Enhua children's new products to be priority review Exclusive declaration impact of domestic first imitation

Pharmaceutical Network July 15th, July 13, CDE official website announced the latest proposed priority review varieties, Enhua Pharmaceuticals hydrochloric acid Midazole syrup (acceptance of CYHS2000375) to be priority review reasons for "in line with the physiological characteristics of children's new quality of medicines, dosage forms, specifications", the current domestic market has not been approved for the product on the market, there are no other pharmaceutical companies to declare the listingFigure 1: Nhua Pharmaceuticals hydrochloric acid midazolam syrup specific situation Source: CDE official website Minet net data show that in 2019 in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal medapyrifem sales of 630 million yuan, the current market approved products include Malayacid Medalen tablets, midazolam injections, Medazol mouth mucosasolution solution, injection of the largest market share of 4.4%Figure 2: China's public medical institutions terminal Midazolam enterprise competition pattern source: China's public medical institutions terminal competition pattern Enhua Pharmaceutical industry is the leader of this variety, the market share in 2019 reached 79.2%, with products including midazolam injection, Malayacid mitazole tabletsFigure 3: Market situation of micaapine syrup hydrochloric acid source: Minnet net one key search to be included in the priority review of the hydrochloric acid Midazole syrup in the current market no enterprises approved, Enhua Pharmaceuticals is an exclusive declaration, registered classification as 3 types of imitation, if successfully approved, the same as the evaluation, the product listed, is expected to improve the company's leading advantage in the midazolam market