Huada Gene (300676.SZ) announced that Huada Biotechnology (Wuhan) Co., Ltd., a wholly-owned subsidiary of the company (simplified...
Zhitong Finance App News, Huada Gene (300676.SZ) announced that the BRCA1/2 gene mutation detection kit (joint probe anchored polymerization sequencing method) of Huada Biotech (Wuhan) Co., Ltd. (Wuhan Biotechnology for short), a wholly-owned subsidiary of the company, passed the special approval of the State Drug Administration for innovative medical devices in July 2018, and its registration application obtained the “Notice of Acceptance” issued by the State Drug Administration in June 2020. Recently, Wuhan Biotechnology received the “Non-registration Approval for Medical Devices/In Vitro Diagnostic Reagents” issued by the State Drug Administration.
According to the announcement, the company's BRCA1/2 gene mutation test kit (combined probe-anchored polymerization sequencing) was prepared for clinical trials during the prevention and control of public health emergencies. The main correction data requirements include supplementing pharmacodynamic clinical trial data and related data in people applying diagnostic drugs. Some enrolled subjects have not yet reached the required pharmacodynamic follow-up endpoints. Failure to submit registration correction data in a timely manner in accordance with the “Administrative Measures on Registration and Filing of In Vitro Diagnostic Reagents”, registration was terminated. The company and Wuhan Biotech attach great importance to the registration of this product and will re-submit the registration application to the State Drug Administration after completing the efficacy follow-up of the remaining test subjects.