Company - CloudTop New Horizon has signed an exclusive licensing agreement with Visara to develop, manufacture, and commercialize VIS-101 in Greater China, Singapore, South Korea, and several Southeast Asian countries [1] - VIS-101 is a novel dual-function biologic targeting VEGF-A and ANG-2, aimed at providing longer-lasting treatment benefits for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) [1] - The company will pay an upfront fee of $7 million (approximately 49.7 million yuan), reimburse up to 24 million yuan in self-paid expenses, and may pay up to $89 million (approximately 632 million yuan) in potential development and sales milestone payments, along with royalties based on net sales [1] - VIS-101 has completed preliminary safety and dose-escalation studies in the US and China, and is currently undergoing a randomized dose-ranging Phase II clinical trial in China, with expectations to enter Phase III trials by 2026 [1] Industry - The ophthalmic drug market has been growing rapidly, with the global anti-VEGF ophthalmic drug market projected to reach approximately $23 billion in 2024 and exceed $40 billion by 2030 [2] - Retinal disease drugs are a significant driver of market growth, with substantial unmet clinical needs remaining [2] - In China, the number of existing and new patients with wet AMD and DME has surpassed 15 million, with approximately 600,000 new cases annually, while only about 500,000 patients are currently receiving anti-VEGF treatment, indicating a large unmet clinical demand [2]

"未来，我们将依托公司卓越的临床开发能力和商业化平台，高效推进VIS-101这一潜在同类最佳的双功 能生物制剂在中国及亚洲地区的临床开发与商业化进程，尽快为患者提供这一创新治疗选择。"云顶新 耀首席执行官罗永庆表示。 VIS-101是一款新型双功能生物制剂，针对VEGF-A与ANG-2，其疗效较第一代治疗更为显著，可有望 为湿性年龄相关性黄斑部病变(wet AMD)、糖尿病性黄斑部水肿(DME)及视网膜静脉阻塞(RVO)患者提 供更持久的治疗效益。该药物已于美国及中国完成初步安全性与剂量递增研究，目前正于中国进行随机 分组的剂量范围II期临床试验，预计将于2026年具备进入III期临床试验的条件。Visara联合创始人兼执 行董事长Emmett J. Cunningham, Jr.博士表示："VIS-101有望成为该类别第二款上市的药物，并具备同类 最佳的潜力，这源于其在生物工程上的优异设计，使其具备更强的靶点中和能力。" 智通财经APP获悉，10月30日，港股创新药企云顶新耀(01952)宣布，与Visara签订协议，获得独家许 可，在大中华区、新加坡、韩国及若干东南亚国家进行临床开发、生产和商业化VIS- ...