, US time, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical—an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., Ltd. (SH.688068)—received Fast Track Designation from the United States Food and Drug Administration (FDA).

美国时间，由北京热景生物技术股份有限公司（SH.688068）孵化的创新生物制药公司舜歌生物医药研发的全球首款急性心肌梗死（AMI）抗体药物SGC001，获得美国食品药品监督管理局（FDA）快速通道资格。

Currently, SGC001 is under clinical research for patients with AMI. Completed clinical trials in healthy individuals have demonstrated its favorable safety profile and tolerability. The FDA's Fast Track designation is expected to accelerate the commercialization of SGC001, thereby providing more effective treatment options for patients with AMI..

目前，SGC001正在针对急性心肌梗死患者进行临床研究。已完成的健康人群临床试验表明其具有良好的安全性和耐受性。FDA的快速通道资格预计将加速SGC001的商业化进程，从而为急性心肌梗死患者提供更有效的治疗选择。

FDA Fast Track Designation is a regulatory mechanism intended to expedite the development and approval of new drugs. This designation facilitates interaction and communication with FDA throughout the drug development process, enables a rolling review during the marketing application submission, and provides greater access to priority review and accelerated approval pathways.

FDA快速通道指定是一种旨在加速新药开发和批准的监管机制。该指定促进了在整个药物开发过程中与FDA的互动和沟通，允许在上市申请提交期间进行滚动审查，并提供更多的优先审查和加速批准途径的机会。

As a result, it reduces the overall approval timeline, allowing patients to benefit from critical therapies sooner. Typically, this designation is awarded to treatments targeting serious or life-threatening conditions with unmet medical needs, provided they demonstrate meaningful innovation and are supported by robust clinical data..

因此，它缩短了整体审批时间，让患者能够更早从关键治疗中受益。通常，这一认定会授予针对未满足医疗需求的严重或危及生命的疾病治疗药物，前提是它们展现出显著的创新性，并有强有力的临床数据支持。