Shanghai, China, August 27, 2026 — Asieris Pharmaceuticals (Stock Code: 688176.SH), a global innovative pharmaceutical company focused on genitourinary tumors and women’s health, announced that its independently developed portable blue light flexible cystoscope APLD-2304 has recently obtained the EU MDR CE Mark, granting market access in the European Union. APLD-2304 is the world’s first portable, single‑use blue light flexible cystoscope developed by the company to address the clinical needs and usage scenarios for bladder cancer diagnosis and follow‑up monitoring[1].
Driven by an aging population and high smoking rates, Europe faces a high annual incidence of bladder cancer, exceeding 130,000 new cases[2]. 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.
In clinical practice in Europe and the United States, white light cystoscopy is commonly used for bladder cancer diagnosis and follow up, yet it often fails to detect flat or small peripheral early stage lesions, leading to low detection rates and high recurrence rates. The Company’s APLD 2304, used in combination with a blue light imaging agent Hexvix®, 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 its portable, flexible, sterile, and single use design offers greater convenience for physicians, enhances patient comfort during surgical procedures, and reduces the risk of cross infection.
This CE certification for APLD 2304 was issued by the EU Notified Body (BSI Group The Netherlands B.V.) in accordance with the Medical Devices Regulation (EU) (MDR) certification rules, along with a quality system certificate under ISO 13485:2016. This marks the first time that a company developed product has obtained regulatory registration in the EU, signifying that Asieris has established a medical device quality management system that complies with EU MDR requirements. APLD 2304 meets the latest EU market access criteria and can be sold in regions that recognize EU medical device regulations. In addition, APLD-2304 has full independent intellectual property rights, and multiple patent applications for this product have been filed both domestically and internationally.
Mr. Richard Zhao, Senior Vice President of Business Development at Asieris Pharmaceuticals, stated: “The EU CE Mark for APLD 2304 is a significant step in our strategic focus on specialized clinical fields and our comprehensive planning for holistic bladder cancer management. It also underscores Asieris’s firm commitment to addressing critical unmet global clinical needs. We will continue to drive the advancement of clinical treatment protocols, deliver innovative solutions for patients, and elevate the diagnostic and therapeutic standards for bladder cancer.”
[1]GlobalData Medical Devices database
[2]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.