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展品详情
产品：诺和泰®（司美格鲁肽注射液）
介绍：
诺和泰®（司美格鲁肽注射液）是通过基因重组技术，利用酿酒酵母细胞生产的人胰高血糖素样肽-1（GLP-1）类似物，具有94%的序列同源性。
司美格鲁肽已经在中国、美国、欧盟、加拿大、日本等多个国家及地区获批上市。2021年4月27日，国家药品监督管理局（NMPA）批准了诺和泰®（司美格鲁肽注射液）的上市申请，用于成人2型糖尿病患者的血糖控制，同时还可用于降低伴有心血管疾病的2型糖尿病成人患者主要心血管不良事件风险。诺和泰®（司美格鲁肽注射液）于2021年纳入国家医保目录。
2025年7月18日，国家药品监督管理局（NMPA）正式批准了诺和泰®（司美格鲁肽注射液）用于降低伴有慢性肾脏病的2型糖尿病成人患者eGFR持续下降、终末期肾病和心血管死亡的风险。该适应症的获批标志着诺和泰®（司美格鲁肽注射液）成为全球首个且目前唯一（截止2025年9月25日）覆盖降糖、心血管和肾脏三大适应症的人胰高血糖素样肽-1受体激动剂（GLP-1RA）。诺和泰®（司美格鲁肽注射液）通过心-肾-代谢综合管理，为中国2型糖尿病患者提供了“一药多效”的疾病管理方案。
Product: Ozempic® (Semaglutide Injection)
Introduction:
Ozempic® (Semaglutide Injection) is a human glucagon-like peptide-1 (GLP-1) analogue produced in Saccharomyces cerevisiae cells by recombinant DNA technology with 94% sequence homology to human GLP-1.
Semaglutide has received marketing authorization across multiple countries and regions including China, the United States, the European Union, Canada, and Japan. On April 27, 2021, China National Medical Products Administration (NMPA) approved Ozempic® (semaglutide injection) for glycemic control in adults with type 2 diabetes (T2D), concurrently endorsing its use to reduce the risk of major adverse cardiovascular events (MACE) in T2D adults with established cardiovascular disease. Ozempic® was included in China National Reimbursement Drug List (NRDL) in 2021.
On July 18, 2025, the NMPA formally approved Ozempic® (semaglutide injection) for reducing the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in T2D adults with chronic kidney disease (CKD). This approval establishes Ozempic® as the first and only GLP-1 receptor agonist (as of September 25, 2025) globally to cover all three therapeutic domains: glycemic control, cardiovascular risk reduction, and renal protection. By enabling integrated cardio-renal-metabolic management, Ozempic® provides a "multi-benefit" treatment strategy for T2D patients in China.