艾德生物（AmoyDx）作为中国领先的分子诊断企业，近年来积极拓展国际市场，尤其在北美地区取得了显著进展。公司通过其位于美国的子公司AmoyDx USA，成功承接了多家跨国制药企业的伴随诊断（CDx）开发与商业化合作项目。这些合作通常围绕靶向治疗和免疫治疗药物展开，旨在为新药临床试验提供精准的患者筛选工具，并支持药品在全球范围内的注册申报。艾德生物凭借其成熟的NGS（下一代测序）、PCR等技术平台，以及符合FDA、CE等国际监管标准的产品体系，赢得了国际药企的信任。此外，公司在北美的本地化团队具备丰富的法规事务、临床开发及市场准入经验，能够高效响应客户需求。通过深度绑定创新药研发管线，艾德生物不仅提升了自身在全球伴随诊断领域的影响力，也为中国体外诊断企业‘出海’树立了标杆。未来，随着更多合作项目的落地，艾德北美有望成为公司国际化战略的重要增长引擎。
AmoyDx, a leading Chinese molecular diagnostics company, has made significant strides in expanding its international presence, particularly in North America. Through its U.S.-based subsidiary, AmoyDx USA, the company has successfully secured companion diagnostic (CDx) development and commercialization partnerships with multiple multinational pharmaceutical companies. These collaborations primarily focus on targeted and immunotherapies, providing precise patient selection tools for clinical trials and supporting global regulatory submissions of novel drugs. Leveraging its robust technology platforms—including next-generation sequencing (NGS) and PCR—and a portfolio compliant with international regulatory standards such as FDA and CE, AmoyDx has earned the trust of global pharma partners. Additionally, its localized North American team brings extensive expertise in regulatory affairs, clinical development, and market access, enabling agile and responsive client support. By deeply integrating into innovative drug development pipelines, AmoyDx not only enhances its global influence in the CDx space but also sets a benchmark for Chinese IVD companies going global. As more collaborations materialize, AmoyDx’s North American operations are poised to become a key driver of its international growth strategy.
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