Tonghua Dongbao Submits NDA for Insulin Aspart 50 Injection, First Domestic Filing Beyond Originator

On July 13, the CDE website indicated that Tonghua Dongbao has submitted its Insulin Aspart 50 for marketing approval. This is the first domestic application for marketing approval of Insulin Aspart 50 in China, apart from the originator product.

Insulin Aspart 50 Injection is a biphasic insulin analogue composed of 50% insulin aspart and 50% insulin aspart protamine. The innovator product is from Novo Nordisk, which was approved for marketing in 2012 under the trade name NovoMix 50. Compared with soluble human insulin, Insulin Aspart 50 has a rapid onset of action and can be administered closer to mealtimes (0–10 minutes before a meal).