On November 29, 2023 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that its partner Asieris Pharmaceuticals (SSE: 688176) communicated that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix (APL-1706) in China (Press release, PhotoCure, NOV 29, 2023, View Source [SID1234638057]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Results of the Hexvix (APL-1706) Phase III clinical trial in China were presented at the 43rd Congress of the Société 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.
"We are glad to see our partners at Asieris driving the submission process with conviction and speed. The acceptance of the Hexvix submission by NMPA is the positive outcome of months of collaboration between the Asieris and Photocure teams," said Dan Schneider, President and CEO of Photocure. "We believe that BLC can make a difference which evident in the robust clinical data from many years of experience and the recent Chinese RCT data presented at SIU earlier this year. Both companies remain committed to bringing Blue Light Cystoscopy with Hexvix to more patients with bladder cancer and elevate the standard of care."
Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.
Read Asieris’ full media release here: View Source