这是一项多中心、随机、双盲、安慰剂对照临床试验，纳入了318例接受过标准治疗的IgAN成人患者， 泰它西普的使用剂量为240mg，皮下注射，每周1次。A 阶段分析结果显示：与对照组相比，泰它西普 组患者在治疗39周时的24小时尿蛋白肌酐比值(UPCR)降低了55%(P<0.0001)，且表现出良好的耐受性和 安全性。详细数据将在国际重大学术会议上公布。 （原标题：荣昌生物(09995)：泰它西普(商品名：泰爱®)治疗IgA肾病中国III期临床研究A阶段达到主要 终点） 智通财经APP讯，荣昌生物(09995)发布公告，公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创 新药泰它西普(商品名：泰爱)用于治疗IgA肾病(IgAN)的中国III 期临床研究，达到A阶段的主要研究终 点。集团将尽快向中国国家药品监督管理局(NMPA)药品审评中心(CDE)递交上市申请(BLA)。 研究表明，B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)是促进Gd-IgA1及其抗体产生的重要细胞 因子。泰它西普是由公司自主研发的重组BLyS/APRIL 双靶点融合蛋白，通过同时抑制BLyS和APRIL与 B细胞表面受 ...

IgAN是一种常见的原发性肾小球疾病，该病临床表现多样，如反复发作的镜下血尿或肉眼血尿，伴有 不同程度蛋白尿，部分患者可以出现严重高血压或者肾功能异常。IgA肾病也是中国慢性肾脏病和终末 期肾病的主要原因之一，高达40%的 IgA肾病患者在诊断后20年内达到终末期肾病，产生对新型药物迫 切的未满足医疗需求。目前学术界认为，半乳糖缺乏型IgA1(Gd-IgA1)分泌过多是IgA肾病的发病的核心 及始动因素。 荣昌生物(09995)发布公告，公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普(商品 名：泰爱®)用于治疗IgA肾病(IgAN)的中国III 期临床研究，达到A阶段的主要研究终点。集团将尽快向 中国国家药品监督管理局(NMPA)药品审评中心(CDE)递交上市申请(BLA)。 研究表明，B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)是促进Gd-IgA1及其抗体产生的重要细胞 因子。泰它西普是由公司自主研发的重组BLyS/APRIL 双靶点融合蛋白，通过同时抑制BLyS和APRIL与 B细胞表面受体结合，阻止B细胞异常分化和成熟，有效减轻机体的病理性免疫反应。目前在中国已获 ...

这是一项多中心、随机、双盲、安慰剂对照临床试验，纳入了318例接受过标准治疗的IgAN成人患者， 泰它西普的使用剂量为240mg，皮下注射，每周1次。A阶段分析结果显示：与对照组相比，泰它西普组 患者在治疗39周时的24小时尿蛋白肌酐比值(UPCR)降低了55%(P<0.0001)，且表现出良好的耐受性和安 全性。详细数据将在国际重大学术会议上公布。 荣昌生物(09995)发布公告，公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普(商品 名：泰爱)用于治疗IgA肾病(IgAN)的中国III期临床研究，达到A阶段的主要研究终点。集团将尽快向中 国国家药品监督管理局(NMPA)药品审评中心(CDE)递交上市申请(BLA)。 研究表明，B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)是促进Gd-IgA1及其抗体产生的重要细胞 因子。泰它西普是由公司自主研发的重组BLyS/APRIL双靶点融合蛋白，通过同时抑制BLyS和APRIL与 B细胞表面受体结合，阻止B细胞异常分化和成熟，有效减轻机体的病理性免疫反应。目前在中国已获 批治疗重症肌无力(MG)、系统性红斑狼疮(SLE)和类风湿关节 ...

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 Insights - Cloudtop New Horizon's core product, Nefikang®, has received full approval from Taiwan's drug regulatory authority, removing previous conditions related to clinical efficacy proof, thus solidifying its position as a first-line treatment for IgA nephropathy in Asia [1][3] - The product's production capacity upgrade has been approved by the NMPA, allowing for a more efficient response to the growing clinical demand in China and Asia [1][2] - Nefikang® is projected to achieve sales of 1 billion yuan in its first full year post-launch, highlighting its market potential [1] Product Approval and Market Position - Nefikang® is the first non-oncology drug to be included in China's breakthrough therapy category, addressing the treatment gap for IgA nephropathy [2][3] - The drug has been fully approved in all authorized regions, including major markets like the US, EU, and several Asian countries, enhancing its commercial viability [4] - The drug's unique mechanism of action targets gut mucosal immunity, effectively controlling proteinuria and protecting kidney function, establishing it as a cornerstone treatment [3][4] Clinical Demand and Commercial Strategy - IgA nephropathy is prevalent in Asia, with over 5 million patients in China and an annual increase of over 100,000 new cases, indicating a significant unmet clinical need [2][4] - Cloudtop New Horizon has established an efficient commercialization system, covering over 80% of potential hospitals in mainland China, benefiting more than 20,000 patients [4] - Securities firms predict peak sales for Nefikang® could reach 5 billion yuan, indicating its potential as a major product in the nephrology market [4]

Core Viewpoint - Yunding Xinyao's core product, Nefukang (Budesonide enteric-coated capsules), has received approval from the National Medical Products Administration (NMPA) for production expansion, marking a significant step in addressing the clinical demand for IgA nephropathy treatment in China [1][2]. Group 1: Product and Market Demand - IgA nephropathy is a common primary glomerular disease with over 5 million patients in China, and more than 100,000 new cases diagnosed annually, indicating a high unmet clinical need [1]. - Nefukang has a unique mechanism that regulates intestinal mucosal immunity, reducing the production of Gd-IgA1, which is implicated in IgA nephropathy, effectively controlling proteinuria and protecting kidney function [1]. - Clinical data from the global Phase III NefIgArd study shows that Nefukang can reduce the risk of kidney function decline by 50%, with a 66% delay in kidney function deterioration for the Chinese population, potentially postponing the need for dialysis or kidney transplant by 12.8 years [1]. Group 2: Regulatory and Commercialization Progress - Nefukang has been included in both international and domestic clinical management guidelines, making it the only IgA nephropathy treatment recommended by both [2]. - Following its approval in November 2023, Nefukang filled a gap in the treatment of IgA nephropathy at the disease source and is expected to be included in the national medical insurance drug list by November 2024, expanding its eligible patient population threefold [2]. - The surge in market demand has led to supply constraints in Q2 2023, prompting the production expansion to address this issue and potentially serve as a turning point for Yunding Xinyao's performance [2]. Group 3: Future Potential and Strategic Developments - Nefukang's first full-year sales are projected to exceed 1 billion yuan, positioning it as one of the fastest-growing chronic disease drugs in China, with peak sales estimates reaching 5 billion yuan [3]. - Yunding Xinyao also has a next-generation covalent reversible BTK inhibitor, EVER001, which is expected to address broader kidney disease areas and fill several global clinical gaps [3]. - The ongoing clinical research for the Gd-IgA1 diagnostic reagent aims to replace kidney biopsy for auxiliary diagnosis, creating a "diagnosis-treatment" loop that enhances the precision and effectiveness of kidney disease treatment [3].

Core Viewpoint - The release of the "Clinical Practice Guidelines for Adult IgA Nephropathy and IgA Vasculitis (Preliminary Version)" marks a significant advancement in the treatment of IgA nephropathy, with the inclusion of NEFECON as a recommended therapy for patients at risk of disease progression [1][2][3] Group 1: Guidelines and Recommendations - The guidelines emphasize the need for etiology-based treatment, early intervention, and comprehensive management strategies for IgA nephropathy patients in China [2] - For patients with proteinuria ≥0.5g/d, kidney biopsy and treatment initiation are recommended, aiming for proteinuria <0.5g/d and an estimated glomerular filtration rate (eGFR) decline of less than 1ml/min per year [2] - The guidelines introduce blood urine monitoring and suggest interventions targeting immune damage, including the use of NEFECON to reduce pathogenic IgA levels [2] Group 2: NEFECON's Clinical Significance - NEFECON is recognized as the only etiology-based treatment for IgA nephropathy, establishing its position as a first-line therapy in global kidney disease guidelines [3][4] - The NefIgArd study demonstrated that NEFECON significantly reduces the risk of kidney function decline, with a 50% reduction in eGFR decline compared to placebo, and up to 66% in the Chinese population [4] - NEFECON's approval by the National Medical Products Administration (NMPA) and its inclusion in the national medical insurance drug list further solidify its role in treating IgA nephropathy [4][5]

Core Viewpoint - Yunding Xinyao's drug, Naisukan® (Budesonide Enteric Capsules), has received full approval from the National Medical Products Administration (NMPA) for treating adult patients with Immunoglobulin A Nephropathy (IgAN) at risk of disease progression, marking it as the first and only drug in China for this indication [1][2] Group 1: Drug Approval and Clinical Impact - The full approval of Naisukan® is based on complete data from a Phase III clinical trial, demonstrating significant renal function protection and removing restrictions on proteinuria levels, thus broadening the patient base [2][4] - The drug is expected to delay the progression of IgAN to end-stage renal disease by an estimated 12.8 years, significantly reducing the burden on patients, families, and the healthcare system [2][4] Group 2: Market Penetration and Accessibility - Naisukan® has been included in the national medical insurance drug list, enhancing affordability and accessibility for IgAN patients, with implementation starting from January 1, 2025 [3] - As of March 2024, the drug has reached over 600-700 core hospitals across 26 provinces, covering more than 60% of the target patient population [3] Group 3: Future Growth Potential - The combination of increasing clinical demand, gradual insurance coverage, and recommendations from authoritative guidelines is expected to drive market penetration and sales growth for Naisukan® [4] - The drug is projected to achieve peak annual sales exceeding 5 billion by 2030, solidifying Yunding Xinyao's market leadership in IgAN treatment and providing sustainable long-term returns [4]