China Tongfu (01763): CNNC Headway 50mg urea 13C breath test kit obtained a drug registration certificate

Zhitong Finance App News, China Tongpo (01763) issued an announcement. Recently, the 50mg urea 13C powder breath test kit (this product) independently developed by Shenzhen CNNC Headway Biotechnology Co., Ltd. (CNNC Headway), a subsidiary of China Tongfu, obtained a drug registration certificate issued by the China Drug Administration. This product is used to diagnose gastric Helicobacter pylori infection. It is the first generic drug of the same type approved in China since the implementation of the new drug registration regulations in 2017.

After the product was approved, it formed a dual-dosage and dual-specification product matrix with CNNC Headway's existing 75mg urea 13C breath test kit. The two products complement each other in terms of dosage form and specification, providing more flexible medication options for clinical use. Currently, CNNC Headway is making every effort to promote GMP compliance checks. The product is expected to be put into production and launch in December 2026.