Core Viewpoint - Cloudtop New Horizon Pharmaceutical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the expansion of production for its drug, Nefukang (Budenoside Enteric-Coated Capsules), which is the first and only approved treatment for IgA nephropathy in China, the US, and Europe, aiming to meet the growing clinical demand in China and Asia [2] Company Summary - Nefukang was approved in November 2023 through a priority review process, becoming the first approved drug for the cause of IgA nephropathy in China, filling a significant treatment gap [2] - The projected annual sales for Nefukang in 2024 are expected to reach 354 million yuan [2] - In November 2024, Nefukang will be included in the national medical insurance catalog, and by May 2025, it will receive full approval from NMPA, removing previous restrictions on proteinuria levels, thus expanding the potential patient population by three times [2] - Currently, Nefukang has covered over 80% of potential hospitals in China, benefiting more than 20,000 patients, indicating a strong demand for increased production capacity to meet patient needs [2] Industry Summary - China has the highest incidence rate of primary glomerular diseases globally, highlighting the urgent need for effective treatments like Nefukang [2] - Cloudtop New Horizon is also developing a next-generation covalent reversible BTK inhibitor, EVER001, which aims to address global clinical gaps in diseases such as primary membranous nephropathy (pMN), minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS) [2] - The company is advancing clinical research for a Gd-IgA1 diagnostic reagent, expected to be approved for market by 2026, which may replace kidney biopsy as an auxiliary diagnostic tool [2]

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。 ...

Core Viewpoint - CloudTop New Horizon (HKEX 1952.HK) announced the approval of its expanded production application for NEFECON (Budesonide Enteric-Coated Capsules), the first and only fully approved IgA nephropathy targeted therapy in China, which will enhance production capacity and meet the growing clinical demand in China and Asia [1][2]. Group 1: Product Approval and Market Impact - NEFECON is the first and only IgA nephropathy targeted therapy fully approved in China, the US, and Europe, establishing it as a cornerstone drug for IgA nephropathy treatment [1][3]. - The approval for expanded production will allow for a more efficient response to the increasing clinical needs of IgA nephropathy patients in Asia, where the disease is highly prevalent [1][2]. - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, indicating a significant unmet clinical need [1][2]. Group 2: Clinical Efficacy and Guidelines - NEFECON has been shown to reduce the risk of kidney function decline by 50% in global Phase III NefIgArd studies, with a 66% reduction observed in the Chinese population [2][5]. - The drug delays the progression to dialysis or kidney transplantation by an average of 12.8 years, highlighting its clinical significance [2][5]. - NEFECON is the only IgA nephropathy targeted therapy recommended by both international and domestic clinical guidelines, solidifying its position as a first-line treatment [3][5]. Group 3: Mechanism of Action - NEFECON works by specifically modulating intestinal mucosal immunity to reduce the production of Gd-IgA1, which triggers IgA nephropathy, thereby effectively controlling proteinuria and protecting kidney function [2][5]. - The formulation includes a unique triple-layer coating that ensures targeted release of Budesonide to the mucosal B cells in the ileum, enhancing its therapeutic effect [5].

Core Insights - The approval of the expanded production application for the drug Neficon (Budesonide Enteric-Coated Capsules) marks a significant milestone as it is the first and only fully approved treatment for IgA nephropathy in China, the US, and Europe [1][2] - The drug is positioned as a cornerstone therapy for IgA nephropathy, addressing the growing clinical demand in China and Asia, where the disease prevalence is notably high [1] - The drug's unique mechanism of action and clinical advantages have led to its inclusion in both international and domestic clinical guidelines, solidifying its status as a first-line treatment [2] Company Developments - The National Medical Products Administration (NMPA) approved Neficon in November 2023 for adult patients with progressive primary IgA nephropathy, filling a treatment gap in China [2] - Neficon was included in the national medical insurance drug list in November 2024, and received full approval in May 2025, removing restrictions on proteinuria levels for most patients [2] - The CEO of the company emphasized the importance of increasing production capacity to meet the rising clinical treatment needs of IgA nephropathy patients in Asia [1] Industry Context - IgA nephropathy has a high incidence in Asia, with China having one of the highest rates of primary glomerular diseases, estimated to have over 5 million patients and more than 100,000 new cases annually [1] - The drug Neficon has demonstrated significant clinical efficacy, reducing the risk of kidney function decline by 50% in global studies, and by 66% in the Chinese population, delaying disease progression to dialysis or kidney transplantation by an average of 12.8 years [1]

Core Insights - The approval of the expanded production application for the drug Nefikang® (Budesonide Enteric-Coated Capsules) marks a significant milestone as it is the first and only fully approved treatment for IgA nephropathy in China, the US, and Europe [1][2] - The drug addresses a critical unmet medical need in Asia, particularly in China, where the incidence of primary glomerular diseases is the highest globally, with over 5 million patients currently diagnosed with IgA nephropathy [1] - Nefikang® has been recognized in both international and domestic clinical guidelines as the cornerstone treatment for IgA nephropathy, highlighting its innovative mechanism and clinical advantages [2] Company Developments - The CEO of the company emphasized that the increase in production capacity will better meet the growing clinical treatment needs of IgA nephropathy patients in Asia [1] - The drug has been included in the National Medical Insurance Drug List in November 2024, and received full approval from the NMPA in May 2025, removing restrictions on proteinuria levels for most patients [2] - Nefikang® has demonstrated a 50% reduction in the risk of kidney function decline in global Phase III studies, with Chinese population data showing a 66% reduction [1] Industry Context - IgA nephropathy has a high prevalence in Asia, with rapid disease progression and poor prognosis, indicating a significant market opportunity for effective treatments [1] - The approval and subsequent inclusion in treatment guidelines position Nefikang® as a transformative option in the management of IgA nephropathy, shifting the treatment paradigm towards etiology-based therapy [2] - The drug's unique mechanism of action, which targets the underlying causes of IgA nephropathy, sets it apart from traditional supportive treatments [2]

Group 1 - The approval of the expanded production application for the drug Nefikang (Budesonide Enteric-Coated Capsules) marks it as the first and only fully approved treatment for IgA nephropathy in China, enhancing its supply to meet the growing clinical demand in Asia [1] - The CEO of the company emphasized that the increased production capacity will better address the rising clinical treatment needs of IgA nephropathy patients in Asia, particularly in China, which has the highest incidence of primary glomerular diseases globally, with over 5 million patients and more than 100,000 new cases diagnosed annually [1] - Nefikang is currently the only drug recommended by both domestic and international guidelines for the treatment of IgA nephropathy, and its expanded production will accelerate the adoption of targeted treatment, helping more patients initiate standardized treatment early to delay disease progression and protect kidney function [1] Group 2 - Nefikang received formal approval from the NMPA in November 2023 through a priority review process for treating adult patients with primary IgA nephropathy at risk of progression, filling a gap in the domestic treatment landscape [2] - The drug was included in the National Medical Insurance Drug List in November 2024 and received full NMPA approval in May 2025, removing restrictions on proteinuria levels, making it applicable to the majority of IgA nephropathy patients [2] - Nefikang has been incorporated into both the 2024 KDIGO Clinical Practice Guidelines for IgA Nephropathy and the Chinese Clinical Practice Guidelines for Adult IgA Nephropathy, establishing it as a cornerstone treatment for IgA nephropathy [2]

Core Insights - A sudden shortage of the kidney disease drug, Nefukang (Budesonide Enteric Capsules), has drawn significant market attention, highlighting the unmet demand among IgA nephropathy patients in China [1][3] - The drug, introduced and commercialized by Gensun Biopharma, is the first and only approved treatment for IgA nephropathy in China, with widespread shortages reported across multiple cities [1][3] - Gensun Biopharma is expected to achieve its first annual commercial profitability in 2024, driven by Nefukang's strong sales performance, which is projected to exceed 5 billion yuan [3][10] Company Overview - Gensun Biopharma has transitioned from a struggling company three years ago to a commercial success, with a projected annual revenue of over 7 billion yuan in 2024, marking a 461% year-on-year increase [10] - The company has adopted a License-in strategy, allowing it to bypass early-stage R&D and focus on late-stage products, which has contributed to its rapid commercialization [10][16] - Gensun Biopharma's stock has seen a significant rebound, increasing over 237% from its low point, reflecting market optimism about its future prospects [21] Market Demand - IgA nephropathy is a serious chronic kidney disease with a high prevalence in China, where the patient population is estimated to be in the millions, contrasting with the much smaller patient base in the U.S. [7][9] - The introduction of Nefukang has filled a critical gap in treatment options, as prior therapies were limited to off-label use of antihypertensive medications [5][7] - The drug's inclusion in the national health insurance scheme has significantly improved its affordability, with prices dropping from approximately 23,800 yuan to around 5,000 yuan per bottle [6][10] Supply Chain Challenges - The current supply shortage of Nefukang is attributed to its reliance on overseas production, with all manufacturing conducted by Patheon Pharmaceuticals in the U.S. [9] - Gensun Biopharma is in the process of establishing local production capabilities, but the transition is expected to take time due to regulatory and technical challenges [9][10] - The shortage has underscored the significant market demand for kidney disease treatments, as well as the vulnerabilities in the supply chain for innovative drugs [9][21] Investment Dynamics - Gensun Biopharma's major shareholder, Kangqiao Capital, has been reducing its stake in the company, selling over 13% of its shares in two large transactions earlier this year [19][21] - The rationale behind the sell-off includes optimizing the investor structure and responding to liquidity pressures from limited partners [21] - Despite the successful commercialization of Nefukang, the timing of Kangqiao Capital's divestment raises questions about the company's future trajectory and investor confidence [21][22]

Core Viewpoint - Genting New Year (01952) has announced a subscription for 15.8462 million American Depositary Shares (ADS) of I-Mab at a price of $1.95 per ADS, totaling approximately $30.9 million, which will result in a 16.1% ownership stake in I-Mab post-transaction [1][2] Group 1 - Genting New Year shares rose over 3% and were trading at HKD 63.5 with a transaction volume of HKD 147 million at the time of reporting [1] - The subscription price of $1.95 per ADS is equivalent to approximately HKD 15.3 per ADS [1] - The total consideration for the subscription amounts to approximately HKD 243 million [1] Group 2 - I-Mab is a global biotechnology company based in the United States, focusing on developing precision immuno-oncology drugs for cancer treatment [1] - I-Mab currently has three clinical-stage pipeline products: Givastomig, Ragistomig, and Uliledlimab [1] - The board believes that the subscription will confirm I-Mab's unique capabilities in clinical translation, particularly in the U.S., and will complement Genting New Year's strong influence in Asia [2]