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]

随着市场需求快速增长，耐赋康提升产能的需求日益迫切。此次扩产补充申请获NMPA批准，作为全球 首个且目前唯一获完全批准的IgA肾病对因治疗药物，将有力推动产能提升，充分保障中国乃至整个亚 洲地区的临床用药供应，缓解市场巨大未被满足的临床需求。 耐赋康在IgA肾病治疗领域脱颖而出的核心在于其独特作用机制：通过特异性调节肠道黏膜免疫，减少 诱发IgA肾病的半乳糖缺陷的IgA1（Gd-IgA1）产生，阻止下游病理途径，有效控制蛋白尿并保护肾功 能。凭借这一靶向肠道、对因治疗的机制及安全性优势，耐赋康成为目前唯一同时获国际与国内指南推 荐的IgA肾病对因治疗药物，确立了其一线治疗的基石地位。 耐赋康在中国台湾地区完全获批基于NefIgArd III期临床研究的2年完整数据。该研究显示，其展现出优 异的肾功能保护效果，能减少肾功能衰退达50%；在中国人群中可减少66%肾功能下降，将疾病进展至 透析或肾移植的时间延缓12.8年。这一临床优势在评审中获认可，相关数据被纳入药品说明书，进一步 佐证其疗效。 作为云顶新耀在肾病领域的重磅产品，耐赋康目前是全球首个同时获中国国家药品监督管理局 （NMPA）、美国食品药品监督管理局 ...

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]

云顶新耀首席执行官罗永庆表示："中国是全球原发性肾小球疾病发病率最高的国家之一，本次产品生 产产能的提高，将更好满足中国IgA肾病患者日益增长的临床治疗需求。作为目前唯一获国内外指南共 同推荐的IgA肾病对因治疗药物，耐赋康的扩产将加速对因治疗的普及，助力更多患者尽早开启规范治 疗、延缓疾病进展、保护肾功能。未来，我们将持续推动耐赋康的可及性与可负担性，加速其从'改变 治疗格局'迈向'重塑治疗标准'。" 本报讯 （记者金婉霞）8月4日，港股创新药企云顶新耀医药科技有限公司（以下简称"云顶新耀"）宣 布，旗下全球首个且目前唯一在中国、美国和欧洲获得完全批准的IgA肾病对因治疗药物耐赋康（布地 奈德肠溶胶囊）的扩产补充申请已正式获得中国国家药品监督管理局（NMPA）批准。企业方面表示， 这将进一步增加产品供应，更高效地响应中国乃至亚洲地区持续增长的临床需求。 资料显示，耐赋康于2023年11月份通过优先审评程序在国内获批，成为中国首个获批的IgA肾病对因治 疗药物，填补了对因治疗的空白；2024年，该产品的全年销售额达3.54亿元。2024年11月份，耐赋康被 纳入国家医保目录；2025年5月份，耐赋康获得NMP ...

Core Viewpoint - Yunding Xinyao's core product, Nefukang (Budesonide enteric-coated capsules), has received approval from the National Medical Products Administration (NMPA) for production expansion, marking a significant step in addressing the clinical demand for IgA nephropathy treatment in China [1][2]. Group 1: Product and Market Demand - IgA nephropathy is a common primary glomerular disease with over 5 million patients in China, and more than 100,000 new cases diagnosed annually, indicating a high unmet clinical need [1]. - Nefukang has a unique mechanism that regulates intestinal mucosal immunity, reducing the production of Gd-IgA1, which is implicated in IgA nephropathy, effectively controlling proteinuria and protecting kidney function [1]. - Clinical data from the global Phase III NefIgArd study shows that Nefukang can reduce the risk of kidney function decline by 50%, with a 66% delay in kidney function deterioration for the Chinese population, potentially postponing the need for dialysis or kidney transplant by 12.8 years [1]. Group 2: Regulatory and Commercialization Progress - Nefukang has been included in both international and domestic clinical management guidelines, making it the only IgA nephropathy treatment recommended by both [2]. - Following its approval in November 2023, Nefukang filled a gap in the treatment of IgA nephropathy at the disease source and is expected to be included in the national medical insurance drug list by November 2024, expanding its eligible patient population threefold [2]. - The surge in market demand has led to supply constraints in Q2 2023, prompting the production expansion to address this issue and potentially serve as a turning point for Yunding Xinyao's performance [2]. Group 3: Future Potential and Strategic Developments - Nefukang's first full-year sales are projected to exceed 1 billion yuan, positioning it as one of the fastest-growing chronic disease drugs in China, with peak sales estimates reaching 5 billion yuan [3]. - Yunding Xinyao also has a next-generation covalent reversible BTK inhibitor, EVER001, which is expected to address broader kidney disease areas and fill several global clinical gaps [3]. - The ongoing clinical research for the Gd-IgA1 diagnostic reagent aims to replace kidney biopsy for auxiliary diagnosis, creating a "diagnosis-treatment" loop that enhances the precision and effectiveness of kidney disease treatment [3].

此外，云顶新耀于8月1日宣布战略增持I-Mab公司股权，投资金额达3090万美元，折合约2.426亿港元。 此次交易完成后，云顶新耀将合计持有I-Mab约16.1%的股份，成为该公司第一大股东。云顶新耀首席 执行官罗永庆表示，此次增加对I-Mab的战略性股权投资，进一步推动了公司在全球范围布局新一代肿 瘤免疫治疗管线。 消息面上，据澎湃报道，近期，有患者在社交平台上发帖称，其使用的布地奈德肠溶胶囊(商品名：耐 赋康)出现缺货情况。对于缺货情况，云顶新耀表示，公司已于今年2月向国家药监局提交扩大产能的补 充申请。8月4日，云顶新耀宣布，其中国首个且唯一获得完全批准的IgA肾病对因治疗药物耐赋康扩产 补充申请已正式获得中国国家药品监督管理局批准。 云顶新耀(01952)午后涨超8%，截至发稿，涨8.05%，报67.1港元，成交额4.08亿港元。 ...

智通财经APP获悉，云顶新耀(01952)午后涨超8%，截至发稿，涨8.05%，报67.1港元，成交额4.08亿港 元。 消息面上，据澎湃报道，近期，有患者在社交平台上发帖称，其使用的布地奈德肠溶胶囊（商品名：耐 赋康）出现缺货情况。对于缺货情况，云顶新耀表示，公司已于今年2月向国家药监局提交扩大产能的 补充申请。8月4日，云顶新耀宣布，其中国首个且唯一获得完全批准的IgA肾病对因治疗药物耐赋康扩 产补充申请已正式获得中国国家药品监督管理局批准。 此外，云顶新耀于8月1日宣布战略增持I-Mab公司股权，投资金额达3090万美元，折合约2.426亿港元。 此次交易完成后，云顶新耀将合计持有I-Mab约16.1%的股份，成为该公司第一大股东。云顶新耀首席 执行官罗永庆表示，此次增加对I-Mab的战略性股权投资，进一步推动了公司在全球范围布局新一代肿 瘤免疫治疗管线。 ...