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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
智通财经网· 2025-08-27 10:45
Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰爱®), a first-in-class BLyS/APRIL dual-target fusion protein, has met the primary endpoint in the Phase III clinical trial for treating IgA nephropathy (IgAN) in China [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment, with a dosage of 240mg administered subcutaneously once a week [1] - Results from the A stage analysis showed that patients in the Tai'aisip group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group at 39 weeks (P<0.0001), demonstrating good tolerability and safety [1] Group 2 - IgAN is a common primary glomerular disease with diverse clinical manifestations, including recurrent microscopic or macroscopic hematuria and varying degrees of proteinuria, and is a major cause of chronic kidney disease and end-stage renal disease in China [2] - Up to 40% of IgAN patients may reach end-stage renal disease within 20 years of diagnosis, indicating a pressing unmet medical need for new therapies [2] - The company’s Tai'aisip targets the underlying mechanisms of IgAN by inhibiting the production of Gd-IgA1 and its antibodies through the dual inhibition of BLyS and APRIL, which are key cytokines in the disease process [2]
荣昌生物: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
Zhi Tong Cai Jing· 2025-08-27 10:42
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 ...
荣昌生物(09995.HK):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
Ge Long Hui· 2025-08-27 10:36
格隆汇8月27日丨荣昌生物(09995.HK)宣布,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。公司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)。 ...
荣昌生物(09995) - 自愿公告 - 泰它西普治疗IgA肾病中国III期临床研究A阶段达到主要终...
2025-08-27 10:30
(股份代號:9995) 自願公告 泰它西普(商品名:泰愛®)治療IgA腎病 中國III期臨床研究A階段達到主要終點 本公告由榮昌生物製藥(煙台)股份有限公司(「本公司」)自願作出。 本公司董事會(「董事會」)欣然宣佈,本公司自主研發的全球首創BLyS/APRIL雙 靶點融合蛋白創新藥泰它西普(商品名:泰愛®)用於治療IgA腎病(IgAN)的中國III 期臨床研究,達到A階段的主要研究終點。我們將盡快向中國國家藥品監督管理 局(NMPA)藥品審評中心(CDE)遞交上市申請(BLA)。 這是一項多中心、隨機、雙盲、安慰劑對照臨床試驗,納入了318例接受過標準 治療的IgAN成人患者,泰它西普的使用劑量為240mg,皮下注射,每週1次。A 階段分析結果顯示:與對照組相比,泰它西普組患者在治療39周時的24小時尿蛋 白肌酐比值(UPCR)降低了55%(P<0.0001),且表現出良好的耐受性和安全性。詳 細數據將在國際重大學術會議上公佈。 IgAN是一種常見的原發性腎小球疾病,該病臨床表現多樣,如反覆發作的鏡下血 尿或肉眼血尿,伴有不同程度蛋白尿,部分患者可以出現嚴重高血壓或者腎功能 異常。IgA腎病也是中國慢性腎臟 ...
县城医院的未来,正在易主
Hu Xiu· 2025-08-27 10:23
Core Viewpoint - The surgical robotics market is undergoing significant changes, particularly in China, where local companies are breaking through in technology development, clinical application, and business models, leading to a transformation in the industry [6][11]. Group 1: Market Dynamics - The global surgical robotics market has been dominated by Intuitive Surgical's "da Vinci" system, which has created substantial technical and commercial barriers [7][8]. - The high price of the "da Vinci" system, approximately 30 million RMB per unit, has limited access for many medical institutions in China [8][9]. - Local companies are entering the market by offering surgical robots at about one-third the price of the "da Vinci" system, making them more accessible [9]. Group 2: Investment Trends - From 2020 to 2022, the Chinese surgical robotics industry saw nearly 100 financing events, with disclosed total funding exceeding 20 billion RMB [12]. - The market is characterized by high technical barriers, high growth potential, and high profit margins, with projections indicating the market could reach 3.84 billion USD by 2026, growing at a rate of 44.3% [13]. Group 3: Challenges and Adjustments - Despite the growth potential, the industry is facing a cooling trend in capital investment, with only nine financing events reported in 2024 [19]. - The lengthy procurement process in hospitals and limited insurance coverage for robotic surgeries are significant barriers to market penetration [23][24]. - The lack of a clear mechanism for medical accident liability is causing hospitals to be cautious in adopting robotic surgeries [26]. Group 4: Strategic Shifts - Companies are moving away from price competition and focusing on differentiated innovation to build core competitiveness [29]. - Many firms are targeting lower-tier cities for market expansion, with a notable increase in installations in county-level hospitals [32]. - International expansion is becoming a crucial growth strategy, with companies like MicroPort and Jingfeng Medical successfully securing overseas orders [35]. Group 5: Future Outlook - The current cooling of capital is viewed as a new starting point for the industry, indicating a shift towards maturity rather than a downturn [36]. - Companies that focus on long-term value and balance technology, clinical application, and commercialization are likely to succeed in the competitive landscape of high-end medical equipment [37].
荣昌生物(688331):1H25收入攀升减亏显著 出海前景可期
Xin Lang Cai Jing· 2025-08-27 08:33
Group 1 - The company reported a significant revenue growth of 48.0% year-on-year, with 1H25 revenue reaching 1.098 billion yuan, and a reduction in net losses by 42.4% to 450 million yuan [1] - The company expects a revenue growth of over 30% for the full year, driven by steady sales of core products and the upcoming commercialization of RC28 [1][2] - The company has made progress in international expansion, with the successful authorization of Tai Tasi Pi and ongoing Phase III trials for Vidisizumab [3] Group 2 - The gross margin improved to 84.1%, an increase of 5.8 percentage points year-on-year, attributed to successful ramp-up of new facilities and process optimizations [4] - Operating cash flow significantly improved, with a 69% reduction in cash outflow in 2Q25, indicating a positive trend towards cash flow turning positive in the future [4] - The company is focusing its resources on potential pipeline and indication development, leading to a reduction in R&D expenses by 19.7% year-on-year [4] Group 3 - The company anticipates narrowing losses in 2025, approaching breakeven in 2026, and achieving profitability in 2027, with projected net profits of 346 million yuan in 2025 and 536 million yuan in 2027 [5] - The target prices based on DCF are set at 107.37 yuan for A-shares and 116.94 HKD for H-shares, with a WACC of 6.8% and a perpetual growth rate of 2.5% [5]
港股生物技术股普跌,科伦博泰生物跌超6%
Ge Long Hui A P P· 2025-08-27 05:41
Group 1 - The biotechnology sector in the Hong Kong stock market experienced a significant decline, with several companies reporting substantial drops in their stock prices [1] - Notable declines include Clover Biopharmaceuticals, which fell by 14.13%, and Beigene, which dropped by 8.33% [2] - Other companies such as Innovent Biologics and WuXi Biologics also saw declines exceeding 5%, indicating a broader trend of negative performance in the sector [1][2] Group 2 - The following companies reported specific percentage declines: Clover Biopharmaceuticals (-14.13%), Beigene (-8.33%), and Innovent Biologics (-6.50%) [2] - Additional companies with notable declines include Kintor Pharmaceutical (-6.38%), CanSino Biologics (-5.98%), and Zai Lab (-5.50%) [2] - The overall trend suggests a challenging environment for biotechnology stocks in the Hong Kong market [1]
荣昌生物(09995):2Q25产品销售强劲增长并减亏,核心资产海外价值可期,上调目标价
BOCOM International· 2025-08-26 14:46
| 医药 | 收盘价 | | 目标价 | | 潜在涨幅 | 2025 年 8 月 26 日 | | --- | --- | --- | --- | --- | --- | --- | | 港元 | | 88.70 | 港元 | 103.00↑ | +16.1% | | | 荣昌生物 (9995 HK) | | | | | | | 2Q25 产品销售强劲增长并减亏,核心资产海外价值可期,上调目标价 公司 2Q25 继续减亏,核心产品销售强劲增长的同时、费用率延续改善趋势, 整体业绩和现金储备稳中向好。泰它西普达成 BD 后海外稳步推进,我们基于 关键适应症上优异的临床数据进一步上调其经 PoS 调整全球销售峰值至 31 亿 美元;同时公司早期管线蕴含巨大的临床和 BD 价值。维持买入评级。 交银国际研究 财务模型更新 个股评级 买入 1 年股价表现 资料来源 : FactSet 8/24 12/24 4/25 -100% 0% 100% 200% 300% 400% 500% 600% 700% 9995 HK 恒生指数 股份资料 | 52周高位 (港元) | 88.70 | | --- | --- | | 5 ...
里昂:一举升荣昌生物目标价至103港元 维持“跑赢大市”评级
Zhi Tong Cai Jing· 2025-08-26 07:11
里昂发布研报称,荣昌生物(09995)次季销售额同比升39.1%,虽低于市场预期但超出公司全年指引。净 亏损同比收窄54.7%,好过市场预期。管理层维持全年销售指引不变,料同比增逾30%,并预期2026年 实现收支平衡。业务方面,RC18与RC48的适应症正逐步扩展,公司新型免疫治疗(I/O)及ADC研发管线 正逐步成型。该行分别上调2025至27年净利润预测79.6%、106.9%及116.4%,将目标价由33.7港元大幅 上调至103港元,维持"跑赢大市"评级。 ...
里昂:一举升荣昌生物(09995)目标价至103港元 维持“跑赢大市”评级
智通财经网· 2025-08-26 07:09
智通财经APP获悉,里昂发布研报称,荣昌生物(09995)次季销售额同比升39.1%,虽低于市场预期但超 出公司全年指引。净亏损同比收窄54.7%,好过市场预期。管理层维持全年销售指引不变,料同比增逾 30%,并预期2026年实现收支平衡。业务方面,RC18与RC48的适应症正逐步扩展,公司新型免疫治疗 (I/O)及ADC研发管线正逐步成型。该行分别上调2025至27年净利润预测79.6%、106.9%及116.4%,将目 标价由33.7港元大幅上调至103港元,维持"跑赢大市"评级。 ...