Core Viewpoint - Dongfang Bio has recently announced the acquisition of medical device registration certificates for various antigen detection kits, enhancing its product offerings in respiratory disease diagnostics [1] Group 1: Product Registrations - The company and its subsidiary, Hangzhou Laihe Biotechnology Co., Ltd., have obtained a medical device registration certificate for the Mycoplasma pneumoniae antigen detection kit (latex method) in China [1] - Multiple products, including influenza A and B antigen detection kits (colloidal gold), Helicobacter pylori antigen detection kits (fecal), Helicobacter pylori antibody detection kits (whole blood/serum/plasma), and COVID-19/flu antigen detection kits (colloidal gold), have received approval for registration in the European Union [1] Group 2: Market Expansion - The registration of these respiratory combined detection kits in both China and the EU enriches and enhances the company's product layout for respiratory specialty testing or combined testing [1] - This development broadens the range of products available for sale, facilitating the detection of seasonal respiratory infections and supporting the overall market expansion of related products domestically and internationally [1]

Company Overview - Oriental Bio (SH 688298) announced on November 14 that Zhejiang Oriental Gene Biological Products Co., Ltd. and its subsidiary Hangzhou Laihe Biotechnology Co., Ltd. have obtained registration certificates for several medical device products, including the "Mycoplasma pneumoniae antigen detection kit (latex method)" [1] Financial Performance - For the year 2024, Oriental Bio's revenue composition is projected to be 97.99% from the in vitro diagnostic industry and 2.01% from other businesses [1] - As of the report date, Oriental Bio has a market capitalization of 5.7 billion yuan [1]

Core Viewpoint - Dongfang Biological (688298.SH) has recently obtained registration certificates for several medical device products, enhancing its product portfolio in respiratory testing and expanding its market reach domestically and internationally [1] Domestic Medical Device Registration - The company has received a registration certificate for the Mycoplasma pneumoniae antigen detection kit (latex method), with certificate number: National Medical Device Approval 20253402221 [1] International Medical Device Registration - The company has secured registration for multiple antigen detection kits, including: - Influenza A and B antigen detection kit (colloidal gold) - Helicobacter pylori antigen detection kit (feces) - Helicobacter pylori antibody detection kit (whole blood/serum/plasma) - Influenza A antigen detection kit (colloidal gold) - Respiratory syncytial virus antigen detection kit - COVID-19/Influenza antigen detection kit (colloidal gold) - A seven-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus/Mycoplasma pneumoniae/human metapneumovirus - A six-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus/Mycoplasma pneumoniae - A five-in-one respiratory test kit for COVID-19/Influenza A and B/RSV/adenovirus - A four-in-one respiratory test kit for COVID-19/Influenza A and B/RSV - A two-in-one respiratory test kit for RSV/adenovirus - Certificate number: IVDR792590 [1] Market Expansion - The acquisition of these respiratory joint detection test kits in both domestic and EU markets enriches and enhances the company's product offerings in respiratory testing, facilitating the detection of seasonal respiratory infections and overall market expansion for related products [1]