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Tonghua Dongbao announces NMPA acceptance of its NDA application for Insulin Aspart 30 and 50 Injections
Date：2021-07-14
Author：東寶
Views：387
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao” or the “Company”) received the notification of acceptance from the National Medical Products Administration (NMPA) on the NDA application for Insulin Aspart 30 and 50 Injections. The acceptance numbers are CXSS2101010 Guo and CXSS2101012 Guo.
Insulin Aspart is a fast-acting insulin analog that lowers glucose levels by facilitating cellular uptake and utilization of glucose while inhibiting the output of glucose from the liver after binding to the insulin receptors on muscle and fat cells. Insulin Aspart is available as an injection or a premixed injection, depending on the production process. The Company has two premixed insulin aspart products, namely Insulin Aspart 50 Injection and Insulin Aspart 30 Injection.
So far, except for the insulin aspart 30 injection from Gan & Lee Pharmaceuticals Co., Ltd. that was approved at the end of 2020, no other similar products produced by domestic companies have been approved in China. And among premixed insulin aspart injection products, only the insulin aspart 50 injection developed by Novo Nordisk has the approval for marketing in China. Tonghua Dongbao is the first Chinese company with the NDA application for Insulin Aspart 50 Injection accepted.
According to Novo Nordisk's financial report, sales of its insulin aspart injection and premixed insulin aspart injection products in Greater China were about RMB 5.499 billion, RMB 6.333 billion, and RMB 7.430 billion in 2018, 2019, and 2020, respectively, with a compound annual growth rate of approximately 10.55%. In addition, according to data from Pharmcube, insulin aspart injections took an increasing share of the total sales of insulin products in China, from 10.73% in 2016 to 19.68% in 2020. Insulin aspart injections see a fast-growing market share in China, with good market prospects.
The NMPA acceptance of Tonghua Dongbao’s NDA application further enriches its insulin product portfolios. Some analysts pointed out that Tonghua Dongbao is expected to launch mass production of the new products quickly by leveraging its advantages in production capacity, product marketing, and market reach, adding strong momentum to its medium and long-term development.
