中国上海—2025年8月4日—云顶新耀(HKEX 1952.HK)是一家专注于创新药研发、临床开发、制造和商 业化的生物制药公司，今日宣布，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(布地 奈德肠溶胶囊)扩产补充申请已正式获得中国国家药品监督管理局批准。作为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，耐赋康已成为IgA肾病治疗的一线基石药物， 此次扩产获批将进一步提升产能，增加产品供应，更高效地响应中国及亚洲地区对耐赋康的持续增长的 临床需求。 耐赋康于2023年11月通过优先审评程序正式获得NMPA的批准，用于治疗具有进展风险的原发性IgA肾 病成人患者，填补了国内从疾病源头治疗IgA肾病的空白，并在2024年11月被纳入国家医保药品目录， 2025年5月获得NMPA完全批准，取消了对蛋白尿水平的限制，适用于绝大部分IgA肾病患者的治疗。 凭借创新的作用机制和突出的临床优势，耐赋康先后被纳入《2024版KDIGO IgA肾病和IgA血管炎临床 管理实践指南（公开审查版）》以及《中国成人IgA肾病及IgA血管炎临床实践指南（预审版本）》， 成为目前唯一同时获国际 ...

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]

智通财经APP了解到，2025年8月4日，云顶新耀(01952)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(布地奈德肠溶胶囊)扩产补充申请已正式获得中国国家药品监督管理局批准。作 为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，耐赋康已成为IgA 肾病治疗的一线基石药物，此次扩产获批将进一步提升产能，增加产品供应，更高效地响应中国及亚洲 地区对耐赋康的持续增长的临床需求。 耐赋康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，从而阻止 下游的病理途径，最终有效控制蛋白尿并保护肾功能。在全球III期NefIgArd研究中，耐赋康能使肾功能 下降风险降低50%，中国人群数据分析显示，能减少66%肾功能下降，疾病进展至透析或肾移植的时间 延缓12.8年。 耐赋康于2023年11月通过优先审评程序正式获得NMPA的批准，用于治疗具有进展风险的原发性IgA肾 病成人患者，填补了国内从疾病源头治疗IgA肾病的空白，并在2024年11月被纳入国家医保药品目录， 2025年5月获得NMPA完全批准，取消了对蛋白尿水平的限制，适用于 ...

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]

据介绍，I-Mab为一间总部设于美国的全球性生物科技公司，专注于研发针对癌症治疗的精准免疫肿瘤 学药物。I-Mab目前有三项处于临床阶段的管线产品，包括Givastomig(Claudin18.2x4-1BB双特异性抗 体)、Ragistomig(PD-L1x4-1BB双特异性抗体)及Uliledlimab(CD73抗体)。 董事会认为，认购事项可确认I-Mab于临床转化方面的独特能力，特别是在美国，与本公司于亚洲地区 的强大影响力，以及于差异化4-1BB技术平台及双特异性抗体研发管线方面的优势，形成互补及协同效 应，并与本公司于mRNA癌症疫苗方面的现有投资相得益彰。 消息面上，云顶新耀发布公告，于2025年8月1日，本公司认购I-Mab(I-Mab)(一间于纳斯达克全球市场上 市的公司，股份代号为"IMAB")的1584.62万股美国预托股份(ADS)(每10股ADS相当于23股普通股)(认购 事项)，每股ADS为1.95美元(相当于约每股ADS15.3港元)。认购事项的总代价为3090万美元(相当于约 2.43亿港元)。认购事项完成后，本公司将合共持有1584.62万股ADS及607.86万股普通股，占 ...

Core Viewpoint - Clouding New Horizon (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 - The subscription price for each ADS is $1.95, equivalent to approximately 15.3 HKD per ADS, with a total transaction value of $30.9 million (approximately 243 million HKD) [1] - After the completion of the subscription, the company will hold a total of 15.8462 million ADS and 6.0786 million ordinary shares of I-Mab, representing about 16.1% of I-Mab's total issued share capital post-transaction [1] - I-Mab is a global biotechnology company focused on developing precision immuno-oncology drugs for cancer treatment, with three clinical-stage pipeline products [1] Group 2 - The board believes that the subscription will confirm I-Mab's unique capabilities in clinical translation, particularly in the U.S., and will complement the company's strong influence in Asia [2] - The collaboration is expected to create synergies between I-Mab's differentiated 4-1BB technology platform and bispecific antibody development pipeline, enhancing the company's existing investments in mRNA cancer vaccines [2]

Core Insights - Genting Yong's strategic investment in I-Mab amounts to $30.9 million, equivalent to approximately HKD 242.6 million, making it the largest shareholder with a 16.1% stake [1] - This investment marks a significant step in Genting Yong's strategic positioning in the next-generation tumor immunotherapy sector [1] I-Mab's Core Technology and Pipeline Products - I-Mab is a global biotechnology company listed on NASDAQ under the ticker "IMAB," focusing on precision tumor immunotherapy [3] - The company has three clinical pipeline products: Givastomig (Claudin18.2x4-1BB bispecific antibody), Ragistomig (PD-L1x4-1BB bispecific antibody), and Uliledlimab (CD73 antibody) [3] - Recent clinical data from I-Mab indicates an objective response rate of 83% for Givastomig in a Phase 1b dose-escalation study for first-line gastric cancer treatment [3] Strategic Synergy and Global Layout Value - Genting Yong's CEO stated that the investment enhances the company's global strategy in next-generation tumor immunotherapy pipelines [4] - Genting Yong has developed proprietary AI+mRNA and autologous CAR-T platforms, focusing on mRNA therapeutic vaccines and autologous CAR-T therapies [4] - The collaboration between Genting Yong and I-Mab is expected to create a matrix of next-generation tumor immunotherapy products, providing innovative solutions for major treatment areas [4] - The investment leverages I-Mab's clinical development capabilities in the U.S. and complements Genting Yong's strong presence in the Asian market, potentially enhancing the value of core self-developed pipeline products in both the U.S. and China [4]

Group 1 - InnoCare (02577.HK) has partnered with NVIDIA to promote the large-scale implementation of the 800 VDC power architecture in AI data centers, which is designed for efficient power supply in megawatt-level computing infrastructure [1] - The 800 VDC system offers significant advantages over traditional 54V systems in terms of efficiency, thermal loss, and reliability, enabling a 100-1000 times increase in AI computing power [1] - The company's third-generation GaN devices provide a comprehensive power solution from 800V input to GPU terminals, covering a voltage range from 15V to 1200V [1] Group 2 - China Ruyi (00136.HK) received a strategic investment of HKD 3.9 billion from Wuji Capital to accelerate business expansion and acquisition plans [2] - LEPU Biopharma-B (02157.HK) has authorized T-cell connector technology with an upfront payment of USD 10 million and potential milestone payments of up to USD 850 million [2] - Sinopec Engineering (02386.HK) signed a front-end engineering design (FEED) contract for a large green hydrogen project in Yanbu, Saudi Arabia [2] Group 3 - Geely Automobile (00175.HK) reported total vehicle sales of 237,700 units in July, a year-on-year increase of 58% [3] - Great Wall Motors (02333.HK) achieved approximately 104,372 vehicle sales in July, reflecting a year-on-year growth of 14.34% [3] - NIO-SW (09866.HK) delivered 21,017 vehicles in July [3]