Core Insights - The company, Tongyuan Kang Pharmaceutical-B (02410.HK), announced that its innovative drug, Aiduotini Tablets (TY-9591), for treating EGFR-mutated non-small cell lung cancer (NSCLC), has had its key Phase II registration clinical trial results accepted for a mini oral report at the 2025 World Lung Cancer Conference (WCLC) [1][2] - Aiduotini Tablets (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs for brain metastases in NSCLC under current treatment standards [1] Study Details - 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) against Osimertinib (80mg once daily) in treatment-naive EGFR-sensitive mutation patients with brain metastases [2] - Primary endpoints include intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS), while secondary endpoints encompass overall response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), depth of tumor response (DepOR), and safety indicators [2] - Interim analyses will occur twice: the first when 220 evaluable intracranial lesions are reached, and the second upon reaching 238 iPFS events, with final analysis conducted after all iPFS events are completed [2] - If primary endpoints are met, the first interim analysis data will be used to submit relevant materials to the National Medical Products Administration (NMPA) for conditional market approval, while the final data analysis will support the application for full market approval of Aiduotini Tablets [2]

TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 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。 （股份代號：2410） 自願性公告 EGFR靶向創新藥艾多替尼在腦轉移肺癌患者中展現突破性療效—— WCLC 2025公佈ESAONA關鍵註冊研究中期結果 本公告乃由浙江同源康醫藥股份有限公司（「本公司」或「同源康醫藥」，連同其附 屬公司統稱「本集團」）自願刊發，以告知本公司股東及潛在投資者有關本集團最 新業務發展的資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，其自主研發的創新藥物艾多替尼 片(TY-9591)治療EGFR變異型非小細胞肺癌(NSCLC)的關鍵性II期註冊臨床試驗 (NCT05948813)結果，已在國際肺癌研究協會(IASLC)舉辦的2025年世界肺癌會 議(WCLC)上被接受為mini oral報告(MA08.06)，並將在會議期間由主要研究者北 京醫學科學院腫瘤醫院 ...