Group 1 - Rongchang Bio's stock price increased by 5.91%, reaching 98.5 yuan per share, marking a new high [1] - The company's total market capitalization surpassed 555.15 billion yuan [1] - The trading volume amounted to 1.88 billion yuan [1]

9月9日，荣昌生物（688331.SH，股价107.10元，市值603.62亿元）开盘大涨，截至发稿涨幅超15%。 今日，公司宣布泰它西普（商品名：泰爱）用于治疗干燥综合征的上市申请，已获国家药品监督管理局药品审评中心（CDE）正式受理，这意味着泰它西普成为干燥综合征领域全球首个申请上市 作为一种双靶点融合蛋白药物，泰它西普是荣昌生物首款商业化产品，最早于2021年在国内获批。截至目前，泰它西普已有治疗系统性红斑狼疮（SLE）、类风湿关节炎（RA）、全身型重症肌 值得一提的是，干燥综合征也是一种慢性炎症性自身免疫疾病，并发症较多，除了外分泌腺受损的症状，还会有关节炎、肌痛、皮疹等腺体外表现，以及多系统内脏损害，在中国的患病率为0.3 根据荣昌生物8月13日发布的公告，泰它西普治疗原发性干燥综合征的Ⅲ期临床研究已达到主要研究终点，可以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。 值得注意的是，在全球范围内，还没有治疗干燥综合征的靶向药物获批上市，所以泰它西普有望成为该领域内首个对因治疗的有效手段——2023年12月，其用于干燥综合征的Ⅲ期临床试验已获得 封面图片来源：视觉中国-VCG41N1 ...

Core Viewpoint - Rongchang Biopharmaceutical (688331) experienced a significant stock price increase, reaching a peak of 16.37% on September 9, following the announcement of its innovative drug application for the treatment of Sjögren's syndrome [1] Company Summary - Rongchang Biopharmaceutical announced that its self-developed innovative drug, Tai Ta Xi Pu, which targets both BLyS and APRIL, has received formal acceptance from the National Medical Products Administration (NMPA) for its market application [1] - This drug is noted to be the first biopharmaceutical in the world to apply for market approval in the field of Sjögren's syndrome [1]

周二（9月9日）早盘，AH创新药再度异动。A股创新药龙头股领涨，百济神州大涨超6%，重仓创新药 的药ETF（562050）盘中续涨逾1%创上市新高！ 港股方面，荣昌生物一度暴拉逾15%创历史新高，乐普生物-B、君实生物大涨超7%，创新药纯度100% 的港股通创新药ETF（520880）开盘后快速探底回升，直线冲高逾1%，开盘不到30分钟成交额超2亿 元。 消息面上，荣昌生物最新宣布，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 用于治疗干燥综合征的上市申请，已获国家药品监督管理局药品审评中心（CDE）正式受理，成为干燥 综合征领域全球首个申请上市的生物药。 值得关注的是，昨日港股通创新药ETF（520880）标的指数"提纯"修订生效，正式成为一只不含 CXO、纯度100%的创新药指数，当日近8200万元大举涌入，至此，520880连续5日获资金加码，金额 合计近1.8亿元。 与此同时，场外投资利器火线上新！港股通创新药ETF（520880）联接基金（A类：025220 / C类： 025221）今日起开放日常申赎，场外投资者也能一键投资纯正创新药。 提醒：近期市场波动可能较大，短期涨 ...

Group 1 - The innovative drug concept showed strong fluctuations in early trading on September 9, with Rongchang Bio rising over 18%, reaching a historical high [1] - Other companies such as Yipinhong, Baiji Shenzhou, Junshi Biosciences, XinNuoWei, and Rejing Bio also experienced gains [1]

（原标题：创新药概念股走高，荣昌生物涨超15%） 人民财讯9月9日电，创新药概念股走高，荣昌生物涨超15%，济民健康涨停，一品红涨超8%，百济神州、君实生物、金城医药跟涨。 ...

Core Viewpoint - The innovative drug concept is gaining momentum, with Rongchang Biopharmaceuticals experiencing a significant stock increase of over 15%, reaching a historical high, following the acceptance of its drug application for a novel treatment for Sjögren's syndrome [1] Company Summary - Rongchang Biopharmaceuticals announced that its self-developed innovative drug, a first-in-class BLyS/APRIL dual-target fusion protein named Tai Tasi Pu, has received formal acceptance from the National Medical Products Administration (NMPA) for its market application [1] - This drug application marks the first-ever submission for a biological drug in the Sjögren's syndrome field globally [1] Industry Summary - The innovative drug sector is experiencing a strong upward trend, with several companies such as Yipinhong, Baiji Shenzhou, Junshi Biosciences, Xin Nuo Wei, and Rejing Biopharmaceuticals also seeing stock price increases alongside Rongchang Biopharmaceuticals [1]

人民财讯9月9日电，9月9日，荣昌生物(688331)在公众号上发文宣布，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)用于治疗干燥综合征的上市申请，已获国 家药品监督管理局药品审评中心(CDE)正式受理，成为干燥综合征领域全球首个申请上市的生物药。 ...

Group 1 - The core viewpoint of the article highlights the significant stock price increase of Rongchang Biologics, with both A-shares and H-shares experiencing substantial gains on September 9, 2025 [1] - Rongchang Biologics' A-shares rose over 13%, surpassing the 100 yuan mark, setting a new historical high [1] - The H-shares of Rongchang Biologics also saw a notable increase of over 11%, continuing to reach new highs for the year [1]

Core Viewpoint - Rongchang Biopharma (09995) experienced a significant stock price increase of nearly 14%, with a year-to-date gain of 600% [1] Group 1: Stock Performance - As of the report, the stock price reached 110.2 HKD, with a trading volume of 494 million HKD [1] Group 2: Product Development - The company announced that its self-developed innovative drug, Tai'aisip (泰它西普), targeting both BLyS and APRIL, has received formal acceptance for market application from the National Medical Products Administration (NMPA) for the treatment of Sjogren's syndrome [1] - This marks the first application for a biological drug in the global market for Sjogren's syndrome, as there are currently no approved targeted therapies for this condition [1] Group 3: Regulatory Approvals - Tai'aisip has been granted Fast Track designation by the U.S. FDA and is approved to conduct Phase III clinical trials in the U.S. [1] - The drug has also received approvals for treating systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) in China [1]