Tonghua Dongbao third generation insulin, insulin glargine, received the information of hair and tonic

According to the website of the State Food and Drug Administration (CFDA) on April 4, the third generation of Tonghua Dongbao insulin "insulin glargine" and "insulin glargine injection" reported clinical delivery information On Friday, Li Cong, the company's general manager, said that this was a written supplement and that some additional information needed to be submitted At the end of 2012, Tonghua Dongbao took the initiative to submit the withdrawal application of insulin glargine to the drug administration due to the problems in the cold chain transportation of the samples submitted for examination At the beginning of 2013, the drug administration accepted the clinical application submitted by the company again At the end of last year, it was expected that the three generations of insulin approved for clinical use would be delivered again Will it delay the approval process of the product again? Li Cong said that the written supplement does not need to be queued up again, so it will not affect the approval process This year, it will be approved Insulin glargine is an insulin analogue, commonly known as the "third generation insulin" At present, the second generation recombinant human insulin is the mainstream of the market The third-generation insulin products are based on the second-generation product technology, which can shield the shortcomings of the second-generation products, effectively shorten the treatment time, and is expected to replace the second-generation insulin in the future Data shows that Tonghua Dongbao began to develop three generations of insulin in 2011, i.e insulin aspart and insulin glargine Before that, the company had been expected to obtain clinical approval documents in the first half of last year and be approved for production in 2015 Now, two three generations of insulin are still in the "under review" state.