Core Insights - The article discusses the recent trends and developments in the pharmaceutical industry, particularly focusing on the performance of innovative drug companies and their clinical trials [5][11][18]. Group 1: Market Performance - The pharmaceutical and biotechnology indices experienced a decline, with the pharmaceutical index dropping by 1.21%, underperforming the Shanghai Composite Index by 0.91 percentage points [5]. - The Hang Seng Healthcare Index fell by 1.55%, and the Hong Kong innovative drug ETF decreased by 1.52% during the same period [5]. Group 2: Company Developments - Xianweida Biotechnology submitted an A1 listing application to the Hong Kong Stock Exchange, with cumulative losses exceeding 1 billion yuan over the past two and a half years [6][7]. - Xianweida's core product, Ecnoglutide, is expected to submit applications for overweight/obesity and type 2 diabetes indications by the end of 2024, with anticipated approval in early 2026 [7][8]. - The company reported no revenue for 2023 and 2024, with losses of 620 million yuan and 486 million yuan, respectively [8]. Group 3: Clinical Trials - Bai Li Tianheng's ADC drug BL-M07D1 has entered a phase III clinical trial for HER2-positive gastric cancer, with a focus on overall survival and progression-free survival as primary endpoints [15][16]. - The SLIMMER study, a significant phase III trial for Ecnoglutide, showed that participants could lose up to 13.8 kg over 48 weeks, with minimal weight regain after stopping the treatment [7]. Group 4: Stock Market Dynamics - The stock of Yaojie Ankang-B experienced extreme volatility, with a price drop from 679.5 HKD to 192 HKD per share, reflecting the high-risk nature of the Hong Kong market for uncommercialized biotech firms [12][13]. - The market's reaction to Yaojie Ankang-B's inclusion in the Hong Kong Stock Connect innovative drug index raised concerns about the decision-making process for including emerging companies in such indices [13]. Group 5: Regulatory Recognition - Yunding Xinyao's core product, Budesonide enteric-coated capsules, has been included in the global kidney disease guidelines, marking it as the only recommended treatment for IgA nephropathy [18].

一项重要的观察性研究证实耐赋康在"长期对因治疗"IgA肾病方面具有显著临床获益，为"对因治疗、尽 早治疗、长期治疗"的IgA肾病新管理策略提供了有力证据。 结果表明，12个月布地奈德肠溶胶囊治疗显著降低IgA肾病患者的尿蛋白水平，稳定了肾功能，并且相 比糖皮质激素和免疫抑制剂的常规治疗，具有更好的安全性。 这一研究结果不仅为IgA肾病患者9个月疗程后的后续治疗提供了清晰方向，而且为 lgA 肾病患者的长 期治疗提供了极具价值的循证医学支持。 在2025年第18届IgA肾病国际研讨会（IIgANN 2025）上，耐赋康（布地奈德肠溶胶囊，NEFECON）展 示了7项来自中国多家顶尖医院的最新真实世界研究数据。其中一项重要的观察性研究评估了耐赋康治 疗IgA肾病12个月的有效性和安全性，其结果证实了耐赋康在"长期对因治疗"IgA肾病方面具有显著临床 获益。这一研究结果不仅为IgA肾病患者9个月疗程后的后续治疗提供了清晰方向，而且为 lgA 肾病患 者的长期治疗提供了极具价值的循证医学支持。第18届IgA肾病国际研讨会于9月17日至20日在捷克共 和国布拉格举行。 IgA肾病是一种慢性自身免疫性肾小球疾病，隐匿起病 ...

9月18日，在2025年第18届IgA肾病国际研讨会(IIgANN2025)上，耐赋康(布地奈德肠溶胶囊， NEFECON)展示了7项来自中国多家顶尖医院的最新真实世界研究数据。其中一项重要的观察性研究评 估了耐赋康治疗IgA肾病12个月的有效性和安全性，其结果证实了耐赋康在"长期对因治疗"IgA肾病方面 具有显著临床获益。这一研究结果不仅为IgA肾病患者9个月疗程后的后续治疗提供了清晰方向，而且 为lgA肾病患者的长期治疗提供了极具价值的循证医学支持。第18届IgA肾病国际研讨会于9月17日至20 日在捷克共和国布拉格举行。 IgA肾病是一种慢性自身免疫性肾小球疾病，隐匿起病。目前，IgA肾病在亚洲高发，亚洲人群进展为 终末期肾病的风险相较于其他人群高56%，且疾病进展更快。IgA肾病也是中国青壮年肾衰的主要病因 之一，约60%的中国患者在15年内会进展为终末期肾病(ESRD)，造成患者、家庭及社会的多重压力。 因此，通过长期对因治疗延缓疾病进展、保护患者肾功能对于IgA肾病的治疗具有至关重要的意义。 为进一步探索在完成9个月治疗后耐赋康的延长用药价值，此次在IIgANN2025上展示的回顾性研究1旨 在评 ...

智通财经APP获悉，9月18日，在2025年第18届IgA肾病国际研讨会(IIgANN 2025)上，耐赋康®(布地奈 德肠溶胶囊，NEFECON®)展示了7项来自中国多家顶尖医院的最新真实世界研究数据。其中一项重要 的观察性研究评估了耐赋康®治疗IgA肾病12个月的有效性和安全性，其结果证实了耐赋康®在"长期对 因治疗"IgA肾病方面具有显著临床获益。这一研究结果不仅为IgA肾病患者9个月疗程后的后续治疗提 供了清晰方向，而且为 lgA 肾病患者的长期治疗提供了极具价值的循证医学支持。第18届IgA肾病国际 研讨会于9月17日至20日在捷克共和国布拉格举行。 结果显示，12个月后，布地奈德肠溶胶囊组24小时尿蛋白从1016 mg降至114 mg(P=0.037)，显著低于对 照组的291mg(P=0.01)。布地奈德肠溶胶囊组eGFR斜率显著优于对照组(5.4 ml/min/1.73m2/年vs. -3.4 ml/min/1.73m2/年，P=0.032)，未发生严重感染。研究表明，12个月的布地奈德肠溶胶囊治疗可显著降 低IgA肾病患者的蛋白尿水平并保护肾功能，且安全性优于传统治疗。 北京大学第一医院吕继 ...

2025年第18届IgA肾病国际研讨会(IIgANN)将于9月17日至20日在捷克共和国布拉格举行。耐赋康(布地 奈德肠溶胶囊，NEFECON)在此盛会中将展示7项最新真实世界数据，进一步展现其在相关领域的深入 研究进展。耐赋康是目前全球首个同时获中国国家药品监督管理局(NMPA)、美国食品药品监督管理局 (FDA)、欧洲药品管理局(EMA)、英国药品和健康产品管理局(MHRA)及云顶新耀(01952)其他亚洲授权 区域(中国香港、中国澳门、中国台湾、新加坡及韩国)完全批准的IgA肾病治疗药物。 此次公布的最新数据来自中国多家顶尖医院的临床实践，从多个维度深入探讨了耐赋康在IgA肾病治疗 中的疗效与安全性。研究结果显示，耐赋康在"对因治疗、尽早治疗、长期治疗"三个方面均展现出显著 的临床价值：在真实世界用药中，其对因治疗的价值得到验证；早期干预被证实对减少蛋白尿和稳定肾 功能方面具有重要意义；同时，超过9个月的延长治疗数据也提供了长期疗效与安全性的有力证据。 这些真实世界证据不仅弥补了随机对照试验(RCT)在临床应用场景中的局限性，也进一步充实了"对因 治疗、尽早治疗、长期治疗"的治疗策略，强化了耐赋康作为全 ...

Core Viewpoint - Cloudtop New Horizon Pharmaceutical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the expansion of production for its drug, Nefukang (Budenoside Enteric-Coated Capsules), which is the first and only approved treatment for IgA nephropathy in China, the US, and Europe, aiming to meet the growing clinical demand in China and Asia [2] Company Summary - Nefukang was approved in November 2023 through a priority review process, becoming the first approved drug for the cause of IgA nephropathy in China, filling a significant treatment gap [2] - The projected annual sales for Nefukang in 2024 are expected to reach 354 million yuan [2] - In November 2024, Nefukang will be included in the national medical insurance catalog, and by May 2025, it will receive full approval from NMPA, removing previous restrictions on proteinuria levels, thus expanding the potential patient population by three times [2] - Currently, Nefukang has covered over 80% of potential hospitals in China, benefiting more than 20,000 patients, indicating a strong demand for increased production capacity to meet patient needs [2] Industry Summary - China has the highest incidence rate of primary glomerular diseases globally, highlighting the urgent need for effective treatments like Nefukang [2] - Cloudtop New Horizon is also developing a next-generation covalent reversible BTK inhibitor, EVER001, which aims to address global clinical gaps in diseases such as primary membranous nephropathy (pMN), minimal change disease (MCD), and focal segmental glomerulosclerosis (FSGS) [2] - The company is advancing clinical research for a Gd-IgA1 diagnostic reagent, expected to be approved for market by 2026, which may replace kidney biopsy as an auxiliary diagnostic tool [2]

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].

Group 1 - The approval of the expanded production application for the drug Nefikang (Budesonide Enteric-Coated Capsules) marks it as the first and only fully approved treatment for IgA nephropathy in China, enhancing its supply to meet the growing clinical demand in Asia [1] - The CEO of the company emphasized that the increased production capacity will better address the rising clinical treatment needs of IgA nephropathy patients in Asia, particularly in China, which has the highest incidence of primary glomerular diseases globally, with over 5 million patients and more than 100,000 new cases diagnosed annually [1] - Nefikang is currently the only drug recommended by both domestic and international guidelines for the treatment of IgA nephropathy, and its expanded production will accelerate the adoption of targeted treatment, helping more patients initiate standardized treatment early to delay disease progression and protect kidney function [1] Group 2 - Nefikang received formal approval from the NMPA in November 2023 through a priority review process for treating adult patients with primary IgA nephropathy at risk of progression, filling a gap in the domestic treatment landscape [2] - The drug was included in the National Medical Insurance Drug List in November 2024 and received full NMPA approval in May 2025, removing restrictions on proteinuria levels, making it applicable to the majority of IgA nephropathy patients [2] - Nefikang has been incorporated into both the 2024 KDIGO Clinical Practice Guidelines for IgA Nephropathy and the Chinese Clinical Practice Guidelines for Adult IgA Nephropathy, establishing it as a cornerstone treatment for IgA nephropathy [2]

Core Insights - A sudden shortage of the kidney disease drug, Nefukang (Budesonide Enteric Capsules), has drawn significant market attention, highlighting the unmet demand among IgA nephropathy patients in China [1][3] - The drug, introduced and commercialized by Gensun Biopharma, is the first and only approved treatment for IgA nephropathy in China, with widespread shortages reported across multiple cities [1][3] - Gensun Biopharma is expected to achieve its first annual commercial profitability in 2024, driven by Nefukang's strong sales performance, which is projected to exceed 5 billion yuan [3][10] Company Overview - Gensun Biopharma has transitioned from a struggling company three years ago to a commercial success, with a projected annual revenue of over 7 billion yuan in 2024, marking a 461% year-on-year increase [10] - The company has adopted a License-in strategy, allowing it to bypass early-stage R&D and focus on late-stage products, which has contributed to its rapid commercialization [10][16] - Gensun Biopharma's stock has seen a significant rebound, increasing over 237% from its low point, reflecting market optimism about its future prospects [21] Market Demand - IgA nephropathy is a serious chronic kidney disease with a high prevalence in China, where the patient population is estimated to be in the millions, contrasting with the much smaller patient base in the U.S. [7][9] - The introduction of Nefukang has filled a critical gap in treatment options, as prior therapies were limited to off-label use of antihypertensive medications [5][7] - The drug's inclusion in the national health insurance scheme has significantly improved its affordability, with prices dropping from approximately 23,800 yuan to around 5,000 yuan per bottle [6][10] Supply Chain Challenges - The current supply shortage of Nefukang is attributed to its reliance on overseas production, with all manufacturing conducted by Patheon Pharmaceuticals in the U.S. [9] - Gensun Biopharma is in the process of establishing local production capabilities, but the transition is expected to take time due to regulatory and technical challenges [9][10] - The shortage has underscored the significant market demand for kidney disease treatments, as well as the vulnerabilities in the supply chain for innovative drugs [9][21] Investment Dynamics - Gensun Biopharma's major shareholder, Kangqiao Capital, has been reducing its stake in the company, selling over 13% of its shares in two large transactions earlier this year [19][21] - The rationale behind the sell-off includes optimizing the investor structure and responding to liquidity pressures from limited partners [21] - Despite the successful commercialization of Nefukang, the timing of Kangqiao Capital's divestment raises questions about the company's future trajectory and investor confidence [21][22]