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    Home > Medical News > Latest Medical News > The National Medical Products Administration officially accepted the listing application of Sanofi's innovative diabetes drug iGlarLixi

    The National Medical Products Administration officially accepted the listing application of Sanofi's innovative diabetes drug iGlarLixi

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
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    Shanghai, September 28, 2021/PRNewswire/ - Sanofi China announced that the National Medical Products Administration (NMPA) has formally accepted the company's fixed-proportion combination of basal insulin and GLP-1RA *SOLIQUA® (iGlarLixi) New drug listing application
    .

    iGlarLixi is an injectable hypoglycemic drug, which is composed of insulin glargine 100U/mL and risnatide in a fixed ratio
    .
    The 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 based on oral drugs and patients with poorly controlled basal insulin.
    Randomized, open label, positive control and parallel grouping are used.
    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 in China, from the Department of Endocrinology, Peking University First Hospital, said: “China has approximately 129.
    8 million diabetic patients[1], 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

    .
    I believe The introduction of iGlarLixi will bring new hope to Chinese diabetic patients

    .
    "

    Dr.
    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 stability to Chinese diabetic patients.
    , Efficient and innovative blood glucose management treatment plan

    .
    This year coincides with September, and we successfully ushered in the new drug application of SOLIQUA® in China

    .
    Sanofi continues to innovate and promises to Chinese diabetic patients.
    We will continue to introduce innovations The products help Chinese diabetic patients to obtain a high-quality and healthy life

    .
    "

    The results of the global phase III clinical study of iGlarLixi show that in patients who have received oral hypoglycemic drugs, basal insulin or GLP-1 receptor agonists (daily or weekly preparations) but still have poor blood glucose levels, it may be compared with basal insulin or 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%)
    .
    [2][3][4]

    The results of the study also showed that compared with basal insulin, 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, the once-a-day administration of iGlarLixi can greatly improve patient compliance

    .
    [2][3][4]

    In June of this year, Sanofi announced the results of SoliMix, the first head-to-head study comparing iGlarLixi and premixed insulin at the annual meeting of the American Diabetes Association (ADA)
    .
    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

    .
    [5]

    * Soliqua® (iGlarLixi) has not yet been approved in China

    [1] Yongze Li, Di Teng, Xiaoguang Shi, et al.
    , Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study.
    BMJ, 2020.
    369: p.
    m997.

    [2] Aroda, Vanita R.
    , et al.
    "Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial.
    " Diabetes care 39.
    11 (2016): 1972-1980.

    [3] Rosenstock, Julio, et al.
    "Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled on oral agents: the LixiLan-O randomized trial.
    "Diabetes Care 39.
    11 (2016): 2026-2035.

    [4] Blonde L, et al.
    Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.
    Diabetes Care.
    2019; 42(11): 2108-2116.

    [5] Rosenstock, Julio et al.
    Diabetes Care.
    2021 Jun 28;dc210393.

    About Sanofi China

    Sanofi is a leading global biopharmaceutical company focusing on human health
    .
    As one of the first multinational companies to enter China after the reform and opening up, Sanofi established an office in China in 1982

    .
    Sanofi China's diversified business covers pharmaceuticals, human vaccines and consumer healthcare

    .
    In China, Sanofi has 12 offices, 3 production bases, 4 major R&D bases and 1 digital innovation center

    .
    Sanofi is committed to accelerating the introduction of innovative drugs and vaccines into China, leading the way in digital innovation, so as to meet the health needs of the vast majority of Chinese people

    .

    For more information, please visit or follow the "Sanofi China" WeChat official account and "Sanofi" LinkedIn account
    .

    About Sanofi

    Sanofi is committed to helping people cope with health challenges
    .
    We are a global biopharmaceutical company focused on human health

    .
    We use vaccines to prevent diseases, and provide innovative treatments to alleviate pain and distress

    .
    We help a very small number of people suffering from rare diseases, and also support tens of millions of patients suffering from chronic diseases for a long time

    .

    Sanofi has more than 100,000 employees in more than 100 countries, committed to transforming scientific innovations into medical and health solutions

    Sanofi, Empowering Life Sanofi, Empowering Life

    Sanofi's forward-looking statements 

    This press release contains forward-looking statements
    .
    Forward-looking statements are not statements of historical facts

    .
    These statements include forecasts and estimates and basic assumptions, statements about the company's future plans, goals, and intentions, prospects for future financial conditions, events, operations, services, product development and potential, and statements about future performance

    .
    Generally, words such as "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions can be used as the basis for determining forward-looking statements

    .
    Although Sanofi’s management believes that the expectations reflected in this forward-looking statement are reasonable, investors should still note that these forward-looking information and statements are subject to many risks and uncertainties, many of which are difficult to predict and are generally not Sanofi controls, which may cause actual results and developments to differ materially from those expressed, implied or predicted in forward-looking information and statements

    .
    These risks and uncertainties mainly include the inherent uncertainties in research and development, future clinical data and analysis, including the data and analysis performed after the product is marketed, and the decisions of regulatory authorities, such as the US Food and Drug Administration The decision of the Agency or the European Medicines Agency on whether and when to approve the marketing of any drugs, medical devices or biological products that may be filed for candidate products, as well as the product labeling and other products that may affect the availability and commercial potential of such candidate products Decisions on matters such as the possibility of commercial success of approved candidate products, the approval of future alternative therapies and their commercial success, the group will benefit from external growth opportunities and completion of related transactions and/or obtaining regulatory approvals Capacity, risks associated with intellectual property rights and any related pending or future litigation and the final outcome of such litigation, turbulent economic and market conditions, the impact of global destruction including global epidemics, exchange rate trends and general Interest rates, cost control policies and the resulting results, the average number of issued shares, and Sanofi’s publicly submitted reports to the US Securities and Exchange Commission (SEC) and the French Financial Market Authority (AMF) have discussed or The clear part, including the "risk factors" and "warning of forward-looking statements" in Sanofi's annual report (as of December 31, 2020) listed in Table 20-F

    .
    Unless applicable legal requirements exist, Sanofi assumes no obligation to update or revise any forward-looking information and statements

    .

    Source: Sanofi China

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