Tonghua Dongbao Ganjing insulin is expected to obtain clinical approval in the first half of the year

On May 9, an executive of Tonghua Dongbao disclosed in a conference call organized by a securities firm that the company's three generations of insulin, insulin glargine and insulin glargine injection, had submitted supplementary information to the drug administration, and could be approved for clinical use in the first half of the year The executive further said that this is the last supplementary information of insulin glargine The company has found a clinical research hospital, "enter the clinical research immediately after the clinical approval is issued" If the approval is obtained in the first half of the year, it is expected to complete the clinical research in the middle of next year, and then apply for production "Another third-generation insulin, insulin aspart and its preparations, will also receive clinical approval by the end of this year or early next year," he added 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 At the end of 2012, four new drugs "aspartic insulin injection", "aspartic insulin", "insulin glargine injection" and "insulin glargine" submitted by the company for approval Due to problems in the cold chain transportation of the samples submitted for inspection, Tonghua Dongbao submitted the withdrawal application to the drug administration At the beginning of this year, the drug administration once again accepted the clinical application re submitted by Tonghua Dongbao At the beginning of April, "insulin glargine" and "insulin glargine injection" applied for clinical delivery information and required a written supplement