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]

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2025-042 | | --- | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | | 一、 说明会类型 本次投资者说明会以网络互动形式召开，公司将针对 2025 年半年度的经营 成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允许的范 围内就投资者普遍关注的问题进行回答。 会议召开时间：2025 年 09 月 16 日(星期二)15:00-17:00 会议召开地点：上海证券交易所上证路演中心 （网址：https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 二、 说明会召开的时间、地点 （一） 会议召开时间：2025 年 09 月 16 日（星期二）15:00-17:00 荣昌生物制药（烟台）股份有限公司 关于参加 2025 年半年度科创板创新药行业 集体业绩说明会的公告 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。 重要内容提示： 投资者可于 2025 年 09 月 09 ...

Company Overview - Rongchang Biopharmaceuticals is an innovative biopharmaceutical company focused on antibody-drug conjugates (ADC), antibody fusion proteins, monoclonal antibodies, and bispecific antibodies [2] - The company aims to discover, develop, and commercialize innovative and best-in-class biopharmaceuticals to address unmet clinical needs in autoimmune diseases, oncology, and ophthalmology [2] - Main business revenue composition: 99.46% from product sales, 0.38% from material sales, and 0.16% from leasing services [2] Financial Performance - As of June 30, 2025, Rongchang Biopharmaceuticals reported a revenue of 1.098 billion yuan, a year-on-year increase of 48.02% [3] - The net profit attributable to shareholders was -450 million yuan, reflecting a year-on-year growth of 42.40% [3] Shareholder and Market Activity - As of June 30, 2025, the number of shareholders increased to 12,900, up by 90.69%, while the average circulating shares per person decreased by 47.56% [3] - The stock price of Rongchang Biopharmaceuticals has increased by 187.28% year-to-date, with a recent decline of 4.82% over the last five trading days [1] - The company has appeared on the "Dragon and Tiger List" four times this year, with the most recent appearance on June 26, where it recorded a net buy of -137 million yuan [1] Institutional Holdings - As of June 30, 2025, notable new institutional shareholders include Hong Kong Central Clearing Limited, Wanjiayouxuan, and ICBC Frontier Medical Stock A [4] - The top ten circulating shareholders include various funds, with some showing significant changes in holdings compared to the previous period [4]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 榮昌生物製藥（煙台）股份有限公司 本月底法定/註冊股本總額： RMB 563,608,243 FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09995 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 208,581,239 | RMB | | 1 | RMB | | 208,581,239 | | 增加 / 減少 (-) | | | 0 | | | | RM ...