ESSEX BIO-TECH: The biological product license application for the anti-VEGF ophthalmic injection (HLX04-O) for the treatment of wet AMD has been accepted
ESSEX BIO-TECH announced that its biologics license application for the anti-VEGF ophthalmic injection biologic (HLX04-O) for the treatment of wet AMD has been accepted by the National Medical Products Administration of China. This product is co-developed by the company's wholly-owned subsidiary and HENLIUS, optimized based on HENLIUS's Hanbeitai, aiming to meet the needs of ophthalmic medications. The Phase III clinical study of HLX04-O is being conducted in China and several other countries, with completion expected in 2025
According to the announcement from ESSEX BIO-TECH (01061), the licensees (all wholly-owned subsidiaries of the company) have entered into a co-development licensing agreement with Shanghai HENLIUS Biotech Co., Ltd. (HENLIUS) to jointly develop licensed products and grant the licensees exclusive rights related to the licensed products. The licensed product is a biopharmaceutical containing recombinant anti-vascular endothelial growth factor humanized monoclonal antibody (anti-VEGF) as the active pharmaceutical ingredient, intended for the treatment of exudative (wet) age-related macular degeneration (wet AMD).
The biopharmaceutical license application for the anti-VEGF ocular injection (HLX04-O) for the treatment of wet AMD has recently been accepted by the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) of China.
HLX04-O is a new ophthalmic formulation product developed based on HENLIUS's independently developed Hanbeitai (Bevacizumab Injection), optimized in terms of formulation, specifications, and production processes according to the needs of ophthalmic medications, while maintaining the same active ingredient, intended for the treatment of wet AMD.
In addition to the Phase III clinical study (AURA-1) of HLX04-O in Chinese patients with wet AMD, which is expected to reach its primary endpoint in April 2025, an international multicenter Phase III clinical study (AURA-2) of HLX04-O in patients with wet AMD is being conducted in several European countries, Australia, the United States, and China, with the last patient visit scheduled to be completed in January 2025
