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Tigermed-Jyton Facilitates Market Approval of China’s First Blue-Light Cystoscopy System

April 13, 2026 — Richard Wolf GmbH’s System blue blue-light imaging system received approval from the National Medical Products Administration (NMPA) for market launch in China. When used in combination with Asieris Pharmaceuticals’ approved blue-light contrast agent, Hexvix® (generic name: hexaminolevulinate hydrochloride), the two products form the complete ‘blue-light combination’ solution for the precise diagnosis and treatment of bladder cancer. Tigermed-Jyton provided end-to-end services for the combined drug-device clinical trials of both products.

 (Image source: National Medical Products Administration website)

The combination of blue-light cystoscopy and Hexvix® heralds the “Year One of Blue-Light” in precision diagnosis and treatment of bladder cancer

Bladder cancer is one of the most common malignant tumors of the urinary system in China. Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancer cases, and its diagnosis and management rely heavily on the accuracy of cystoscopy. However, traditional white-light cystoscopy has limited ability to detect microlesions and carcinoma in situ (CIS), and some lesions may be missed, leading to incomplete resection and postoperative recurrence.

Blue-light cystoscopy (BLC) technology is a vital adjunct to the precise diagnosis and treatment of bladder cancer. The principle is as follows: after the blue-light contrast agent Hexvix® is instilled into the bladder prior to the procedure, lesions appear as red fluorescence under blue-light illumination, forming a striking contrast with normal tissue against a blue background, thereby significantly enhancing the visualization of lesions. Hexvix® has been approved by the NMPA for marketing and is the first blue light contrast agent approved in China for the diagnosis of bladder cancer.

Clinical data show that^[1] compared with white-light cystoscopy alone, the combination of Hexvix® and blue-light cystoscopy with Richard Wolf System blue yields an additional detection rate of 43.3% for subjects with one or more additional bladder cancer lesions, and the detection rate of high-risk carcinoma in situ (CIS) is increased by 9.6%. For carcinoma in situ (CIS): the detection rate is 94.7% with blue-light cystoscopy versus 42.1% with white-light cystoscopy. For Ta-stage lesions: the detection rate is 100% with blue-light cystoscopy versus 76.1% with white-light cystoscopy. For T1-stage lesions: the detection rate is 98.2% with blue-light cystoscopy versus 91.2% with white-light cystoscopy. Meta-analyses indicate that^[2]

 combined use reduces the risk of residual tumor post-surgery by 54%: 7-year follow-up data show an average reduction of 1.2 surgical procedures and an extension of recurrence-free survival (RFS) by up to 7 months. Particularly striking is the number of additionally detected CIS lesions, which reaches an increase of 200% in the trial with System blue, compared with an increase of only 24%–93.9% reported in earlier trials^[3].

 (▲ Left: Richard Wolf System Blue blue-light endoscopy imaging system; Right: Hexvix®)

Tigermed-Jyton overcomes the challenges of drug-device combination clinical trials, securing dual approval for the blue light bladder cancer project

Clinical trials for combined drug-device therapies are undoubtedly challenging—Hexvix® falls under Class 5.1 chemical drugs, with safety and efficacy validated through a Chinese Phase III bridging trial; System Blue is a Class II medical device, with safety and efficacy validated through Chinese registration trials. As neither product had been launched in China prior to the combined clinical trial, the entire process had to comply with regulatory requirements of both ‘Drug Good Clinical Practice (GCP)’ and ‘Medical Device Good Clinical Practice’. During the trials, the management of investigational products and the management of safety events represented the two key differences in drug-device research: Regarding study product management, in addition to standard clinical trial management protocols, the drug Hexvix® emphasizes preparation timelines, stability, and coordination with surgical schedules following patient administration, whilst the active medical device, the Blue Light Mirror Imaging System, requires consideration of installation validation, regular maintenance, operating environment, cleaning and disinfection, and pre-use functional verification; Regarding safety event management, for drugs, SAEs focus on SUSAR assessment and reporting following notification to the sponsor, whereas for medical devices, there is a need for simultaneous coordination with study site institutions, ethics committees, regulatory authorities and the National Health Commission, with additional attention required for device defects; It is precisely through this profound understanding of the differences between the two product categories—from regulatory pathways and risk management to operational procedures—that Tigermed-Jyton is able to meet the dual requirements of drugs and medical devices. From the design of multinational bridging trials, to unified implementation under dual regulatory frameworks, and the implementation of end-to-end quality control across multiple study centers, we have truly realized the delivery capability of “one team, two logics, the same excellence” for combined drug-device projects through our cross-category expertise.

 About Richard Wolf

 Richard Wolf is a medium-sized medical technology company with over 1,800 employees, 18 subsidiaries and 130 overseas agencies worldwide. The company specialises in the research, development, production and sale of endoscopes and extracorporeal shockwave therapy products for human medicine, whilst also providing integrated operating theatre system solutions.

 About Asieris Pharmaceuticals

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 patients’ dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus.

References：

[1] Hexaminolevulinate blue light cystoscopy improves bladder cancer detection in comparison to white light cystoscopy: a prospective, comparative, within-patient controlled multicenter phase III bridging study in China

[2] Launch of Blue-light Cystoscopy System Approved in China: The "Year One of Blue Light" for Precision Diagnosis and Treatment of Bladder Cancer. Official WeChat Account of Asieris, 27 Apr 2026

[3] Di Stasi SM, De Carlo F, Pagliarulo V, Masedu F, Verri C, Celestino F, et al. Hexaminolevulinate hydrochloride in the detection of nonmuscle invasive cancer of the blad der. Ther Adv Urol, 2015, 7(6): 339-350. [Crossref]