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8月6日 FF301 II. 已發行股份及/或庫存股份變動 | 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 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 327,713,384 | | 0 | | 327,713,384 | | 增加 / 減少 (-) | | | 645,659 | | 0 | | | | 本月底結存 | | | 328,359,043 | | 0 | | 328,359,043 | 第 2 頁 共 10 頁 v 1.1.1 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | ...

Core Insights - Yunding Xinyao's core product, Nefikang, has received full approval from Taiwan's drug regulatory authority, removing previous conditions related to clinical efficacy, thus solidifying its position as a first-line treatment for IgA nephropathy in Asia [1][2] - The expansion application for Nefikang's production capacity has been approved by China's National Medical Products Administration (NMPA), enabling the company to meet the growing clinical demand in China and Asia more efficiently [1][3] - Nefikang is the first non-oncology drug in China to be included in the breakthrough therapy category, filling a significant treatment gap for IgA nephropathy [2][3] Market Demand and Clinical Need - IgA nephropathy is the most common primary glomerular disease globally, with a higher progression risk to end-stage renal disease in Asian populations, which is 56% higher than other groups [2] - There are over 5 million patients in China with more than 100,000 new diagnoses annually, highlighting the urgent need for effective treatment options [2] - Nefikang's unique mechanism targets the underlying cause of IgA nephropathy, making it the only drug recommended by both international and domestic guidelines for this condition [2][3] Commercialization and Market Penetration - The company has established an efficient commercialization system, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [4] - Sales projections for Nefikang suggest a peak potential of 5 billion yuan, indicating its potential as a significant product in the nephrology market [4] - The approval and market entry of Nefikang are expected to drive long-term growth for Yunding Xinyao, enhancing patient accessibility and coverage in key Asian markets [3][4]

Core Viewpoint - Genting Yongying (01952) has seen a stock price increase of over 3%, currently trading at 72.05 HKD with a transaction volume of 231 million HKD, following its strategic investment in Tianjing Bio [1] Group 1: Strategic Investment - Genting Yongying participated in Tianjing Bio's capital increase, acquiring new shares at a price of 1.95 USD per ADS, totaling approximately 30.9 million USD, making it the largest single shareholder of Tianjing Bio [1] - This strategic investment allows Genting Yongying to leverage Tianjing Bio's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1] Group 2: Tianjing Bio's Pipeline - Tianjing Bio has a differentiated pipeline for tumor-targeted/immunotherapy, including Givastomig (Claudin18.2/4-1BB dual antibody) and Ragistomig (PD-L1/4-1BB dual antibody) [1] - Givastomig is currently being explored in first-line gastric cancer treatment in combination with O drug and chemotherapy, showing data superior to current first-line gastric cancer standard therapies in a Phase Ib study in the U.S. [1] - Ragistomig features a unique molecular design that binds PD-L1 only in the tumor microenvironment and activates 4-1BB, with Phase I data indicating an overall response rate (ORR) and disease control rate (DCR) superior to competing products targeting the same pathway [1]

Core Viewpoint - CloudTop New Horizon (01952) has increased by over 3%, currently trading at 72.05 HKD with a transaction volume of 231 million HKD, following its strategic investment in Tianjing Bio [1] Group 1: Strategic Investment - CloudTop New Horizon has participated in Tianjing Bio's capital increase, acquiring new shares at a price of 1.95 USD per ADS, totaling approximately 30.9 million USD, making it the largest single shareholder of Tianjing Bio [1] - The investment is expected to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with CloudTop's existing mRNA tumor vaccine portfolio [1] Group 2: Product Pipeline - Tianjing Bio possesses a differentiated pipeline of tumor-targeted/immunotherapies, including Givastomig (Claudin18.2/4-1BB dual antibody) and Ragistomig (PD-L1/4-1BB dual antibody) [1] - Givastomig is currently being explored in first-line gastric cancer treatment in combination with O drug and chemotherapy, showing superior data compared to current standard therapies in the U.S. Phase Ib study [1] - Ragistomig features a unique molecular design that binds PD-L1 only in the tumor microenvironment and activates 4-1BB, with Phase I data indicating better ORR and DCR compared to competing products targeting the same pathway [1]

Core Viewpoint - CloudTop New Horizon (01952) has seen a stock increase of over 3%, currently trading at 72.05 HKD with a transaction volume of 231 million HKD, following its strategic investment in Tianjing Bio [1] Group 1: Strategic Investment - CloudTop New Horizon has participated in Tianjing Bio's capital increase, acquiring new shares at a price of 1.95 USD per ADS, totaling approximately 30.9 million USD, making it the largest single shareholder [1] - This strategic investment allows CloudTop New Horizon to leverage Tianjing's differentiated 4-1BB platform, dual antibody pipeline, and overseas clinical translation capabilities, creating synergies with its existing mRNA tumor vaccine portfolio [1] Group 2: Tianjing Bio's Pipeline - Tianjing Bio possesses a differentiated pipeline of tumor-targeted/immunotherapies, including Givastomig (Claudin18.2/4-1BB dual antibody) and Ragistomig (PD-L1/4-1BB dual antibody) [1] - Givastomig is currently being explored in first-line gastric cancer treatment in combination with O drug and chemotherapy, showing superior data compared to current standard therapies in the U.S. Phase Ib study [1] - Ragistomig features a unique molecular design that selectively binds to PD-L1 in the tumor microenvironment and activates 4-1BB, with Phase I data indicating better overall response rate (ORR) and disease control rate (DCR) compared to competing products targeting the same pathway [1]

Core Insights - Cloudtop New Horizon's core product, Nefikang®, has received full approval from Taiwan's drug regulatory authority, removing previous conditions related to clinical efficacy proof, thus solidifying its position as a first-line treatment for IgA nephropathy in Asia [1][3] - The product's production capacity upgrade has been approved by the NMPA, allowing for a more efficient response to the growing clinical demand in China and Asia [1][2] - Nefikang® is projected to achieve sales of 1 billion yuan in its first full year post-launch, highlighting its market potential [1] Product Approval and Market Position - Nefikang® is the first non-oncology drug to be included in China's breakthrough therapy category, addressing the treatment gap for IgA nephropathy [2][3] - The drug has been fully approved in all authorized regions, including major markets like the US, EU, and several Asian countries, enhancing its commercial viability [4] - The drug's unique mechanism of action targets gut mucosal immunity, effectively controlling proteinuria and protecting kidney function, establishing it as a cornerstone treatment [3][4] Clinical Demand and Commercial Strategy - IgA nephropathy is prevalent in Asia, with over 5 million patients in China and an annual increase of over 100,000 new cases, indicating a significant unmet clinical need [2][4] - Cloudtop New Horizon has established an efficient commercialization system, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [4] - Securities firms predict peak sales for Nefikang® could reach 5 billion yuan, indicating its potential as a major product in the nephrology market [4]

Core Viewpoint - CloudTop New Drug (1952.HK) has received full approval for its core nephrology product, Nefikang, in Taiwan, removing previous conditions and solidifying its position as a first-line treatment for IgA nephropathy in Asia [1][2] Group 1: Product Approval and Market Potential - Nefikang is now fully approved in all authorized regions, enhancing its status as a cornerstone treatment for IgA nephropathy [1] - The product's production capacity upgrade has been approved by the NMPA, allowing for a more efficient response to the growing clinical demand in China and Asia [1][2] - The market potential is significant, with expectations of achieving sales of 1 billion yuan in its first full year post-launch [1] Group 2: Clinical Significance and Treatment Landscape - IgA nephropathy is the most common primary glomerular disease globally, with a higher risk of progression to end-stage renal disease in Asian populations [2] - Nefikang fills a critical gap in the treatment landscape, being the first drug approved for targeted therapy in IgA nephropathy, addressing previous limitations of existing treatments [2][3] - Clinical studies show that Nefikang can reduce kidney function decline by up to 66% in the Chinese population, significantly delaying the need for dialysis or kidney transplantation [3] Group 3: Commercialization and Market Strategy - Nefikang is the first IgA nephropathy treatment to receive full approval from multiple regulatory agencies, including NMPA, FDA, and EMA, establishing a strong foundation for commercialization [4] - The drug has already reached over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients, demonstrating the company's market penetration capabilities [4] - Sales peak forecasts suggest that Nefikang could reach 5 billion yuan, indicating its potential as a major product in the nephrology market [4]

Summary of Key Points from the Conference Call Company Overview - **Company**: 云顶医药 (Cloudtop Pharmaceuticals) - **Industry**: Biopharmaceuticals, specifically focusing on anti-infective and renal disease treatments Core Insights and Arguments - **Market Demand**: The demand for the drug 依拉环素 (Ilaris) is strong, with projected sales reaching 1 billion yuan in 2025, indicating a growing hospital market [2][3] - **Product Pipeline**: The company is expanding its product line with new anti-infective products such as 坦尼彭巴坦 (Tanecomartin) and F206, further solidifying its position in the anti-infective sector [2][3] - **Self-developed Products**: BDK ever 001 has shown impressive results in clinical trials, being recognized as a best-in-class product. The mRNA tumor vaccine platform has entered patient enrollment, with encouraging preliminary data [2][4][5] - **Financial Performance**: The drug 耐福康 (Nafamostat) is expected to achieve sales of 1 billion yuan in 2025, with a potential peak sales target of 4 to 5 billion yuan in the long term [2][18] - **Clinical Data**: For the drug Alpha 001, used in treating membranous nephropathy, the complete remission rates were 76.9% for the low-dose group and 81.8% for the high-dose group, indicating leading efficacy in its class [2][21] Management and Structure - **Stable Shareholding**: The company is controlled by CBC, with the introduction of long-term international investors, ensuring a stable shareholding structure [2][6] - **Experienced Management**: The management team, led by CEO 罗总 and CFO 何总, has extensive experience in large multinational companies, which aids in effective commercialization and strategic planning [2][7] Future Development Goals - **Revenue Target**: The company aims to achieve a revenue target of 10 billion yuan by 2030 through expanding existing product sales and developing new indications for I8-001 and the mRNA platform [2][8] - **Market Positioning**: The company seeks to consolidate its market position and expand its business scale in the coming years [2][9] Additional Important Insights - **IgA Nephropathy Treatment**: The drug 耐赋康 has shown strong performance in treating IgA nephropathy, with a significant market opportunity given the prevalence of the disease in China [2][14][18] - **Competitive Landscape**: Other drugs for IgA nephropathy are in development, but 云顶医药 is expected to maintain a leading position for the next two to three years [2][19] - **mRNA and CAR-T Developments**: The company is advancing its mRNA technology platform and in vivo CAR-T therapy, with significant investments in these areas indicating strong future potential [2][22][23] Conclusion - **Investment Opportunities**: The company presents multiple investment opportunities through its robust product pipeline, strong market demand, and experienced management team, making it a noteworthy player in the biopharmaceutical industry [2][25]

Core Insights - The top three companies by Hong Kong Stock Connect holding ratios are China Telecom (74.76%), Gree Power (70.14%), and China Shenhua (67.05%) [1] - The largest increases in holdings over the last five trading days were seen in the following companies: Yingfu Fund (+2.967 billion), Li Auto-W (+2.821 billion), and Hang Seng China Enterprises (+2.531 billion) [1] - The largest decreases in holdings over the last five trading days were recorded for Pop Mart (-807 million), China Mobile (-777 million), and Geely Automobile (-630 million) [2] Group 1: Hong Kong Stock Connect Holding Ratios - China Telecom (00728) holds 10.377 billion shares with a holding ratio of 74.76% [1] - Gree Power (01330) has 284 million shares and a holding ratio of 70.14% [1] - China Shenhua (01088) possesses 2.265 billion shares with a holding ratio of 67.05% [1] Group 2: Recent Increases in Holdings - Yingfu Fund (02800) saw an increase of +2.967 billion with a change of +11.772 million shares [1] - Li Auto-W (02015) increased by +2.821 billion with a change of +2.787 million shares [1] - Hang Seng China Enterprises (02828) rose by +2.531 billion with a change of +2.782 million shares [1] Group 3: Recent Decreases in Holdings - Pop Mart (09992) experienced a decrease of -807 million with a change of -321.66 thousand shares [2] - China Mobile (00941) saw a reduction of -777 million with a change of -908.28 thousand shares [2] - Geely Automobile (00175) decreased by -630 million with a change of -3,480.90 thousand shares [2]

Group 1 - The top three stocks with net inflows of southbound funds are Yingfu Fund (02800) with 2.858 billion, Hang Seng China Enterprises (02828) with 2.255 billion, and Meituan-W (03690) with 1.397 billion [1][2] - The top three stocks with net outflows of southbound funds are Pop Mart (09992) with -0.382 billion, Ping An of China (02318) with -0.360 billion, and Laopu Gold (06181) with -0.345 billion [1][2] - In terms of net inflow ratio, the top three are Hopson Development Holdings (00754) at 70.43%, K Wah International Holdings (00173) at 64.10%, and Qingdao Port International (06198) at 61.26% [1][2] Group 2 - The top three stocks with the highest net outflow ratios are Gawei Electronics (01415) at -60.55%, Bank of China Aviation Leasing (02588) at -46.75%, and GX Hengsheng Technology (02837) at -43.69% [1][3] - The top ten stocks with the highest net inflows include Kuaishou-W (01024) with 1.391 billion and Alibaba-W (09988) with 1.040 billion [2] - The top ten stocks with the highest net outflows also include CICC (03908) with -0.333 billion and Kangfang Biologics (09926) with -0.263 billion [2]