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AffaMed Therapeutics Enters into a Licensing Agreement with Hanmi Pharmaceutical to Develop and Commercialize Risuteganib (Luminate®)
as a First-In-Class Treatment for Intermediate Dry AMD Patients in Greater China

January 03, 2022

AffaMed Therapeutics (“AffaMed”), a global clinical-stage biopharmaceutical 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 it has entered into a licensing agreement with Hanmi Pharmaceutical Co., Ltd. (“Hanmi”). Through this partnership, AffaMed obtained exclusive rights to manufacture, develop and commercialize first-in-class ophthalmic intravitreal injectable product Risuteganib (Luminate®) targeting intermediate Dry Age-related Macular Degeneration (Dry 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 USD145 million including upfront license fee of USD 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®).

Dr. Dayao Zhao, CEO of AffaMed, noted: “With deep expertise in pre-clinical 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. 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 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 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 Pharm. Co., Ltd. is a Korea-based pharmaceutical company, fully integrated with strong focus in R&D which is strategically designed in 3 major fields: 1) Biologics: LAPSCOVERY platform applied long-acting pipelines. Key targeting areas are diabetes and obesity; 2) NCE: Mainly oncology and auto-immune disease targeted pipelines; and 3) Fixed-dose combination programs. The company has worked closely with global partners on various co-developments and collaborations. Hanmi continues to further expand through "Open Innovation Strategy" by finding potential partners for innovative solutions.