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The field of diabetes welcomes the "New Year", and iGlarLixi is approved in China, opening a new era of quality compliance

 Last Update: 2023-02-01
 Source: Internet
 Author: User

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Shanghai, China, January 12, 2023 – Sanofi China announced that the National Medical Products Administration (NMPA) of China has approved the marketing application for insulin glargine risnatide injections (I), (II), which are suitable for adults with type 2 diabetes mellitus (T2DM) with poor glycemic control In combination with other oral hypoglycemic drugs on the basis of diet and exercise, it is also the first innovative product
approved by Sanofi China this year.

Insulin glargine rissinatide compound preparation is a combination of insulin glargine (basal insulin analogue) and risnatide (GLP-1RA*), which effectively helps patients achieve comprehensive blood glucose goals once a day, and the risk of hypoglycemia is small, and there is no weight
gain 。 Its two-component mechanism is complementary, multi-target regulation, and synergistic inhibition of the pathogenesis of sevenfold diabetes.
Targeted direct attack, synergistic improvement of two core physiological defects, while protecting the patient's islet β cells while effectively improving insulin resistance
.
It is worth mentioning that the advantageous ratio of insulin glargine and risnatide (1IU:1ug and 2IU:1ug) is tailored for Chinese diabetic patients, helping to achieve a good initial treatment experience and full-course management, which will open a new era
of "high-quality compliance".

Mr.
Shi Wang, President of Sanofi Greater China: "Benefiting from the government's positive measures to accelerate the approval of a number of innovative drugs, Sanofi has continued to introduce global innovative therapies to the Chinese market
for more than 40 years after entering China.
In the field of diabetes, we have been exploring more suitable diagnosis and treatment solutions
for Chinese patients with more than 100 years of accumulation.
From the tens of millions of Chinese doctors and patients trusted by insulin glargine U100 and insulin glargine U300 to today's insulin glargine risnatide injection, we are committed to improving drug access with continuous innovation to help more Chinese diabetics rejuvenate their lives and have 'high-quality standards, high-quality life'
.
" ”

China is the world's largest diabetic country, with 141 million [^{1] million} diabetic patients, although there are many existing treatment options, about 50% of diabetic patients still do not meet the blood sugar ^{target [2].}
。 Inadequate initiation of treatment and low patient compliance are the main reasons for unsatisfactory glycemic management, among which concerns about the occurrence of hypoglycemia and weight gain are the main concerns of patients initiating and adhering to insulin therapy ^[3-4].
Therefore, treatment regimens that can achieve strong hypoglycemic reduction, safe onset and worry-free weight will better meet the treatment needs
of Chinese patients with high quality standards.

Professor Yang Wenying of China-Japan Friendship Hospital, the principal investigator of Lixilan-O-AP in the phase III clinical trial of insulin glargine risnatide injection in China, said: "Quality compliance is the general trend
of diabetes management.
Patients need to achieve short-term goals of glycaemic management and further reduce the incidence of long-term complications, so as to truly improve
their quality of life.
We are pleased to see that many clinical trials around the world have proved that the compound preparation represented by the combination preparation of insulin glargine risnatide as an ideal treatment plan with complementary mechanism, synergy and vice reduction, can better improve the blood sugar
of patients.
”

At present, insulin glargine ristinatide compound preparation has been written into a number of authoritative guidelines and consensus at home and abroad, and has been approved by the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China" issued by the Diabetes Branch of the Chinese Medical Association (CDS) in 2020 and the American Diabetes Association (ADA) in 2022 and the European Association for the Study of Diabetes (EASD) jointly issued the "Consensus on the Management of Type 2 Diabetes Mellitus Hyperglycemia" recognition and unanimous recommendation; In patients with poorly controlled oral hypoglycemic agents, basal insulin insulin or GLP-1 RA, insulin glargine ristinatide combination preparations showed excellent hypoglycemic efficacy and safety [^5-6].

As the principal investigator of another phase III clinical trial of Lixilan-L-CN of insulin glargine risnatide injection, Professor Guo Xiaohui of Peking University First Hospital said: "Two studies of insulin glargine risnatide combination preparation LixiLan-O AP and LixiLan-L CN also proved that it has more obvious clinical advantages in the Chinese group, providing more effective, safe and convenient treatment options
for Chinese patients.
The approval of insulin glargine risnatide injection in China is very exciting, and it will undoubtedly open a new journey
of 'high-quality standards' for diabetes treatment in China.
" ”

Powerful sugar control: According to the LixiLan-O-AP study, glycated hemoglobin in insulin glargine rissinatide compound preparation can be reduced by up to 1.
9%, and about 80% of patients achieve blood glucose standards
.
At the same time, taking into account fasting and postprandial blood glucose, patients control blood glucose levels smoothly throughout the day to achieve more effective blood glucose management ^[7];

Safe start: According to the SoliMix study, compared with premixed insulin, insulin glargine risnatide combination preparation can reduce the incidence of hypoglycemia by 68%; Several studies have shown a very low rate of severe hypoglycaemic events, resulting in a more reassuring treatment experience ^[8];

Weight worry-free: According to SoliMix research, compared with premixed insulin, insulin glargine rissinatide compound preparation has obvious weight benefits, and the proportion of patients who meet the safety standard without weight gain increases to nearly 3 times, effectively improving the quality of life and achieving all-round comprehensive benefits ^[8].

* Glucagon-like peptide-1 receptor agonist

References:

[1] Sun, Hong, et al.
Diabetes research and clinical practice 183 (2022): 109119.
[2] Wang, Limin, et al.
"Prevalence and treatment of diabetes in China, 2013-2018.
" JAMA 326.
24 (2021): 2498-2506.
[3] Kim SG, et al.
J Diabetes Investig 2017,8(3):346-353[4] Berard L, et al.
Diabetes Obes Metab 2018,20(2):301-308 [5] Standards of Medical Care in Diabetes.
Diabetes Care 2022, 131-140[6] CDS.
Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes.
2020 Edition[7] Yang W, et al.
Diabetes Obes Metab 2022,24(8):1522-1533 [8] Rosenstock J.
, et al.
“Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial.
” Diabetes Care 2021 Jun; dc210393.
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