Policy & Regulation
Photocure's partner Asieris Pharmaceuticals advances Hexvix NDA in China
29 November 2023 -

Healthcare technology company Photocure ASA (OSE: PHO) announced on Wednesday that a new drug application (NDA) for Hexvix (APL-1706) by its partner Asieris Pharmaceuticals (SSE: 688176) has been accepted by the National Medical Products Administration (NMPA) in China.

Asieris Pharmaceuticals, Photocure's partner since January 2021, is a global biopharmaceutical company that specialises in discovering, developing and commercialising innovative drugs for the treatment of genitourinary tumors and other related diseases. It is is seeking regulatory approval for Hexvix in mainland China and Taiwan.

Presented at the 43rd Congress of Société Internationale d'Urologie, the Phase III clinical trial in China revealed Hexvix's superiority in bladder cancer detection, particularly carcinoma in situ (CIS), using blue light cystoscopy (BLC) compared to white light cystoscopy (WLC). These statistically significant findings align with Photocure's own randomized controlled trials (RCTs), emphasizing Hexvix's clinical benefits.

Hexvix, the only approved global optical imaging agent for bladder cancer diagnosis and surgical management, awaits approval for market launch in China. Asieris Pharmaceuticals is spearheading the submission process with efficiency, showcasing collaboration between the two companies.

The acceptance by NMPA follows Asieris' commitment to a swift submission process and strong collaboration with Photocure. The positive outcome underscores the clinical benefits of Hexvix and the potential to elevate the standard of care for bladder cancer patients.

Bladder cancer, the 8th most common cancer globally, with 573,000 new cases and over 200,000 deaths in 2020, necessitates enhanced diagnostic and management solutions. With high recurrence rates and significant treatment costs, there is an urgent need for improved approaches to benefit both patients and healthcare systems.

Categorized into non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), the disease poses challenges due to its recurrence and potential progression. Asieris Pharmaceuticals, specializing in genitourinary tumors, aims to address these challenges through innovative drug development.

Photocure delivers transformative solutions for bladder cancer patients through its unique technology. Headquartered in Oslo, Norway, Photocure is dedicated to improving the lives of bladder cancer patients globally.