Market Performance - The Hong Kong stock market indices continued to decline, with the Hang Seng Index falling by 0.57% to 24,980.20, the Hang Seng China Enterprises Index down by 0.67% to 8,945.88, and the Hang Seng Tech Index dropping by 1.26% to 5,472.25, marking a breach of the 25,000-point threshold again [1]. Sector Performance - Large technology stocks showed weak performance, with Kuaishou down nearly 5%, Alibaba down 1.6%, JD.com down 1.46%, and Baidu down 1%. Tencent, NetEase, Meituan, and Xiaomi also experienced declines [3]. - The pharmaceutical sector faced significant adjustments, particularly in internet healthcare and innovative drug stocks, with Tongyuan Kangyi falling nearly 22%, and other notable declines from Gilead Sciences, Nuo Cheng Jianhua, and Fosun Pharma [3]. - Chinese brokerage stocks were collectively weak, with Hongye Futures and Dongfang Securities showing notable declines [3]. Notable Stock Movements - Fuyao Glass surged nearly 14% following its earnings report, indicating strong performance in the glass manufacturing sector [3]. - New consumption concept stocks saw a rise, particularly Pop Mart, which increased by 8.6%, surpassing the 300 HKD mark for the first time [3].

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, TY-9591, for a key II phase registration clinical trial report at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Company Developments - The company announced that its self-developed innovative drug, TY-9591, targets EGFR mutation-type non-small cell lung cancer (NSCLC) and has shown promising results in clinical trials [1] - TY-9591 is a highly selective small molecule inhibitor aimed at addressing unmet clinical needs for NSCLC patients with brain metastases under current treatment standards [1] Group 2: Clinical Trial Results - Research indicates that TY-9591, as a new generation EGFR-TKI, demonstrates superior efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for EGFR mutation NSCLC patients with brain metastases [1]

Group 1 - The core viewpoint of the article highlights the positive impact of rising expectations for interest rate cuts in the US on the biotechnology sector, leading to a significant increase in the S&P Biotechnology Index by 2.89% [1] - The Hong Kong pharmaceutical sector continues to show strong performance, with the Hong Kong Pharmaceutical ETF (159718.SZ) rising by 0.38% [1] - Notable individual stock performances include a 6.22% increase for Simcere Pharmaceutical Group (02410), a 3.34% rise for BeiGene (06160), and a 2.29% increase for Kelun-Biotech (06990) [1] Group 2 - The liquidity in the market is robust, with the Hong Kong Pharmaceutical ETF seeing a turnover of 13.3% and a transaction volume of 36.42 million yuan within the first 20 minutes of trading [1] - Guotai Junan Securities has stated that China's innovative drugs are on the rise, entering the initial phase of realizing innovation results, with significant opportunities for independent development and large transactions through business development (BD) licensing [1] - The Hong Kong Pharmaceutical ETF focuses on 18 A-share biotechnology companies, including key innovative drug firms such as BeiGene, WuXi Biologics, and CSPC Pharmaceutical Group, benefiting from global innovation drug research dividends [1] Group 3 - The article emphasizes the favorable conditions for the innovative drug growth sector due to the anticipated US interest rate cuts, which are expected to benefit the domestic innovative drug companies as they expand internationally [1] - The recommendation is to pay attention to the Hong Kong Pharmaceutical ETF (159718.SZ) and its associated funds (Class A: 019598, Class C: 019599) as they are positioned to capitalize on these trends [1]

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, Aditinib (TY-9591), for a key Phase II registration clinical trial in treating EGFR-mutant non-small cell lung cancer (NSCLC) [1] Company Summary - The company's stock rose over 10% in early trading and is currently up 4.78%, priced at 18.2 HKD with a trading volume of 32.2051 million HKD [1] - Aditinib (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] - The drug has shown excellent efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for EGFR-mutant NSCLC patients with brain metastases [1] Industry Summary - The acceptance of the clinical trial results at the 2025 World Lung Cancer Conference (WCLC) highlights the ongoing advancements in targeted therapies for lung cancer, particularly for patients with specific genetic mutations [1] - The focus on brain metastases in NSCLC treatment reflects a growing recognition of the need for effective therapies in this challenging area of oncology [1]

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, TY-9591, for a key Phase II clinical trial report at the 2025 World Lung Cancer Conference (WCLC) [1] Company Summary - The company reported a stock price increase of over 10% in early trading, with a current price of 18.2 HKD and a trading volume of 32.21 million HKD [1] - TY-9591 is a highly selective small molecule inhibitor targeting classic EGFR mutations, aimed at addressing unmet clinical needs in non-small cell lung cancer (NSCLC) with brain metastases [1] - The research indicates that TY-9591 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 [1] Industry Summary - The acceptance of TY-9591's clinical trial results at an international conference highlights the ongoing advancements in targeted therapies for NSCLC, particularly for patients with brain metastases [1] - The focus on EGFR mutations in NSCLC reflects a broader trend in oncology towards personalized medicine and the development of innovative treatments to meet specific patient needs [1]

Core Viewpoint - The announcement highlights the promising results of the innovative drug Eltotinib (TY-9591) developed by the company for treating EGFR-mutated non-small cell lung cancer (NSCLC) with brain metastases, which has been accepted for presentation at the 2025 World Lung Cancer Conference [1][2]. Group 1: Clinical Trial Details - The ESAONA trial is an open-label, multi-center, randomized Phase II study focusing on patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing Eltotinib (160mg once daily) with Osimertinib (80mg once daily) [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 be conducted twice, with the first at 220 evaluable intracranial lesions and the second at 238 iPFS events, with final analysis upon reaching all iPFS events [2]. Group 2: Study Results - As of February 28, 2025, the study enrolled 257 patients with EGFR-mutated NSCLC and brain metastases, with interim analysis based on 224 subjects showing an iORR of 91.9% in the Eltotinib group compared to 76.1% in the Osimertinib group (P=0.001) [3]. - Investigator-assessed iORR was 91.0% for Eltotinib versus 75.2% for Osimertinib (P=0.002), and the overall response rate (ORR) was 84.7% for Eltotinib compared to 75.2% for Osimertinib [3]. - The study indicates that Eltotinib demonstrates superior efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for patients with EGFR-mutated NSCLC and brain metastases [3].

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 ...