Photocure ASA announced that its partner Asieris Pharmaceuticals communicated that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix®? (APL-1706) in China. Hexvix, a pharmaceutical product used in the detection of bladder cancer, was licensed to Asieris by Photocure in January 2021, for the registration and commercialization of Hexvix in mainland China and Taiwan.

Results of the Hexvix (APL-1706") Phase III clinical trial in China were presented at the 43rdCongress of the Societe Internationale d'Urologie (SIU) last month, as a late-breaking abstract. The study confirmed that, in a Chinese patient population, Hexvix blue light cystoscopy (BLC®?) outperformed white light cystoscopy (WLC) in the detection of bladder cancer., particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability. The highly statistically significant results corroborate the findings of Photocure's own randomized controlled trials (RCTs) that demonstrated the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events.

Moreover, Asieris' Phase III Hexvix trial is the first RCT that was conducted with high definition 4K blue light capital equipment. Hexvix is currently the only approved optical imaging agent for diagnosing and surgical management of patients with bladder cancer worldwide. The combined use of Hexvix (APL -1706) and BLC for the management of non-muscle invasive bladder cancer (NMIBC) has been included in the global expert consensus guidelines and Chinese Urological Association Guideline.

The drug has not yet been approved for market launch in China.