APL-1706 (Hexvix®)

Hexvix® (APL-1706) is a new-generation optical imaging agent, and it is the only approved diagnostic imaging agent to support detection or surgery of patients with bladder cancer. In combination with Blue Light Cystoscopy, it can effectively improve the detection rate of non-muscle invasive bladder cancer (NMIBC), especially carcinoma in situ, enable better TURBT procedures and reduce recurrences.

APL-1706, which is developed by Photocure, has been approved in more than 30 countries, and its trade name is Hexvix® (Cysview® in the US). APL-1706 has demonstrated good safety profile and efficacy in clinical use over the years, and has been included in the clinical guidelines in several European countries and the US. In January 2021, Asieris Pharmaceuticals obtained the exclusive rights to register and commercialize APL-1706 in China’s mainland and Taiwan. The company is expected to submit a new drug application to the National Medical Products Administration of China in the second half of 2021. The product is expected to fill the gap in this field in China, and will provide a new diagnosis and treatment option for doctors and patients.

Unmet Market Demand

Cystoscopy and biopsy are the main approaches used to diagnose bladder cancer, as well as one of the main tools to monitor postoperative recurrence. Cystoscopy can determine the number, size, shape, location, and growth pattern of the tumors, as well as abnormality in the surrounding bladder mucosa. Meanwhile, biopsy of tumors and suspicious lesions can help determine the pathological type and degree of differentiation.

Currently, White Light Cystoscopy is the most widely used in clinical settings, but it’s hard to detect tiny cancerous tissues or cells, especially carcinoma in situ, which may lead to incomplete transurethral resection of bladder tumor (TURBT), thereby increasing the risk of recurrence. In addition, the high recurrence rate and high risk of disease progression may also lead to frequent hospital visits and tests, which causes burden on the patient’s life and personal economic situation.

Compared with White Light Cystoscopy, APL-1706 in combination with Blue Light Cystoscopy can effectively improve the detection rate of non-muscle invasive bladder cancer (NMIBC), especially carcinoma in situ, enable better TURBT procedures and reduce recurrences. APL-1706 is now the world’s only approved imaging agent for the diagnosis or surgery of bladder cancer. This product will have a promising market prospect after it is launched in China.

Significant Clinical Value

Due to its significant clinical efficacy and safety profile, APL-1706 has been widely recognized by drug administrations, clinical guidelines and well-known experts and organizations after being launched in the US and Europe. It is recommended as a first-line drug for the diagnosis of bladder cancer by the NMIBC guidelines from the European Association of Urology (EAU), the American Urological Association (AUA), and the National Institute for Health and Care Excellence (NICE).

APL-1706 has the following significant advantages:

Compared with conventional diagnostics, it effectively increases the detection rate of bladder cancer

Bladder cancer is now mainly diagnosed by doctors’ naked eyes and empirical judgment under white light cystoscopy. When APL-1706 is used in combination with blue light cystoscopy, the clear boundary between tumor tissues and healthy tissues can help doctors make judgments more quickly and accurately, and effectively improve the detection rate of bladder cancer.

Enable TURBT procedures to achieve more complete resection of bladder tumor, and reduce the risk of recurrence

Transurethral resection of bladder tumor (TURBT) under White Light Cystoscopy cannot completely remove the tumor, especially the tiny papillary tumor or flat carcinoma in situ (CIS), which is not easy to detect in the first operation. Incomplete resection of the primary tumor during TURBT procedures may lead to the recurrence of bladder cancer. Because the Blue Light Cystoscopy together with APL-1706 provides better visualization, doctors can more accurately assess, identify and remove tumors that are difficult to detect under White Light Cystoscopy, thereby improving TURBT procedures, lower the possibility of tumor recurrence due to missed detection, and prolong the time to recurrence after operation.