Recently , the Center for Drug Evaluation (CDE) announced that Chengdu Hengrui Pharmaceutical's application for marketing approval of hippuric acid urotropine tablets has been officially accepted. This makes it the second company in China to submit an application for marketing approval of this product, following Hunan Mingrui Pharmaceutical, which means that this niche market is about to welcome a new competitor.
Urotropin hippurate is a urinary tract medication primarily used for the prevention and treatment of chronic, recurrent urinary tract infections. This product exerts its antibacterial effect by slowly releasing formaldehyde in an acidic environment, making it particularly suitable for patients requiring long-term preventative medication. While urotropin hippurate tablets haven't been among the most popular blockbuster drugs in recent years, this relatively low competition has created opportunities for newcomers. Especially in clinical settings, products focused on urinary tract infection prevention, although not necessarily large-scale, often have relatively stable demand. According to data from PharmData, urotropin hippurate sales in the domestic market have consistently remained above 50 million RMB in recent years.
Currently, only Hunan Mingrui Pharmaceutical holds a production license for this product in the domestic market, and it successfully passed the consistency evaluation in 2022, giving it a first-mover advantage in this niche market. The acceptance of Chengdu Hengrui's application for production license sends a clear signal: some older products with less competition and existing clinical foundations are still attracting pharmaceutical companies to re-enter the market.
For Chengdu Hengrui, receiving the acceptance notice is only the first step; what truly matters for this product is whether the domestic market will gradually shift from "single-licensed" to "multiple-competition." Once the second company obtains approval, this long-dormant product may experience a new market revaluation.

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