Lilly Announces NMPA Approval of Mounjaro® (Tirzepatide Injection) for Chronic Weight Management in China
Eli Lilly
Global Pharmaceutical R&D and Production Company
July 19, 2024, Eli Lilly Mu Fengda®(Tirzepatide Injection) Receives NMPA Approval for Long-term Weight Management Indication. Mufengda®It is the first and currently the only approved glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist, as well as the first innovative drug in the field of obesity treatment developed by Eli Lilly to be approved in China. Mufengda®Can bind to and activate GIP receptors and GLP-1 receptors, reducing food intake, lowering body weight, and decreasing fat mass by regulating appetite. It is suitable for long-term weight management in adults with a body mass index (BMI) meeting the following criteria, in addition to dietary control and increased physical activity: ≥28 kg/m².2(Obesity), or ≥24 kg/m2(Overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.).
President and General Manager of Eli Lilly China
Ms. Dehlain stated
"Obesity is a chronic disease that, like other chronic diseases, requires effective long-term management. Currently, more than half of Chinese adults are experiencing the effects of obesity or being overweight."1, Eli Lilly is making relentless efforts to improve their health. The approval of Mounjaro's new indication marks the arrival of Eli Lilly China's first innovative drug for long-term weight management. This medication directly addresses the root causes of overweight/obesity and will benefit hundreds of millions.1,2Brings hope to patients who are struggling with obesity and looking forward to better weight management, and helps effectively implement several national action plans such as 'Healthy China Initiative' and 'Weight Management Year'.
Senior Vice President of Eli Lilly and Company
Head of Eli Lilly China Drug Development and Medical Affairs Center
Dr. Wang Li said
"Eli Lilly is making relentless efforts to develop disease solutions for obese and overweight patients, while promoting evidence-based treatment models for obesity and ensuring that patients receive appropriate treatment. At the same time, Eli Lilly is conducting in-depth research into the pathophysiological mechanisms of obesity and its complications, which will help clinicians make more accurate diagnoses and treatments, contribute to eliminating social prejudice about obesity, help patients better understand and manage this chronic disease, and improve their quality of life."
To benefit a wide range of Chinese patients as early as possible, China actively participated in the global registration clinical trial of tirzepatide and conducted studies based on Chinese diagnostic criteria.SURMOUNT-CN: Clinical Trial Registered in China``, and achieved positive research results. The results of the SURMOUNT-CN trial are consistent with the efficacy data from completed global registration trials and align with the known global safety profile.''3。
The principal investigator of SURMOUNT-CN, Professor Li Xiaoying from Zhongshan Hospital Affiliated to Fudan University, stated:
"SURMOUNT-CN is one of the few clinical trials that adopts BMI cut-off points relevant to Chinese diagnostic and treatment standards, and it is the first to confirm the efficacy of tirzepatide in individuals with a BMI ≥28kg/m².2Or with at least one complication and BMI ≥ 24 kg/m²2"Chinese adults have shown significant weight loss effects, and it is well-tolerated. We look forward to Chinese patients with obesity and overweight benefiting from this innovative drug!"
About Mufengda®(Tirzepatide Injection)
Mufengda®(Tirzepatide Injection) is the first and currently the only GIP/GLP-1 receptor agonist approved by the National Medical Products Administration (NMPA) for glycemic control in adult patients with type 2 diabetes mellitus (T2DM) and long-term weight management in adult patients with obesity or overweight.
- Tirzepatide for glycemic control is indicated for adult patients with T2DM whose blood glucose remains inadequately controlled on metformin and/or sulfonylurea therapy, in addition to diet and exercise.
- Tirzepatide for Long-term Weight Management is indicated for the long-term weight management of adults with an initial Body Mass Index (BMI) meeting the following criteria, in conjunction with a controlled diet and increased physical activity: ≥28 kg/m².2(Obesity), or ≥24 kg/m2(Overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.).
References
1. Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol 2021;9:446-61.
2. Sun X, Yan AF, Shi Z, et al. Health consequences of obesity and projected future obesity health burden in China. Obesity (Silver Spring) 2022;30:1724-51.
3. Zhao L, Cheng Z, Lu Y, et al. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA 2024 May 31. doi: 10.1001/jama. 2024. 9217. Online ahead of print.
Lilly
About Eli Lilly and Company
Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation and benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly and Company has nearly 150 years of history. Today, our medicines have helped over 51 million people globally. Harnessing the power of biotechnology, chemistry, and genetic medicine, our scientists are actively advancing new medical breakthroughs to address severe global health challenges. Redefining therapies for diabetes and obesity, reducing the long-term impact of obesity on the body; supporting initiatives for the prevention and treatment of Alzheimer's disease; providing solutions for a range of immune diseases that threaten human health; and transforming difficult-to-treat cancers into manageable conditions. Every step Eli Lilly and Company takes toward a healthier world stems from our belief in "making life better for millions of patients." This includes innovative clinical trials aimed at addressing multiple global challenges while ensuring the accessibility and affordability of medicines. For more information about Eli Lilly and Company, please visit: www.lilly.com.
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