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Home / Company News / Gan & Lee Pharmaceuticals Announces NMPA Acceptance of Investigational New Drug (IND) for Once-Weekly Insulin GZR4
Gan & Lee Pharmaceuticals Announces NMPA Acceptance of Investigational New Drug (IND) for Once-Weekly Insulin GZR4
Date:2021-11-30

Recently, Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH), announced that GZR4, once-weekly, long-acting insulin independently developed by Gan & Lee Pharmaceuticals, has received the Notice of Acceptance issued by the National Medical Products Administration (NMPA), for the treatment of diabetes. As a new generation of once-weekly long-acting insulin, GZR4 is expected to be dosed once a week by subcutaneous injection in humans to achieve smooth control of basal blood glucose for one week.


In accordance with the data released by the IDF Diabetes Atlas, 9th edition (2019), there are 463 million adults diabetics (aged 20-79 years) worldwide. Without an adequate response, the number of people with diabetes will reach 578 million globally by 2030 and 700 million by 20451. According to the latest Chinese adult epidemiological data published in BMJ in April 2020, the proportion of Chinese adults with prediabetes is 35.2%, the prevalence of diabetes among Chinese adults is 12.8%, and the total number of people with diabetes is 129.8 million2.


Insulin analogs occupy a major market share with an absolute advantage due to their relatively good safety and lower immunogenicity, among which long-acting insulins are used for basal glucose control. However, the currently available long-acting insulin analogs in the market are all daily formulations, so patients need to receive the injection every day. There are many reasons that affect the adherence to using insulin, including busy work, irregular meals, fear of injection, which may cause patients to take insulin in a very late stage or have difficulty adhering to long-term insulin therapy. Poor insulin adherence will eventually result in poor glycemic control and increase the probability and severity of diabetic complications34. The once-weekly Insulin GZR4 of Gan & Lee is expected to reduce the fear of injection and alleviate the physical and mental burden of patients by reducing the injection frequency. It has the potential to improve the quality of patients’ lives by improving medication adherence.


Many companies are investigating the once-weekly long-acting insulin injection, given its features of stable drug effect, maintaining smooth plasma concentration, and less risk of hypoglycemia. However, there are no marketed once-weekly insulin injections in the US, EU, and China so far. For Gan & Lee Pharmaceuticals, the IND of GZR4 in China is expected to further enrich and expand the company's product pipeline and bring new therapies to diabetics worldwide.



References 

1. IDF Diabetes Atlas 9th edition (2019). https://diabetesatlas.org/atlas/ninth-edition/

2. Li, Y., et al (2020). Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ, 369.

 3. Chinese Journal of Diabetes, 2014,6(1) : 59-60. DOI: 10.3760/cma.j.issn.1674- 5809.2014.01.014 

4. Doggrell, S. A., et al. (2015). Adherence to insulin treatment in diabetes: can it be improved?. Journal of diabetes, 7(3), 315-321.



About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).

 

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics. 

 




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