On thenight of July 20, Yichang HumanwellPharmaceuticalCo.,Ltd. announced that new Class 1 drug besylate remazolamused for injection obtained the drug registration certificate and was officially approved for marketing.
Remazolam is a new drugdeveloped by Yichang Humanwelland PAION Company in Germany. The Remazolamproject was approved in 2010and research on thedrug started ever since. Application for marketingof Remazolamwas submitted to the National Medical Products Administration in November 2018.
Compared with generic drugs, innovative drugs require not only higher techniques but also more stringent quality standardsbefore they can be approved. A comprehensive study on 57 substances involved in besylate remazolam was conducted with a variety of quality analysis methods newly developed by the R&D personnel of Yichang Humanwell. With the more stringent standards, the new drug with fewer impurities and higher quality was eventually developed.
The drug was simultaneously beingdeveloped by eightcountries and regions including China, the United States, Germany and Japan. This approvalof the Humanwellmarks the symbolic milestone of R&D strength of Yichang Humanwellfrom catching up withothers and running side by side to taking the lead. As the first class 1 chemical drug approved in Hubei province, during the development and production process of besylate remazolam, Yichang Humanwellapplied for 10 patents and mastered manycore techniques of process synthesis and quality inspection standards of new class 1 drugs.