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]

Core Viewpoint - CloudTop New Drug (云顶新耀) 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, marking a strategic entry into the ophthalmic treatment market valued at over 100 billion [1][2]. Group 1: Company Developments - The company will pay a total of $7 million (approximately 49.7 million RMB) as an upfront payment, along with potential milestone payments of up to $89 million (approximately 632 million RMB) based on development and sales [1]. - VIS-101 is a novel dual-function biologic targeting VEGF-A and ANG-2, expected to provide longer-lasting treatment benefits for patients with wet AMD, DME, and RVO [2]. - The strategic partnership with Visara enhances the company's product pipeline and expands its operations into the ophthalmic sector, which has significant unmet clinical needs [3]. Group 2: Market Insights - The global anti-VEGF ophthalmic drug market is projected to grow from approximately $23 billion in 2024 to over $40 billion by 2030, driven by increasing demand for retinal disease treatments [2]. - In China alone, the number of existing and new patients with wet AMD and DME exceeds 15 million, with about 600,000 new cases annually, highlighting a substantial unmet clinical demand [2]. - Current anti-VEGF treatments require frequent injections, leading to low patient compliance and high dropout rates, indicating a need for more effective solutions [3]. Group 3: Strategic Vision - The company aims to leverage its clinical development capabilities and commercialization platform to expedite the clinical development and commercialization of VIS-101 in China and Asia [1]. - The introduction of VIS-101 is part of the company's "dual-engine" strategy, which focuses on building a robust commercialization platform and advancing its proprietary CAR-T and mRNA cancer vaccine platforms [3]. - The collaboration with Visara is seen as a significant step in optimizing global commercial layouts and promoting collaborative clinical development [3].