Dongyang Sun Pharmaceutical "Insulin Glargine" Approved for Listing

On October 28, the official website of NMPA showed that Dongyang Sun Pharmaceutical "Insulin Glargine Injection" was approved for listing
.

Insulin glargine is one of the types of centralized insulin procurement.
A total of 4 companies have been approved before, including the original research company Sanofi and 3 domestic companies: Ganli Pharmaceutical, Tonghua Dongbao and United Laboratories
.

Dongyang Sunshine is the fourth domestic product approved

From: NMPA official website

The development of insulin has gone through three generations: the first-generation insulin-animal insulin, the second-generation insulin-human insulin, and the third-generation insulin-insulin analogues.
The most widely used clinically is the third-generation insulin-insulin analogues
.

The first-generation insulin is derived from animals.
Due to the structural difference with human insulin, it is very easy to activate the body's own immune response, leading to allergic reactions in patients, and the effect of reducing blood sugar is unstable
.

Thanks to recombinant DNA technology, the second-generation insulin can be industrially produced and its structure is exactly the same as the insulin secreted by the human body, but it also has limitations: it cannot simulate the physiological human insulin secretion mode, and short-acting, pre-mixed human insulin requires 30 before meals.

Compared with human insulin, insulin analogues are closer to biological insulin secretion in terms of onset time, peak time, and duration of action
.

Insulin analogues have similar or better blood sugar control, lower risk of hypoglycemia, more flexible and convenient injection time, no need to wait 30 minutes, long-acting insulin analogue injection time is convenient, and one injection per day can meet the demand

Insulin glargine injection is a new type of insulin analogue with long-acting effect, no peak blood concentration, and a steady lowering of blood sugar in patients.
It was developed by Sanofi and was issued by American Foods in April and June 2000, respectively.
The Drug Administration (FDA) and the European Medical Products Review Board approved it for diabetes, and its trade name is Lai De Shi
.

Since 2004, Deshi has been listed in China

Among domestic companies, the earliest approval was Gan Li's Chang Xiulin, which was approved for listing in 2005, and then United Laboratories and Tonghua Dongbao were approved in 2016 and 2019, respectively
.

In addition to Dongyangguang, four companies including Liaoning Boao Biopharmaceutical Co.

From: Insight database (http://db.
dxy.
cn/v5/home/)

In the sixth round of centralized insulin procurement of the list announced in September, the products included are all second- and third-generation insulins, grouped by quick-acting, basic and premix
.

Among Dongyang Pharmaceutical's insulin products, insulin aspart and insulin aspart 30 are also under review for marketing

Insulin centralized procurement product list (published version on September 10)