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欧康维视生物-B(01477):OT-702获批于中国上市
Zhi Tong Cai Jing· 2025-11-26 09:37
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(01477) - 自愿性公告 OT-702获批於中国上市
2025-11-26 09:20
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 OT-702由本集團合作夥伴山東博安生物技術股份有限公司(「博安生物」)(其股份 於香港聯合交易所有限公司上市(股份代號:6955))開發。根據雙方於2020年10 月訂立的合作及獨家推廣協議,本集團與博安生物應共同推進OT-702的III期臨床 試驗,且本集團獲授在中國推廣及商業化該產品的獨家權利。 OT-702作為可溶性的誘餌受體,可與VEGF-A、VEGF-B及P1GF等細胞因子結 合,阻斷VEGFR的下游信號通路、抑制新生血管生成並降低血管通透性,從而治 療視網膜及脈絡膜的病理性新生血管類眼部疾病。OT-702是EYLEA®的生物類似 藥,EYLEA®在全球已獲批的適應症包括nAMD、DME、視網膜靜脈阻塞(RVO) 後黃斑水腫、糖尿病性視網膜病變(DR)、近視脈絡膜新生血管(mCNV)和早產兒 視網膜病變(ROP),在中國獲批用於nAMD和DME的治療;根據CDE發佈的《生 物類似藥相似性評價 ...