▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,AffaMed Therapeutics' AM011 Injection Granted Clinical Approval for DevelopmentDry (non-exudative) age-related macular degeneration (AMD). Public information shows,AM011 InjectionLiquidIs aIntegrin Modulator`, with a completely new mechanism of action`。AmMax Bio Obtains the Product Through a Total $145 Million CollaborationThe exclusive rights to production, development, and commercialization in Greater China (including mainland China, Hong Kong, Taiwan, and Macao).

Screenshot source: CDE official website

Age-related macular degeneration (AMD) is a chronic progressive disease that affects the macular region of the retina, leading to central vision impairment, with its incidence increasing with age.Among them, patients with dry AMD account for 80% to 90% of the total number of AMD patients, and it is one of the leading causes of vision loss in the elderly.

Public information shows that AM011 (risuteganib, also known as Luminate) is an integrin modulator.Capable of regulating multiple pathways of oxidative stress responses, including mitochondrial dysfunction, which can lead to diseases such as AMD.。AM011By targeting multiple pathways to reduce the cellular burden of oxidative stress and restore retinal homeostasis.

In 2015, Hanmi Pharmaceuticals obtained the exclusive rights for the development and commercialization of AM011 for intravitreal use in Korea and China from Allegro Ophthalmic. In January 2022, Aimmu Healthcare reached a licensing agreement with Hanmi Pharmaceuticals to obtain the exclusive rights for the production, development, and commercialization of AM011 in Greater China. According to the terms of the agreement, Hanmi will receive a total of $145 million, including a $6 million upfront licensing fee, as well as milestone payments related to development, registration, and sales. Hanmi Pharmaceuticals will also be entitled to receive a proportional share of the net sales revenue generated by the drug.

AM011 has previouslyIn a 2The primary endpoint was reached in the Phase concept validation clinical trial.ThisIt is a prospective, randomized, doubleBlind, placebo-controlled, multicenter study designed to evaluateAM011Moderate TreatmentSafety and efficacy in patients with dry AMD.The research results show that,In Week 28, 48%AM011The group of patients (vs. 7% in the control group) achieved ≥8 letters of vision improvement at week 12, reaching the primary endpoint.。The drugGood safety profile`, no serious adverse events related to the drug were reported.`。Other findings supporting vision improvementIncludingRetinal Sensitivity（Microscopic Vision）And Color VisionImprovement.

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Sep 14, 2023, from https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2] Aimmu Medical announces a licensing agreement with Hanmi Pharmaceuticals to advance the development and commercialization of Risuteganib (Luminate®) in Greater China. Retrieved Jan 3, 2022, from https://mp.weixin.qq.com/s/uyurFCiBRJDf-pkGoo641Q