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亿腾嘉和:EDP167 II期临床试验完成首例受试者给药
Zhi Tong Cai Jing· 2026-02-09 00:37
亿腾嘉和(06998)发布公告,旗下小核酸创新药EDP167II期临床试验成功完成首例受试者给药。 EDP167II期临床试验是一项针对纯合子家族性高胆固醇血症(HoFH)成人患者的多中心、剂量探索、开 放标签的试验,旨在评估EDP167在HoFH患者中的疗效和安全性,其主要终点为首次给药24周后低密度 脂蛋白胆固醇(LDL-C)水平相较基线的变化,预计于2026年第四季度完成主要终点的评估。 ...
亿腾嘉和(06998):EDP167 II期临床试验完成首例受试者给药
智通财经网· 2026-02-09 00:33
智通财经APP讯,亿腾嘉和(06998)发布公告,旗下小核酸创新药EDP167 II期临床试验成功完成首例受 试者给药。 EDP167 II期临床试验是一项针对纯合子家族性高胆固醇血症(HoFH)成人患者的多中心、剂量探索、开 放标签的试验,旨在评估EDP167在HoFH患者中的疗效和安全性,其主要终点为首次给药24周后低密度 脂蛋白胆固醇(LDL-C)水平相较基线的变化,预计于2026年第四季度完成主要终点的评估。 ...
亿腾嘉和(06998.HK):EDP167 II期临床试验完成首例受试者给药
Ge Long Hui· 2026-02-09 00:29
格隆汇2月9日丨亿腾嘉和(06998.HK)发布公告,旗下小核酸创新药EDP167 II期临床试验成功完成首例 受试者给药。EDP167 II期临床试验是一项针对纯合子家族性高胆固醇血症("HoFH")成人患者的多中 心、剂量探索、开放标签的试验,旨在评估EDP167在HoFH患者中的疗效和安全性,其主要终点为首次 给药24周后低密度脂蛋白胆固醇("LDL-C")水平相较基线的变化,预计于2026年第四季度完成主要终点 的评估。 ...
牛市早报|央行连续15个月增持黄金,预制菜国标征求意见
Xin Lang Cai Jing· 2026-02-09 00:18
Market Data - As of February 6, the Shanghai Composite Index fell by 0.25% to 4065.58 points, the Sci-Tech Innovation 50 Index dropped by 0.71% to 1422.41 points, the Shenzhen Component Index decreased by 0.33% to 13906.73 points, and the ChiNext Index fell by 0.73% to 3236.46 points [1] - In the US market, major indices saw significant gains, with the Dow Jones Industrial Average closing at 50115.67 points, marking a 2.47% increase; the S&P 500 Index rose by 1.97% to 6932.30 points; and the Nasdaq Composite Index increased by 2.18% to 23031.21 points [1] Economic News - China's gold reserves have increased for 15 consecutive months, reaching 7419 million ounces by the end of January 2026, up by 4 thousand ounces from December 2025 [2] - China's foreign exchange reserves continued to grow, reaching 33990.78 billion USD at the end of January 2026, an increase of 412.09 billion USD or 1.23% from December 2025 [3] - The People's Bank of China and eight other departments issued a notice to further prevent and address risks related to virtual currencies, reiterating that virtual currencies do not have the same legal status as fiat currencies [4] Industry Developments - The National Health Commission released a draft national standard for pre-prepared dishes, which does not include staple foods and sets specific requirements for food additives [5][6] - The State Council and other departments announced measures to enhance consumer rights in the catering industry, encouraging transparency in the use of pre-prepared foods [6] - A new strategic partnership was formed between Innovent Biologics and Eli Lilly to advance global R&D of innovative drugs in oncology and immunology, with potential payments totaling up to 88.5 billion USD [7] - The company Beike (688793.SH) is under investigation by the China Securities Regulatory Commission for alleged market manipulation, marking the second investigation in a short period [8]
孙飘扬“借船出海”破局内卷 恒瑞医药创新药收入占比突破60%
Chang Jiang Shang Bao· 2026-02-08 23:53
中国创新药正步入全面收获期。在刚刚过去的2025年,我国生物医药产业创新活力迸发——全年76个创 新药获批,国产占比超八成;对外授权交易总额突破1300亿美元,创历史新高。 以仿制药起家,到转型创新药,"药王"恒瑞医药(600276)(600276.SH、01276.HK)的发展历程堪称是 中国医药产业升级的缩影。从以仿制药为营收支柱,到创新药收入占比突破60%,复出五年,孙飘扬带 领恒瑞医药转型攻坚,通过持续创新、差异化与国际化破局行业"内卷"。 2026年2月1日,恒瑞医药第九届董事会任期届满,68岁的孙飘扬会否继续担任董事长一职?恒瑞医药的 创新药全球化征程会走向怎样的新高度? 仿制药巨头大象转身 将时间拨回2020年,那一年,恒瑞医药以超6100亿元的市值傲视群雄,稳坐A股"医药一哥"。当年,恒 瑞医药的营业收入和归母净利润分别达到277.35亿元、63.28亿元的高峰。当年,在执掌恒瑞医药近三十 年后,孙飘扬决定退居幕后,将恒瑞交给职业经理人团队。 也是在那一年,国家药品集采政策全面实施,宣告着仿制药的高利润时代终结。以仿制药起家的恒瑞医 药危机悄然浮现。 随着集采不断扩围,市场被蚕食,2021年, ...
信达生物与礼来就创新药研发达成战略合作,最高可获85亿美元里程碑付款
Xin Lang Cai Jing· 2026-02-08 23:16
Core Viewpoint - Cinda Biologics has entered into a strategic collaboration with Eli Lilly to advance the global development of innovative drugs in the oncology and immunology fields [1] Group 1: Collaboration Details - Cinda Biologics will lead the projects from drug discovery to clinical concept validation in China, specifically through the completion of Phase II clinical trials [1] - Eli Lilly will obtain exclusive development and commercialization rights for the related projects outside of Greater China, while Cinda Biologics retains all rights within Greater China [1] Group 2: Financial Terms - Cinda Biologics will receive an upfront payment of $350 million [1] - Upon achieving specific subsequent milestones, Cinda Biologics is eligible for up to approximately $8.5 billion in milestone payments related to research, regulatory, and commercialization [1] - Cinda Biologics will also have the right to receive a tiered sales share based on net sales outside of Greater China for each product [1]
中国生物制药:维特柯妥拜单抗“CLDN18.2 ADC”III期临床试验完成受试者入组
Zhi Tong Cai Jing· 2026-02-08 22:25
Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its self-developed innovative drug, LM-302, targeting CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma [1][2]. Group 1: Clinical Development - LM-302 is the first CLDN18.2 antibody-drug conjugate (ADC) to complete patient enrollment in a Phase III clinical trial globally [1]. - The drug specifically targets CLDN18.2-positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The ongoing Phase III trial focuses on patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma who have received three or more prior lines of therapy [2]. Group 2: Clinical Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical reported that in 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4% [2]. - Among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2]. - The study also indicated that for patients with PD-L1 CPS <1, the ORR was 63.3%, while for those with CPS ≥1, the ORR was 77.8% [2]. Group 3: Future Plans and Regulatory Status - In addition to the ongoing Phase III study, LM-302 is set to undergo another Phase III registration trial in China, focusing on first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma [2]. - LM-302 has been included in the breakthrough therapy designation by the China National Medical Products Administration (NMPA) and has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) [2]. Group 4: Company Strategy - Leveraging strong resources and industrial capabilities, Lixin Pharmaceutical is accelerating the clinical translation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].
中国生物制药(01177):维特柯妥拜单抗“CLDN18.2 ADC”III期临床试验完成受试者入组
智通财经网· 2026-02-08 22:23
智通财经APP讯,中国生物制药(01177)发布公告,集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号:LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101),已顺利完成患者入组。其中,LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC),通过与CLDN18.2阳性肿瘤细胞特异性结合,并 经内吞作用进入细胞后释放小分子毒素,从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物,LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力,并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上,礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据:在41例疗效可评估的患者中,客观缓解率(ORR)为65.9%,疾病控制率(DCR)为 ...
中国生物制药(01177) - 自愿公告 - 维特柯妥拜单抗「CLDN18.2 ADC」III期临床...
2026-02-08 22:10
中國生物製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董事會」)宣佈,本集團全 資附屬公司禮新醫藥科技(上海)有限公司(「禮新醫藥」)自主研發的國家1類創新藥維特柯妥拜單抗(研 發代號:LM-302)「CLDN18.2 ADC」正在開展用於治療三線及以上CLDN18.2陽性的局部晚期或轉移 性胃及胃食管交界部腺癌的III期註冊臨床試驗(LM302-03-101),已順利完成患者入組。其中,LM- 302是全球首款完成註冊III期臨床試驗入組的CLDN18.2 ADC藥物。 LM-302是一款靶向CLDN18.2的抗體偶聯藥物(ADC),通過與CLDN18.2陽性腫瘤細胞特異性結合, 並經內吞作用進入細胞後釋放小分子毒素,從而實現對腫瘤細胞的精準殺傷。作為潛在同類首創 (FIC)藥物,LM-302在胃癌、胰腺癌及膽道癌等多個消化道腫瘤中展現出良好的臨床開發潛力,並有 望為CLDN18.2低表達和PD-L1低表達患者提供新的治療選擇。 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,概不對因本公告全部或任何部份內容而產生 ...
未来智造局|上海发力科研“新基建”:让AI读懂生命代码,跑出药物研发加速度
Xin Lang Cai Jing· 2026-02-08 15:28
Core Insights - The article discusses the integration of artificial intelligence (AI) in drug development, particularly focusing on siRNA (small interfering RNA) technology, which has shown significant potential in silencing disease-causing genes. AI models, such as the "Nüwa RNA model," are enhancing the efficiency of siRNA drug screening processes, moving from traditional trial-and-error methods to more precise selection techniques [1][2]. Group 1: AI and Drug Development - The application of AI models has improved in vitro screening efficiency by approximately 1.6 times compared to traditional methods [1]. - The Nüwa RNA model, developed by the Shanghai Institute of Intelligent Science in collaboration with Fudan University, aims to create a living scientific intelligence infrastructure that can be continuously evolved and utilized by scientists [2][3]. - The model integrates over 1 billion RNA sequences, structures, functions, and chemical modifications, achieving leading performance in RNA structure prediction and reverse folding tasks [2]. Group 2: Research and Development Process - The Nüwa RNA model allows for the rapid selection of around 200 high-potential candidates from thousands of sequences within hours, significantly enhancing the drug development process [3]. - The model has already validated siRNA design processes for over five targets, with preliminary experiments conducted for chronic diseases such as hyperlipidemia and hypertension [3][4]. - A closed-loop system has been established, where experimental data is continuously fed back into the AI model, facilitating iterative improvements in drug design [4]. Group 3: Star River Intelligence Platform - The "Star River Intelligence" platform consolidates over 400 scientific models and tools, aiming to lower research barriers and streamline the entire research process [5][6]. - The platform has built a repository of 40,000 high-value scientific datasets and covers nearly 500 million scientific papers, enabling intelligent search and report generation [6]. - The platform is designed to integrate various data, models, and methods into a unified research environment, enhancing the systematic advancement of scientific inquiries [6][7]. Group 4: Collaborative Research and Innovation - The platform promotes cross-disciplinary collaboration, allowing scientists from different backgrounds to work alongside AI algorithm experts, fostering innovation in life sciences [7]. - Successful outcomes from the platform include high-level research results, such as the "Sui Ren Catalytic Reaction Model," which have been published in top journals [7]. - The platform has seen significant engagement, with approximately 23,000 daily visits and active use among over 7,600 students and faculty from Fudan University and its affiliated hospitals [7].