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 - Zhejiang Oriental Gene Biological Products Co., Ltd. has obtained registration certificates for several medical device products, enhancing its product offerings in HPV virus detection and respiratory virus testing [1][2]. Group 1: Medical Device Registration - The company’s subsidiary, Hangzhou Danwei Biotechnology Co., Ltd., has received registration certificates for 14 types of high-risk HPV nucleic acid detection and 16/18 typing reagents in China, expanding the company's product range for HPV virus detection [1]. - Additionally, the company has obtained registration for COVID-19 and influenza A/B virus nucleic acid co-detection reagents, further improving its portfolio in respiratory combined detection products [1]. Group 2: Impact on the Company - The new product registrations are expected to broaden the company's sales offerings in molecular diagnostic technology, facilitating overall market expansion in China [1].