Asieris Pharmaceuticals, in partnership with Photocure ASA, has announced that Jiangsu Yahong Meditech Co., Ltd. has received marketing authorization from the National Medical Products Administration (NMPA) in China for Hexvix (hexaminolevulinate hydrochloride). This approval marks a significant advancement in bladder cancer diagnostics within China, offering improved detection rates, especially for carcinoma in situ (CIS).
Enhanced Bladder Cancer Detection with Hexvix
Hexvix, when used in conjunction with blue light cystoscopy, significantly increases the detection rate of bladder cancer. The drug contains hexaminolevulinate (HAL), which is taken up by bladder cells and converted to photoactive porphyrins. During blue light cystoscopy (wavelengths of 360-450nm), these porphyrins cause tumor tissue to fluoresce bright red, distinguishing cancerous cells from normal tissue, which appears deep blue. This enhanced visualization aids in more complete surgical resections and reduces tumor recurrence rates.
Clinical Guidelines and Recommendations
Leading urological associations, including the European Association of Urology (EAU), the American Urological Association (AUA), the National Comprehensive Cancer Network (NCCN), and the Chinese Urological Association (CUA), recommend HAL as the preferred agent for fluorescence cystoscopy. These guidelines emphasize that fluorescence cystoscopy aids in detecting small lesions, particularly CIS, which can be easily missed under standard white light cystoscopy.
Market Access and Future Prospects
While marketing approval has been granted, the commercial success of Hexvix in China is linked to the approval and availability of blue light cystoscopes. Richard Wolf’s System Blue, used in the Phase III clinical trial for Hexvix, is currently under regulatory review by the NMPA. The integration of Hexvix with approved blue light cystoscopy systems promises to improve diagnostic accuracy and patient outcomes in bladder cancer management across China.
About Bladder Cancer
Bladder cancer is the 8th most common cancer worldwide, with approximately 614,000 new cases and over 220,000 deaths in 2022. It is characterized by high recurrence rates, with up to 61% in the first year and up to 78% over five years, leading to substantial lifetime treatment costs. Non-muscle invasive bladder cancer (NMIBC) accounts for 75% of all cases and includes subtypes Ta, CIS, and T1 lesions. Improving the diagnosis and management of bladder cancer is crucial for both patient outcomes and healthcare system efficiency.
