AffaMed Therapeutics Announces Clinical Trial Application Approval in Mainland China for Risuteganib (Luminate®) First-in-Class Candidate for the Treatment of Intermediate Dry AMD

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SHANGHAI, Sept. 25, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, today 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."

About Dry AMD

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^[1]. There are currently no approved therapies for the treatment of Intermediate Dry AMD.

About Risuteganib (Luminate^®)

In 2015, Hanmi acquired the exclusive rights for intravitreal use from Allegro Ophthalmic LLC, for the development and commercialization of Risuteganib (Luminate^®) in Korea and China. Luminate® is a first-in-class integrin regulator with a novel mechanism of action to regulate multiple pathways of oxidative stress response, including mitochondrial dysfunction, which contributes to diseases such as intermediate Dry AMD. Risuteganib (Luminate®) has successfully met the primary endpoint in a Phase 2 proof of concept clinical trial with statistically significant vision improvement in patients with intermediate Dry AMD versus placebo. Allegro has entered into a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration to advance Risuteganib (Luminate^®) into a Phase 2b/3 pivotal registration program.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.

About Hanmi Pharmaceuticals

Hanmi Pharmaceutical, founded in 1973, is an R&D-oriented biopharmaceutical company representing Korea. After the establishment by Pharmacist Lim Sung-ki, it was converted into a holding company system in 2010 and incorporated into a subsidiary of Hanmi Science. Hanmi Pharmaceutical invests more than 15% of its sales in R&D every year and is developing 26 drug candidates for innovative new drugs in three major fields; 1) Biologics: LAPSCOVERY platform applied long-acting pipeline; 2) NCE: Primarily oncology and auto-immune disease targeted pipelines; and 3) Fixed-dose combination programs. Hanmi Pharmaceutical's representative new drug target diseases include metabolic diseases such as obesity, rare diseases, and various types of cancer. In addition, Hanmi Pharmaceutical operates production facilities ranging from raw materials to chemicals and biopharmaceuticals and has more than 5,000 employees in Korea and China.

SOURCE AffaMed Therapeutics Ltd.