Sanofi Announces NMPA Approval of Toujeo® (Insulin Glargine Injection) for Adults with Type 2 Diabetes in China

Shanghai, September 3, 2020 /PRNewswire/ -- Sanofi announced that the National Medical Products Administration of China(NMPA)Officially approved the new formulation of "Insulin Glargine Injection" (strength: 1.5 mL: 450 units/pre-filled pen) (trademark: Toujeo^®，Toujeo^®), hereinafter referred to as Toujeo^®Product, for the treatment of adults with type 2 diabetes requiring insulin therapy.

Toujeo®^®The product’s unique sustained-release mechanism enables slower and more stable insulin release after subcutaneous injection, providing smoother and more effective glycemic control for patients with diabetes.ⁱ, a more reassuring initial titration experience^i,ii,iii, a more flexible injection time window^{i, ii,iii}。

This Visit to UCB^®The product's approval in China is based on a study named"EDITION AP"Phase III clinical study, which enrolled a total of 604 adult patients with type 2 diabetes, met the primary endpoint, confirming that Toujeo^®Efficacy and Safety of the Product in the Treatment of Type 2 Diabetes in Adults^iv。 

Compared with existing treatments, Toujeo^®The product can reduce blood glucose fluctuations, lower the risk of hypoglycemia, achieve more stable and effective glycemic control, and provide a more reassuring experience for initial dose titration. A study involving 929 patients with type 2 diabetes named"BRIGHT"of the international multicenter randomized controlled study results showed that Toujeo^®Glycated Hemoglobin After 24 Weeks of Treatment in the Product Group(HbA1c)Decreased by 1.64% from baselineⁱⁱ; during the most critical initiation and dose titration phases of insulin therapy, Toujeo^®The product group had a 43% significantly lower incidence of hypoglycemic events compared to the control group.ⁱⁱ。

Based on the overall clinical study results, Toujeo^®Professor Ji Linong, Head of the China Registration Study for the Product and Director of the Department of Endocrinology at Peking University People’s Hospital, pointed out:“Toujeo^®Product's mechanism of action confers favorable controlSugarStability,Helps toPatientMore Aggressiveand carry out in a timely mannerDosageAdjustmentOptimization; coupled with its flexibility in use，CapableSatisfactionDifferentPatient'sClinicalRequirement,EnhancementPatient Compliance,EnterAndAchieve long-term effective control of blood glucose. Toujeo^®The approval of this product adds another powerful weapon to China’s arsenal in the fight against diabetes, helping our countryBroadReceiving insulin therapyPatientFurtherImproving the Rate of Glycemic Control Target Achievement 。”

Professor Zhu Dalong, Director of the Department of Endocrinology at Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, stated:"Epidemiological survey data show that there are over 100 million patients with type 2 diabetes in China, most of whom are diagnosed at a relatively late stage. If insulin supplementation or replacement therapy is required due to disease progression, basal insulin should be the first-line choice."Toujeo®^®Product, its advantages such as potent and stable efficacy and a lower risk of hypoglycemia meet clinical needs that existing insulins cannot address, offering new options for patients with diabetes.”

For many patients with diabetes, initiating insulin therapy can be challenging, as they must not only learn how to use the injection product but also manage the potential risk of hypoglycemia. As an innovative long-acting basal insulin, Toujeo^®The product provides patients with more stable and effective blood glucose control through its unique, smooth sustained-release mechanism.ⁱ, lower risk of hypoglycemia, and a more reassuring experience with initial dose titrationⁱⁱ, a more flexible injection time window^i,ii,iii, facilitating more reassuring and convenient initiation of insulin therapy for patients, thereby further improving the rate of achieving glycemic control targets.

"The approved this time"Toujeo®^®Yes2020Sanofi's Year of Entry into China6innovative drug. We are accelerating the introduction of innovative drugs in China at an unprecedented pace. This demonstrates Sanofi’s commitment to achieving its goal of2030“the grand vision of reversing the spread of chronic diseases within a year.”Dr. Pius S. Hornstein, President of Sanofi China, stated, “By virtue ofA Century of Expertise and Heritage in Diabetes Careand Toujeo^®Successfully introduced to China, Sanofi will bring stable and highly effective innovative blood glucose management treatment solutions to the vast number of diabetic patients in China.”