Core Insights - Oriental Bio has successfully registered its self-developed nucleic acid joint detection reagent for COVID-19 and influenza viruses with the National Medical Products Administration (NMPA) in China, enhancing its product portfolio in respiratory diagnostics [1] - The company has established a dual-market strategy focusing on both domestic and international markets, along with a parallel approach for professional testing and home self-testing [1][9] Technology Platforms - Oriental Bio has developed three core technology platforms: immunodiagnostic platform, nucleic acid testing platform, and liquid chip technology platform, each catering to different detection needs [2] - The immunodiagnostic platform offers rapid results in as little as 15 minutes, suitable for home testing and primary healthcare settings [2] - The nucleic acid testing platform emphasizes high sensitivity, meeting the diagnostic needs of medical institutions [2] - The liquid chip technology platform supports multiplex testing, allowing for the simultaneous identification of multiple respiratory pathogens [2] Product Pipeline - The company has created a diverse product pipeline for respiratory diagnostics, covering common pathogens like COVID-19, influenza A and B, and other viruses such as RSV and adenovirus [3] - Products include rapid test kits that do not require instruments and high-sensitivity nucleic acid tests, as well as multiplex tests that can detect up to nine pathogens simultaneously [3] Global Certifications - Oriental Bio has achieved significant global certifications, including 66 EU CE IVDR registrations, 6 US FDA registrations, and 16 NMPA registrations, making it one of the leading companies in respiratory diagnostics with global certifications [4] - Notable products include self-testing kits for influenza A and B that have received both EU IVDR and NMPA certifications, enabling dual-market circulation [4] - The COVID-19 and influenza joint detection self-testing kit has received both EU IVDR and FDA De Novo certifications, marking it as a pioneering product in the US market [4] Market Expansion - The year 2025 is identified as a critical year for Oriental Bio's overseas market expansion, with recent approvals for new products in Europe, New Zealand, and Brazil [7] - The company has successfully penetrated major global markets, including Europe, North America, South America, Oceania, the Middle East, and Southeast Asia [7] Dual-Line Strategy - Oriental Bio employs a dual-line strategy, offering both professional and self-testing versions of its products, which enhances market coverage [9] - The company has successfully entered mainstream retail channels in the US, significantly expanding its consumer reach [9] - As of now, Oriental Bio has obtained certifications for over 130 products related to various respiratory pathogens, establishing a leading position in the global respiratory diagnostics market [9]

Core Viewpoint - The recent EU IVDR certification of the new combined antigen detection kit for COVID-19, influenza A and B, respiratory syncytial virus, and adenovirus by Dongfang Bio signifies a major advancement in the company's capabilities in respiratory virus detection and enhances its international recognition in the field [1][2] Group 1: Product Development and Certification - Dongfang Bio's newly developed antigen detection kit has received EU IVDR certification, indicating a higher regulatory standard compared to the previous IVDD certification, which enhances the product's legal status and compliance requirements [1] - The detection kit allows for the qualitative and differential detection of five viruses from a single nasal swab sample within 15 minutes, meeting the rapid testing needs during high incidence periods of respiratory diseases [1] Group 2: Market Position and Global Expansion - Dongfang Bio has established a strong presence in the respiratory infectious disease detection market, having previously obtained various IVDR and FDA certifications for its products in Europe and the United States [2] - The company's COVID-19 and influenza combination detection product has been recognized as one of the "Top 5 Medical Breakthroughs of 2024" by ABC News and is currently available in major retail pharmacies like Walgreens [2] - Dongfang Bio is accelerating its global expansion with local production bases in the US, UK, and Canada, which supports scalable production and aligns with the demand for efficient diagnostic solutions in the post-pandemic era [2]