CIRC (01763) has issued an announcement that its subsidiary, Shenzhen CNNC Haidewei Biotechnology Co., Ltd. (CNNC Haidewei), has recently obtained a drug registration certificate from the National Medical Products Administration for its independently developed 50mg urea 13C powder breath test kit (the Product).
The Product is used for diagnosing Helicobacter pylori infection of the stomach and represents the first approved generic drug of the same variety in China since the implementation of new drug registration regulations in 2017.
Following approval, the Product forms a dual-dosage form, dual-specification product matrix together with CNNC Haidewei's existing 75mg urea 13C breath test kit, with the two products complementing each other in dosage form and specification, offering more flexible medication options for clinical use.
Currently, CNNC Haidewei is making full efforts to advance GMP compliance inspection, and the Product is expected to be put into production and launched in December 2026.
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