Core Viewpoint - The approval of OT-702, a biosimilar to EYLEA®, by the National Medical Products Administration of China marks a significant advancement in the treatment options for age-related macular degeneration and diabetic macular edema in adults [1][2]. Group 1: Product Approval - OT-702 has been approved for the treatment of adult patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in China [1]. - The product was developed in collaboration with Shandong Boan Biotechnology Co., Ltd., which is listed on the Hong Kong Stock Exchange [1]. Group 2: Mechanism of Action - OT-702 functions as a soluble decoy receptor that binds to VEGF-A, VEGF-B, and P1GF, inhibiting downstream signaling pathways of VEGFR, thereby suppressing neovascularization and reducing vascular permeability [2]. - The biosimilar is positioned to treat various retinal and choroidal pathologies associated with neovascularization [2]. Group 3: Market Potential - EYLEA® has received global approval for multiple indications, including nAMD, DME, retinal vein occlusion (RVO) with macular edema, diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and retinopathy of prematurity (ROP) [2]. - OT-702 is eligible to apply for approval for all indications for which EYLEA® has been approved in China, according to the guidelines published by the Center for Drug Evaluation [2].
欧康维视生物-B(01477)：OT-702获批于中国上市