Core Viewpoint - The announcement highlights the recent achievements of Oriental Bio in obtaining multiple medical device registrations for its products, enhancing its product portfolio and international market presence [1][2]. Group 1: Product Registrations - Oriental Bio's subsidiary, Shanghai Wanzijian Bio, and Healgen Scientific LLC have recently obtained medical device registrations in China, Australia, and Singapore [1]. - The domestic registrations include the Gastrin-17 test kit and the N-terminal pro B-type natriuretic peptide test kit, which assist in diagnosing atrophic gastritis and heart failure, respectively [1]. - The international registration includes Healgen's rapid test for COVID-19 and Influenza A/B antigens, suitable for individuals aged 14 and above, to be conducted within 7 days of symptom onset [1]. Group 2: Technological Advancements - The respiratory triple test kit has a sensitivity of over 90% and specificity of over 99%, marking it as a core component of Oriental Bio's global respiratory detection product matrix [1]. - Research from Emory University indicates that Healgen's triple test kit demonstrates 2 to 20 times higher sensitivity compared to other LFA products used in similar studies, with detection limits approaching molecular testing levels [1]. Group 3: Regulatory Milestones - The triple test kit is the first product to receive FDA De Novo certification in the U.S. and is also the first over-the-counter (OTC) testing product to achieve this certification [2]. - This product does not require emergency use authorization and can be self-administered by non-professional users at home [2]. - The FDA has created a new regulatory classification for this test kit, which has been recognized as one of the "Top 5 Breakthroughs in U.S. Medicine for 2024" by ABC News [2]. Group 4: Market Penetration - Healgen's triple test kit has successfully entered over 13,000 stores under Walmart, CVS, and Walgreens, as well as on Amazon and other professional channels [3]. - The product has received high praise from customers, contributing to steady market sales growth [3].

Group 1 - The company Zhejiang Oriental Gene Biological Products Co., Ltd. has approved a share repurchase plan to maintain company value and shareholder rights, with a maximum repurchase price of RMB 32.44 per share and a total repurchase amount between RMB 25 million and RMB 50 million [2][3] - As of July 31, 2025, the company has repurchased a total of 234,591 shares, accounting for 0.1164% of the total share capital, with a total payment of RMB 6.812262 million [3][4] Group 2 - The company and its subsidiaries have obtained several medical device registration certificates, enhancing its product series in the domestic inflammation indicator detection field and expanding the application of its flow cytometry technology platform [6][7] - The company has also achieved major product self-testing certifications in the United States, the United Kingdom, and Thailand, which will help expand its market presence in these key regions [7]