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].

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]

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 ...

Core Viewpoint - Company completed the placement agreement conditions and successfully placed 9.23 million shares at a price of HKD 17.01 per share, raising approximately HKD 157 million in total proceeds [1] Fund Allocation - Approximately 60% of the net proceeds from the placement, around HKD 93 million, will be used for the research and commercialization of existing pipelines [1] - About 30% of the net proceeds, approximately HKD 46.5 million, will be allocated to enhance internal research capabilities and expand the product portfolio [1] - The remaining 10% of the net proceeds, around HKD 15.5 million, will be utilized for working capital and general corporate purposes [1]

配售事项所得款项总额约为1.57亿港元，而配售事项所得款项净额约为1.55亿港元。公司拟按如下方式 分配配售事项所得款项净额：配售事项所得款项净额的约60%用于现有管线的研发及商业化;配售事项 所得款项净额的约30%用于加强其内部研发技术能力及扩展其产品组合;及配售事项所得款项净额的约 10%用于营运资金及一般企业用途。 智通财经APP讯，同源康医药-B(02410)发布公告，配售协议所载的所有条件已获达成并于2025年8月4日 完成。配售代理已按每股配售股份17.01港元的配售价成功配售合共923万股配售股份予不少于六名承配 人。 ...

Group 1 - The company announced that all conditions of the placement agreement have been met and completed on August 4, 2025 [1] - The placement agent successfully placed a total of 9.23 million shares at a price of HKD 17.01 per share to no less than six subscribers [1]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 浙江同源康醫藥股份有限公司 呈交日期： 2025年8月4日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 02410 | 說明 | H股 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | | 已發行股份（ ...

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聲明，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。 本公告僅供參考，並不構成收購、購買或認購任何證券的邀請或要約，亦並非擬用作邀請提出 相關要約或邀請。本公告或其任何副本概不得直接或間接帶入美國或於美國（包括其領土及屬 地、美國任何州及哥倫比亞特區）派發。尤其是，本公告並不構成亦並非在美國或其他地方出 售證券的要約或招攬購買或認購證券的任何要約。除非已根據1933年美國證券法（經修訂）登記 或獲豁免登記，否則證券不得在美國提呈發售或出售。於美國進行的任何證券公開發售將僅以 招股章程的方式進行，該招股章程可向發行人或出售證券持有人取得，並載有發行人及管理層 的詳細資料以及財務資料。本公司無意於美國公開發售本公告所述證券。 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） 完成根據一般授權配售新H股 配售代理 完成配售 本公司欣然宣佈，配售協議所載的所有條件已獲達成並於2025 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非上巿股份 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 4,608,000 | RMB | | 1 | RMB | | 4,608,000 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 4,608,000 | RMB | | 1 | RMB | | 4,608,000 | 本月底法定/註冊股本總額： RMB 370,835,818 公司名稱: 浙江同源康醫藥股份有限公司 (於中華人民共 ...