AffaMed Signs Licensing Agreement with Hanmi Pharma for Investigational Dry AMD Treatment in Greater China

AffaMed Signs Licensing Agreement with Hanmi Pharma for Investigational Dry AMD Treatment in Greater China

January 05, 2022

AffaMed Therapeutics and Hanmi Pharmaceutical Co. have entered into a licensing agreement, according to a company news release.

As a part of this partnership, AffaMed gains exclusive rights to manufacture, develop, and commercialize first-in-class ophthalmic intravitreal injectable product Risuteganib (Luminate) targeting intermediate dry age-related macular degeneration (AMD) and other vitreo-retinal diseases, in Greater China (mainland China, Hong Kong, Taiwan and Macau).

Under the terms of the agreement, Hanmi will receive up to $145 million, including upfront license fee of $6 million, and development, regulatory and sales milestone payments. Hanmi will also be eligible to receive tiered royalties on the net sales of Risuteganib (Luminate).

“With deep expertise in preclinical and clinical development, regulatory and commercialization, AffaMed has built a strong ophthalmologic pipeline that covers diseases from the anterior segment of the eye to the retina. To date, there is no approved and effective treatment for patients suffering from dry AMD, which represents the vast majority of AMD patient population,” said Dr. Dayao Zhao, CEO of AffaMed.

“We are excited to partner with Hanmi to accelerate the development and commercialization of Risuteganib (Luminate) in intermediate dry AMD patients and bring this innovative treatment option to millions of patients in Greater China.”

“Risuteganib (Luminate), which has its unique competitiveness, will prove its value through development and commercialization by AffaMed with great potential”, said Hanmi's CEO, Se-Chang Kwon. “Hanmi will try its best to commercialize Luminate as an ophthalmic innovative drug through a collaboration with our partners”.

About Risuteganib (Luminate)

In 2015, Hanmi acquired the exclusive rights for intravitreal use from Allegro Ophthalmic 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 Special Protocol Assessment (SPA) agreement with the FDA to advance Risuteganib (Luminate) into a phase 2b/3 pivotal registration program.