CIRC (01763.HK): Subsidiary's 50mg 13C-Urea Breath Test Kit Obtains Drug Registration Certificate

NewTimeSpace News: On 9 October 2026, China Isotope & Radiation Corporation (stock code: 01763) issued a voluntary announcement that the 50mg 13C-urea powder breath test kit independently developed by its subsidiary, Shenzhen Sino-Hta Bio-Science & Technology Co., Ltd., has obtained a drug registration certificate issued by the National Medical Products Administration; the product is used to diagnose Helicobacter pylori infection and is the first approved generic of the same variety in China since the implementation of the new drug registration rules in 2017.

Following approval, the product forms a dual-dosage-form, dual-specification product matrix together with the subsidiary's existing 75mg 13C-urea breath test kit, with the two products complementing each other in dosage form and specification and providing clinicians with more flexible treatment options.

The subsidiary is now making every effort to advance its GMP compliance inspection, and the product is expected to commence production and launch in December 2026.

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