Betta Pharmaceuticals’ EYP-1901 Implant Secures NMPA Clinical Trial Nod for Wet AMD

Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its EYP-1901 intravitreal implant, intended for the treatment of wet age-related macular degeneration (wAMD). The drug candidate is a combination of vorolanib, a multi-target tyrosine kinase VEGFR/PDGFR inhibitor, and Durasert, a proven intravitreous drug delivery system. This development comes after Betta expanded its partnership with US-based EyePoint Pharmaceuticals, Inc (NASDAQ: EYPT) in May 2022, securing development and commercialization rights for the drug in Greater China, which includes Hong Kong, Macau, and Taiwan. Betta Pharma retains the intellectual property rights for EYP-1901 .

EYP-1901 is designed to provide a sustained release of vorolanib over an extended period, offering patients a potentially more convenient treatment option with fewer injections compared to existing therapies. The implant’s mechanism of action is to target solid tumors through the EPR effect of tumor blood vessels and specific receptors on tumor cells, with the drug being released within the tumor cells to inhibit their growth .

The NMPA’s approval allows Betta Pharmaceuticals to proceed with clinical trials to further evaluate the safety and efficacy of EYP-1901 in wet AMD patients. This milestone underscores the company’s commitment to advancing innovative treatments for serious eye disorders and improving patient outcomes. The drug candidate has already shown promising results in multiple clinical studies for various types of cancers, including esophageal cancer and cervical cancer, and has received fast-track designations (FTDs) and an orphan drug designation (ODD) in the US for specific indications .- Flcube.com

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