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荣昌生物(688331):泰它西普 pSS 达成III期终点,先发优势显著
SINOLINK SECURITIES· 2025-08-14 07:34
Investment Rating - The report maintains a "Buy" rating for the company [5]. Core Insights - The company has achieved the primary endpoint in the Phase III clinical trial of its innovative drug, Taitasip (BLyS/APRIL dual-target fusion protein), for the treatment of primary Sjögren's syndrome (pSS) and plans to submit a marketing application to the National Medical Products Administration (NMPA) [2]. - There is a large patient base for Sjögren's syndrome in China, with an estimated prevalence of 0.3%-0.7%, translating to approximately 4.2 to 9.8 million patients, and the demand for effective treatments is significant due to the limited availability of specialized therapies [3]. - The company is progressing rapidly in the development of Taitasip, which has a clear first-mover advantage in the domestic market, as it is among the few innovative therapies for Sjögren's syndrome currently in clinical trials [3]. - Taitasip has demonstrated good efficacy and safety in its Phase II clinical trial, with no deaths or serious adverse events reported [3]. - The company is also advancing its PD-1/VEGF dual antibody, RC148, which has received FDA IND approval and is expected to enter international Phase II clinical trials [4]. Financial Forecast and Valuation - The company is projected to achieve revenues of 2.339 billion RMB, 3.247 billion RMB, and 4.597 billion RMB in 2025, 2026, and 2027, respectively, with a net profit of -855 million RMB, -90 million RMB, and 362 million RMB in the same years [5][9]. - The revenue growth rates are expected to be 40.26%, 58.54%, 36.26%, 38.78%, and 41.58% from 2023 to 2027 [9].
荣昌生物创新药获新进展,科创100ETF华夏(588800)多股飘红
Xin Lang Cai Jing· 2025-08-14 06:05
Group 1 - The core viewpoint of the news highlights the performance of the Sci-Tech Innovation Board, with Rongchang Biologics leading the gains at 9.77% and the overall market showing mixed results [1] - Rongchang Biologics announced the successful completion of the primary endpoint in the Phase III clinical trial of its innovative drug, RC18 (brand name: Tai Ai®), for the treatment of primary Sjögren's syndrome (pSS) [1] - Jianghai Securities emphasizes that innovation-driven growth and internationalization are the main themes in the industry, with increased policy support for innovative drugs and enhanced R&D capabilities of domestic pharmaceutical companies [1] Group 2 - The Sci-Tech 100 ETF (588800) closely tracks the Sci-Tech 100 Index, which is the first and only mid-cap style index on the Sci-Tech Innovation Board, focusing on high-growth tech companies in the semiconductor, pharmaceutical, and new energy sectors [2]
港股异动 荣昌生物(09995)高开近5% 泰它西普治疗原发性干燥综合征III期临床达到主要终点
Jin Rong Jie· 2025-08-14 01:57
本文源自:智通财经网 消息面上,荣昌生物发布公告,公司自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普(RC18, 商品名:泰爱 )用于治疗原发性干燥综合征(pSS)的Ⅲ期临床研究,达到方案设计的临床试验主要研 究终点。 智通财经获悉,荣昌生物(09995)高开近5%,截至发稿,涨4.7%,报71.35港元,成交额1184.41万港 元。 公告称,泰它西普已经在中国完成治疗原发性干燥综合征的Ⅲ期临床研究,达到方案设计的临床试验主 要研究终点。临床研究结果显示,泰它西普可持续有效改善干燥综合征患者的临床症状,显示良好的有 效性和安全性。公司将尽快向国家药品监督管理局药品审评中心(CDE)递交上市申请,详细数据将在国 际重大学术会议上公布。 ...
荣昌生物高开近5% 泰它西普治疗原发性干燥综合征III期临床达到主要终点
Zhi Tong Cai Jing· 2025-08-14 01:28
Core Viewpoint - Rongchang Biologics (09995) experienced a nearly 5% increase in opening price, currently up 4.7% at HKD 71.35, with a trading volume of HKD 11.84 million [1] Group 1: Clinical Research Announcement - The company announced that its self-developed BLyS/APRIL dual-target fusion protein innovative drug, Tai'aisip (RC18), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS), achieving the primary endpoint as per the study design [1] - The clinical research results indicate that Tai'aisip can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) as soon as possible, with detailed data to be presented at major international academic conferences [1]
港股异动 | 荣昌生物(09995)高开近5% 泰它西普治疗原发性干燥综合征III期临床达到主要终点
智通财经网· 2025-08-14 01:28
智通财经APP获悉,荣昌生物(09995)高开近5%,截至发稿,涨4.7%,报71.35港元,成交额1184.41万港 元。 消息面上,荣昌生物发布公告,公司自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普(RC18, 商品名:泰爱 )用于治疗原发性干燥综合征(pSS)的Ⅲ期临床研究,达到方案设计的临床试验主要研 究终点。 公告称,泰它西普已经在中国完成治疗原发性干燥综合征的Ⅲ期临床研究,达到方案设计的临床试验主 要研究终点。临床研究结果显示,泰它西普可持续有效改善干燥综合征患者的临床症状,显示良好的有 效性和安全性。公司将尽快向国家药品监督管理局药品审评中心(CDE)递交上市申请,详细数据将在国 际重大学术会议上公布。 ...
瑞康医药董秘解除留置;智翔金泰启动GR1802注射液过敏性鼻炎III期临床|医药早参
Mei Ri Jing Ji Xin Wen· 2025-08-13 23:33
Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]
荣昌生物制药(烟台)股份有限公司自愿披露关于泰它西普治疗原发性干燥综合征Ⅲ期临床研究达到主要研究终点的公告
Shang Hai Zheng Quan Bao· 2025-08-13 19:00
Core Viewpoint - Rongchang Biopharmaceutical's innovative drug Tai'ta Xipu (RC18) has successfully met the primary endpoint in its Phase III clinical trial for treating primary Sjögren's syndrome, indicating its potential effectiveness and safety in addressing this chronic autoimmune disease [1][3]. Group 1: Clinical Research Overview - The Phase III clinical trial for Tai'ta Xipu is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the drug's efficacy and safety in patients with primary Sjögren's syndrome [1][3]. - Primary Sjögren's syndrome is characterized by chronic inflammation and damage to exocrine glands, leading to symptoms such as dry mouth and dry eyes, with a prevalence rate in China estimated between 0.3% and 0.7% [1][2]. Group 2: Mechanism of Action - Tai'ta Xipu is a recombinant dual-target fusion protein that inhibits both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are crucial in the abnormal activation of B cells, thereby reducing pathological immune responses [2]. Group 3: Clinical Progress - The clinical trial results indicate that Tai'ta Xipu can sustainably and effectively improve the clinical symptoms of patients with primary Sjögren's syndrome, demonstrating good efficacy and safety [3]. - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [3].
荣昌生物: 荣昌生物自愿披露关于泰它西普治疗原发性干燥综合征Ⅲ期临床研究达到主要研究终点的公告
Zheng Quan Zhi Xing· 2025-08-13 16:11
荣昌生物制药(烟台)股份有限公司 自愿披露关于泰它西普治疗原发性干燥综合征Ⅲ期临床 研究达到主要研究终点的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 证券代码:688331 证券简称:荣昌生物 公告编号:2025-037 荣昌生物制药(烟台)有限公司(以下简称"公司"或"荣昌生物")自主研发的 BLyS/APRIL 双靶点融合蛋白创新药泰它西普(RC18,商品名:泰爱)用于治疗原发性 干燥综合征(pSS)的Ⅲ期临床研究,达到方案设计的临床试验主要研究终点。现将情 况公告如下: 港股代码:09995 港股简称:榮昌生物 一、 基本情况介绍 本研究是一项多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究。旨在评价泰它西 普用于治疗原发性干燥综合征患者的有效性和安全性。 特此公告。 干燥综合征是一种慢性炎症性自身免疫性疾病,以淋巴细胞浸润和外分泌腺体损伤 为主要特征。除唾液腺和泪腺功能障碍导致的持续口干、眼干外,还可累及多系统器官。 我国干燥综合征的患病率为 0.3%-0.7%,且呈上升趋势,存在巨大尚未被满足的临床需 求。 研 ...
8月13日中银创新医疗混合C净值增长3.87%,近6个月累计上涨86.76%
Sou Hu Cai Jing· 2025-08-13 12:22
简历显示:郑宁先生:中国,研究生、硕士。曾任泰康资产管理有限责任公司股票研究经理、高级股票研 究经理;中庚基金管理有限公司研究员、高级研究员(医药组组长)。2022年加入中银基金管理有限公司。 2022年7月1日担任中银创新医疗混合型证券投资基金基金经理。2022年10月13日担任中银医疗保健灵活 配置混合型证券投资基金基金经理。2023年2月28日任中银大健康股票型证券投资基金基金经理。 来源:金融界 金融界2025年8月13日消息,中银创新医疗混合C(010500) 最新净值2.1969元,增长3.87%。该基金近1个 月收益率15.09%,同类排名1008|4699;近6个月收益率86.76%,同类排名26|4543;今年来收益率 85.33%,同类排名30|4501。 中银创新医疗混合C股票持仓前十占比合计62.83%,分别为:信达生物(8.33%)、科伦博泰生 (8.15%)、恒瑞医药(8.08%)、康方生物(8.07%)、新诺威(6.13%)、百利天恒(5.99%)、百济 神州-U(5.97%)、翰森制药(4.15%)、荣昌生物(4.05%)、康诺亚-B(3.91%)。 公开资料显示,中银创新医疗 ...