Group 1 - The company announced a commercialization service agreement with Haisen Bio, effective December 11, 2025, allowing the company to provide CSO services in China [1] - The board believes that this agreement will create synergies in regions and customer groups not fully covered by Haisen Bio, enhance product lifecycle management, and generate recurring service fee income from CSO services [1] - The company expects to leverage its existing infrastructure, sales team, and key customer relationships to create incremental sales and improve the scale, experience, and efficiency of its commercial organization [1] Group 2 - The company has also entered into an exclusive licensing agreement with Haisen Bio, granting limited rights to develop, commercialize, and sell licensed compounds and products in the specified region [1] - Mr. Sun Xin has been appointed as a non-executive director, effective December 11, 2025 [2]

Group 1 - Company entered into a commercialization service agreement with Haisen Bio, effective December 11, 2025, to provide CSO services in China [1] - The agreement aims to create synergies in regions and customer groups not fully covered by Haisen Bio, enhancing product lifecycle management and commercialization capabilities [1] - The company expects to generate recurring service fee income from CSO services, improving the utilization and productivity of its existing commercial platform [1] Group 2 - An exclusive, non-transferable license agreement was established with Haisen Bio, allowing the company to develop, commercialize, and sell licensed compounds and products in the designated region [1] - The agreement includes limited rights to sublicense based on the licensor's patents and proprietary technology [1] Group 3 - Mr. Sun Xin has been appointed as a non-executive director, effective December 11, 2025 [2]

獨立非執行董事 執行董事 吳以芳先生 （ 主席 ） 羅永慶先生 （ 首席執行官 ） 何穎先生 （ 總裁、首席財務官 ） 非執行董事 傅唯先生 （ 榮譽主席 ） 曹基哲先生 孫欣先生 （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 董事名單及其角色和職能 雲頂新耀有限公司（「本公司」）的董事會（「董事會」）成員載列如下。 徐海音女士 李軼梵先生 蔣世東先生 董事會設有三個委員會。下表載列該等委員會的成員詳情。 | 董事 | 審核委員會 | 薪酬委員會 | 提名委員會 | | --- | --- | --- | --- | | 吳以芳先生 | | 成員 | 主席 | | 羅永慶先生 | | | | | 何穎先生 | | | | | 傅唯先生 | | | | | 曹基哲先生 | | | | | 孫欣先生 | | | | | 徐海音女士 | 成員 | 主席 | 成員 | | 李軼梵先生 | 主席 | | 成員 | | 蔣世東先生 | 成員 | 成員 | | 香港，2025年12月11日 ...

（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 (1)有關商業化服務協議的持續關連交易； (2)有關授權許可協議的關連交易；及 (3)委任非執行董事 (1) 有關商業化服務協議的持續關連交易 董事會欣然宣佈，於2025年12月11日，該附屬公司（ 本公司的全資附屬公司 ） 與 海 森 生 物 訂 立 商 業 化 服 務 協 議 ， 據 此 ， 該 附 屬 公 司 將 於 中 國 就 產 品 提 供 CSO服務（ 定義見下文 ）。商業化服務協議的主要條款載列如下。 – 1 – 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。 日期： 2025年12月11日 訂約方： (i) 該附屬公司；及 (ii) 海森生物 期限 在訂約各方遵守適用法律（ 包括但不限於上市規則 ）的前提下，(i)商業化服務 協議期限應自生效日期起生效，初步持續有效為期三年，除非根據商業化服 務 ...

Core Viewpoint - The company, Genscript Biotech, is focusing on a dual-driven growth strategy through "License-in products" and self-developed platforms, particularly in the fields of kidney disease, anti-infection, and autoimmune diseases, while also advancing in oncology with innovative therapies [1] Group 1: License-in Products - The company has introduced several key products, including Durvalumab (Budesonide), EVER001 (BTK inhibitor), and others, which are expected to solidify its growth foundation [1] - Durvalumab is the first and only approved drug for IgA nephropathy treatment globally, showing significant clinical benefits such as a 33.6% reduction in proteinuria over 9 months and a 5.05 mL/min/1.73m improvement in kidney function over 2 years [2] - EVER001, a new generation BTK inhibitor for primary membranous nephropathy, has shown over 93% reduction in anti-PLA2R antibodies and an 80% proteinuria remission rate, filling a clinical treatment gap [3] Group 2: Self-developed Products - Aikumo (Ibudilast) is an oral S1P receptor modulator targeting moderate to severe ulcerative colitis (UC), demonstrating a 27% clinical remission rate at 12 weeks and a 51.9% mucosal healing rate at 52 weeks, indicating its potential as a best-in-disease option [3] Group 3: Financial Projections - The company forecasts revenues of 1.791 billion, 3.169 billion, and 4.822 billion yuan for 2025-2027, with net profits of -376 million, 285 million, and 868 million yuan respectively, leading to an EPS of -1.06, 0.81, and 2.45 [4]

Core Insights - The article highlights the significant clinical research data presented at the 23rd Asia Pacific Congress of Nephrology (APCN 2025) regarding the core product of the company, NEFECON® (Budesonide Enteric Capsules), which provides evidence-based support for the treatment of IgA nephropathy [1] Group 1: Clinical Research Findings - NEFECON® has shown promising results in multiple clinical studies from top hospitals in China, emphasizing its efficacy and safety in treating IgA nephropathy, a condition affecting approximately 5 million patients in China [1] - The studies presented at the conference indicate a shift in clinical focus from merely improving proteinuria to protecting kidney function for long-term management of IgA nephropathy patients [1] Group 2: Treatment Strategies - Research from Xi'an Jiaotong University First Affiliated Hospital confirms the importance of a full course of targeted therapy for kidney function protection, suggesting a combined approach of "targeted treatment + supportive treatment" for better disease control [2] - A study from Xinjiang Medical University First Affiliated Hospital shows that NEFECON® combined with non-steroidal agents can improve eGFR and reduce proteinuria in patients intolerant to systemic glucocorticoids, with no reported adverse events during the treatment period [2] - Research from Nanchang University First Affiliated Hospital explores the synergistic effects of NEFECON® and hydroxychloroquine, indicating improved outcomes in proteinuria and kidney function across various baseline levels [3] Group 3: Long-term Treatment Benefits - A retrospective real-world study from Macau Kiang Wu Hospital involving 12 patients treated with NEFECON® for 12 months shows significant advantages in proteinuria control and kidney function protection compared to a control group receiving traditional treatment [4] - The NEFECON® group demonstrated a reduction in proteinuria from 1016 mg/d to 114 mg/d, while the control group showed a decrease from 1074 mg/d to 291 mg/d, indicating a more substantial effect [4] - The study supports extending the treatment duration beyond 9 months to achieve sustained kidney protection benefits [5] Group 4: Clinical Value and Market Potential - The findings from APCN 2025 validate NEFECON®'s core value in targeted therapy and enrich its clinical evidence for long-term treatment, providing new therapeutic strategies for IgA nephropathy patients [6] - NEFECON® has been recommended in both the 2025 KDIGO guidelines and the 2025 Chinese guidelines for IgA nephropathy, making it the only drug with dual recognition [7] - The product's sales revenue reached nearly 1 billion yuan from January to September 2025, with annual sales guidance raised to 1.2-1.4 billion yuan, indicating it is one of the fastest-growing chronic disease innovative drugs in recent years [7] - Forecasts suggest that NEFECON® sales could reach 2.4-2.6 billion yuan by 2026, with peak sales potentially hitting 5 billion yuan [7]

Core Insights - The core product of Cloudtop New Medicine, NEFECON, showcased 11 new clinical research data from China at the 23rd Asia-Pacific Nephrology Congress (APCN2025), reinforcing its efficacy and safety in treating IgA nephropathy [1][2] Group 1: Clinical Research Findings - Research from Xi'an Jiaotong University First Affiliated Hospital indicates that while supportive treatment can improve proteinuria, its effect on kidney function protection is limited, suggesting a dual approach of "etiological treatment + supportive treatment" for better disease control [2] - A study from Xinjiang Medical University First Affiliated Hospital highlights that NEFECON can provide effective renal function protection for patients who are intolerant to conventional treatments, while minimizing systemic drug exposure risks [2] - Research from Nanchang University First Affiliated Hospital explores the combined effect of NEFECON and hydroxychloroquine, indicating that their long-term use can synergistically reduce proteinuria and improve kidney function with good safety [2] - A retrospective real-world study from Macau Kiang Wu Hospital shows that long-term treatment with NEFECON can further enhance proteinuria control and stabilize kidney function, with manageable safety [2] Group 2: Market Position and Financial Performance - NEFECON is the only IgA nephropathy treatment drug recognized by both the 2025 KDIGO Clinical Practice Guidelines and the 2025 Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis in China [3] - In 2024, NEFECON was included in the national medical insurance directory, with cumulative sales revenue nearing 1 billion yuan in the first three quarters of 2025 [3] - Multiple brokerages predict that NEFECON's sales could reach between 2.4 billion to 2.6 billion yuan in 2026, with a potential peak sales value of 5 billion yuan [3]

Core Insights - The article highlights the significant clinical research data presented at the 23rd Asia Pacific Nephrology Congress (APCN2025) regarding the core product of the company, NEFECON, which provides evidence-based support for the treatment of IgA nephropathy [1][2][3] Group 1: Clinical Research Findings - NEFECON has been demonstrated to have a foundational role in the first-line treatment of IgA nephropathy, with approximately 5 million patients in China and over 120,000 new diagnoses each year [1] - Research from Xi'an Jiaotong University First Affiliated Hospital confirms the importance of a full course of targeted therapy for kidney function protection, suggesting a dual approach of "targeted therapy + supportive treatment" for better disease control [1][2] - A study from Xinjiang Medical University First Affiliated Hospital shows that NEFECON combined with non-steroidal agents can improve eGFR and reduce proteinuria in patients intolerant to systemic glucocorticoids, with no reported serious adverse events during the treatment period [2][3] Group 2: Long-term Treatment Benefits - A retrospective real-world study from Macau Kiang Wu Hospital involving 12 patients treated with NEFECON for 12 months shows significant advantages in proteinuria control and kidney function protection compared to a control group [3] - The NEFECON group saw proteinuria levels decrease from 1016 mg/d to 114 mg/d, while the control group experienced a decrease from 1074 mg/d to 291 mg/d, indicating a significantly greater reduction in the NEFECON group [3] - The annual change in eGFR for the NEFECON group was +5.4 ml/min/1.73m²/year, while the control group showed a decline of -3.4 ml/min/1.73m²/year, demonstrating superior kidney function stability [3] Group 3: Commercial Performance - NEFECON has been included in both the 2025 KDIGO Clinical Practice Guidelines and the 2025 Chinese Adult IgA Nephropathy Clinical Practice Guidelines, making it the only IgA nephropathy targeted therapy recognized by both international and domestic guidelines [4] - Since the implementation of the insurance payment policy on January 1, 2025, NEFECON's sales revenue reached nearly 1 billion yuan from January to September 2025, prompting the company to raise its annual sales guidance to 1.2 billion to 1.4 billion yuan [4] - Multiple brokerages predict that NEFECON's sales could reach 2.4 billion to 2.6 billion yuan by 2026, with peak sales potentially reaching 5 billion yuan [4]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [12][14]. Core Insights - The company, Genting Biopharma, focuses on innovative drug and vaccine research, manufacturing, and commercialization, establishing a dual-driven growth model through license-in products and self-developed high-barrier pipelines [3][8]. - Key products include Nefukang (Budesonide) for IgA nephropathy, EVER001 for primary membranous nephropathy, and Aicuo Mod (Etrolizumab) for moderate to severe ulcerative colitis, all showing significant clinical evidence and market potential [9][10][11]. - The company has seen substantial revenue growth, with projected revenues of 1.791 billion, 3.169 billion, and 4.822 billion RMB for 2025-2027, respectively, and a turnaround in profitability expected by 2025 [12][30]. Summary by Sections Company Overview - Genting Biopharma was founded in July 2017 and has developed a diverse product pipeline covering oncology, nephrology, and infectious diseases [18]. - The company has shifted focus towards nephrology and autoimmune diseases, divesting from oncology to enhance resource allocation [18]. Product Pipeline - The product pipeline includes Nefukang, which is the first approved drug for IgA nephropathy globally, and EVER001, a reversible BTK inhibitor targeting primary membranous nephropathy [9][10]. - Aicuo Mod has shown rapid efficacy in inducing clinical remission in ulcerative colitis patients, with a significant mucosal healing rate [11]. Financial Performance - The company achieved a revenue of 707 million RMB in 2024, a 461% increase year-on-year, and expects continued growth with a revenue of 446 million RMB in the first half of 2025 [28][30]. - The net profit is projected to improve from a loss of 376 million RMB in 2025 to a profit of 868 million RMB by 2027, indicating a strong recovery trajectory [12][30]. Market Potential - The chronic kidney disease (CKD) patient population is substantial, with approximately 1.25 billion patients in China, representing a significant market opportunity for the company's nephrology products [32]. - The company’s products are positioned to address unmet medical needs in the nephrology and autoimmune disease sectors, with a focus on innovative treatment approaches [3][8].

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12月3日 I. 法定/註冊股本變動 | 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 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 ...