A new anesthesia class 1 drug of Enhua Pharmaceutical was approved for clinical trials

Shanghai Securities News China Securities Network News (reporter Qiu Dekun) Enhua Pharmaceutical announced at noon on December 13 that the company recently received the "Drug Clinical Trial Approval Notice" of Class 1 chemical NH600001 emulsion injection approved and issued by the State Drug Administration, and will carry out clinical trials in the near future.

The approval conclusion shows that according to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the NH600001 emulsion injection accepted on October 11 met the relevant requirements of drug registration, and agreed that the product should carry out clinical trials for anesthesia induction and short-term surgical anesthesia.

The molecular structure of NH600001 is similar to that of etomidate, and it is proposed to develop a new drug of short-acting intravenous anesthesia class 1 with obvious advantages over etomidate. The results of preclinical studies show that NH600001 emulsion injection retains the advantages of fast onset of etomidate anesthesia, rapid awakening, large safety window, and small impact on the respiratory and circulatory system. At the same time, the product overcomes the shortcomings of etomidate inhibiting the function of the adrenal cortex, and there is no obvious inhibitory effect on adrenal corticosteroids.

Enhua Pharmaceutical said that for the above-mentioned class 1 chemical drugs, the company will conduct clinical trials in accordance with the requirements of the "Drug Clinical Trial Approval Notice" issued by the Food and Drug Administration, and will declare the production approval of the drug after the clinical trial is successful.