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复宏汉霖(02696.HK):注射用HLX43联合HLX07或汉斯状®在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国大陆完成首例患者给药
Ge Long Hui· 2026-02-11 09:13
格隆汇2月11日丨复宏汉霖(02696.HK)宣布,近日,注射用HLX43(靶向PD-L1抗体偶联药物) (「HLX43」)联合HLX07(重组抗EGFR人源化单克隆抗体注射液)(「HLX07」)或汉斯状®(斯鲁利单抗注 射液)(「汉斯状®」)在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国大陆完成首例患者给 药。 本研究为一项1b/2期临床研究,旨在评估HLX43联合HLX07或汉斯状®,在晚期或转移性结直肠癌患者 中的安全性、耐受性和有效性。该研究包括两个部分:第一部分包括第一阶段(安全导入期)和第二阶段 (剂量扩展)。第一阶段采用3+3剂量递增设计,患者将接受HLX43 2.5 mg/kg或3.0 mg/kg,联合固定剂量 HLX07(1000 mg)每三周一次(Q3W)静脉输注给药。第一阶段主要目的为评估不同剂量水准HLX43联合 HLX07在晚期或转移性结直肠癌患者中的安全性和耐受性,次要目的是研究HLX43的药代动力学(PK) 特徵和免疫原性、疗效、潜在药效学、潜在预测性或耐药性生物标志物。第二阶段是随机、多中心、开 放标签研究,HLX43两个剂量水准分别联合固定剂量HLX07进行扩展, ...
复宏汉霖(02696):注射用HLX43联合HLX07或汉斯状®在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国境内完成首例患者给药
智通财经网· 2026-02-11 09:05
智通财经APP讯,复宏汉霖(02696)发布公告,近日,注射用HLX43(靶向PD-L1抗体偶联药物) ("HLX43")联 合 HLX07(重组抗EGFR人源化单克隆抗体注射液)(" HLX07")或汉斯状®(斯鲁利单抗注射 液)("汉斯状®")在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国境内(不包括中国港澳台地 区,下同)完成首例患者给药。 ...
复宏汉霖(02696) - 自愿公告 - 注射用HLX43(靶向PD-L1抗体偶联药物)联合HLX0...
2026-02-11 09:00
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的內容概不負責,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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2696) 自願公告 注射用HLX43(靶向PD-L1抗體偶聯藥物) 聯合HLX07(重組抗EGFR人源化單克隆抗體注射液) 或漢斯狀® (斯魯利單抗注射液) 在晚期或轉移性結直腸癌患者中開展的1b/2期臨床研究 於中國境內完成首例患者給藥 A. 緒言 1 料,暫定HLX43的劑量水準為2.5 mg/kg和3.0 mg/kg,該階段主要目的是研究不 同劑量HLX43聯合固定劑量HLX07在轉移性結直腸癌(mCRC)患者中的有效性, 次要目的包括評價其安全性和耐受性、HLX43的PK特徵和免疫原性、並研究潛在 預測性或耐藥性生物標誌物。第二部分為一項隨機、多中心、開放標籤研究,評 估HLX43 2.0 mg/kg或2.5 mg/kg聯合固定劑量漢斯狀®(30 ...
正海生物:公司在钙硅生物陶瓷口腔骨修复材料取证上市前提前规划建设了产品独立生产线
Mei Ri Jing Ji Xin Wen· 2026-02-11 08:39
Core Viewpoint - The company is effectively managing its production capacity to meet market demand for its products, particularly in the field of calcium silicate bioceramics for dental bone repair [2]. Group 1: Production Capacity - The company reported that its overall production capacity is operating within a normal and efficient range, responding to customer order demands [2]. - A dedicated production line for calcium silicate bioceramics has been established prior to product certification and market launch, ensuring stable and efficient production [2]. Group 2: Market Demand - The production capacity of the new product line is sufficient to meet the anticipated market demand for calcium silicate bioceramics [2].
君实生物跌1.93% 2020年上市2募资共86亿元
Zhong Guo Jing Ji Wang· 2026-02-11 08:29
Group 1 - The core point of the news is that Junshi Biosciences (688180.SH) is currently experiencing a decline in stock price, closing at 35.03 yuan with a drop of 1.93% [1] - Junshi Biosciences was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on July 15, 2020, with an initial issuance of 87.13 million shares at a price of 55.50 yuan per share [1] - The stock reached its highest point at 220.40 yuan on the first day of trading but is now in a state of decline [1] Group 2 - In 2020, Junshi Biosciences raised a total of 4.836 billion yuan from its initial public offering, with a net amount of 4.497 billion yuan after deducting issuance costs [1] - The company initially planned to raise 2.7 billion yuan, which was exceeded by 1.797 billion yuan [1] - The total fundraising amount from the company's specific issuance of A-shares in 2022 was approximately 3.7765 billion yuan, with a net amount of about 3.7448 billion yuan after fees [2] - The total amount raised by Junshi Biosciences from both fundraising rounds is 8.612 billion yuan [2]
康希诺生物2026年业绩扭亏为盈,多款疫苗研发与审批进展受关注
Jing Ji Guan Cha Wang· 2026-02-11 07:45
Core Viewpoint - The company, CanSino Biologics, is expected to turn a profit in 2025, with significant advancements in vaccine development and ongoing expansion into international markets [1][2]. Financial Performance - The company forecasts revenue between 1.04 billion to 1.08 billion yuan for 2025, representing a year-on-year growth of 22.88% to 27.61%. Net profit attributable to shareholders is projected to be between 24.5 million to 29 million yuan, indicating a turnaround from previous losses. The audited annual report is scheduled for release in 2026 [2]. Product Development Progress - The self-developed DTPa vaccine has completed Phase III clinical trials and is expected to receive market approval in the first half of 2026, potentially replacing imported products and expanding into the high-end vaccine market. The 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) has been approved for clinical trials by the National Medical Products Administration of China, marking it as the first 24-valent pneumonia vaccine to enter clinical trials globally [3]. Business Expansion - The company is actively expanding into overseas markets in Southeast Asia, the Middle East, North Africa, and South America. For instance, the Manhaixin vaccine has received halal certification in Indonesia and has begun exports, with potential for deeper local partnerships and technology transfers [4]. Future Development - Other research pipeline updates include the prioritization of the DTPa vaccine for infants, acceptance of the application for the Tetanus vaccine, and international support for the recombinant poliovirus vaccine (VLP-Polio). The clinical and approval progress of these products may significantly impact the company's long-term development [5].
华兰疫苗股价连续4天下跌累计跌幅5.91%,南方基金旗下1只基金持165.22万股,浮亏损失221.39万元
Xin Lang Cai Jing· 2026-02-11 07:18
2月11日,华兰疫苗跌1.25%,截至发稿,报21.34元/股,成交1.96亿元,换手率1.51%,总市值128.26亿 元。华兰疫苗股价已经连续4天下跌,区间累计跌幅5.91%。 资料显示,华兰生物疫苗股份有限公司位于河南省新乡市华兰大道甲1号附1号,成立日期2005年11月9 日,上市日期2022年2月18日,公司主营业务涉及人用疫苗的研发、生产和销售。主营业务收入构成 为:疫苗制品98.11%,其他1.89%。 从华兰疫苗十大流通股东角度 数据显示,南方基金旗下1只基金位居华兰疫苗十大流通股东。南方中证1000ETF(512100)三季度减 持8700股,持有股数165.22万股,占流通股的比例为0.28%。根据测算,今日浮亏损失约44.61万元。连 续4天下跌期间浮亏损失221.39万元。 南方中证1000ETF(512100)成立日期2016年9月29日,最新规模789.96亿。今年以来收益8.61%,同类 排名1564/5569;近一年收益34.61%,同类排名1862/4295;成立以来收益24.22%。 南方中证1000ETF(512100)基金经理为崔蕾。 截至发稿,崔蕾累计任职时间7年98 ...
药明生物:利润同比增长45.3%至57.33亿元,欧洲生产基地产能爬坡
Cai Jing Wang· 2026-02-11 06:36
2月11日,药明生物发布公告,公司截至2025年12月31日止全年度收益将增长约16.7%至人民币217.90亿 元;毛利率将提升约5个百分点至46.0%;经调整毛利将增长至约人民币106.38亿元,同比增长约 25.5%;公司截至2025年12月31日止全年度的利润及归属于公司权益股东的利润将分别增长约45.3%至 人民币57.33亿元及约46.3%至人民币49.08亿元; 以及经调整以股份为基础的薪酬开支、外汇损益、以及股权投资、资产出售、重组损益及相关一次性成 本后,公司非国际财务报告准则经调整纯利将增长约22.0%至人民币65.86亿元。 公告表示,该等增长主要归因于(其中包括)以下因素: (iii) 集团对现有及新增产能的利用,包括欧洲生产基地的产能爬坡; (iv) 集团通过药明生物精益运营管理系统(WBS)及数字化方案实现成本节约与效率改善; (v) (vi)公司通过投资投资组合而获得的投资收益。 (药明生物公告) (编辑:杨燕 林辰) (i) "跟随并赢得分子"战略的成功执行,以及领先的技术平台、行业最佳的项目交付时间及优秀的项目 执行过往记录,推动集团收益增长; (ii) 基于双特异性抗体和A ...
港股异动 午后涨超6% 25年业绩预告亮眼 对外授权打开长期增长天花板
Zhi Tong Cai Jing· 2026-02-11 06:09
Core Viewpoint - The stock of Baiaosaitu-B (02315) rose over 6% following the release of its 2025 performance forecast, indicating strong growth potential driven by external licensing agreements and innovative business models [1] Group 1: Financial Performance - Baiaosaitu expects to achieve revenue between 1.369 billion to 1.389 billion yuan for the year 2025, representing a year-on-year growth of 39.61% to 41.65% [1] - The company anticipates a net profit attributable to shareholders of approximately 162 million to 182 million yuan, reflecting a significant year-on-year increase of 384.26% to 443.88% [1] Group 2: Business Drivers - The strong performance is attributed to the innovative advantages in model animals and preclinical CRO (Contract Research Organization) business, as well as the antibody platform supported by the "Thousand Mice, Ten Thousand Antibodies" initiative [1] - Since 2025, the company has established external licensing agreements with several leading domestic and international pharmaceutical companies, which is expected to enhance revenue through milestone payments as the licensed pipelines progress [1]
“跃赛生物”完成逾五千万元A+轮融资
Xin Lang Cai Jing· 2026-02-11 06:00
近日,上海跃赛生物科技有限公司(简称"跃赛生物")宣布完成逾五千万元A+轮融资,本次融资由磐 霖资本、全村创投、外高桥私募基金共同完成。本轮资金将用于加速推进公司癫痫和帕金病森通用型细 胞药物管线的临床试验,进一步深化创新细胞治疗药物的规模化开发和产业化建设。 ...