China Isotope & Radiation (01763): Subsidiary Zhonghe Headway Secures NMPA Approval for 50mg Urea 13C Breath Test Kit
China Isotope & Radiation Corporation (HKEX: 01763) has secured a key regulatory milestone for its nuclear medicine subsidiary, marking the first generic drug approval of its kind under China's reformed pharmaceutical registration system.
The company announced that Shenzhen Zhonghe Headway Bio-Sci&Tech Co.,Ltd., its subsidiary, has obtained a drug registration certificate from the National Medical Products Administration (NMPA) for its self-developed 50mg Urea 13C Powder Breath Test Kit. The product is used to diagnose Helicobacter pylori infection, a condition affecting millions of people worldwide and a major risk factor for gastric diseases.
The approval carries particular significance for China's pharmaceutical industry. According to the company, this is the first generic drug of the same variety to receive approval since China implemented new drug registration regulations in 2017, a reform aimed at accelerating the entry of affordable generic medicines into the market.
A Dual-Product Strategy
With this new approval, Zhonghe Headway now offers a dual-formulation, dual-specification product portfolio in the urea breath test market. The newly approved 50mg formulation complements the company's existing 75mg Urea 13C Breath Test Kit, providing clinicians with more flexible dosing options for patients.
The complementary products are designed to give healthcare providers greater flexibility in clinical settings, potentially expanding the company's addressable market in gastrointestinal diagnostics.
Path to Market
The company is now actively pursuing Good Manufacturing Practice (GMP) compliance inspection for the newly approved product. According to China Isotope & Radiation, the product is expected to enter production and reach the market by December 2026.
The timeline suggests the company is moving swiftly to commercialize the product, positioning itself to capture market share in China's growing diagnostics sector as demand for non-invasive H. pylori testing continues to rise.