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和黄医药(00013) - 和黄医药於AACR-NCI-EORTC分子靶向和癌症治疗国际会议上公佈H...

2025-10-23 00:00
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 對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。 HUTCHMED (China) Limited 和黃醫藥(中國)有限公司 和黃醫藥於AACR-NCI-EORTC分子靶向和癌症治療國際會議上公佈HMPL-A251數據 — 首個利用和黃醫藥ATTC技術平台打造的研究性候選藥物,搭載強效的靶向有效載荷並降低相關毒性 — ― 獨特的強效PI3K/PIKK抑制劑有效載荷,經過優化可充分發揮抗體偶聯物的優勢, 具有定向遞送及游離有效載荷血漿暴露量低的特點 — ― 臨床前數據顯示其具有強大的抗腫瘤活性,並具有協同作用和旁觀者殺傷效應 — (於開曼群島註冊成立的有限公司) (股份代號:13) 自願性公告 和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或 「HUTCHMED」)於2025年10月22至26日在美國波士頓舉行的 AACR-NCI-EORTC分子靶向和癌症治療國際會議上公佈HMPL-A251的臨床前數據。HMPL-A251是一款全球首創的 PI3K/AKT/m ...
HUTCHMED Highlights HMPL-A251 Data Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-23 00:00
Core Insights - HUTCHMED announced preclinical data for HMPL-A251, a first-in-class PI3K/AKT/mTOR-HER2 Antibody-Targeted Therapy Conjugate, at the AACR-NCI-EORTC International Conference, showcasing its potential in cancer treatment [1][5] Summary by Sections Drug Candidate Overview - HMPL-A251 utilizes HUTCHMED's ATTC technology platform to create targeted therapy payloads while reducing associated toxicities [1] - The drug is designed to exploit the advantages of antibody-conjugates, featuring a highly potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody [1][2] Mechanism of Action - The PI3K/PIKK inhibitor payload demonstrated high potency and selectivity across 130 tumor cell lines, inducing apoptosis in HER2-positive cells regardless of PAM pathway alterations [3] - HMPL-A251 showed a bystander effect on HER2-null cells when co-cultured with HER2-positive cells, indicating its broad anti-tumor activity [3] Efficacy and Safety - In vivo studies revealed that HMPL-A251 had superior anti-tumor efficacy and tolerability compared to traditional naked antibodies and payloads [4] - A single intravenous dose of HMPL-A251 led to tumor regression in various models, with efficacy correlating strongly with payload concentration and target inhibition [4] Comparison with Existing Treatments - When compared to T-DXd (trastuzumab deruxtecan), HMPL-A251 achieved superior or comparable efficacy at equivalent doses in most tested models [4] - The plasma exposure of free payload was significantly lower than for HMPL-251, suggesting reduced toxicity [4] Future Development Plans - HUTCHMED plans to initiate global clinical trials for HMPL-A251 by the end of 2025, with additional Investigational New Drug filings for more ATTC candidates in 2026 [5] ATTC Platform Insights - The ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with small-molecule inhibitor payloads for enhanced anti-tumor activity and safety [6][7] - This platform aims to overcome challenges associated with traditional small-molecule inhibitors and improve long-term safety and efficacy in cancer treatments [7] Company Background - HUTCHMED is a commercial-stage biopharmaceutical company focused on the discovery and development of targeted therapies and immunotherapies for cancer and immunological diseases [8]
2025年中国生物创新药市场跟踪报告:呋喹替尼6月市场动向
Tou Bao Yan Jiu Yuan· 2025-10-16 13:59
Investment Rating - The report indicates a strong performance in the biopharmaceutical innovation sector, particularly highlighting the significant growth in the Hong Kong innovation drug sector, which saw a cumulative increase of 59.51% in the first half of 2025, outperforming both A-shares and the Hang Seng Index [7]. Core Insights - The report emphasizes the impressive sales performance of Fitinib in China, with a notable increase in sales from 2019 to 2024, despite a temporary decline in the first half of 2025 due to intensified market competition and strategic adjustments [9][10]. - Fitinib has received multiple approvals in major markets, including the U.S., Europe, and Japan, with sales expected to continue growing due to expanding indications and deeper market penetration [17][18]. - The report highlights the clinical efficacy of Fitinib in treating metastatic colorectal cancer, demonstrating significant improvements in overall survival (OS) and progression-free survival (PFS) compared to other treatments [22][24]. Summary by Sections Market Dynamics - Fitinib's sales in China have shown an upward trend from 2019 to 2024, with a peak sales figure of 115 million USD in 2024, although the first half of 2025 saw a decline to 43 million USD, a 29% decrease year-on-year due to market competition and strategic changes [9][10]. - The report notes that the sales volume in hospitals increased from 13,000 boxes in 2021 to 24,100 boxes in 2024, indicating a growing market acceptance [9]. Competitive Landscape - The competitive landscape for Fitinib is characterized by aggressive bidding strategies, with the company actively participating in tenders across multiple provinces in China, leading to significant price reductions post-medical insurance negotiations [14][15]. - The report outlines the pricing dynamics, showing a substantial price drop of 68% in the first year after Fitinib was included in the medical insurance list, with ongoing negotiations further driving prices down [15]. Clinical Performance - Fitinib has shown superior clinical outcomes in treating metastatic colorectal cancer, with the FRESCO-2 trial reporting a median OS of 7.4 months compared to 4.8 months for the placebo group, and a median PFS of 3.7 months versus 1.8 months [22][24]. - The report also highlights the potential of Fitinib in treating gastric cancer, where it has demonstrated promising efficacy compared to other available treatments [26][29]. Pipeline and Future Prospects - Fitinib's pipeline includes various ongoing studies targeting multiple cancer indications, with several trials reaching significant endpoints or receiving regulatory approval, indicating a robust development trajectory [29]. - The report mentions a licensing agreement with Takeda for global commercialization outside of China, which includes an upfront payment of 400 million USD, showcasing the drug's potential in international markets [19].
和黄医药(00013) - 董事名单及其角色与职能

2025-10-15 08:35
董事名單及其角色與職能 和黃醫藥(中國)有限公司董事會由 10 名董事組成,載列如下: 主席兼非執行董事 Dr Dan Eldar(艾樂德博士) 執行董事 蘇慰國博士 (首席執行官* 兼首席科學官) 鄭澤鋒先生 (代理首席執行官兼首席財務官) 非執行董事 HUTCHMED (China) Limited 和黃醫藥(中國)有限公司 (於開曼群島註冊成立的有限公司) (股份代號:13) 莫樹錦教授 (高級兼首席獨立非執行董事) Dr Renu BHATIA(言思雅醫生) Dr Chaohong HU(胡朝紅博士) 陳邵文教授 黃德偉先生 下表提供董事會成員在委員會中之職務。 | 董事委員會 | 審核委員會 | 提名委員會 | 薪酬委員會 | 可持續發展 | 技術委員會 | | --- | --- | --- | --- | --- | --- | | 董事 | | | | 委員會 | | | 艾樂德 | - | M | - | - | M | | 蘇慰國 | - | - | - | - | M | | 鄭澤鋒 | - | - | - | M | - | | 施熙德 | - | - | M | C | - | | ...
和黄医药(00013.HK)委任陈邵文为独立非执行董事

Ge Long Hui· 2025-10-14 08:44
Core Viewpoint - Hutchison China MediTech Limited (00013.HK) announced the appointment of Chen Shaowen as an independent non-executive director and a member of the Technical Committee, effective from October 15, 2025 [1] Group 1 - The appointment of Chen Shaowen is aimed at enhancing the governance and technical expertise within the company [1]
和黄医药:陈邵文获委任为独立非执行董事及技术委员会成员
Zhi Tong Cai Jing· 2025-10-14 08:39
Core Viewpoint - The announcement by Hutchison China MediTech Limited (和黄医药) regarding the appointment of Professor Chen Shaowen as an independent non-executive director and a member of the technical committee, effective from October 15, 2025 [1] Group 1 - Professor Chen Shaowen has been appointed to enhance the company's governance and technical expertise [1]
和黄医药(00013):陈邵文获委任为独立非执行董事及技术委员会成员

智通财经网· 2025-10-14 08:33
Core Points - Professor Chen Shaowen has been appointed as an independent non-executive director and a member of the technical committee of Hutchison China MediTech Limited, effective from October 15, 2025 [1]
和黄医药(00013) - 和黄医药宣佈委任独立非执行董事及董事委员会成员

2025-10-14 08:30
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 對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。 HUTCHMED (China) Limited 和黃醫藥(中國)有限公司 (於開曼群島註冊成立的有限公司) (股份代號:13) 和黃醫藥宣佈委任獨立非執行董事及董事委員會成員 和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或「本公司」)今天宣佈,陳邵文教授獲委任為本公司獨立非執行 董事及技術委員會成員,自2025年10月15日起生效。 陳教授,47歲,在腫瘤學擁有超過20年經驗,主要研究領域針對胸腔、頭頸部惡性腫瘤及藥物開發。他目前擔任新 加坡國家癌症中心(「NCCS」)臨床試驗與流行病學科學部主管,並為醫學腫瘤科的高級顧問。他是杜克-新加坡 國立大學醫學院教授,並擔任新加坡基因組研究院高級臨床科學家。 和黃醫藥主席艾樂德博士表示:「本人謹代表董事會熱烈歡迎陳教授。陳教授在新型療法早期臨床試驗方面的往績 卓越 ,而我們相信,他在標靶治療、生物標記開發及臨床腫瘤學方面的專業知識,將大力支持本公司的策略增長, ...
裕元集团年内综合营收超60亿美元 新城发展前三季销售额同比下滑逾5成
Xin Lang Cai Jing· 2025-10-13 13:24
Company News - Yuanshan Group (00551.HK) reported a cumulative operating income of approximately $6.017 billion for the first nine months, a decrease of 1% year-on-year [2] - Baoshan International (03813.HK) recorded a cumulative operating income of 12.903 billion yuan for the first nine months, down 7.7% year-on-year [2] - Longyuan Power (00916.HK) achieved a cumulative power generation of 56,546,706 MWh in the first nine months, a decline of 0.53% year-on-year; excluding the impact of thermal power, there was a year-on-year increase of 13.81%, with wind power up 5.30% and solar power up 77.98% [2] Financial Performance - Qinhuangdao Port Co., Ltd. (03369.HK) reported a total throughput of 317 million tons for the first nine months, an increase of 5.56% year-on-year [3] - New China Life Insurance (01336.HK) expects net profit attributable to shareholders for the first three quarters to be between 29.986 billion yuan and 34.122 billion yuan, representing a year-on-year growth of 45% to 65% [3] - Jiangshan Holdings (00295.HK) reported a total power generation of approximately 238,787 MWh for the first nine months, a decrease of 4.83% year-on-year [3] - Morning News Technology (02000.HK) reported an unaudited revenue of 270 million HKD for the first nine months, down 7.6% year-on-year [3] - Dekang Agriculture and Animal Husbandry (02419.HK) sold approximately 7.5509 million pigs in the first nine months, with sales revenue of approximately 14.277 billion yuan [3] Drug Approvals and Developments - Hengrui Medicine (01276.HK) received a clinical trial approval notice for SHR-A2102, a targeted Nectin-4 antibody-drug conjugate (ADC) developed in-house; global sales for similar products are expected to reach approximately $1.949 billion in 2024 according to EvaluatePharma [3] - Hutchison China MediTech (00013.HK) plans to announce FRUSICA-2 registration study data at the 2025 European Society for Medical Oncology annual meeting [3] - CSPC Pharmaceutical Group (01093.HK) had its new drug application for Idaglutide α injection accepted by the National Medical Products Administration [3] Corporate Actions - Huazhen Medical (01931.HK) announced the acquisition of U.S. properties and the establishment of a U.S. subsidiary, ETHK BANK, to promote stablecoins and intellectual property securitization in the U.S. [3] - Lihigh Holdings (08472.HK) plans to invest 24 million HKD in cryptocurrency and commodities [3] - Hisense Home Appliances (00921.HK) and its subsidiaries subscribed to a financial product from Jingu Trust worth 1.739 billion HKD [3] Real Estate Performance - New Town Development (01030.HK) reported cumulative contract sales of 15.050 billion yuan for the first nine months, a decrease of 52.72% year-on-year [3] - Longfor Group (00960.HK) achieved total contract sales of 50.75 billion yuan in the first nine months [3] - CIFI Holdings Group (00884.HK) reported cumulative contract sales of approximately 13.06 billion yuan for the first nine months [3] - Ronshine China Holdings (03301.HK) reported contract sales of 3 billion yuan for the first nine months, down 45.3% year-on-year [3] - Yuzhou Group (01628.HK) reported cumulative sales of 4.913 billion yuan for the first nine months [3] - Yida China (03639.HK) reported contract sales of approximately 572 million yuan for the first nine months, down 24.74% year-on-year [3] Financing and Buyback Activities - Geely Automobile (00175.HK) was approved to issue debt financing instruments totaling no more than 10 billion yuan [3] - HSBC Holdings (00005.HK) repurchased 1.58 million HKD worth of shares at prices ranging from 102.2 to 103.77 HKD [3] - Xiaomi Group-W (01810.HK) repurchased 400 million HKD worth of shares at prices ranging from 47.82 to 50.55 HKD [3] - Shoucheng Holdings (00697.HK) repurchased 890 million HKD worth of shares at prices ranging from 2.21 to 2.27 HKD [3]
和黄医药(00013)将于2025年欧洲肿瘤内科学会年会公布FRUSICA-2注册研究数据
智通财经网· 2025-10-13 04:15
Core Viewpoint - The FRUSICA-2 study results indicate that the combination of fruquintinib and sintilimab may provide a valuable new treatment option for patients with advanced renal cell carcinoma, addressing significant unmet medical needs in this patient population [1][3]. Group 1: Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial aimed at evaluating the efficacy and safety of fruquintinib combined with sintilimab compared to axitinib or everolimus monotherapy for second-line treatment of advanced renal cell carcinoma [1]. - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy [1]. Group 2: Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab group was 22.2 months, compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio (HR) of 0.373 and a p-value of <0.0001 [2]. - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy, with an odds ratio of 4.622 and a p-value of <0.0001 [2]. - The median duration of response (DoR) was 23.7 months for the combination group compared to 11.3 months for the monotherapy group [2]. Group 3: Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments, with 71.4% of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) compared to 58.8% in the axitinib/everolimus group [2]. Group 4: Regulatory Progress - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3].