17][19]. - Domestic companies such as BeiGene, Zai Lab, and Ascentage Pharma are increasingly active in MRCTs, with their participation rising significantly from less than 3% in 2015 to 30.1% in 2024 [15][17]. Group 5: Future Trends in MRCT - The trend towards MRCTs is expected to continue, driven by supportive policies and an improving market environment, enhancing the market position of domestic companies [21][23]. - Biotech companies are increasingly engaging in MRCTs as a first step towards internationalizing their products for overseas registration [21][23].