NMPA accepted the registration applications for Uro-G and Uro-3500

Shanghai, China, 20 February 2023 – Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the registration applications for the single-use, handheld electronic cystoscope cannula Uro-G and electronic endoscope image processor Uro-3500 it represents have been accepted by the National Medical Products Administration (NMPA).

Compared with the widely used cystoscopes currently available on the market, the Uro-G insertion cannula has a flexible structure that can significantly reduce pain and improve comfort. In addition, the Uro-G offers a viewing angle of 120°, both 210° upward and 130° downward motion angles, and a 90° angle of rotation clockwise and counterclockwise. These angles provide doctors with the flexibility to manipulate the lens, allowing them to view the panorama of the bladder while looking directly at the screen, which also reduce blind spots. The Uro-G also has its own operating orifice, so that doctors don’t have to change the equipment frequently. The cystoscope also contains an LED light source at the tip to provide intracavity illumination for enhanced visualization during cystoscopy.

Used together with the handheld Uro-3500 electronic endoscope image processor of unique design, the images collected by the Uro-G can be processed and transmitted to the display screen for image visualization, so that the target tissue, the equipment, and the endoscope image remain in doctors’ straight line of sight, facilitating examination. The integrated, portable design of the cystoscope enables doctors to complete cystoscopy single-handedly, thereby increasing its applicability.

The standard disinfection process for conventional endoscopes involves scrubbing them in disinfectant solutions, which are prone to bacterial residues and pose a hidden risk of infection. From 2017 to 2021, the FDA received more than 450 medical device reports (MDRs) associated with urological endoscope related infections1. Uro-G is disposed after use on one patient and thus simplifies the clinical disinfection and sterilization process mandated for conventional cystoscopy, thereby reducing the risk of cross infection caused by repeated use and ensuring safer examination for patients. Additionally, the Uro-G is more economical than conventional reusable flexible endoscopes as far as acquisition cost, service life, turnover frequency, disinfection difficulty, maintenance cost, etc.

Uro-G and Uro-3500 were developed by Uroviu Corporation, and both received U.S. Food and Drug Administration (FDA) clearance in 2018 and 2021, respectively. Asieris Pharmaceuticals signed a collaboration agreement with UroViu in May 2021, and obtained the commercialization rights of UroViu’s single-use cystoscopy system in China. Uro-G and Uro-3500 have completed their first domestic use case for bladder cancer diagnosis and perfusion at Hainan Provincial People’s Hospital in Boao Lecheng in August 2022.

“We are pleased that the registration applications for Uro-G and Uro-3500 have been accepted by NMPA, which is an important milestone for the company to realize its commercial strategy for integrated diagnosis and treatment.”Mr. Jiang Xinming, Vice President of Marketing Department of Asieris said, “As a leading global innovator in the pharmaceutical industry, Asieris is committed to advancing the research, development, and promotion of cutting-edge medical technologies and products that are both high-quality and highly effective. Our goal is to continuously raise the standard of medical care and provide better health services for patients all around the world.”

1. https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urological-endoscopes-letter-health-care-providers

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 other related diseases. We strive to improve human health and help people live more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.

The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.

Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs and adopts a forward-looking approach to product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.