REMEGEN(09995)

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荣昌生物(688331):业绩符合预期 泰它西普和RC28成功授权
Xin Lang Cai Jing· 2025-08-29 00:46
事件:公司发布2025半年度报告,2025上半年实现营业收入达11亿元(+48%),归属于上市公司股东 的净亏损-4.5 亿元,业绩符合预期。 泰它西普成功授权,重症肌无力适应症上市。2025 年6月,公司将泰它西普有偿许可给 Vor Bio,Vor Bio 获得在除大中华区以外的全球范围内开发和商业化的独家权利。荣昌生物及其全资附属主体荣普合 伙将从 Vor Bio 取得价值 1.25亿美元现金及认股权证,最高可达41.05 亿美元的临床注册及商业化里程 碑付款,以及高个位数至双位数销售提成款。7 月14 日,公司收到Vor Bio 支付的4500 万美元首付款。 泰它西普中国治疗重症肌无力适应症于2025 年5 月批准上市。海外治疗重症肌无力于2024 年8月获首例 患者入组,目前患者入组工作正在进行中。泰它西普治疗原发性干燥综合症(pSS)的III 期临床试验于 2025 年8 月达到主要研究终点。 RC28 授权参天中国,维迪西妥单抗持续探索UC、GC、BC及妇科肿瘤等适应症。2025 年8月,公司将 RC28-E 注射液有偿许可给参天中国,根据协议,荣昌生物将从参天中国取得2.5 亿元人民币的不可退 ...
荣昌生物(09995.HK):商业化放量驱动减亏 泰它西普IGA肾病即将申报上市
Ge Long Hui· 2025-08-28 20:00
Core Viewpoint - The company reported a revenue of 1.09 billion yuan for the first half of 2025, representing a year-on-year growth of 48%, while the net loss attributable to shareholders was 450 million yuan, a reduction in loss by 330 million yuan compared to the previous year, aligning with expectations [1] Group 1: Financial Performance - The company's gross margin reached 84.0% in the first half of 2025, an increase of 5.8 percentage points compared to the same period in 2024 [1] - The sales expense ratio was 47.9%, a decrease of 4.6 percentage points year-on-year, indicating effective cost and expense management [1] - The company reduced its losses by 42.4% year-on-year and by 23.2% quarter-on-quarter in the second quarter of 2025 [1] Group 2: Product Development and Market Potential - The core product, Tai Tasi Pu (泰它西普), has been approved for market launch, with expectations for pSS and IgAN to submit applications in the second half of 2025 [1] - The company has received approval for the use of Vidi Xi Tuo (维迪西妥单抗) in treating second-line HER2-positive breast cancer with liver metastasis, and has submitted applications for other indications [1] - The PD-1/VEGF dual antibody is advancing in global clinical research, with a focus on its potential for international expansion [2] Group 3: Clinical Trials and Regulatory Approvals - Tai Tasi Pu has reached the primary endpoint in the Phase III clinical trial for IgA nephropathy in China, with plans to expedite the application for market approval [2] - The trial included 318 adult patients receiving standard treatment, showing a 55% reduction in the urine protein-to-creatinine ratio after 39 weeks of treatment [2] Group 4: Profit Forecast and Valuation - Based on the semi-annual report and expected potential collaboration funds, the profit forecast for 2025/2026 has been adjusted from a loss of 915 million yuan/333 million yuan to a loss of 345 million yuan and a profit of 34 million yuan, respectively [3] - The target price has been raised by 10.6% to 105.44 HKD, indicating a 20% upside potential from the current stock price [3]
交银国际:升荣昌生物(09995)目标价至103港元 维持“买入”评级
智通财经网· 2025-08-28 09:12
智通财经APP获悉,交银国际发布研报称,荣昌生物(09995)核心产品海内外研发进展顺利,旗下泰它西 普用于治疗干燥综合症的国内三期研究达主要终点,下半年将递交上市申请,并公布数据。计及泰它西 普授权,该行下调荣昌生物2027年收入预测,但上调净利润预测,目标价上调至103港元,维持"买 入"评级。 交银国际认为,荣昌生物第二季产品销售强劲增长,收入同比增长47.6%,毛利率较去年同期提升7.3个 百分点至84.4%,亏损录1.95亿元人民币,同比及按季均有所收窄。管理层维持全年产品销售增长30% 以上的指引,目标明年实现收支平衡,预期至2027年撇除BD后可实现盈利。 ...
交银国际:升荣昌生物目标价至103港元 维持“买入”评级
Zhi Tong Cai Jing· 2025-08-28 09:12
交银国际发布研报称,荣昌生物(09995)核心产品海内外研发进展顺利,旗下泰它西普用于治疗干燥综 合症的国内三期研究达主要终点,下半年将递交上市申请,并公布数据。计及泰它西普授权,该行下调 荣昌生物2027年收入预测,但上调净利润预测,目标价上调至103港元,维持"买入"评级。 交银国际认为,荣昌生物第二季产品销售强劲增长,收入同比增长47.6%,毛利率较去年同期提升7.3个 百分点至84.4%,亏损录1.95亿元人民币,同比及按季均有所收窄。管理层维持全年产品销售增长30% 以上的指引,目标明年实现收支平衡,预期至2027年撇除BD后可实现盈利。 ...
荣昌生物(688331):2025年半年报点评:核心产品销售显著放量,在研药品临床进展加速
EBSCN· 2025-08-28 06:57
2025 年 8 月 28 日 公司研究 核心产品销售显著放量,在研药品临床进展加速 ——荣昌生物(688331.SH、9995.HK)2025 年半年报点评 要点 事件:公司发布 2025 年半年报,公司实现营业收入 10.98 亿元,较去年同期的 7.42 亿元增加 48.02%,归属于上市公司股东的净亏损 4.50 亿元,归属于上市 公司股东的扣除非经常性损益的净亏损 4.46 亿元,亏损金额同比大幅下降。 点评: 核心产品泰它西普和维迪西妥单抗销售显著放量:25H1 营业收入同比增加 48.02%,主要是由于泰它西普和维迪西妥单抗销量持续增加,产品销售收入增 加。以上两个核心产品均于 2021 年进入医保目录。截至 2025 年 6 月 30 日止, 公司自身免疫商业化团队已组建约 900 人的销售队伍,并已完成超过 1,000 家 医院的药品准入;公司肿瘤科商业化团队已组建超过 500 人的销售队伍,并已 完成超过 1,000 家医院的药品准入。 在研药品在中国和海外的临床试验进展加速:公司共有多个药物分子处于临床阶 段,正在针对几十种适应症进行开发,具体进展如下:截至 2025 年 6 月 30 ...
生物制品板块竞价活跃,西藏药业一字涨停
Mei Ri Jing Ji Xin Wen· 2025-08-28 01:47
Group 1 - The biopharmaceutical sector is experiencing active bidding, with notable stock performance including Tibet Pharmaceutical hitting the daily limit up, and Kangchen Pharmaceutical, Maiwei Biotech, and others opening higher [1] - Specific stock movements include Kangchen Pharmaceutical opening up by 5% and Maiwei Biotech also opening up by 4%, indicating positive market sentiment [1] - Other companies in the sector such as Rongchang Biotech, Hualan Vaccine, and Hualan Biotech also opened higher, reflecting a broader trend of optimism in the biopharmaceutical industry [1]
中信银行上半年净赚约365亿元 周生生中期盈利同比增超7成
Xin Lang Cai Jing· 2025-08-27 12:23
Performance Summary - China People's Insurance Group reported revenue of 324.12 billion yuan, a year-on-year increase of 10.87%, and a net profit of 26.67 billion yuan, up 13.98% [1] - China Life Insurance recorded revenue of 239.49 billion yuan, a 2.2% increase, with a net profit of 40.93 billion yuan, growing by 6.9% [1] - CNOOC's revenue was approximately 207.61 billion yuan, down 8.45%, with net profit around 69.5 billion yuan, a decrease of 13% [2] - Meituan's revenue reached 178.40 billion yuan, up 14.7%, but adjusted net profit fell by 41% to 12.44 billion yuan [3] - CITIC Bank's revenue was 105.43 billion yuan, down 2.96%, while net profit increased by 2.8% to 36.48 billion yuan [3] - Fosun International's revenue decreased by 10.8% to 87.28 billion yuan, with net profit down 8.2% to 0.66 billion yuan [3] - New Hope Energy reported revenue of 55.67 billion yuan, a 2% increase, but net profit decreased by 5.6% to 2.43 billion yuan [4] - China Cinda's revenue was 34.36 billion yuan, down 2%, while net profit increased by 5.8% to 2.28 billion yuan [5] - China Orient Group's revenue decreased by 12% to 19.86 billion yuan, but net profit surged by 116% to 0.20 billion yuan [6] - Shimao Group's revenue fell by 49% to 14.80 billion yuan, with a net loss of 8.93 billion yuan, narrowing by 61% [7] - Chongqing Steel's revenue was approximately 13.08 billion yuan, down 13.26%, with a net loss of 0.13 billion yuan, narrowing by 81% [8] - United Group's revenue increased by 197.3% to 12.08 billion yuan, with a net profit of 1.69 billion yuan, reversing from a loss of 0.21 billion yuan [9] - Chow Sang Sang's revenue decreased by 2.5% to 11.04 billion yuan, while net profit increased by 71.4% to 0.90 billion yuan [10] - Tianhong International's revenue was 11.03 billion yuan, down 1.86%, with net profit rising by 53.33% to 0.42 billion yuan [11] - Meidong Automotive's revenue fell by 4.9% to 10.14 billion yuan, with a net loss of approximately 0.82 billion yuan, expanding by about 29 times [12] - Jian Sha Tsui's revenue was 8.24 billion yuan, down 6.6%, with net profit of 2.33 billion yuan, a decrease of 7.06% [13] - Sino Land's revenue decreased by 6.64% to 8.18 billion yuan, with net profit down 8.7% to 4.02 billion yuan [14] - Xinyi International's revenue was 8.10 billion yuan, down 5.7%, with net profit of 0.14 billion yuan, a decrease of 19.22% [15] - Fuyao Glass reported revenue of approximately 7.74 billion yuan, down 27.7%, with net profit of approximately 0.26 billion yuan, a decrease of 82.6% [16] - Tianjin Port Development's revenue increased by 3% to 6.95 billion yuan, while net profit decreased by 17.3% to 0.35 billion yuan [17] - Guotai Junan International's revenue was approximately 2.83 billion yuan, up 30%, with net profit of approximately 0.55 billion yuan, a growth of 182% [21] - IGG's revenue decreased by 0.5% to 2.72 billion yuan, with net profit down 2.85% to 0.32 billion yuan [22] - China Aircraft Leasing's revenue was 2.40 billion yuan, down 4.86%, while net profit increased by 6.66% to 0.14 billion yuan [22] - China Orient Education's revenue increased by 10.2% to 2.19 billion yuan, with net profit rising by 48.4% to 0.40 billion yuan [23] Corporate News - China Shengmu signed a new procurement framework agreement with Yiyingmei Dairy for milk powder [24] - Rongchang Bio's clinical trial for Taitasip in treating IgA nephropathy reached its primary endpoint in Phase III [24] - China Huaxing's Bagua City project is expected to start construction in October, with completion by the end of 2026 [24] Buyback Activities - Tencent Holdings repurchased 909,000 shares for 550 million HKD at prices between 596-614.5 HKD [24] - HSBC repurchased 1.5472 million shares for approximately 156 million HKD at prices between 100.2-101.5 HKD [24] - Hang Seng Bank repurchased 210,000 shares for approximately 23.49 million HKD at prices between 111.5-112.2 HKD [24] - MGM China repurchased 1 million shares for approximately 16.02 million HKD at prices between 15.92-16.13 HKD [24]
荣昌生物(688331) - H股公告


2025-08-27 11:20
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 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病和終末期腎病的主要原因之一,高達40%的 IgA腎病患者在診斷後20年內達到終末期腎病,產生對新型藥物迫切的未滿足醫 療需求。目前學術界認為,半乳糖缺乏型IgA1(Gd-IgA1)分泌過多是IgA腎病的發 病的核心及始動因素。 1 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥( 煙 台 )股 份 有 限 公 司 (於中華人民共和國註冊成立的股份有限公司) (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/APR ...
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
Zhi Tong Cai Jing· 2025-08-27 10:47
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。 (原标题: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APP讯,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 ...
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 A P P· 2025-08-27 10:45
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)。 ...