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」） ...

Core Insights - The new guidelines recommend a 9-month treatment with NEFECON® (budenoside enteric-coated capsules) for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1) [1][2] - NEFECON® has received recommendations from both the global Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and the new Chinese guidelines, making it the only drug for IgA nephropathy with such dual recognition [2][4] - The 2025 Chinese guidelines emphasize a "stratified and staged" comprehensive treatment approach, highlighting the importance of etiology-based, early, and long-term treatment [1][3] Treatment Strategy - The new guidelines outline a two-phase treatment strategy for IgA nephropathy, including induction of remission and maintenance therapy, focusing on controlling the driving factors of progressive IgA nephropathy [2][3] - The guidelines stress the need for further research on pathogenic Gd-IgA1 and other biomarkers to facilitate etiology-based treatment, marking a significant shift from symptomatic to etiological treatment [3] Patient Demographics and Market Need - Approximately 5 million patients in China suffer from IgA nephropathy, with over 120,000 new diagnoses each year, indicating a substantial unmet clinical need [3] - NEFECON® targets intestinal mucosal immune B cells to reduce pathogenic IgA and IgA-IC formation, thereby alleviating immune damage to the kidneys, demonstrating both efficacy and safety [3][5] Regulatory Approvals - NEFECON® is the first drug for IgA nephropathy to receive full approval from multiple regulatory bodies, including the NMPA, FDA, EMA, and MHRA, without baseline proteinuria level restrictions [4][6] Company Overview - Cloudbreak New Horizon is a biopharmaceutical company focused on innovative drug and vaccine development, clinical development, manufacturing, and commercialization, addressing unmet medical needs in the Asian market [7]

Core Insights - The new guidelines recommend a 9-month treatment with Budesonide delayed-release capsules (NEFECON) for IgA nephropathy patients at risk of disease progression to reduce pathogenic IgA (Gd-IgA1) [2][3] - NEFECON is the only drug approved for causal treatment of IgA nephropathy that has received recommendations from both international and domestic guidelines [2][4] Industry Overview - The 2025 Chinese guidelines for IgA nephropathy emphasize a "layered and staged" comprehensive treatment approach, highlighting the importance of causal treatment, early intervention, and long-term management [7] - The guidelines focus on pathogenic galactose-deficient IgA1 (Gd-IgA1) as a key factor in disease onset, marking a shift from symptomatic to causal treatment [3][7] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [3] Company Insights - NEFECON has shown efficacy in reducing kidney function decline by 50% globally and can delay kidney function deterioration by up to 66% in the Chinese population, extending the time to dialysis or kidney transplantation by 12.8 years [5] - NEFECON is the first drug for IgA nephropathy to receive full approval from multiple regulatory bodies, including NMPA, FDA, EMA, and others, without baseline proteinuria level restrictions [4] - The drug is designed to target intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA-IC, thereby alleviating immune damage to the kidneys [5]

Core Insights - The company held a strategic investor communication meeting to outline its latest strategic planning, R&D progress, and long-term development blueprint [1] - The new chairman, Wu Yifang, emphasized the importance of strategic direction and management efficiency to drive the company's growth and innovation [1] Group 1: Strategic Focus - The company will implement a "dual-drive" strategy focusing on self-research, licensing, acquisitions, and capital empowerment to enrich its product pipeline and maximize commercial value [1] - The company aims to accelerate its global expansion and self-research initiatives to benefit more patients and become a leading global biopharmaceutical company [1] Group 2: Product Pipeline and Financial Projections - The company’s product pipeline in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases is entering a critical harvest period [2] - The sales revenue for the product Neficon is projected to reach between 1.2 billion to 1.4 billion yuan for the full year, with expectations of maintaining high growth in 2026 [2] - The company plans to introduce more than three significant products in the next 6 to 12 months, with potential domestic sales peak exceeding 10 billion yuan for these new products [2]

Core Insights - The company, CloudTop New Medicine, held a strategic investor meeting on October 21, where the new chairman, Wu Yifang, outlined the company's strategic direction focusing on key initiatives such as strategic transactions, R&D innovation, and stakeholder management [1] - The controlling shareholder, Kangqiao Capital, will not reduce its stake in the company in the short term [1] - The company aims to enhance its product pipeline through self-research, licensing, acquisitions, and capital empowerment, with a goal to maximize commercial value and expand globally [1] Product Pipeline and Financial Projections - CloudTop New Medicine's product pipeline in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases is entering a critical harvest period [1] - The company estimates that sales for its product, Naisankang®, will reach between RMB 1.2 billion and RMB 1.4 billion for the year, with a target of RMB 2.4 billion to RMB 2.6 billion by 2026 [1] - The product Weishiping® (Aicuo Mod) is expected to become the next significant product for the company [1] Future Plans and Collaborations - The company plans to introduce more than three heavyweight products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 10 billion, aiming for an overall domestic sales peak of over RMB 20 billion [2] - CloudTop New Medicine has signed a cooperation development letter of intent with I-Mab for the treatment of retinal diseases, which will strengthen collaboration in innovative R&D and international development [2] - The global anti-VEGF ophthalmic drug market is projected to reach approximately USD 40 billion by 2030, indicating significant growth potential in this sector [2]