亚虹医药：APLD-2304申报欧盟医疗器械注册获接收

Core Viewpoint - Aihong Pharmaceutical has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body, which has been accepted, pending further review and approval for market launch [1][2] Group 1: Product Development and Market Potential - APLD-2304 is the world's first portable disposable blue light cystoscope developed for bladder cancer diagnosis and monitoring, addressing the limitations of traditional white light cystoscopy [1] - The product aims to improve bladder cancer detection rates and reduce recurrence rates, leveraging blue light imaging technology to identify small lesions and carcinoma in situ [1] - The European market has a high incidence of bladder cancer, with over 130,000 new cases annually, creating significant clinical demand for effective monitoring solutions [1] Group 2: Regulatory and Approval Process - The acceptance of the registration application does not have a significant impact on the company's recent performance, as the product still requires further evaluation and approval [2] - Medical devices are characterized by high technology, high risk, and high added value, with lengthy development and approval cycles influenced by various factors [2] Group 3: Recent Clinical Trial Approvals - Aihong Pharmaceutical received approval from the National Medical Products Administration for the clinical trial of APL-2401 in patients with advanced solid tumors driven by FGFR2/3, marking a significant milestone in the company's research efforts [3] - APL-2401 is a globally developed innovative drug that successfully entered the "30-day channel" for clinical trial approval, receiving approval in just 22 working days [3] Group 4: Financial Performance and Strategic Focus - The company reported revenue of approximately 216 million yuan for the first three quarters of 2025, representing a year-on-year growth of 55.74% [3] - Aihong Pharmaceutical is focused on the urogenital oncology and women's health sectors, developing a competitive product pipeline to address unmet clinical needs [4] - The company is actively advancing its research and development of several products, including APL-1702, APL-1202/APL-1501, APL-2302, APLD-2304, APL-1401, and APL2301 [4]