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]

Core Insights - CloudTop New Horizon (云顶新耀) held a strategic investor communication meeting on October 21, 2023, with key management team members present, including the new chairman Wu Yifang [2] - The company aims to enhance its product pipeline and maximize commercial value through a "dual-driven" strategy, focusing on self-research, licensing, acquisitions, and capital empowerment [2] - CloudTop plans to introduce more than three significant products in the next 6 to 12 months [2] Product Development - The company has entered a critical harvest period in its product pipeline, particularly in nephrology, infectious diseases, and autoimmune diseases, with sales revenue from the product Renfu Kang® nearing RMB 1 billion by Q3 2025 [3] - The product Weishiping® (艾曲莫德) is expected to become a significant growth driver for the company [3] - CloudTop is leveraging its mRNA tumor therapeutic vaccine platform and autologous CAR-T platform to strengthen its self-research capabilities and explore high-growth areas like ophthalmology [3] Clinical Trials and Collaborations - The new generation covalent reversible BTK inhibitor EVER001 (希布替尼) has shown promising results, with sustained benefits observed in patients during a 104-week follow-up period [3] - The company plans to initiate pivotal registration clinical trials for EVER001 in 2026 and is set to start human trials for its autologous CAR-T project by the end of 2025 [3] - CloudTop has signed a collaboration agreement with I-Mab for the development of the eye disease treatment VIS-101 in Greater China, South Korea, and Southeast Asia, aiming to enhance cooperation in innovative research and international development [4]

Core Insights - The company, CloudTop New Drug (01952.HK), held a strategic investor communication meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the executive team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, enhancing shareholder structure stability [2] Group 2: Strategic Focus and Market Expansion - The company will implement a "dual-engine" strategy, focusing on self-research and external collaborations to enrich its product pipeline and maximize commercial value [3] - CloudTop New Drug aims to accelerate its global expansion and self-research initiatives, particularly in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases [3] Group 3: Product Pipeline and Financial Projections - The company’s products, including Nefukang® and Yijia®, have shown sustainable commercialization capabilities, with Nefukang® expected to achieve sales of approximately RMB 12 to 14 billion in 2025, and projected to grow to RMB 24 to 26 billion by 2026 [3] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 100 billion, aiming for an overall domestic sales peak of over RMB 200 billion [4] Group 4: R&D Innovations and Collaborations - The company is leveraging its mRNA cancer vaccine platform and CAR-T technology to establish a strong R&D foundation, with plans to enter high-growth areas such as ophthalmology [4] - A collaboration with I-Mab on the innovative product VIS-101 aims to enhance the company's presence in the ophthalmology market, which is projected to grow significantly [5][6] - VIS-101 has shown promising results in initial studies and is expected to enter Phase III trials by 2026, indicating a strong potential for market entry [5][6] Group 5: Overall Market Position and Future Outlook - The meeting highlighted the company's systematic progress in capital empowerment, innovation breakthroughs, and global expansion, reinforcing its competitiveness in the global innovative drug sector [6] - As core pipelines enter the value realization phase, the company is on a steady path toward becoming a leading comprehensive biopharmaceutical enterprise globally [6]

Core Insights - CloudTop New Drug Company (云顶新耀) held a strategic investor communication meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the management team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and long-term value, indicating no plans for short-term share reduction, which stabilizes the shareholder structure [2] Group 2: Dual-Engine Strategy and Market Expansion - The company will implement a "dual-engine" strategy, focusing on both independent R&D and partnerships, acquisitions, and capital empowerment to enhance its product pipeline and maximize commercial value [3] - Key therapeutic areas include nephrology, infectious diseases, and autoimmune diseases, with products like Naisikan and Yijia showing sustainable commercialization capabilities [3] - The sales forecast for Naisikan is projected to reach approximately RMB 1 billion for the first nine months of 2025, with an annual target of RMB 1.2 to 1.4 billion, and a growth target of RMB 2.4 to 2.6 billion for 2026 [3] Group 3: R&D Advancements and New Growth Areas - The company is leveraging its mRNA cancer vaccine platform and autologous CAR-T platform to strengthen its R&D capabilities and explore high-growth areas like ophthalmology [4] - The new generation covalent reversible BTK inhibitor, EVER001, has shown promising clinical results, with plans for pivotal registration trials starting in 2026 [4] - The company aims to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peaks exceeding RMB 10 billion, contributing to an overall sales peak of over RMB 20 billion [4] Group 4: Strategic Collaboration with I-Mab - CloudTop has signed a collaboration agreement with I-Mab for the development of VIS-101, a dual-specificity biologic targeting VEGF-A and ANG2, enhancing its portfolio in the ophthalmology market [5][6] - The global anti-VEGF ophthalmic drug market is projected to grow from approximately $23 billion in 2024 to over $40 billion by 2030, indicating significant potential for VIS-101 [5][6] - The collaboration aims to accelerate the clinical development of VIS-101 in the Asia-Pacific and U.S. markets, enhancing R&D efficiency and global expansion [6] Group 5: Overall Market Position and Future Outlook - The meeting highlighted the systematic progress in capital empowerment, innovation breakthroughs, and global expansion, positioning the company to enhance its competitiveness in the global innovative drug sector [6] - As core pipelines enter the value realization phase, the company is steadily moving towards its goal of becoming a leading comprehensive biopharmaceutical enterprise globally [6]

Core Insights - The company, CloudTop New Medicine (01952), held a strategic investor meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the management team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, which stabilizes the shareholder structure [2] Group 2: Dual-Engine Strategy and Market Expansion - The company will implement a "dual-engine" strategy, focusing on both in-house R&D and external collaborations, acquisitions, and capital empowerment to maximize commercial value [3] - Key therapeutic areas include nephrology, infectious diseases, and autoimmune diseases, with products like Nefukang® and Yijia® showing sustainable commercialization capabilities [3] - Nefukang® is projected to achieve sales of approximately RMB 1 billion in the first nine months of 2025, with an annual forecast of RMB 1.2 to 1.4 billion and a target of RMB 2.4 to 2.6 billion by 2026 [3] Group 3: R&D Advancements - The company is leveraging its mRNA cancer vaccine platform and autologous CAR-T platform to strengthen its R&D capabilities and explore high-growth areas like ophthalmology [4] - The new generation covalent reversible BTK inhibitor, EVER001, has shown promising clinical results and is set to enter pivotal trials in 2026 [4] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peaks exceeding RMB 10 billion [4] Group 4: Strategic Collaboration with I-Mab - CloudTop New Medicine has signed a collaboration agreement with I-Mab for the development of VIS-101, a dual-specificity biologic for retinal diseases, enhancing its portfolio in the ophthalmology sector [5][6] - The global anti-VEGF ophthalmic drug market is projected to reach approximately $23 billion in 2024 and exceed $40 billion by 2030, indicating significant growth potential for innovative therapies [5][6] - The collaboration aims to accelerate the development of VIS-101 in the Asia-Pacific and the U.S., enhancing R&D efficiency and global expansion [6]