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 an independent supply matrix of “capsule + powder” dual dosage forms and “75mg + 50mg” dual specifications in the field of Helicobacter pylori (Hp) breath testing.

As a key track in nuclear medicine and isotope drug applications supported by the national health “15th Five-Year Plan,” the urea [¹³C] breath test, with its non-invasive, non-radioactive, and highly specific characteristics, is internationally recognized by the medical community as the gold standard for detecting the Class I carcinogen Helicobacter pylori. The newly approved 50mg powder sachet and the existing 75mg capsule dosage form are clinically complementary, capable of covering a broader population of examinees and providing more flexible, high-quality, and affordable screening options at the grassroots level.

On the industrial side, the commercialization of this kit marks that China's nuclear medicine stable isotope industry chain has broken long-term import dependence and achieved full-chain independent controllability:

Breakthrough in core raw materials: For a long time, the high-abundance ¹³CO gas required for synthesizing carbon-13 urea relied heavily on overseas imports. CNNC Headway has overcome isotope industrial enrichment technology and built one of the few bases globally with large-scale high-abundance ¹³CO production capacity.

Dual-base capacity layout: Relying on two thousand-kilogram-level high-abundance ¹³CO enrichment bases in Anhui and Guangdong, as well as a multi-ton-level ¹³C urea API production base in Anhui, the company has fully connected the complete upstream and downstream supply chain from “high-abundance isotope enrichment — API synthesis — terminal formulation production.”

Business extension and cutting-edge innovation: As a national manufacturing single-item champion enterprise, CNNC Headway's breath diagnostic products have covered more than 20,000 medical institutions in China and been exported to over 70 countries and regions. Leveraging the platform synergy of its parent company China Isotope & Radiation Corporation, CNNC Headway is advancing deeply from breath diagnosis as a foundation toward “integrated diagnosis and treatment,” accelerating the layout of boron drugs for boron neutron capture therapy (BNCT) and deuterated drugs and other cutting-edge technology research and development.