CNNC Headway's Self-Developed 50mg Urea [¹³C] Powder Sachet Kit Approved, Establishing an Independent "Dual Dosage Form, Dual Specification" Landscape for Carbon-13 Breath Diagnosis
On October 8, 2026, the 50mg urea [¹³C] powder sachet breath test kit independently developed by Shenzhen CNNC Headway Biotechnology Co., Ltd. (CNNC Headway), a subsidiary of China Isotope & Radiation Corporation under CNNC, officially obtained the drug registration certificate issued by the National Medical Products Administration. This product is not only the first generic drug of the same variety approved for marketing in China in the 9 years since the implementation of the new drug review and approval regulations in 2017, but also another key achievement of CNNC Headway following the 75mg urea [¹³C] breath test kit becoming the first to pass the generic drug consistency evaluation, marking that China has officially formed a capsule + powder dual dosage form and 75mg + 50mg dual specification independent supply matrix in the field of Helicobacter pylori (Hp) breath testing...
2026-10-11
![CNNC Headway's Self-Developed 50mg Urea [¹³C] Powder Sachet Kit Approved, Establishing an Independent "Dual Dosage Form, Dual Specification" Landscape for Carbon-13 Breath Diagnosis](https://www.cinie.net/uploadfile/2026/1011/20261011102120494.jpg)