AffaMed Therapeutics has received approval from the China’s National Medical Products Administration (NMPA) for its clinical trial application (CTA) of Risuteganib (Luminate) for the treatment of intermediate dry age-related macular degeneration (Dry AMD).
With the approval, the ophthalmic intravitreal injectable product Risuteganib is anticipated to become the first candidate in China to enter Phase III development.
In the study, the efficacy and safety of Risuteganib will be evaluated.
“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,” said AffaMed Therapeutics CEO Dr Dayao Zhao.
“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.”
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The company signed a licensing agreement with Hanmi Pharmaceutical in December 2021 for the manufacturing, development and commercialisation of Risuteganib in Greater China, including Hong Kong, mainland China, Macau, and Taiwan.
Previously, Hanmi gained exclusive rights from Allegro Ophthalmic for Risuteganib’s development and commercialisation in China and Korea.
Luminate is an integrin regulator that controls several pathways of oxidative stress response such as mitochondrial dysfunction.
In a Phase II proof of concept study, Risuteganib met the primary endpoint of vision improvement in patients with intermediate Dry AMD against placebo.
AffaMed is also engaged in developing pharmaceutical, surgical, and digital products for treating neurological, psychiatric, and ophthalmological disorders.