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].

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。 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） （股份代號：2410） 自願公告 甲磺酸艾多替尼片（TY-9591片）的新藥上市申請 獲國家藥品監督管理局受理 浙江同源康醫藥股份有限公司（「本公司」，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。 本公司董事會（「董事會」）欣然宣佈，本公司在研1類新藥甲磺酸艾多替尼片 （TY-9591片）的新藥上市申請（「NDA」）被國家藥品監督管理局（「NMPA」）藥品 審評中心（「CDE」）受理。現將相關情況公告如下： 甲磺酸艾多替尼片（TY-9591片）為奧希替尼的氘代物，生物利用度高，入腦效 果好，本次NDA註冊申報適應症為具有EGFR外顯子19缺失(19DEL)或外顯子 21(L858R)置換突變，並伴有CNS轉移的局部晚期或轉移性NSCLC成人患 ...