| 截至月份: | | --- | | 2025年10月31日 狀態: | | 新提交 | I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01952 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 致：香港交易及結算所有限公司 公司名稱: 雲頂新耀有限公司 呈交日期: 2025年 ...

Core Insights - Cloudy New Horizon has entered into an exclusive licensing agreement with Visara, Inc. for the development, production, and commercialization of the dual-action biopharmaceutical VIS-101 in Greater China, Singapore, South Korea, and several Southeast Asian countries [1] Group 1: Product Development - VIS-101 targets VEGF-A and ANG-2, showing significantly improved efficacy over the first generation, potentially offering longer-lasting treatment benefits for patients with wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion [1] Group 2: Financial Terms - Cloudy New Horizon will pay a $7 million upfront fee and up to $24 million in reimbursable expenses, with potential development and sales milestone payments totaling up to $89 million, in addition to royalties based on net sales [1] Group 3: Strategic Expansion - This collaboration will enhance Cloudy New Horizon's late-stage product pipeline, allowing the company to expand into the ophthalmology sector [1]

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 Insights - Cloud-based innovative pharmaceutical company, CloudTop New Horizon, has signed an exclusive licensing agreement with Visara for the clinical development, production, and commercialization of VIS-101 in Greater China, Singapore, South Korea, and parts of Southeast Asia, marking its entry into the ophthalmology treatment sector [1][2] - The CEO of CloudTop New Horizon emphasized that VIS-101 has high differentiation and commercial potential, which will enrich the company's product pipeline and expand its business into the ophthalmology market [1] - The agreement includes a $7 million upfront payment, reimbursement of up to 24 million RMB in self-paid expenses, potential milestone payments of up to $89 million, and royalties based on net sales [1] Company Developments - Visara, a subsidiary of New Bridge Bio (formerly I-Mab), is involved in this licensing agreement, with CloudTop New Horizon being the largest shareholder of New Bridge Bio [2] - The CEO of New Bridge Bio stated that this authorization is a significant step in optimizing global commercial layout and promoting global clinical development collaboration [2] - VIS-101 is a novel dual-function biologic targeting VEGF-A and ANG-2, showing improved efficacy over first-generation treatments, and is expected to provide lasting treatment benefits for patients with wet AMD, DME, and RVO [2] Market Potential - The ophthalmic drug market is experiencing rapid growth, with the global anti-VEGF ophthalmic drug market projected to reach approximately $23 billion in 2024 and exceed $40 billion by 2030 [3] - In China, there is a significant unmet clinical need in the retinal disease market, with over 15 million existing and new patients for wet AMD, DME, and RVO, but only about 500,000 currently receiving anti-VEGF treatment [3] - The company plans to introduce at least three more major products, with expected peak sales in the domestic market exceeding 10 billion RMB, and overall domestic sales potentially surpassing 20 billion RMB [3]

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].

Core Viewpoint - Cloud-based innovative pharmaceutical company, CloudTop New Medicine, has signed an exclusive licensing agreement with Visara to develop, produce, and commercialize VIS-101 in Greater China, Singapore, South Korea, and several Southeast Asian countries, marking a significant entry into the ophthalmic treatment market valued at over 100 billion [1][2]. Group 1: Company Developments - CloudTop New Medicine will pay a total of $7 million (approximately 49.7 million RMB) as an upfront payment, along with potential milestone payments up to $89 million (approximately 632 million RMB) based on development and sales achievements [1]. - The CEO of CloudTop New Medicine emphasized the company's commitment to leveraging its clinical development capabilities to expedite the clinical development and commercialization of VIS-101 in China and Asia [1][2]. - The strategic partnership with Visara is expected to enhance CloudTop's product pipeline and expand its business into the ophthalmic sector, which has unmet clinical needs [3]. Group 2: Product and Market Insights - VIS-101 is a novel dual-function biologic targeting VEGF-A and ANG-2, showing improved efficacy over first-generation treatments for conditions like wet AMD, DME, and RVO [2]. - 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 significant unmet clinical needs in 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]. Group 3: Strategic Collaboration - Visara is a subsidiary of New Bridge Bio, which is listed on NASDAQ, and CloudTop New Medicine is the largest shareholder of New Bridge Bio [3]. - The collaboration aims to optimize global commercial layouts and promote clinical development synergies in Asia [3]. - CloudTop New Medicine plans to build a commercial platform based on its "dual-engine" strategy, focusing on CAR-T and mRNA therapeutic vaccine platforms to drive breakthrough developments in commercialization [3].

Core Viewpoint - Company has entered into an exclusive licensing agreement with Visara, Inc. for the development, production, and commercialization of VIS-101 in Greater China, Singapore, South Korea, and several Southeast Asian countries, which is expected to provide significant therapeutic benefits for patients with various eye conditions [1][2] Group 1: Licensing Agreement Details - The agreement includes an upfront payment of $7 million (approximately RMB 49.7 million) and reimbursement of costs up to RMB 24 million [1] - Potential development and sales milestone payments could reach up to $89 million (approximately RMB 632 million) [1] - The company will also pay potential royalties based on net sales [1] Group 2: Product Information - VIS-101 is a novel dual-function biologic targeting VEGF-A and ANG-2, showing stronger efficacy compared to first-generation treatments [2] - It is expected to provide more durable therapeutic effects for patients with wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion [2] - VIS-101 has completed initial 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 [2]

Core Viewpoint - The company, CloudTop New Medicine (云顶新耀), has entered into an exclusive licensing agreement with Visara, Inc. for the development, production, and commercialization of VIS-101, a novel dual-function biopharmaceutical targeting VEGF-A and ANG-2, aimed at treating various eye conditions with improved efficacy compared to first-generation therapies [1] Financial Obligations - The company's payment obligations under the licensing agreement include: - An upfront payment of $7 million (approximately RMB 49.7 million) and reimbursement of up to RMB 24 million for out-of-pocket expenses [1] - Potential development and sales milestone payments of up to $89 million (approximately RMB 632 million) [1] - Potential royalties based on net sales [1] Strategic Collaboration - The strategic collaboration between the company and Visara is expected to provide highly differentiated and commercially attractive assets, enriching the company's late-stage product pipeline [1] - VIS-101 allows the company to expand into the competitive ophthalmology field, which has significant unmet medical needs [1]

Core Viewpoint - The company has entered into an exclusive licensing agreement with Visara, Inc. to develop, produce, and commercialize VIS-101, a novel dual-function biologic targeting VEGF-A and ANG-2, which is expected to provide more durable treatment benefits for patients with wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion [1] Financial Obligations - The company's payment obligations under the exclusive license include: - An upfront payment of $7 million (approximately RMB 49.7 million) and reimbursement of self-paid expenses up to RMB 24 million [1] - Potential development and sales milestone payments of up to $89 million (approximately RMB 632 million) [1] - Potential royalties based on net sales [1] Strategic Collaboration - The board believes that the strategic collaboration with Visara will provide the company with highly differentiated and commercially attractive assets, enriching the company's late-stage product pipeline [1] - VIS-101 allows the company to expand into the competitive ophthalmology field, which has significant unmet medical needs [1]

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，概不對因本公告全部 或任何部份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。 – 1 – 由 於 協 議 項 下 擬 進 行 交 易 的 最 高 適 用 比 率 低 於 5 % ， 有 關 交 易 不 構 成 本 公 司 的 須 予披露交易，並獲全面豁免遵守香港聯合交易所有限公司證券上市規則第14章項 下的申報、公告及股東批准規定。 有關VIS -101的資料 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 自願公告 與VISARA訂立協議 於大中華區及其他亞洲市場開發及商業化VIS -101 本公告由雲頂新耀有限公司（「本公司」）自願作出。 本 公 司 董 事（「 董 事 」）會（「 董 事 會 」）欣 然 宣 佈 ， 於 2025 年 10 月 28 日 ， 本 公 司 與 Visara, Inc.（「Visara」） ...