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东方生物十款呼吸道检测试剂获注册证,国内外产品布局再升级
Zheng Quan Shi Bao Wang· 2025-11-16 14:44
Core Insights - Oriental Bio has recently announced the acquisition of multiple medical device registration certificates, including 10 respiratory test kits, which are significant for both domestic and EU markets [1][2] Group 1: Product Registrations - The company obtained the "Mycoplasma pneumoniae antigen detection kit (latex method)" registration certificate in China, valid until November 3, 2030 [1] - Hangzhou Laihe, a subsidiary, received 9 EU IVDR certifications for various combined respiratory tests, covering major pathogens such as COVID-19, influenza A and B, and respiratory syncytial virus [1] Group 2: Market Strategy - Oriental Bio has established itself as a leader in the IVD industry for infectious disease testing, with over ten EU CE IVDR registrations and multiple FDA and NMPA registrations, making it one of the companies with the most global certifications in respiratory testing [2] - The company employs a dual strategy of "professional version + self-test version," significantly expanding its market coverage [2] Group 3: Market Impact - The acquisition of these registrations is expected to enhance the company's product offerings in respiratory testing, aiding market expansion, although the actual sales performance will depend on product competitiveness and market sales capabilities [1]