Aimusic Healthcare Announces NMPA Approval to Initiate Clinical Trials of Risuteganib (Luminate®) Injection for Dry Age-Related Macular Degeneration in Mainland China

ShanghaiSeptember 25, 2023PR Newswire -- AffaMed Therapeutics, a global innovative biopharmaceutical technology company dedicated to developing and commercializing innovative drugs, digital therapies, and medical device products to meet critical unmet medical needs of patients in the fields of ophthalmology, neurology, and psychiatry, today announced its first-in-class intravitreal injection product with a novel mechanism of action, Risuteganib (also known as "Luminate").^®", AM011) has been approved by the China National Medical Products Administration (NMPA) to conduct clinical trials in China, aimed at evaluating its efficacy and safety in treating dry (non-exudative) age-related macular degeneration (AMD). With the approval of AM011 for clinical trials, this product is expected to become the first investigational product in China to enter Phase III development for the treatment of dry AMD.

In January 2022, AffaMed Therapeutics entered into a licensing agreement with Hanmi Pharm Co., Ltd. ("Hanmi") to obtain the exclusive rights for the production, development, and commercialization of Risuteganib in China (including mainland China, Hong Kong, Taiwan, and Macao).

Dr. Dayao Zhao, CEO of AffaMed Therapeutics, stated: "The majority of AMD patients suffer from dry AMD, and currently, there are no approved effective treatments for this disease in China. We are encouraged by the efficiency of the Chinese regulatory authorities in approving the AM011 clinical trial application and look forward to bringing this innovative treatment to the large number of dry AMD patients in China as soon as possible."