Orient Biotech(SH:688298) Zheng Quan Shi Bao Wang·2024-11-02 12:41Core Viewpoint - The achievement of FDA's first DeNovo marketing authorization for OTC respiratory triple test kits by the subsidiary, American Hengjian Biotechnology, marks a milestone in the company's development history [1][3]. Group 1: FDA Authorization and Product Details - American Hengjian received its first OTC flu test kit marketing authorization through traditional pre-market review on October 8, eliminating reliance on emergency use authorization [1]. - The newly authorized product ranks among the top in sensitivity and specificity compared to other OTC flu and COVID-19 test kits that were launched under emergency use authorization [1]. - The FDA's announcement highlighted that this is the first OTC flu and COVID-19 combined home test kit authorized without emergency use, establishing a new regulatory category for similar devices [2]. Group 2: Company Background and Achievements - American Hengjian, a subsidiary of Oriental Bio, is located in Houston, Texas, and focuses on the research, development, production, and sales of diagnostic reagents and instruments for infectious diseases and tumor markers [2]. - The company has made significant progress in respiratory test reagents and instruments, achieving FDA authorization for various products, including the flu and COVID-19 triple test kit [2]. - Both Oriental Bio and American Hengjian have large production bases and automated assembly lines in China and Texas, with a daily production capacity exceeding 10 million tests in both locations [2]. Group 3: Team and R&D Efforts - The company emphasizes the recruitment and training of high-tech talent to build a first-class team dedicated to addressing global respiratory and COVID-19 outbreaks [3]. - The achievement of the FDA DeNovo certificate for the COVID-19/flu triple test reflects the collective efforts of the company's teams in the U.S. and China, showcasing their commitment to high-quality and reliable diagnostic reagents [3].