CIRC (01763): China Isotope & Radiation Corporation's HTA 50mg Urea 13C Breath Test Kit Obtains Drug Registration Certificate

CIRC (01763) has announced that recently, the 50mg Urea 13C Powder Breath Test Kit (the Product), independently developed by Shenzhen CNNC Headway Biotechnology Co., Ltd. (CNNC Headway), a subsidiary of CIRC, has obtained a drug registration certificate issued by the National Medical Products Administration. The Product is used for diagnosing Helicobacter pylori infection of the stomach and is the first approved generic drug of the same variety in China since the implementation of the new drug registration regulations in 2017. Following approval of the Product, together with CNNC Headway's existing 75mg Urea 13C Breath Test Kit, a dual-dosage form and dual-specification product matrix has been formed. The two products complement each other in dosage form and specification, providing more flexible medication options for clinical use. Currently, CNNC Headway is making every effort to advance GMP compliance inspection, and the Product is expected to be put into production and launched on the market in December 2026.