智通财经APP获悉，9月18日，在2025年第18届IgA肾病国际研讨会(IIgANN 2025)上，耐赋康®(布地奈 德肠溶胶囊，NEFECON®)展示了7项来自中国多家顶尖医院的最新真实世界研究数据。其中一项重要 的观察性研究评估了耐赋康®治疗IgA肾病12个月的有效性和安全性，其结果证实了耐赋康®在"长期对 因治疗"IgA肾病方面具有显著临床获益。这一研究结果不仅为IgA肾病患者9个月疗程后的后续治疗提 供了清晰方向，而且为 lgA 肾病患者的长期治疗提供了极具价值的循证医学支持。第18届IgA肾病国际 研讨会于9月17日至20日在捷克共和国布拉格举行。 结果显示，12个月后，布地奈德肠溶胶囊组24小时尿蛋白从1016 mg降至114 mg(P=0.037)，显著低于对 照组的291mg(P=0.01)。布地奈德肠溶胶囊组eGFR斜率显著优于对照组(5.4 ml/min/1.73m2/年vs. -3.4 ml/min/1.73m2/年，P=0.032)，未发生严重感染。研究表明，12个月的布地奈德肠溶胶囊治疗可显著降 低IgA肾病患者的蛋白尿水平并保护肾功能，且安全性优于传统治疗。 北京大学第一医院吕继 ...

人民财讯9月15日电，9月15日，云顶新耀宣布，耐赋康将于9月17—20日举办的第18届IgA肾病国际研 讨会上，展示7项最新真实世界数据，从多个维度深入探讨其在IgA肾病治疗中的疗效与安全性。研究 结果显示，其在"对因治疗、尽早治疗、长期治疗"上展现出显著临床价值：在真实世界用药中，其对因 治疗的价值得到验证；早期干预被证实对减少蛋白尿和稳定肾功能方面具有重要意义；同时，超过9个 月的延长治疗数据也提供了长期疗效与安全性的有力证据。相关证据弥补了RCT在临床应用场景中的局 限性，充实了治疗策略。 ...

2025年第18届IgA肾病国际研讨会(IIgANN)将于9月17日至20日在捷克共和国布拉格举行。耐赋康(布地 奈德肠溶胶囊，NEFECON)在此盛会中将展示7项最新真实世界数据，进一步展现其在相关领域的深入 研究进展。耐赋康是目前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 (FDA)、欧洲药品管理局(EMA)、英国药品和健康产品管理局(MHRA)及云顶新耀(01952)其他亚洲授权 区域(中国香港、中国澳门、中国台湾、新加坡及韩国)完全批准的IgA肾病治疗药物。 此次公布的最新数据来自中国多家顶尖医院的临床实践，从多个维度深入探讨了耐赋康在IgA肾病治疗 中的疗效与安全性。研究结果显示，耐赋康在"对因治疗、尽早治疗、长期治疗"三个方面均展现出显著 的临床价值：在真实世界用药中，其对因治疗的价值得到验证；早期干预被证实对减少蛋白尿和稳定肾 功能方面具有重要意义；同时，超过9个月的延长治疗数据也提供了长期疗效与安全性的有力证据。 这些真实世界证据不仅弥补了随机对照试验(RCT)在临床应用场景中的局限性，也进一步充实了"对因 治疗、尽早治疗、长期治疗"的治疗策略，强化了耐赋康作为全 ...

Core Insights - The 18th International Symposium on IgA Nephropathy (IIgANN) will be held in Prague, Czech Republic from September 17 to 20, 2025, where Nefecon® will present seven new real-world data studies showcasing its advancements in the field [1] - Nefecon® is the first IgA nephropathy treatment drug fully approved by multiple regulatory agencies including NMPA, FDA, EMA, and MHRA, highlighting its global significance [1][2] - Recent data from top hospitals in China demonstrate Nefecon®'s efficacy and safety in treating IgA nephropathy, emphasizing its clinical value in "etiological treatment, early intervention, and long-term treatment" [1][2] Group 1: Clinical Efficacy and Safety - Nefecon® has shown significant clinical value in treating IgA nephropathy, with real-world evidence validating its efficacy in reducing proteinuria and stabilizing kidney function [1][2] - A 12-month study indicated that Nefecon® significantly lowers proteinuria and protects kidney function compared to traditional treatments, with better safety profiles [3] - A 6-month retrospective cohort study confirmed that Nefecon® effectively reduces proteinuria levels and improves kidney function in Chinese patients, supporting its potential as a first-line treatment [4] Group 2: Treatment Guidelines and Recommendations - Nefecon® has been included in the 2024 KDIGO clinical management guidelines for IgA nephropathy and IgA vasculitis, as well as the Chinese adult guidelines, establishing its foundational role in treatment [2] - The drug emphasizes the need for both etiological and supportive treatments, marking a shift in traditional IgA nephropathy treatment approaches [2] Group 3: Special Cases and Observational Studies - Case reports indicate that Nefecon® can effectively treat IgA nephropathy patients co-infected with hepatitis B virus without causing viral reactivation, providing evidence for its use in this specific population [6] - Observational studies show that Nefecon® maintains kidney protection in patients with primary IgA nephropathy and renal insufficiency, demonstrating its potential in high-risk groups [8]

Group 1 - The company reported a revenue of RMB 446 million for H1 2025, representing a 48% year-on-year increase, with a significant reduction in non-IFRS losses by 31% [1] - The gross margin, excluding non-cash items, was 76.4%, and the cash reserves reached RMB 1.6 billion by the end of June 2025 [1] - Sales of the drug NAI Fukan reached RMB 303 million in H1 2025, an 81% increase year-on-year, with expectations for annual sales to reach RMB 1.2-1.4 billion [1] Group 2 - The drug NAI Fukan is the first targeted therapy for IgA nephropathy, successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [1] - The company anticipates that NAI Fukan will be included in the KDIGO 2025 guidelines and the first IgA nephropathy guidelines in China [1] - Sales of the drug Yijia reached RMB 143 million in H1 2025, a 6% increase year-on-year, with a 37% increase in pure sales from core hospitals [1] Group 3 - The drug EVER001 (Hibutinin) is positioned as a potential best-in-class product, with positive results from ongoing clinical trials presented at the ERA 2025 conference [2] - The drug Aiqumide has completed a significant clinical study in Asia for moderate to severe ulcerative colitis and is expected to receive approval in mainland China by H1 2026 [2] - The company is leveraging its proprietary mRNA technology platform to develop globally competitive products, including personalized cancer vaccines [3] Group 4 - The mRNA-based cancer vaccine EVM16 completed its first patient dosing in March 2025, while EVM14 received FDA IND approval, marking a significant milestone for the company [3] - The company expects to complete preclinical milestones for its CAR-T project based on the mRNA technology platform in the second half of 2025 [3] - The revenue forecast for the company has been raised, with projected total revenues of RMB 1.738 billion, RMB 2.869 billion, and RMB 3.351 billion for 2025-2027 [3]

Core Viewpoint - The company reported a significant increase in revenue for the first half of 2025, driven by the inclusion of its product in the national medical insurance directory and deepening market penetration, indicating strong growth potential in the healthcare sector [1][2]. Group 1: Financial Performance - In the first half of 2025, the company achieved revenue of 446 million RMB, representing a year-on-year increase of 48% [1]. - The non-deductible net profit attributable to the parent company was -250 million RMB, showing a year-on-year reduction in losses of 59.44% [1]. Group 2: Kidney Disease Sector - The product "耐赋康" has been included in the national medical insurance directory since 2024, covering 29 provinces, with sales reaching 303 million RMB in the first half of 2025, an increase of 81% year-on-year [1]. - The product's sales in August alone reached 520 million RMB, with an expected annual revenue of 1.2 to 1.4 billion RMB, leading to anticipated operational profitability in the second half of 2025 [1]. - The clinical trial data for EVER001, a treatment for membranous nephropathy, shows significant reductions in anti-PLA2R antibodies and proteinuria, with a clinical remission rate exceeding 90% [1]. Group 3: Infection Sector - The product "依嘉" achieved revenue of 143 million RMB in the first half of 2025, reflecting a year-on-year growth of 37% [2]. - The company plans to initiate local production and expects to start medical insurance negotiations in 2026 [2]. - Combined revenue from "耐赋康" and "依嘉" is projected to be between 1.6 to 1.8 billion RMB in 2025 [2]. Group 4: Autoimmune Sector - "艾曲莫德" is positioned to become a key product for ulcerative colitis, having been included in the 2025 ACG clinical guidelines as a strongly recommended first-line treatment [2]. - The product has received approvals in multiple regions, with expectations for domestic approval in the first half of 2026 [2]. Group 5: Strategic Developments - The company has launched an AI+mRNA platform and achieved its first clinical results, with the personalized tumor vaccine EVM16 completing its first administration [3]. - The self-generating CAR-T project EVM18 is set to begin clinical trials by the end of 2025 after successful preclinical studies [3]. - The company invested 30.9 million USD in I-Mab, becoming its largest shareholder, which is a strategic move in the field of tumor immunotherapy [3]. Group 6: Revenue Forecast - The company forecasts revenues of 1.806 billion RMB, 3.396 billion RMB, and 5.380 billion RMB for 2025, 2026, and 2027, respectively, with growth rates of 155.63%, 87.98%, and 58.43% [3]. - The net profit attributable to the parent company is projected to be -486 million RMB, 146 million RMB, and 744 million RMB for the same years, with growth rates of -1.38%, 0.42%, and 2.12% [3].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 73.6 per share, up from the previous target of HKD 59.15 [7]. Core Insights - The company has significantly raised its guidance for the drug Naisukan, expecting sales to reach RMB 12-14 billion in 2025, with continued high growth projected for 2026 at RMB 24-26 billion [2]. - The company reported a revenue of RMB 4.46 billion for the first half of 2025, marking a 48% year-on-year increase, with a notable reduction in non-IFRS losses by 31% [1]. - The company is focusing on innovative products with differentiated competitive advantages, particularly in the fields of anti-infection and kidney disease treatments [7]. Summary by Sections Naisukan Performance - Naisukan achieved sales revenue of RMB 3.03 billion in H1 2025, representing an 81% year-on-year growth, with August sales reaching RMB 5.20 billion [2]. - The drug was successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [2]. Other Drug Developments - The drug Yijia generated revenue of RMB 1.43 billion in H1 2025, a 6% increase, with a 37% growth in direct sales to hospitals [3]. - EVER001 (Hibutinib) is showing promising clinical trial results, positioning it as a potential best-in-class product for broad-spectrum autoimmune kidney diseases [4]. Clinical Trials and Approvals - The drug Aiqumide has completed a significant clinical study in Asia and is expected to receive approval in mainland China by H1 2026 [5]. - The company is advancing its mRNA technology platform, with the EVM16 personalized cancer vaccine having completed its first patient dosing and EVM14 receiving FDA IND approval [6]. Financial Projections - The company has revised its revenue forecasts for 2025-2027 to RMB 17.38 billion, RMB 28.69 billion, and RMB 33.51 billion respectively, reflecting the strong performance of Naisukan and the anticipated approval of Aiqumide [7].

2025年9月5日，根据于2018年12月25日采纳的首次公开发售前雇员购股权计划(经于2020年2月17日修订 及重列)及于2020年9月21日采纳的首次公开发售后股份奖励计划发行260.61万股股份。 云顶新耀(01952)发布公告，2025年9月2日，员工(董事除外)根据首次公开发售后购股权计划行使购股权 而发行1257股。 ...

Group 1 - Company announced the issuance of 1,257 shares on September 2, 2025, under the post-IPO employee stock option plan [1] - On September 5, 2025, the company issued 2.6061 million shares based on the pre-IPO employee stock option plan adopted on December 25, 2018, and revised on February 17, 2020, as well as the post-IPO share award plan adopted on September 21, 2020 [1]

| 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 01952 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | 每股發行/出售價 (註4) | | 已發行股份總數 | | | | 已發行股份（不包括庫存股份）數 目 | | 佔有關事件前的現有已發 行股份（不包括庫存股 份）數目百分比 (註3) | 庫存股份數目 | | | | | 於下列日期開始時的結存(註1) | 2025年8月31日 | | 350,928,043 | | 0 | | | 350,928,043 | | 1). 就根據股份計劃授予參與人（發行人的董事除外）的股份獎勵或期權 而發行新股或轉讓庫存股份 - 涉及新股 | | | 1,257 | 0.0004 % ...