Autobio Diagnostics expands portfolio with new device registrations

Zhengzhou Autobio Diagnostics Co., Ltd. (Autobio Diagnostics) and its subsidiaries, Zhengzhou Silkebio Bio-engineering Co., Ltd. and Zhengzhou Biaoyuan Biotechnology Co., Ltd., have announced the receipt of several medical device registration certificates from the National Medical Products Administration and the Henan Provincial Medical Products Administration. This development, effective as of December 2, 2025, significantly enriches the company’s product pipeline.

Key new registrations include Silkebio Bio-engineering's Gene Sequencer (Sikun2000, Sikun1000, Sikun500) and Autobio Diagnostics' Neutral Gelatinase-associated Lipocalin (NGAL), Chitinase 3-like Protein 1 (CHI3L1), and Anti-U1RNP IgG detection kits, all utilizing magnetic particle chemiluminescence. Additionally, Biaoyuan Biotechnology received approvals for control products related to hypertension markers and bone metabolism markers.

The company states that these new registrations will meet market demand and enhance overall competitiveness. While short-term impact on operating performance is expected to be minimal, the long-term sales performance will depend on future market promotion efforts. Investors are advised to be aware of potential risks.