On December 30, AmoyDx (300685) announced that the company recently received the "Medical Device Registration Certificate of the People's Republic of China" issued by the National Medical Products Administration (NMPA). The registration is valid from December 29, 2025, to December 28, 2030.
The approved product is the "Human BRCA1/BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing)," a Class III medical device primarily used for the in vitro qualitative detection of gene mutations in prostate cancer patients. This kit marks the first domestic approval of a Homologous Recombination Deficiency (HRD) test for prostate cancer indications, offering comprehensive coverage of various mutation types.
The product, along with its companion drug Niraparib and Abiraterone Acetate tablets, has been included in the National Reimbursement Drug List (NRDL). This integration creates a synergistic "Precision Testing + Medical Insurance Medication" system, which helps improve treatment accessibility for patients.
In the first three quarters of 2025, AmoyDx achieved a revenue of 866 million RMB and a net profit attributable to the parent company of 263 million RMB.

https://finance.eastmoney.com/a/202512303605708953.html