肺癌治疗药物研发
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同源康医药-B午前涨超5% 公司正在准备TY-9591附条件上市NDA申请
Xin Lang Cai Jing· 2025-12-12 03:49
同源康医药-B(02410)早盘涨超5%,截至发稿, 股价上涨5.21%,现报13.54港元,成交额2597.09万 港元。 在今年9月份的世界肺癌大会上,同源康医药发布的艾多替尼片针对非小细胞肺癌脑转移关键Ⅱ期临床 试验引起同行高度关注。据悉,艾多替尼片(TY-9591)是同源康医药针对EGFR经典突变开发的高选 择性小分子抑制剂,公司已于2024年11月完成附条件批准上市资格的224例患者入组,并已于2025年4月 提交预上市(Pre-NDA)申请,预计2025年4季度正式提交附条件上市申请。 公司在中期业绩会上表示,目前正在准备TY-9591附条件上市NDA申请,将其用于表皮生长因子受体 (EGFR)突变肺癌脑转移的一线治疗,以及正在中国进行TY-9591单药治疗的注册性III期临床试验, 将其用于EGFRL858R突变的局部晚期(IIIb至IV期)或转移性NSCLC的一线治疗。 责任编辑:卢昱君 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 同源康医药-B(02410)早盘涨超5%,截至发稿, 股价上涨5.21%,现 ...
同源康医药-B早盘涨超5% 公司正在准备TY-9591附条件上市NDA申请
Zhi Tong Cai Jing· 2025-12-12 03:07
同源康医药-B(02410)早盘涨超5%,截至发稿,涨3.73%,报13.35港元,成交额2154.6万港元。 公司在中期业绩会上表示,目前正在准备TY-9591附条件上市NDA申请,将其用于表皮生长因子受体 (EGFR)突变肺癌脑转移的一线治疗,以及正在中国进行TY-9591单药治疗的注册性III期临床试验,将其 用于EGFRL858R突变的局部晚期(IIIb至IV期)或转移性NSCLC的一线治疗。 消息面上,在今年9月份的世界肺癌大会上,同源康医药发布的艾多替尼片针对非小细胞肺癌脑转移关 键Ⅱ期临床试验引起同行高度关注。据悉,艾多替尼片(TY-9591)是同源康医药针对EGFR经典突变开发 的高选择性小分子抑制剂,公司已于2024年11月完成附条件批准上市资格的224例患者入组,并已于 2025年4月提交预上市(Pre-NDA)申请,预计2025年4季度正式提交附条件上市申请。 ...
港股异动 | 宜明昂科-B(01541)再涨超9% 公司近日提交IMM2510三期临床试验申请
Zhi Tong Cai Jing· 2025-10-08 03:16
Core Viewpoint - The stock of Iminco-B (01541) has increased by over 9%, currently trading at 15.77 HKD, following the submission of a Phase III clinical trial application for IMM2510 to treat immune-resistant non-small cell lung cancer (NSCLC) [1] Company Developments - Iminco has submitted an application to the National Medical Products Administration for a Phase III clinical trial of IMM2510 aimed at treating immune-resistant NSCLC [1] - The company has also submitted two additional Phase III registration clinical trials for different types of lung cancer [1] Clinical Trial Results - Recent Phase I study data presented at the 2025 World Lung Cancer Conference showed that among 17 evaluable patients with advanced squamous NSCLC who had previously received immunotherapy, the objective response rate and disease control rate for IMM2510 were 35.3% and 76.5%, respectively [1] - The median duration of response was reported at 7.59 months, while the median progression-free survival was 9.4 months [1] - Based on these results, the company plans to further validate the efficacy and safety of IMM2510 through Phase III clinical trials, aiming to provide more effective treatment options for lung cancer patients [1]
同源康医药:艾多替尼在脑转移肺癌患者中展现疗效,将在世界肺癌会议专题汇报
Xin Lang Cai Jing· 2025-08-13 23:12
Core Viewpoint - The announcement highlights the acceptance of the key Phase II registration clinical trial results for TY-9591, a novel EGFR-TKI, at the 2025 World Lung Cancer Conference, indicating significant progress in the treatment of EGFR mutation-positive NSCLC with brain metastases [1] Company Summary - Company has developed TY-9591, a new generation EGFR-TKI, aimed at treating EGFR mutation-positive non-small cell lung cancer (NSCLC) [1] - The clinical trial results will be presented by Professor Shi Yuankai from the Beijing Cancer Hospital, showcasing the drug's efficacy in controlling brain metastases and alleviating symptoms [1] - Company acknowledges uncertainty regarding the successful development, commercialization, and market launch of TY-9591 [1] Industry Summary - The acceptance of the trial results at a prestigious international conference underscores the potential of new treatments in the oncology sector, particularly for challenging cases like NSCLC with brain metastases [1] - The development of targeted therapies like TY-9591 reflects ongoing innovation in the pharmaceutical industry aimed at improving patient outcomes in cancer treatment [1]