Tonghe Pharmaceutical (300636.SZ): Mirabelone API obtains FDA registration approval letter DA registration approval letter

Zhitong Finance App News, Tonghe Pharmaceutical (300636.SZ) issued an announcement. The company recently received the DMF No Further Comments Letter (“NFC Letter”) from the US Food and Drug Administration (“FDA”) for the registration approval of mirabelone APIs. Mirabeiron is a selective beta3-adrenal receptor agonist. It can improve bladder filling and urinary storage capacity by activating beta3-adrenal receptors on the urinary bladder. It is clinically used to treat overactive bladder with symptoms such as urgent incontinence, urgency to urinate, and frequent urination.