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同源康医药:多款创新药展现出肿瘤临床应用前景
肺癌脑转移发生率远高于其他肿瘤。晚期肺癌初治患者的脑转移发生率达25%—44%,EGFR突变型肺 癌患者的3年累积脑转移率可达29.4%—60.3%。肺癌脑转移患者经治后的中位生存期短,仅7—12个 月。吴豫生博士说,目前全球尚无针对肺癌脑转移适应症的第三代EGFR-TKIs获批上市,艾多替尼有望 满足该类患者人群亟待解决的临床治疗需求。而第三代EGFR-TKIs中国销售额已超过100亿元。 CDK2/4、CDK7等管线展现出临床应用前景 CDK4/6抑制剂联合内分泌治疗彻底改变了HR+/HER2-晚期乳腺癌的治疗格局,成为一线治疗的金标 准。然而CDK4/6抑制剂治疗耐药不可避免,几乎所有患者最终都会经历疾病进展。CDK4/6抑制剂治疗 失败后的药物选择成为临床医生面临的重大挑战。 在2025年9月份的世界肺癌大会上,同源康医药(02410.HK)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。同源康医药用了7年不到的时间实现在香港上市,并于今年3月10 日进入港股通。快速成长的背后是其亮丽的研发管线。据悉,除了艾多替尼片,同源康医药还有多个肿 瘤创新药展现出临床应用前景。 同源康 ...
艾多替尼关键注册Ⅱ期临床成果获选WCLC口头报告,同源康医药-B(02410)差异化创新价值获国际学界认可
智通财经网· 2025-09-11 07:36
Core Insights - The 2025 World Lung Cancer Conference (WCLC) in Barcelona focuses on advancements in lung cancer research, clinical diagnosis, and innovative therapies, serving as a key platform for global lung cancer treatment innovation [1] Group 1: Clinical Trial Overview - The key registration trial for the drug Aido Tini (TY-9591) by company Same Source Pharmaceutical-B (02410) was selected for a Mini Oral presentation at WCLC 2025, highlighting its significance in the field [1] - The trial is an open-label, multi-center, randomized controlled phase II study targeting NSCLC patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing the efficacy and safety of Aido Tini (160mg daily) against Osimertinib (80mg daily) [2] Group 2: Efficacy Results - As of February 28, 2025, the study enrolled 257 patients, with a mid-term analysis of 224 patients showing an intracranial objective response rate (iORR) of 92.8% for Aido Tini compared to 76.1% for Osimertinib, with a statistically significant P-value of 0.0006 [2] - Investigator-assessed iORR for Aido Tini was 91.0% versus 75.2% for Osimertinib, with a P-value of 0.002, indicating strong efficacy [3] Group 3: Safety Profile - The incidence of grade ≥3 treatment-related adverse events was 31.5% for Aido Tini and 15.0% for Osimertinib, with common severe adverse reactions including elevated creatine phosphokinase and QTc interval prolongation [3] - The incidence of interstitial lung disease (ILD) was 6.3% and QTc prolongation was 4.5%, both within manageable limits [3] Group 4: Market Potential - Currently, there are no approved third-generation EGFR-TKIs for NSCLC with brain metastases, positioning Aido Tini as a promising candidate to meet the clinical needs of this patient population [4] - The recognition of Aido Tini's efficacy and safety data at an international academic conference underscores its potential for clinical translation and commercial success in a supportive policy environment for innovative drug development in China [4]
艾多替尼关键注册Ⅱ期临床成果获选WCLC口头报告,同源康医药-B差异化创新价值获国际学界认可
Zhi Tong Cai Jing· 2025-09-11 07:35
Core Insights - The 2025 World Lung Cancer Conference (WCLC) in Barcelona focuses on advancements in lung cancer research, clinical treatment, and innovative therapies, serving as a key platform for global lung cancer treatment innovation [1] Group 1: Clinical Trial Overview - The key registration trial for the drug Aido Tini (TY-9591) was selected for a Mini Oral presentation at WCLC 2025, highlighting its significance in the field [1] - The trial is an open-label, multi-center, randomized controlled phase II study comparing Aido Tini (160mg daily) to Osimertinib (80mg daily) in untreated EGFR mutation-positive NSCLC patients with brain metastases [2] - A total of 257 patients with EGFR mutation-positive NSCLC and brain metastases were enrolled by February 28, 2025, with a mid-term analysis based on 224 patients showing a high intracranial objective response rate (iORR) of 92.8% for Aido Tini compared to 76.1% for Osimertinib [2] Group 2: Efficacy and Safety Results - The investigator-assessed iORR for Aido Tini was 91.0%, while for Osimertinib it was 75.2%, with a statistically significant difference (P=0.002) [3] - According to RANO-BM criteria, the confirmed iORR was 90.1% for Aido Tini and 74.3% for Osimertinib (P=0.0023) [3] - The incidence of grade ≥3 treatment-related adverse events was 31.5% for Aido Tini and 15.0% for Osimertinib, with the most common severe adverse reactions including elevated creatine phosphokinase and QTc interval prolongation [3] Group 3: Market Potential and Implications - Currently, there are no approved third-generation EGFR-TKIs for NSCLC with brain metastases, positioning Aido Tini as a promising candidate to meet the clinical needs of this patient population [4] - The recognition of Aido Tini's efficacy and safety data at an international academic conference underscores its clinical translation potential [4] - With supportive policies for innovative drug development in China, Aido Tini is expected to establish a solid foundation for future commercialization [4]
同源康医药-B(02410):EGFR靶向创新药艾多替尼在脑转移肺癌患者中展现突破性疗效——WCLC 2025公布ESAONA关键注册研究中期结果
智通财经网· 2025-08-13 23:23
Core Viewpoint - The company, Tongyuan Kang Pharmaceutical-B, announced that its innovative drug, Aiduotini Tablets (TY-9591), has been accepted for a mini oral report at the 2025 World Lung Cancer Conference, highlighting its potential in treating EGFR-mutant non-small cell lung cancer (NSCLC) with brain metastases [1][2]. Group 1 - Aiduotini Tablets (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs in NSCLC patients with brain metastases [1][2]. - The ESAONA key trial is an open-label, multi-center, randomized Phase II study focusing on patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing the efficacy and safety of Aiduotini (160mg once daily) versus Osimertinib (80mg once daily) [2]. - The primary endpoints of the study include intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS), with secondary endpoints including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), depth of tumor response (DepOR), and safety indicators [2]. Group 2 - As of February 28, 2025, a total of 257 patients with EGFR-mutant NSCLC and brain metastases were enrolled in the study, with interim analysis based on 224 subjects showing an iORR of 91.9% in the Aiduotini group compared to 76.1% in the Osimertinib group [3]. - The investigator-assessed iORR was 91.0% for Aiduotini and 75.2% for Osimertinib, indicating statistically significant differences (P=0.001 for iORR and P=0.002 for investigator assessment) [3]. - The study led by Professor Shi Yuankai across 51 centers in the country demonstrates that Aiduotini shows superior efficacy in controlling brain metastases and alleviating symptoms, potentially providing a new and more effective first-line treatment option for EGFR-mutant NSCLC patients with brain metastases [3].