China News Service, Beijing, September 3 (Reporter Li Yanan) Sanofi announced on the 2nd that China’s National Medical Products Administration (NMPA) formally approved the new formulation of "Insulin Glargine Injection" on the same day (Specification: 1.5ml: 450 units/ Pre-filled injection pen) (registered trademark: Laiyoushi, Toujeo), used for adult type 2 diabetes who require insulin treatment.

  The latest Chinese population epidemiological study shows that there are 129 million adults with diabetes in China.

At present, the overall diagnosis and treatment rate of diabetes patients in China is low. Less than half of the patients (43.25%) are diagnosed, while less than half (48.95%) of the diagnosed diabetes patients are treated.

In addition, the blood glucose compliance rate of Chinese diabetic patients is less than half (49.41%).

In China, more than 30% of diabetic patients use insulin for long-term treatment, and the use rate of insulin in diabetic patients is lower than that in developed countries.

  According to reports, the approval of Laiyoushi's products in China is based on a phase III clinical study called "Edition AP". The study enrolled 604 adults with type 2 diabetes. Compared with existing treatments, Layoshi's products are more effective. Reduce blood glucose fluctuations, reduce the risk of hypoglycemia, achieve a more stable and effective blood glucose standard, and provide a more assured initial adjustment experience.

The results of an international multi-center randomized controlled study named "BRIGHT" covering 929 patients with type 2 diabetes showed that after 24 weeks of treatment in the Laiyoushi product group, glycosylated hemoglobin (HbA1c) decreased by 1.64% from baseline; it was the most effective in insulin treatment. In the important initial and dose adjustment phase, the incidence of hypoglycemia in the Laiyoushi product group was significantly lower than that of the control group by 43%.

  Professor Ji Linong, head of the China registration research of Laiyoushi products and director of the Endocrinology Department of Peking University People’s Hospital, pointed out: "The drug action mechanism of Layoushi products gives them good sugar control stability, which helps patients to be more active and timely. Dosage adjustment and optimization; coupled with its flexibility of use, it can meet the clinical needs of different patients, improve patient compliance, and achieve long-term effective blood glucose control."

  Professor Zhu Dalong, director of the Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University School of Medicine, said: “Epidemiological survey data show that there are more than 100 million type 2 diabetes patients in my country. Most of them are discovered and diagnosed late. If the disease progresses If insulin supplementation or replacement therapy is needed, then basal insulin should be the first choice. Laiyoushi products, with its strong and stable advantages and lower risk of hypoglycemia, meet the clinical needs that existing insulin cannot meet, and bring new ideas to patients with diabetes select."

  It is reported that the Sanofi Laiyoushi project has recently signed a contract and settled in Beijing Economic and Technological Development Zone. The total investment of the project is 200 million yuan. While meeting the Chinese market, the products produced will also be exported to Australia, Japan and other Asia-Pacific countries and regions.

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