NMPA Nods AffaMed Therapeutics Clinical Trial application For dry AMD

AffaMed Therapeutics, a global biotechnology company, announced that China's National Medical Products Administration has approved AffaMed’s Clinical Trial Application (CTA) to investigate the efficacy and safety of risuteganib (Luminate), its first-in-class, new mechanism of action ophthalmic intravitreal injectable product candidate for the treatment of Intermediate dry age-related macular degeneration (dry AMD). Under the CTA approval, AM011 is expected to become the first product in China to enter phase 3 development for the treatment of dry AMD .

In December 2021, AffaMed Therapeutics entered into a licensing agreement with Hanmi Pharmaceutical Co., Ltd. (Hanmi) for the manufacturing, development and commercialization of risuteganib (Luminate) in Greater China (mainland China, Hong Kong, Taiwan and Macau). Dr. Dayao Zhao, CEO of AffaMed commented: "To date there is no approved and effective treatment in China for patients suffering from dry AMD which represents the vast majority of the AMD patient population. We are encouraged by the Chinese regulator's efficiency in approving our application for this innovative therapy. We are looking forward to bringing this innovative treatment to dry AMD patients in Greater China as soon as possible.”

Age-related macular degeneration (AMD) is a progressive blinding disease that currently affects millions of people worldwide and is the leading cause of blindness in the elderly. Dry AMD accounts for approximately 80-90% of the total AMD patient population. As of 2020, the number of Dry AMD patients in China was estimated at 33.5 million and is projected to exceed 43 million by the end of this decade. There are currently no approved therapies for the treatment of Intermediate Dry AMD.