Core Insights - The ASN Kidney Week 2025 highlighted multiple real-world study results for the core product of Cloudtop New Horizon, Budesonide Enteric Capsules, which confirmed its core value in the new management strategy for IgA nephropathy, reinforcing its first-line treatment position [1][6] - The drug is accelerating market penetration due to endorsements from domestic and international guidelines and favorable healthcare policies, becoming a key driver of commercial growth for the company [1][5] Group 1: Clinical Evidence - Research from Huazhong University confirmed the effectiveness of Budesonide in special populations, including patients with severe renal impairment and children, showing significant improvement in proteinuria and renal function without serious adverse events [2] - A retrospective study from Sichuan University provided evidence for early treatment benefits, indicating that patients with proteinuria levels below 0.5g/d can also benefit from Budesonide therapy, thus supporting early intervention strategies [3] - Long-term treatment studies from Macau and Dalian Medical University demonstrated that Budesonide significantly reduces proteinuria and improves renal function over extended periods, supporting its use in long-term treatment plans [4] Group 2: Market Dynamics - The introduction of Budesonide into the National Medical Insurance Directory in 2024 and its subsequent reimbursement policy has rapidly activated clinical demand, with sales reaching nearly 1 billion yuan in the first nine months of 2025 [5] - The company has raised its annual sales guidance to 1.2 to 1.4 billion yuan, with projections for 2026 sales potentially reaching 2.4 to 2.6 billion yuan, and peak sales expected to hit 5 billion yuan [5] - Cloudtop New Horizon is building a comprehensive diagnostic and treatment ecosystem around IgA nephropathy, with ongoing clinical research for a non-invasive diagnostic test expected to launch in 2026, enhancing synergy with Budesonide [5] Group 3: Industry Outlook - The IgA nephropathy market is still in a blue ocean phase, with Budesonide establishing significant competitive barriers through its first-mover advantage, comprehensive evidence chain, and healthcare access [6] - The new data presented at ASN 2025 further validates the clinical advantages of Budesonide, with expectations for continued market penetration as guidelines and insurance coverage deepen [6] - The product is anticipated to be a core pillar of Cloudtop New Horizon's growth, advancing the treatment landscape for IgA nephropathy into a new era of targeted, early, and long-term treatment strategies [6]

Core Insights - The article discusses the recent developments and strategic initiatives of Everest Medicines, highlighting its focus on expanding its product pipeline and market presence in the Asia-Pacific region [1] Group 1: Company Developments - Everest Medicines has made significant progress in advancing its clinical trials for multiple drug candidates, aiming to address unmet medical needs in oncology and autoimmune diseases [1] - The company reported a substantial increase in its research and development budget, reflecting its commitment to innovation and long-term growth [1] - Everest Medicines is actively seeking partnerships and collaborations to enhance its capabilities and accelerate the commercialization of its products [1] Group 2: Market Position - The company is positioning itself as a key player in the Asia-Pacific biopharmaceutical market, which is expected to grow significantly in the coming years [1] - Everest Medicines aims to leverage its strategic location and expertise to capture a larger market share in the region [1] - The competitive landscape in the biopharmaceutical industry is intensifying, with Everest Medicines focusing on differentiating its offerings through unique drug formulations and targeted therapies [1]

| 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]