Novo Nordisk's Semaglutide Injection Gains New Approval in China for Diabetic Kidney Disease

On July 17, the NMPA official website showed that Novo NordiskSemaglutide InjectionThe approval of a new indication. According to publicly available data and clinical trial progress,Insight database speculates that the newly approved indication this time may be:Adult Type 2 Diabetes Mellitus with Chronic Kidney Disease。*For more information in 2025, pleaseNew Drug ApprovalIntelligence,Scan the QR code at the end of the article to add Xiaoyin and download for free.

Screenshot source: NMPA official website

Chronic Kidney Disease (CKD) A common complication of type 2 diabetes,Approximately 40% of patients with type 2 diabetes will develop CKD.For patients with type 2 diabetes, CKD imposes a significant burden and is a major cause of morbidity, including increased cardiovascular risk and mortality. Despite the availability of effective treatments for these patients, there remains a substantial residual risk of CKD progression and cardiovascular events in individuals with type 2 diabetes.

At the 84th Scientific Sessions of the American Diabetes Association held in June 2024, Novo Nordisk presented the results of the Phase 3 FLOW trial.

FLOW is a randomized, double-blind, parallel, placebo-controlled international multicenter clinical trial.（CTR20192594）, Aiming to CompareFor InjectionSemaglutide 1 mg AndPlaceboAs an adjunct to standard treatment comparedTo reduce the risk of renal function impairment progression in patients with type 2 diabetes and CKDAndRisk of Renal and Cardiovascular MortalityThe impact.

Trial data shows,The study met its primary endpoint.. Compared with placebo, 1 mg semaglutide group patientsThe risk of kidney disease progression and cardiovascular and renal death was reduced by 24%.（331 cases vs. 410 cases; Risk Ratio: 0.76）。 

 Overview Diagram of the FLOW Trial Study

Screenshot from:Insight Database

In addition, the study also found that,In all evaluated secondary endpoints, semaglutide 1 mg was superior to placebo., including the average annual glomerular filtration rate (eGFR)The slope decreased significantly by 1.16 ml/min/1.73 m²/year.（-2.19 vs. -3.36 ml/min/1.73 m²/year）。The risk of major cardiovascular events was significantly lower in the semaglutide group than in the placebo group.（212 vs. 254 incidents; Risk Ratio: 0.82）。The risk of death from any cause was significantly lower in the semaglutide group than in the placebo group.（227 cases vs. 279 cases; Hazard Ratio: 0.80）。

In terms of safety, the number of serious adverse events reported in the semaglutide group was less than that in the placebo group. Adverse events of special pre-specified interest in the semaglutide group and the placebo group.（≥5%）Including diabetic retinopathy, COVID-19-related diseases, severe cardiovascular diseases, heart failure, acute renal failure, malignant tumors, and severe gastrointestinal diseases.

•  Ozempic （Hypoglycemic Injection Edition）Sales were approximately 174.66billion US dollars（120.342 billion Danish kroner,1 Danish Krone = 0.14514 USD）, an increase of 26% year-on-year;

•  Rybelsus （Hypoglycemic Oral Version）Sales are approximatelyUSD 3.382 billion（233.01 Million Danish Kroner)，Year-on-yearGrowth 26 %；

•  Wegovy （Weight Loss Edition）Sales are approximately$8.448 billion（582.06Million Danish Kroner), an increase of 86% year-on-year.

WithThe continuous expansion of new indications,The sales volume of Semaglutide will undoubtedly see a further increase.

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Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If you have any needs, please consult and contact正规医疗机构.

Editor:Xin Yao

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