Core Viewpoint - CloudTop New Drug (01952) has made significant progress in the commercialization of its innovative drug, Eiqumod (维长宁), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Eiqumod has received regulatory approvals in Macau, Singapore, Hong Kong, and its NDA has been accepted in South Korea, marking important advancements in its market access across Asia [1] - The drug is expected to receive approval from the National Medical Products Administration (NMPA) in China by the end of 2024 or early 2025 [1] - Eiqumod is recognized as a first-line oral treatment that effectively promotes mucosal healing in UC patients, which is a key treatment goal according to clinical guidelines [1][2] Group 2: Clinical Research and Efficacy - The NDA application for Eiqumod is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC52 and ELEVATE UC12) and the ENLIGHT study (ES101002), which demonstrated significant clinical efficacy and safety [2][3] - The ELEVATE UC studies showed that Eiqumod achieved both clinical remission and deep mucosal healing at 12 and 52 weeks, with 100% of clinical remission being steroid-free [2] - The ENLIGHT study is the largest Phase III clinical trial for moderate UC in Asia, involving 340 patients, and provided strong evidence for the drug's application in this patient population [3] Group 3: Market Potential and Strategic Initiatives - The CEO of CloudTop highlighted the growing number of UC patients in Asia, with an estimated 800,000 patients in China in 2024, projected to reach 1 million by 2030, indicating a significant unmet medical need [2] - Eiqumod has been included in the urgent import drug list for the Greater Bay Area in 2024, allowing for early access to patients in that region [3] - The company has initiated local production of Eiqumod in its Jiaxing facility to support supply and commercialization in Greater China and other Asian markets [3][4] Group 4: Company Overview - CloudTop New Drug focuses on the research, clinical development, manufacturing, and commercialization of innovative drugs and vaccines, aiming to meet unmet medical needs in the Asian market [5] - The management team has extensive experience in high-quality research and development, regulatory affairs, and commercialization operations within leading pharmaceutical companies [5]

智通财经APP获悉，云顶新耀(01952)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，近日宣布中国台湾地区药政主管部门(TFDA)已正式受理维长宁®(艾曲莫德，中国台湾地区商品 名：維長寧®)用于治疗中重度活动性溃疡性结肠炎(UC)患者的新药上市许可申请(NDA)。此次受理标志 着艾曲莫德继中国澳门、新加坡和中国香港获批和韩国NDA获正式受理之后，其在亚洲市场的准入取 得重要进展。中国国家药品监督管理局也于2024年12月正式受理艾曲莫德(维适平®)的新药上市申请， 预计今年年底或明年年初获批。 艾曲莫德是一款针对溃疡性结肠炎，每日一次的口服一线治疗药物，能够强效实现肠道黏膜愈合，且使 用便捷，并具有良好的安全性特征。黏膜愈合是国内外溃疡性结肠炎临床指南一致认定的溃疡性结肠炎 治疗目标。溃疡性结肠炎患者尽早实现黏膜愈合，可大幅降低疾病复发率、住院率、结直肠切除手术率 和结直肠癌发生风险。艾曲莫德已被纳入2024年美国胃肠病学协会(AGA)临床实践指南, 推荐作为溃疡 性结肠炎的一线治疗。2025年，艾曲莫德获得2025年美国胃肠病学会(ACG)成人UC临床指南的一线治 疗推荐，进一步印证了 ...

Core Viewpoint - CloudTop New Drug (HKEX 1952.HK) has made significant progress in the commercialization of its innovative drug, Aikumo (维长宁®), for the treatment of moderate to severe active ulcerative colitis (UC) in Taiwan, with the new drug application (NDA) officially accepted by the Taiwan Food and Drug Administration (TFDA) [1][2] Group 1: Drug Development and Approval - Aikumo has received regulatory approvals in Macau, Singapore, Hong Kong, and has its NDA accepted in South Korea, marking important advancements in its market access across Asia [1] - The National Medical Products Administration of China has also accepted the NDA for Aikumo (维适平®), with expectations for approval by the end of this year or early next year [1] - Aikumo is recognized as a first-line oral treatment for ulcerative colitis, promoting effective mucosal healing and demonstrating good safety profiles [2] Group 2: Clinical Research and Evidence - The NDA application for Aikumo is based on the results of the ELEVATE UC Phase III registration studies (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002), which showed significant clinical efficacy and safety in patients with moderate to severe active UC [2][3] - The ENLIGHT study is the largest Phase III clinical trial for moderate ulcerative colitis in Asia, involving 340 patients, and demonstrated significant clinical and statistical differences in treatment outcomes [3] Group 3: Market Potential and Strategic Plans - The CEO of CloudTop highlighted the growing number of ulcerative colitis patients in Asia, with approximately 800,000 patients in China expected to rise to 1 million by 2030, indicating a substantial unmet medical need [2] - Aikumo has been included in the list of urgently needed imported drugs and medical devices in the Greater Bay Area for 2024, facilitating its early use in the region [3] - The company has initiated local production of Aikumo at its Jiaxing factory to support supply and commercialization in Greater China and other Asian markets [3]

格隆汇8月11日丨云顶新耀(01952.HK)公布，谨定于2025年8月28日(星期四)举行董事会会议，以考虑及 通过集团截至2025年6月30日止六个月的中期业绩，以及处理其他事项。 ...

於本公告日期，董事會包括主席兼執行董事傅唯先生，執行董事羅永慶先生及何穎先生，非執行 董事曹基哲先生及馮洪剛先生，以及獨立非執行董事徐海音女士、李軼梵先生及蔣世東先生。 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 董事會會議召開日期 雲頂新耀有限公司（「本公司」及其附屬公司「本集團」）董事會（「董事會」）茲通告謹 定於2025年8月28日（ 星期四 ）舉行董事會會議，以考慮及通過本集團截至2025年 6月30日止六個月的中期業績，以及處理其他事項。 承董事會命 雲頂新耀有限公司 主席兼執行董事 傅唯 香港，2025年8月11日 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該 等內容而引致的任何損失承擔任何責任。 ...

Core Insights - The article highlights the significant progress made by the Hong Kong-based innovative pharmaceutical company, YunTing New Medicine, with its drug, Naisufang® (Budesonide Enteric-Coated Capsules), which is the first and only fully approved treatment for IgA nephropathy [1][6] - The drug has received approval for a new indication in Taiwan, allowing it to be used for all adult patients at risk of disease progression, thus expanding its patient base and market potential [1][5] Group 1: Market Potential and Demand - IgA nephropathy is the most common primary glomerular disease globally, with a notably higher prevalence in Asian populations, where the risk of progression to end-stage renal disease is 56% higher compared to other populations [2] - In China, there are over 5 million patients with IgA nephropathy, with more than 100,000 new diagnoses each year, indicating a substantial market demand for effective treatments [2] - The approval of Naisufang® is expected to generate sales of 1 billion yuan in its first full year post-launch, reflecting its strong market potential [1][6] Group 2: Clinical and Regulatory Advancements - Naisufang® has been recognized as a breakthrough therapy by the Chinese National Medical Products Administration (NMPA), filling a significant gap in the treatment of IgA nephropathy [2][4] - The drug's unique mechanism of action, which targets gut mucosal immunity and reduces the production of pathogenic IgA1, has been validated through clinical studies, demonstrating a 50% reduction in kidney function decline [4] - The drug has received dual recommendations from both domestic and international guidelines, solidifying its position as a first-line treatment for IgA nephropathy [4] Group 3: Supply and Production Capacity - The approval for the expansion of Naisufang® production capacity was granted in August, addressing the urgent need to meet the growing market demand [3] - The expansion will ensure a steady supply of the drug across China and the broader Asian region, alleviating the unmet clinical needs for IgA nephropathy treatments [3] Group 4: Commercialization and Market Strategy - YunTing New Medicine has established an efficient commercialization framework, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [6] - The drug's comprehensive approval across multiple regulatory bodies, including the NMPA, FDA, and EMA, enhances its market accessibility and patient coverage in Asia [6] - Analysts predict that Naisufang® could reach peak sales of 5 billion yuan, indicating its potential as a blockbuster product in the nephrology market [6]

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]