Shanghai, China, December 21, 2025 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced the submission of a CE Mark application for its portable blue light flexible cystoscope APLD-2304 (a company-led development) to the EU Notified Body BSI Group The Netherlands B.V.; the application has been accepted.
APLD-2304 is the world’s first portable, single-use blue light flexible cystoscope developed by the Company to meet the clinical needs and usage scenarios for bladder cancer diagnosis and follow-up monitoring. In clinical practice in Europe and the United States, white light cystoscopy is the standard method for bladder cancer diagnosis and follow-up. However, it often fails to detect flat or small peripheral early-stage lesions, resulting in low detection rates and high recurrence rates. The Company’s APLD-2304, used in combination with a blue light imaging agent, forms an integrated drug-device diagnostic solution for bladder cancer. This solution improves the detection rate of bladder cancer, reduces the recurrence rate for patients, and APLD-2304 adopts portable, flexible, sterile and single-use design—offers greater convenience for physicians, improves patient comfort during surgical procedures, and reduces the risk of cross-infection.
Driven by an aging population and high smoking rates, Europe faces a high annual incidence of bladder cancer, exceeding 130,000 new cases1. The high recurrence rate of the disease creates a major unmet need for long-term post-operative patient surveillance. Leveraging the advantage of blue light imaging in identifying minute lesions and carcinoma in situ, APLD-2304 holds considerable potential in the bladder cancer monitoring market.
Mr. Richard Zhao, Senior Vice President of Business Development at Asieris Pharmaceuticals, stated, “The acceptance of the medical device registration application for APLD-2304 in Europe is a crucial step in our focused strategy within the specialty field and our comprehensive planning for holistic bladder cancer management. We will continue to deeply explore patients’ unmet clinical needs, drive the advancement of clinical treatment protocols, provide innovative solutions for patients, and elevate the diagnostic and therapeutic standards for bladder cancer.”
Reference：
1．Global Cancer Observatory (WHO)
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and women’s health. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.
Through proprietary R&D and strategic collaborations, the company is committed to developing first-in-class drugs and other innovative technologies and products that address significant unmet medical needs, building a robust portfolio spanning from disease diagnosis to treatment within its focused therapeutic areas. Driven by patient needs, we are comprehensively advancing Commercialization 2.0 to improve the accessibility and affordability of innovative products, thereby benefiting more patients in China and globally.