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On March 5, Novo Nordisk announced its GLP-1 drugSemaglutide Injection (1.0mg) Phase III FLOW Trial Meets Primary Endpoint, Reducing Nephropathy-Related Risk by 24% in Type 2 Diabetes and Chronic Kidney Disease (CKD) Patients.
Semaglutide, a GLP-1 receptor agonist developed by Novo Nordisk, functions by mimicking a hormone that suppresses appetite and has therapeutic significance for conditions such as type 2 diabetes and obesity.Semaglutide Injection was approved by the FDA in 2017 for the treatment of type 2 diabetes (Product Name: Ozempic); Oral semaglutide was approved by the FDA in September 2019 for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes (Product Name: Rybelsus); In June 2021, it was again approved by the FDA for weight loss indications (Product Name: Wegovy）。Novo Nordisk's 2023 financial report shows:Ozempic Sales Reach $13.89 Billion, a year-on-year increase of 60%; Rybelsus sales reached $2.72 billion, a year-on-year increase of 66%; Wegovy sales reached $4.548 billion, a year-on-year increase of 407%.2023DepartmentCombined Sales of Three Wegovy Products Reach $21.157 Billion。
The FLOW trial is a randomized, double-blind, placebo-controlled clinical trial that compared the effects of injectable semaglutide (1.0 mg) versus placebo as an adjunct to standard care in preventing the progression of kidney damage and the risk of renal and cardiovascular death in patients with type 2 diabetes and CKD.The trial began in 2019 and recruited a total of 3,533 patients with type 2 diabetes and CKD.. The trial met the primary endpoint:Compared with placebo，Patients treated with semaglutide injection (1.0 mg) showed a significant 24% reduction in the risk of kidney disease progression, as well as cardiovascular and renal death.。In terms of safety, semaglutide has demonstrated good safety and tolerability, consistent with previous studies.Novo Nordisk states that approximately 40% of type 2 diabetes patients have chronic kidney disease, affecting about 700 million patients globally."Martin Holst Lange, Novo Nordisk's head of development, said: 'The positive results from the FLOW trial indicate that semaglutide has the potential to become the first GLP-1 treatment for patients with type 2 diabetes and chronic kidney disease.'"The companySubmission of a New Indication Marketing Application for Semaglutide (Ozempic) in the U.S. and EU Expected in 2024The detailed results of the FLOW study are also expected to be released at scientific conferences in 2024.
Since the advent of semaglutide, the popularity of GLP-1 drugs has remained high. Companies in China that are involved in this field include: Hengrui Medicine, Zhongsheng Pharmaceutical, Innovent Biologics, Hanmi Pharmaceuticals, Pagatech Biotech, Huadong Medicine, United Laboratories, Renhe Biotechnology, Yinnuo Pharmaceuticals, Ganli Pharmaceuticals, Changshan Pharmaceuticals, and Chengyi Biotechnology.
Among them, the ones with faster progress are:- In November 2023 and February 2024, Hanyu Pharmaceutical successively signed procurement orders for liraglutide injection with U.S. clients worth 103 million yuan and 72 million yuan (tax included).
- On February 7, 2024, Innovent Biologics' GLP-1R/GCGR dual agonist Mastytide NDA was accepted by the NMPA, and is expected to be approved in early 2024.
- On February 27, the Phase II clinical trial of RAY1225 Injection, a long-acting GLP-1 class drug developed by Zhenzhong Medicine's holding subsidiary Zhenzhong Ruichuang for patients with type 2 diabetes, completed the enrollment of its first participant.
References:
https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=167028#
