财报分析 公司2025年中期业绩显示经营效率提升，但该数据发布于2025年8月31日，非近期热点。报告期内研发 成本同比收窄35.6%至8875.8万元，亏损同比收窄48.79%至1.12亿元，管线包括11款候选药物。当前收 入主要依赖与丽珠医药的授权协议，商业化团队已初步搭建，为产品上市铺垫。 以上内容基于公开资料整理，不构成投资建议。 经济观察网同源康医药近期热点集中于核心产品进展及资本运作。2026年2月9日，公司宣布其自主研发 的甲磺酸艾多替尼片(TY-9591)新药上市申请(NDA)获国家药监局药审中心受理，该药针对非小细胞肺 癌脑转移，为首个新一代EGFR-TKI抑制剂，且已于2026年1月纳入优先审评程序，上市进程提速。公 司董事长吴豫生表示，该药国内峰值年销售额预估超50亿元，针对脑转移及L858R突变市场潜力显著。 此外，2026年2月11日，联交所批准公司H股全流通安排，涉及460.8万股非上市股份转换，有助于提升 股份流动性。 股票近期走势 近期股价呈现震荡态势。截至2026年2月13日收盘，股价报12.80港元，较2月9日收盘价12.86港元微跌 0.78%，区间振幅达7.52%。成交 ...

同源康医药-B(02410)公布，公司已向联交所上市委员会申请批准公司根据转换公司1名股东持有的460.8 万股非上市股份转换的460.8万股H股上市及买卖经转换H股。联交所已于2026年2月11日授出上市批 准。 ...

智通财经APP讯，同源康医药-B(02410)公布，公司已向联交所上市委员会申请批准公司根据转换公司1 名股东持有的460.8万股非上市股份转换的460.8万股H股上市及买卖经转换H股。联交所已于2026年2月 11日授出上市批准。 ...

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意見，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。 本公告乃由浙江同源康醫藥股份有限公司（「本公司」）根據香港聯合交易所有限公 司（「聯交所」）證券上市規則（「上市規則」）第13.09(2)(a)條及香港法例第571章證 券及期貨條例第XIVA部項下內幕消息條文（「內幕消息條文」）（定義見上市規則） 作出。 茲提述(i)本公司日期為2025年6月6日的公告，內容有關本公司申請H股全流通； 及(ii)本公司日期為2026年1月23日的公告，內容有關中國證監會發出關於本公司 申請H股全流通的備案通知書（統稱「該等公告」）。除文義另有所指外，本公告所 用詞彙與該等公告所界定者具有相同涵義。 聯交所授出上市批准 本公司董事會欣然宣佈，本公司已向聯交所上市委員會申請批准本公司根據轉換 本公司1名股東持有的4,608,000股非上市股份（「轉換」）轉換的4,608,000股H股 （「經轉換H股」）上市（「上市」）及買賣經轉換H股（「上市批准」）。本公司欣然宣 佈，聯交 ...

同源康医药是一家专注于肿瘤创新药物研发的生物医药公司。由吴豫生于2017年11月发起创办，其现任 公司董事长、总裁，拥有超20年医药行业从业经验，曾任职于美国跨国药企先灵葆雅新药研发中心，具 备深厚的新药研发与项目管理能力。公司于2024年8月登陆港交所，开启研发与商业化协同发展新阶 段，始终致力于通过自主研发与全球合作，为患者提供突破性治疗方案。目前已有多个创新项目处于临 床或临床前开发阶段，形成了丰富的产品管线布局。 同源康医药近日迎来发展里程碑。公司宣布，其自主研发的针对非小细胞肺癌（NSCLC）脑转移的甲 磺酸艾多替尼片（TY-9591）新药上市申请（NDA）已获得国家药监局药审中心受理。 该药作为首个针对肺癌脑转移的新一代EGFR-TKI抑制剂，凭借差异化优势备受市场关注。公司管线布 局及差异化价值传递，也成为投资者聚焦的核心。 截至2月6日收盘，同源康医药股价为12.9港元/股，市值为49亿港元。 纳入优先审评阶段 产品上市进程提速 据介绍，甲磺酸艾多替尼片是已上市同类药物奥希替尼的氘代产品，通过技术改良，可减少药物有毒代 谢物AZ5104的产生，这一技术优化使得甲磺酸艾多替尼片能够以160mg的 ...

Core Viewpoint - The announcement of the New Drug Application (NDA) acceptance for TY-9591, a new generation EGFR-TKI inhibitor targeting brain metastases from non-small cell lung cancer (NSCLC), marks a significant milestone for the company and the treatment landscape for lung cancer patients in China [1][3]. Group 1: Drug Development and Clinical Trials - The NDA for TY-9591 has been officially accepted by the National Medical Products Administration (NMPA) in China, making it the first new generation EGFR-TKI specifically for lung cancer brain metastases [1][3]. - The NDA submission is based on results from a pivotal clinical study (ESAONA) that evaluated the efficacy and safety of TY-9591 compared to Osimertinib in NSCLC patients with brain metastases [3][4]. - The interim analysis of the ESAONA study showed an intracranial objective response rate (iORR) of 92.8% for the TY-9591 group compared to 76.1% for the Osimertinib group, indicating a statistically significant difference [4]. Group 2: Company Strategy and Future Plans - The submission of the NDA for TY-9591 represents a critical milestone for the company, indicating its entry into the commercialization phase and its commitment to addressing unmet clinical needs in cancer treatment [6][8]. - The company plans to continue exploring combination therapies and further clinical research to meet the clinical demands of patients with advanced NSCLC [5][6]. - The company has developed over ten innovative products since its establishment in 2017, focusing on next-generation kinase inhibitors to fulfill unmet clinical needs in cancer treatment [8].

中国医学科学院肿瘤医院石远凯教授：肺癌脑转移是临床治疗的一大挑战，不仅严重影响患者的生活质量和神经认知功能，更是导致临床治疗失败和患者死 亡的主要原因之一。现有临床数据表明，艾多替尼单药治疗肺癌脑转移展示出令人鼓舞的临床疗效和良好的安全性，我们期待该药物能早日获批上市，为肺 癌脑转移患者带来更多的治疗选择。 2月6日，同源康医药-B(02410)宣布其自主研发的针对非小细胞肺癌(NSCLC)脑转移的甲磺酸艾多替尼片(TY-9591)新药上市申请(NDA)已获得中国国家药品 监督管理局(NMPA)药品审评中心(CDE)正式受理。这是首个针对肺癌脑转移的新一代EGFR-TKI抑制剂。 | 12547 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 受理品种目录浏览 | | 在审品种目录浏览 | | | | | | | 受理品种信息 | | | | | | | | | | 审评任务公示 | 年 | 2026 | レ 药品类型: | ਵਿੱਚ | ▼ 申请类型: | 全部 | V | 童训 | | | 受理号: ...

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its investigational drug, TY-9591, by the National Medical Products Administration (NMPA) in China, indicating a significant step towards potential market approval for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][2]. Group 1: Drug Development and Clinical Trials - TY-9591 is a deuterated derivative of Osimertinib, demonstrating high bioavailability and effective brain penetration [1]. - The NDA application targets adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, particularly those with CNS metastases [1]. - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data indicate excellent intracranial and overall response rates in NSCLC patients with brain metastases, showcasing significant clinical benefits and addressing unmet medical needs [1]. - Key Phase II clinical trial data (TYKM1601202) further confirm superior efficacy compared to Osimertinib, particularly in terms of intracranial response rates and overall clinical benefits [1]. Group 2: Clinical Value and Advantages - TY-9591 exhibits enhanced clinical value and advantages over Osimertinib in terms of chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2]. - The drug is expected to significantly improve disease prognosis for patients with EGFR mutation lung cancer and brain metastases [2].

Core Viewpoint - The company has received acceptance from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) of its investigational drug, TY-9591, which is a deuterated derivative of Osimertinib, targeting advanced or metastatic non-small cell lung cancer (NSCLC) patients with specific EGFR mutations [1][2] Group 1: Drug Development and Clinical Trials - TY-9591 is designed for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, along with CNS metastases [1] - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data have shown excellent intracranial and overall response rates in NSCLC patients with brain metastases, indicating significant clinical benefits and addressing unmet medical needs [1] - Key Phase II clinical trial data (TYKM1601202) further confirms the superior efficacy of TY-9591 over Osimertinib in terms of intracranial response rates and clinical benefits [1] Group 2: Clinical Value and Advantages - As a deuterated compound of Osimertinib, TY-9591 demonstrates enhanced clinical value and advantages across various aspects, including chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2] - The drug shows a significant improvement in disease prognosis for patients, highlighting its potential impact on treatment outcomes [2]

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its investigational drug, TY-9591, by the National Medical Products Administration (NMPA) in China, indicating a significant step towards potential market approval for treating advanced non-small cell lung cancer (NSCLC) with specific mutations [1][2]. Group 1: Drug Development and Clinical Trials - TY-9591 is a deuterated derivative of Osimertinib, demonstrating high bioavailability and effective brain penetration [1]. - The NDA application targets adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions (19DEL) or exon 21 (L858R) mutations, particularly those with CNS metastases [1]. - Phase I (TYKM1601101) and Phase II (TYKM1601201) clinical trial data indicate excellent intracranial and overall response rates in NSCLC patients with brain metastases, fulfilling unmet clinical needs [1]. - Key Phase II clinical trial data (TYKM1601202) further confirm the superior efficacy of TY-9591 over Osimertinib in terms of intracranial response rates and clinical benefits [1]. Group 2: Clinical Value and Advantages - TY-9591 shows significant clinical value and advantages in terms of chemical structure, pharmacological action, clinical efficacy, safety, and resistance mechanism analysis [2]. - The drug is expected to improve disease prognosis significantly for patients with EGFR mutation lung cancer and brain metastases [2].