证券代码：688289 证券简称：圣湘生物 公告编号：2025-040

Group 1 - The company, Shengxiang Biotechnology Co., Ltd., has received medical device registration certificates for its nucleic acid detection kits for Pneumocystis jirovecii, Cryptococcus neoformans, and Aspergillus species from the National Medical Products Administration [1] - Invasive pulmonary fungal disease (IPFD) is a significant public health threat, characterized by acute or chronic tissue damage due to fungal invasion, with common pathogens including Aspergillus, Cryptococcus neoformans, and Pneumocystis jirovecii [1] - The incidence of IPFD is rising, necessitating efficient laboratory testing methods to aid in timely diagnosis and treatment, thereby improving patient survival rates [1] Group 2 - The newly certified detection products utilize real-time fluorescent PCR technology, which offers higher sensitivity and efficiency compared to traditional methods such as microscopy, culture, and serology [2] - The product can simultaneously detect three high-risk pulmonary fungal pathogens, enhancing the company's respiratory product ecosystem and providing more effective diagnostic solutions for clinical settings [2] - The approval of these products is expected to contribute positively to the company's offerings, although future performance will depend on market expansion efforts, brand influence, and actual market demand [2]