Core Viewpoint - The company, CloudTop New Horizon (01952.HK), announced the granting of stock options and employee stock options as part of its incentive plans following its initial public offering [1] Group 1 - The board granted a total of 74,000 stock options under the post-IPO stock option plan [1] - Additionally, a total of 234,800 reward options were granted under the pre-IPO employee stock option plan [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。 （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 授出購股權及獎勵 本公告乃根據上市規則第17.06A、17.06B及17.06C條刊發。 於2025年10月2日，董事會(i)根據首次公開發售後購股權計劃合共授出74,000份購 股權；及(ii)根據首次公開發售前僱員購股權計劃合共授出234,800份獎勵。有關上 述授出的詳情如下： (1) 授出購股權 董事會宣佈，於2025年10月2日，本公司根據首次公開發售後購股權計劃向購 股權承授人授出74,000份購股權。 授出購股權的詳情如下： 授出日期： 2025年10月2日 購股權承授人數目： 3名 所授出購股權的數目： 74,000份 所授出購股權的行使價： 57.50港元 股份於授出日期的市價： 每股股份57.50港元 行使期： 授出日期起計7年 – 1 – 歸 ...

Core Viewpoint - Genting Yongying (01952) has seen a significant increase in stock price, attributed to the approval of production expansion for its core product, Naisfankang, and its inclusion in a global kidney disease management guideline, indicating a strategic shift in treatment options for IgA nephropathy patients [1] Group 1: Financial Performance - Genting Yongying's stock rose over 6%, currently up 5.39% at HKD 57.65, with a trading volume of HKD 300 million [1] - Naisfankang's sales revenue reached HKD 520 million in August, with a shipment volume exceeding 100,000 bottles, marking a new monthly high since its launch [1] - The company has raised its revenue guidance for the full year 2025 to HKD 1.2-1.4 billion, with expectations to further increase it to HKD 2.4-2.6 billion in 2026 [1] Group 2: Product Development and Market Position - The production expansion application for Naisfankang was approved by the National Medical Products Administration in early August, allowing the company to resume its sales growth [1] - On September 19, Genting Yongying announced that Naisfankang was included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended treatment for IgA nephropathy in the guideline [1] - The inclusion in the KDIGO guidelines is seen as a significant milestone, providing new treatment options for IgA nephropathy patients and indicating a shift in global treatment strategies [1]

Core Viewpoint - CloudTop New Horizon (01952) has seen a significant increase in stock price, rising over 6% in the afternoon trading session, attributed to the approval of production expansion for its core product, Naisukan, and its inclusion in a global kidney disease management guideline [1] Group 1: Financial Performance - Naisukan's sales revenue reached 520 million yuan in August, marking a record high for monthly sales since its launch, with over 100,000 bottles shipped [1] - The company has raised its revenue guidance for the full year 2025 to 1.2-1.4 billion yuan, with expectations to further increase to 2.4-2.6 billion yuan in 2026 [1] Group 2: Regulatory and Market Developments - The production expansion application for Naisukan was approved by the National Medical Products Administration in early August, allowing the company to resume its sales growth [1] - On September 19, Naisukan was included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended treatment for IgA nephropathy in the guideline, indicating a shift in global treatment strategies [1]

Core Insights - The core product of the company, NEFECON® (Budesonide Delayed-Release Capsules), has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, establishing its position as the only recommended disease-modifying treatment for IgA nephropathy [1][4] - The inclusion in the global guidelines is expected to solidify NEFECON®'s leading position in the market, with projected sales reaching 1.2-1.4 billion CNY in 2025 and potentially increasing to 2.4-2.6 billion CNY in 2026, with long-term forecasts suggesting sales could exceed 5 billion CNY [1][5] Industry Developments - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "disease-modifying treatment," emphasizing the need for early intervention and long-term management [2][4] - The guidelines recommend a 9-month treatment course with NEFECON® for all IgA nephropathy patients at risk of renal function decline, with considerations for extending treatment duration to maintain clinical benefits [2][3] - The guidelines also optimize the timing of diagnosis and treatment, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment promptly, which is expected to expand the patient population eligible for treatment [2][3] Mechanism and Efficacy - NEFECON® is recognized for its unique mechanism that targets intestinal mucosal immune B cells, reducing the formation of pathogenic IgA and IgA immune complexes (IgA-IC), thereby alleviating renal immune damage [4][5] - Clinical studies and real-world data have demonstrated that NEFECON® can significantly lower proteinuria levels and delay renal function decline, particularly in the Chinese population, where it can extend the time to dialysis or kidney transplantation by up to 12.8 years [4][5] Market Impact - The recommendation of NEFECON® in the 2025 KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, where there are approximately 5 million patients and over 120,000 new cases diagnosed annually [5] - This shift towards "disease-modifying treatment" is anticipated to provide new hope for IgA nephropathy patients globally and lays a solid foundation for the company's future commercialization strategies [5]

Core Insights - The core product of the innovative drug company, Cloudtop New Medicine Technology Co., Ltd. (云顶新耀), NEFECON® (Budesonide Enteric Capsules), has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended causal treatment for IgA nephropathy in the guidelines [1] Group 1 - IgA nephropathy is characterized by the deposition of Immunoglobulin A (IgA) immune complexes in the glomeruli, leading to kidney inflammation and potential progression to chronic kidney failure. In China, there are approximately 5 million IgA nephropathy patients, with over 120,000 new cases diagnosed each year [1] - The guidelines emphasize "early intervention, precise treatment, and improved prognosis" as core objectives, achieving multidimensional breakthroughs in the entire process of IgA nephropathy diagnosis and treatment, which is considered a milestone for global clinical practice [1] - The guidelines highlight the need to manage specific driving factors of nephron loss and stress the importance of intervening at the source to reduce immune damage to the kidneys [1] Group 2 - The inclusion of NEFECON® in the 2025 KDIGO guidelines not only provides new treatment options for IgA nephropathy patients but also signifies a shift in global treatment strategies. Previously, due to a lack of effective causal treatment, nearly all patients faced the risk of kidney function decline to end-stage renal disease [1] - The new guidelines advocate for early diagnosis and treatment, focusing on immunological interventions to reduce kidney immune damage, thereby changing the treatment pathway and promoting causal treatment as the mainstream approach [1]

Core Viewpoint - CloudTop New Horizon's core product NEFECON® has been included in the 2025 KDIGO guidelines as the only recommended treatment for IgA nephropathy, marking a significant shift in global treatment strategies for this condition [2][2][2] Company Summary - NEFECON® (Budesonide enteric-coated capsules) is recognized as a new treatment option for IgA nephropathy patients, addressing a previously unmet need in the market [2][2] - The inclusion in the KDIGO guidelines signifies a milestone in clinical practice for IgA nephropathy treatment, emphasizing early diagnosis and intervention from an immunological perspective [2][2] Industry Summary - IgA nephropathy is characterized by the deposition of immunoglobulin A (IgA) immune complexes in the glomeruli, leading to inflammation and potential chronic kidney failure, with approximately 5 million patients in China and over 120,000 new cases diagnosed annually [2][2] - The KDIGO guidelines focus on early intervention, precise treatment, and improving prognosis, highlighting the need to manage specific factors driving kidney unit loss and the formation of pathogenic immune complexes [2][2]

Core Viewpoint - CloudTop New Horizon's core product, NEFECON, has been included in the 2025 KDIGO guidelines as the only recommended treatment for IgA nephropathy, marking a significant shift in global treatment strategies for this condition [1][1][1] Company Summary - NEFECON is recognized as a disease-modifying treatment for IgA nephropathy, which is characterized by the deposition of IgA immune complexes in the kidneys, leading to inflammation and potential chronic kidney failure [1][1] - The inclusion in the KDIGO guidelines provides new treatment options for the approximately 5 million IgA nephropathy patients in China, with over 120,000 new cases diagnosed annually [1][1][1] Industry Summary - The KDIGO guidelines emphasize early intervention, precise treatment, and improved prognosis, representing a milestone in the clinical management of IgA nephropathy [1][1] - The guidelines highlight the need to manage specific factors driving kidney unit loss and stress the importance of intervening at the source of pathogenic immune complex formation to reduce kidney immune damage [1][1][1] - The shift towards "etiological treatment" as a mainstream approach is expected to change the treatment landscape for IgA nephropathy, reducing the risk of progression to end-stage kidney disease for patients [1][1]

Core Insights - The core product of the company, NEFECON® (Budesonide Delayed-Release Capsules), has been included in the 2025 KDIGO Clinical Practice Guidelines for IgA Nephropathy and IgA Vasculitis, becoming the only recommended drug for the etiology-based treatment of IgA nephropathy [2][5] - This inclusion solidifies NEFECON®'s position as a cornerstone treatment for IgA nephropathy, with projected sales reaching 1.2 to 1.4 billion yuan in 2025 and potentially increasing to 2.4 to 2.6 billion yuan in 2026, with long-term forecasts suggesting sales could exceed 5 billion yuan [2][5] Industry Impact - The 2025 KDIGO guidelines mark a significant shift in the treatment of IgA nephropathy from "supportive treatment" to "etiology-based treatment," establishing NEFECON® as a first-line therapy [3][4] - The guidelines recommend a 9-month treatment course with NEFECON® for all IgA nephropathy patients at risk of renal function decline, with considerations for extending treatment duration to maintain long-term clinical benefits [3][4] - The guidelines also optimize diagnostic and treatment timing, indicating that patients with proteinuria ≥0.5g/d should undergo kidney biopsy and start treatment early, which is expected to expand the patient population for treatment [3][4] Treatment Strategy - The treatment goals focus on controlling the rate of renal function decline to physiological levels and reducing proteinuria in IgA nephropathy patients [4] - The guidelines emphasize a comprehensive approach to treatment, addressing both immune-driven renal unit loss and the progression to chronic kidney disease (CKD), advocating for early, precise, and long-term management strategies [4][5] - NEFECON® targets intestinal mucosal immune B cells to reduce pathogenic IgA and IgA immune complex formation, thereby mitigating renal immune damage, aligning with the new treatment strategies outlined in the guidelines [5][6] Market Potential - In China, there are approximately 5 million IgA nephropathy patients, with over 120,000 new cases diagnosed annually, indicating a significant market opportunity for NEFECON® [6] - The inclusion of NEFECON® in the KDIGO guidelines is expected to accelerate the standardization of IgA nephropathy treatment in China, alleviating disease burden and improving treatment outcomes for patients [6]

Core Insights - CloudTop New Drug's NEFECON has been included in the 2025 KDIGO guidelines as the only recommended first-line treatment for IgA nephropathy, solidifying its foundational status in the treatment landscape [1][5][6] - The inclusion in the KDIGO guidelines is expected to accelerate the shift from "supportive treatment" to "causal treatment" for IgA nephropathy globally, providing a strong impetus for the clinical adoption of NEFECON [2][6] Company Summary - NEFECON's unique mechanism of action, targeting pathogenic IgA and IgA immune complexes, aligns with the new treatment strategies outlined in the KDIGO guidelines, which emphasize early intervention and immunological management [5][6] - The drug is projected to achieve sales of 1.2 to 1.4 billion yuan in 2025, increasing to 2.4 to 2.6 billion yuan in 2026, with long-term potential to reach 5 billion yuan [1][2] Industry Summary - The 2025 KDIGO guidelines represent a significant shift in the treatment paradigm for IgA nephropathy, focusing on early diagnosis and treatment, which will likely expand the patient population eligible for treatment [3][4] - The guidelines recommend a 9-month treatment course with NEFECON for patients at risk of renal function decline, with considerations for extending treatment duration to maintain long-term clinical benefits [3][4] - The emphasis on a multi-drug approach and the management of immune-driven renal unit loss indicates a move towards more comprehensive treatment strategies for IgA nephropathy [4][6]