Core Insights - CloudTop New Medicine (01952.HK) has initiated the first patient dosing in a global multi-center Phase I clinical trial for its universal on-demand tumor therapeutic vaccine EVM14, marking a significant milestone in the company's mRNA technology platform and its global clinical development efforts [1] Group 1: Product Development - EVM14 is developed based on CloudTop's proprietary mRNA technology platform and targets five tumor-associated antigens (TAA), intended for treating various squamous cell carcinomas, including non-small cell lung squamous carcinoma (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC) [1] - Approximately 96% of sq-NSCLC patients and 97% of HNSCC patients express at least one TAA gene, indicating a strong potential patient population for EVM14 [1] Group 2: Clinical Trial Details - The Phase I clinical trial design includes both EVM14 monotherapy and EVM14 in combination with PD-1 monoclonal antibodies, with primary endpoints focusing on safety and tolerability, and secondary endpoints on efficacy [2] - The project is expected to complete the dose escalation for monotherapy by 2026, providing initial safety and tolerability data [2] - Clinical centers involved include NEXT Oncology Virginia, The University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Shanghai Chest Hospital in China [2] Group 3: Preclinical Results - Preclinical trials demonstrated that EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in various mouse tumor models [2] - EVM14 also showed the ability to induce immune memory and effectively reduce tumor recurrence, supporting the exploration of combination therapy with immune checkpoint inhibitors (ICIs) [2] Group 4: Broader Pipeline - CloudTop is developing a range of tumor and other therapeutic mRNA drugs, leveraging its leading self-developed mRNA tumor therapeutic vaccine platform and autologous CAR-T platform, with full intellectual property rights and global rights for its pipeline [3] - In addition to EVM14, the pipeline includes autologous CAR-T project EVM18, personalized tumor therapeutic vaccine (PCV) EVM16, and on-demand immune modulation vaccine EVM15 [3]

Group 1 - The stock of CloudTop New Horizon (01952.HK) increased by over 5%, currently up by 4.07%, trading at 48.56 HKD [2] - The trading volume reached 158 million HKD [2]

Core Viewpoint - Cloud Peak New Medicine (01952) has seen a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Research Findings - NEFECON demonstrated significant clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with progression risks, highlighting issues with delayed treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Viewpoint - Clouding New Horizon (01952) saw a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Company Developments - NEFECON demonstrated substantial clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with existing progression risks, highlighting a delay in treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Insights - YunTing New Drug's core product, Naisukan (Budesonide enteric-coated capsules), has demonstrated clinical value in the new management strategy for IgA nephropathy, focusing on "etiological treatment, early treatment, and long-term treatment" [1][3] - The drug has shown effectiveness in special populations, including patients with severe renal impairment and children, reinforcing its position as a first-line treatment for IgA nephropathy [1] - The cumulative sales revenue of Naisukan reached nearly 1 billion yuan from January to September this year, marking it as one of the fastest-growing chronic disease innovative drugs in recent years [2] Group 1 - The real-world studies presented at ASN Kidney Week 2025 validate the clinical advantages of Naisukan, with evidence supporting its efficacy in early treatment for patients with proteinuria levels below 0.5g/d [1][2] - The introduction of Naisukan into the National Medical Insurance Directory in 2024 is expected to activate clinical demand significantly, with the reimbursement policy effective from January 1, 2025 [2] - YunTing New Drug is developing diagnostic testing reagents for IgA nephropathy, which are expected to fill the gap in non-invasive diagnosis in China, potentially replacing kidney biopsy as an auxiliary diagnostic method [2] Group 2 - The company anticipates that the deepening of clinical consensus and insurance coverage will enhance the market penetration of Naisukan, making it a core pillar for the company's performance growth [3] - The new management strategy for IgA nephropathy aims to provide patients with hope for delaying disease progression and improving long-term outcomes [3] - The clinical data for the next-generation BTK inhibitor EVER001 is promising, indicating potential coverage for a broader range of kidney disease indications [2]

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]