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Tonghua Dongbao receives the registration approval for premixed insulin aspart injections
Date：2022-11-15
Author：東寶
Views：2
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company” or “Tonghua Dongbao”) received the Pharmaceutical Product Registration Certificate from the National Medical Products Administration (NMPA) for Insulin Aspart 30 and 50 Injections.
Insulin aspart is a fast-acting insulin analog that binds to the insulin receptors on muscle and fat cells and lowers glucose levels by facilitating cellular uptake and utilization of glucose while inhibiting the output of glucose from the liver. Insulin aspart is available as an injection or a premixed injection, depending on the production process.
Premixed insulin aspart injections mimic the pattern of natural insulin secretion in the body and improve both fasting and post-meal blood sugar control. They can reduce the risk of pre-meal hypoglycemia while controlling fluctuations in post-meal blood sugar. These injections work faster than premixed human insulin injections and can be administered before meals without the need to wait.
The Company has received pharmaceutical product registration certificates for two premixed insulin aspart products, namely Insulin Aspart 50 Injection (a 50/50 ratio of rapid-acting and intermediate-acting insulin aspart) and Insulin Aspart 30 Injection (a 30/70 ratio of rapid-acting and intermediate-acting insulin aspart). Tonghua Dongbao is the first company other than the original drug developer to receive the registration approval for insulin aspart 50 injections in China.
Premixed insulin aspart is popular in China, with a market share of approximately 20.11% according to data from Menet.com. In 2021, sales of insulin aspart 30 and 50 at public medical institutions and physical pharmacies in Chinese cities totaled about RMB 6.494 billion. Sales of insulin aspart 50 injections grew rapidly in H1 2022 at public medical institutions in China, with a YoY increase of 129.52%.
With the approval of premixed insulin aspart injections, the Company offers a comprehensive range of human insulin and insulin analog products, including rapid-acting, basal, and premixed options. The launch of premixed insulin aspart will allow the Company to meet the needs of a wider range of patients and create more headroom for growth.
We will continue to focus on our core business and promote the development of various Class 1 antidiabetic drugs, including rapid-acting insulin, dual insulin compound preparations, GLP-1RA, long-acting GLP-1RA, and insulin analog and GLP-1RA co-formulations. We will also enhance our R&D capabilities and efficiency, stay up-to-date with international research and technology developments, and expand our product portfolio and R&D pipeline for novel drugs to support long-term growth.
