| | | 12月22日，据NMPA官网显示，海南合瑞制药提交的4类仿制药布地奈德肠溶胶囊获批上市，斩获国内首仿，打破云顶新耀在igAN对因治疗市场的独占局 面，重塑该领域竞争格局。 截图来源：NMPA 布地奈德肠溶胶囊是一款布地奈德的创新口服靶向迟释制剂，用于治疗具有进展风险的原发性IgA肾病成人患者。作为全球首个IgA肾病的对因治疗药物， 布地奈德肠溶胶囊不仅填补了国内从疾病源头治疗IgA肾病的空白，更为患者提供了创新的治疗选择。 大涨1581%重磅品种，云顶新耀独占鳌头 布地奈德肠溶胶囊原研公司为Calliditas，作为重磅药物，2019年，云顶新耀从Calliditas公司引进了该产品在大中华地区和新加坡的商业化权益，2023年11 月21日在国内获批上市，商品名为耐赋康，用于治疗具有进展风险的原发性免疫球蛋白A（IgA）肾病成人患者，以降低蛋白尿水平。2025年1月1日起布地 奈德肠溶胶囊正式纳入医保报销。 | 药品名称 | 通用名 | 医保目录剂型 ( | 注册剂型 0 | 医保类别 | 医保编号 | 药品分类(功能) | 区域 | 增补情况 | | --- | --- | --- | --- ...

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 company Vera has reported positive Phase III data for its treatment targeting IgA nephropathy, a type of kidney disease, which was presented at the ASN meeting and published in the New England Journal of Medicine [2] Group 1: Clinical Development - Vera has completed Phase III trials that yielded compelling results in the treatment of glomerulonephritis, specifically IgA nephropathy [2] - The company submitted its Biologics License Application (BLA) on November 7, with a review timeline of 2 months plus an additional 6 months [2] Group 2: Regulatory Milestones - Vera has received breakthrough designation for its treatment, which is expected to expedite the review process [2] - A PDUFA date is anticipated in early January, with a potential final decision expected in July [2]

Core Viewpoint - Cloud Peak New Medicine (01952) has seen a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Research Findings - NEFECON demonstrated significant clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with progression risks, highlighting issues with delayed treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Core Viewpoint - Clouding New Horizon (01952) saw a stock increase of over 5%, currently trading at 48.56 HKD with a transaction volume of 158 million HKD, following the announcement of significant research results on NEFECON for IgA nephropathy patients at the ASN Kidney Week 2025 [1] Group 1: Company Developments - NEFECON demonstrated substantial clinical value in the new management strategy for IgA nephropathy, emphasizing "etiological treatment, early intervention, and long-term management" [1] - The research presented at the ASN conference integrates multiple real-world studies from China, confirming NEFECON's unique value in targeting intestinal mucosal immunity and intervening in disease progression from the source [1] Group 2: Market Context - Over 70% of IgA nephropathy patients in China are diagnosed with existing progression risks, highlighting a delay in treatment initiation [1] - There are approximately 5 million IgA nephropathy patients in China, with over 120,000 new diagnoses each year, indicating a significant unmet clinical need [1] - Early and long-term etiological treatment is crucial for delaying disease progression and protecting kidney function in IgA nephropathy patients [1]

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Event**: Conference Call at TD Cowen I&I Summit on November 13, 2025 Key Industry Insights - **Focus**: IgA nephropathy treatment and clinical trial results - **Recent Achievements**: Presentation at ASN and publication in the New England Journal of Medicine [1][2] Core Findings from Clinical Trials - **Phase 2b Results**: - Two-thirds reduction in autoantigen over two years [3] - 75% of patients showed resolution of hematuria [3] - Over 50% reduction in proteinuria, a key FDA measure for accelerated approval [4] - Annual rate of loss of GFR was -0.6 mL/min, comparable to healthy population [4] - **Phase 3 Results**: - 46% reduction in proteinuria for atacicept-treated patients vs. 7% for placebo [4] - Placebo-adjusted reduction in proteinuria was 42%, exceeding the FDA's 30% threshold [5] - Consistent efficacy across various patient subgroups, including age, sex, and race [5][12] - **Safety Profile**: - Favorable safety data comparable to placebo, with no evidence of opportunistic infections [9][30] - Mild injection site reactions were self-limited [10] Regulatory and Market Position - **BLA Submission**: Submitted to FDA, with anticipation of bringing the new medicine to market next year [2][12] - **Market Strategy**: Confidence in leading position due to comprehensive data set and positive patient experience [14][21] Competitive Landscape - **Comparison with Competitors**: - Discussion on differential efficacy between atacicept and competitor Sibeprenlimab, particularly regarding proteinuria reduction [11][20] - Emphasis on the strength of atacicept's data set in the context of other B-cell modulating drugs [23] Future Directions - **Pioneer Basket Study**: Phase 2 program focusing on IgA nephropathy and other autoimmune kidney diseases, with data expected in 2026 [31][32] - **Long-term Goals**: Aim to stabilize GFR and reduce the need for dialysis or transplant in patients [19][26] Additional Considerations - **Hematuria as a Marker**: Early reduction in hematuria indicates anti-inflammatory benefits and potential long-term kidney function preservation [18][19] - **Hypogammaglobulinemia Concerns**: No significant findings in atacicept program, contrasting with other drugs in the class [28][30] This summary encapsulates the critical insights and data shared during the conference call, highlighting Vera Therapeutics' advancements in treating IgA nephropathy and its strategic positioning in the market.

Core Viewpoint - Rongchang Biopharma (09995) saw a stock increase of over 7%, reaching 109.4 HKD with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy, significantly reducing proteinuria levels [1][1][1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE announced that Taitasip is proposed for priority review for treating IgA nephropathy, which poses a risk of progression [1] - On August 27, Rongchang Biopharma reported that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1][1][1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, acting as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1][1][1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taizhisip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Company Developments - On September 28, the CDE announced that Rongchang Biologics' Taizhisip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics reported that the Phase III study of Taizhisip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Drug Mechanism - Taizhisip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taizhisip can reduce B cell proliferation, lower plasma cell counts, and decrease abnormal immunoglobulin production, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, currently at 109.4 HKD, with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics announced that the Phase III study of Taitasip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

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]