速递｜中国GLP-1原料药被盯上了：美国国会议员点名三家中国公司

Core Viewpoint - The article discusses the increasing regulatory scrutiny by the U.S. Congress on GLP-1 drugs and their production by Chinese biotechnology companies, driven by concerns over the safety and legality of these products entering the U.S. market [6][7][9]. Regulatory Concerns - U.S. Congressman Raja Krishnamoorthi has formally requested three Chinese biotech companies to provide detailed information regarding the production, labeling, and export of GLP-1 drugs, amid rising concerns about unregulated products entering the U.S. drug supply chain [6]. - The companies named include Chinese Peptide Company, Zhongtai Biochemical Co., Ltd., and Hubei JXBio Biotech, which are believed to produce semaglutide and tirzepatide that may bypass FDA regulations [6][7]. Patient Safety and Health Risks - Krishnamoorthi emphasized that drug safety is non-negotiable for millions of American patients relying on GLP-1 medications, warning that illegal manufacturing could expose patients to unstudied health risks and undermine the U.S. drug safety system [7]. - The FDA has received hundreds of adverse reaction reports related to illegal compounded GLP-1 drugs, with potential links to serious health issues, including gastrointestinal disorders and even death [7][8]. Supply Chain and Compliance Issues - Despite the FDA declaring an end to the supply shortage of semaglutide, Krishnamoorthi warned that the underground supply chain remains active, with Chinese GLP-1 products potentially entering the U.S. market through mislabeling and other evasive actions [8]. - The Congressman posed 13 specific questions to the companies regarding their production processes, customer lists, and compliance with U.S. regulations, indicating a thorough examination of the GLP-1 global supply chain [8][9]. Shift in Regulatory Focus - The regulatory focus is shifting from merely approving and pricing end drugs to scrutinizing cross-border manufacturing, raw material sources, and traceability, indicating a broader competition involving compliance capabilities and supply chain transparency [9].