The National Medical Products Administration officially accepted the application for the marketing of the innovative diabetes drug iGlarLixi

September 27, 2021, Sanofi announced the Chinese State Drug Administration Bureau (NMPA) has formally accepted the company's basal insulin and GLP-1RA fixed proportion of compound preparation * SOLIQUA® (iGlarLixi) of the New Drug Application
.

iGlarLixi is an injectable hypoglycemic drug, which is composed of insulin glargine 100U/mL and risnatide in a fixed ratio

September 27, 2021, Sanofi announced the Chinese State Drug Administration Bureau (NMPA) has formally accepted the company's basal insulin and GLP-1RA fixed proportion of compound preparation * SOLIQUA® (iGlarLixi) of the New Drug Application
.
Management iGlarLixi is an injectable hypoglycemic drug, which is a combination of insulin glargine 100U/mL and risnatide in a fixed ratio
.
This new drug listing application is based on the data support of two phase III clinical studies conducted by Sanofi in China.
The two studies are respectively aimed at patients with oral medication and poorly controlled basal insulin, using random, open label, positive control and parallel grouping.
The design of the experiment, and the study has been successfully completed, and the results will be announced in the near future
.
Experts in the diabetes field are confident that this innovative drug will bring benefits to Chinese diabetic patients
.
Professor Yang Wenying from the Endocrinology Department of China-Japan Friendship Hospital, the main investigator of the LixiLan-O AP in China’s Phase III clinical trial, said: “With the continuous improvement of medical standards, China’s diabetes clinical treatment concepts and plans are continuously updated and iterated, but injection therapy is still Currently one of the most effective methods for the treatment of diabetes
.
iGlarLixi, which only needs to be injected once a day, has better efficacy and safety in the Chinese population with poor oral drug control.
We look forward to the official release of China’s Phase III study and the official launch of new drugs.

" Professor Guo Xiaohui, the main investigator of the LixiLan-L CN Phase III clinical trial of diabetes in China, said: "China has approximately 129.
8 million diabetic patients, ranking first in the world.
There is still a huge unsatisfied diabetes field in China.
needs
.
basal insulin to normalize fasting blood glucose by reducing overall blood glucose, postprandial blood glucose in patients still control requirements, in such a situation, iGlarLixi provides one more double control of glucose solution for these patients
.
It is believed that the introduction of iGlarLixi will bring new hope to Chinese diabetic patients
.
" Pius S.
Hornstein, PhD, President of Sanofi Greater China, said: "In September last year, Sanofi's ultra-long-acting basal insulin Layurse® was successfully approved in China, bringing great benefits to Chinese diabetic patients.
A stable and efficient innovative blood glucose management treatment plan
.
This year coincides with September, and we successfully ushered in a new drug application for SOLIQUA® in China
.
Sanofi continues to innovate and promises to Chinese diabetic patients.
We will continue to introduce innovative products to help Chinese diabetic patients obtain a high-quality and healthy life
.
The results of iGlarLixi’s global phase III clinical study showed that in patients who received oral hypoglycemic drugs, basal insulin, or GLP-1 receptor agonists (daily or weekly preparations) but still had poor blood glucose levels, it was compared with basal insulin.
Compared with GLP-1 receptor agonists alone, iGlarLixi has a better effect on reducing the level of glycosylated hemoglobin (HbA1c), and the proportion of patients reaching the standard is higher (HbA1c <7%)
.
The results of the study also show that it is comparable to basal insulin.
Compared with, iGlarLixi does not increase the risk of hypoglycemia and weight gain.
Compared with GLP-1 receptor agonists, iGlarLixi causes fewer gastrointestinal reactions due to the stepwise titration of doses
.
In addition, iGlarLixi once a day is extremely effective.
Dadi improves patient compliance
.
Hypoglycemia In June this year, Sanofi announced the results of SoliMix, the first head-to-head study comparing iGlarLixi and premixed insulin at the American Diabetes Association (ADA) annual meeting.

.
SoliMix data shows that in patients who have received basal insulin therapy but still have poor blood glucose control, iGlarLixi once a day has a better effect on lowering the level of glycosylated hemoglobin (HbA1c) than premixed insulin twice a day, and The risk of hypoglycemia and weight gain is lower
.
* Soliqua® (iGlarLixi) has not yet been approved in China, leave a message here