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和黄医药(00013)启动ATTC候选药物HMPL-A251用于治疗实体瘤的全球临床开发
Zhi Tong Cai Jing· 2025-12-17 00:21
(原标题:和黄医药(00013)启动ATTC候选药物HMPL-A251用于治疗实体瘤的全球临床开发) 智通财经APP讯,和黄医药(00013)发布公告,启动HMPL-A251的全球I期临床开发项目。 HMPL-A251 是一款全球首创的PI3K/PIKK- HER2抗体靶向偶联药物("ATTC"),由高选择性、强效的 PI3K/PIKK抑制 剂作为有效载荷(payload)和人源化抗HER2 IgG1抗体通过可裂解的连接子(linker)偶联而成。研究将于美 国和中国开展。首名患者已于2025年12月16日于中国接受首次给药治疗。 这项首个人体试验是一项 I/IIa 期、开放标签、多中心临床研究,旨在评估HMPL-A251单药用于治疗不 可切除、伴有HER2 表达的晚期或转移性实体瘤成人患者。研究分为两个阶段:I 期剂量递增阶段和 IIa 期剂量扩展及优化阶段。研究的主要指标为HMPL-A251的安全性和耐受性 ,在I期部分确定最大耐受剂 量(MTD)和/或剂量扩展推荐剂量(RDE), 并进一步评估RDE下的安全性和初步疗效,及在IIa期部分确 定II期(RP2D)或III期(RP3D)临床试验推荐剂量。次要 ...
和黄医药启动ATTC候选药物HMPL-A251用于治疗实体瘤的全球临床开发
Zhi Tong Cai Jing· 2025-12-17 00:21
和黄医药(00013)发布公告,启动HMPL-A251的全球I期临床开发项目。HMPL-A251是一款全球首创的 PI3K/PIKK-HER2抗体靶向偶联药物("ATTC"),由高选择性、强效的PI3K/PIKK抑制剂作为有效载荷 (payload)和人源化抗HER2IgG1抗体通过可裂解的连接子(linker)偶联而成。研究将于美国和中国开展。 首名患者已于2025年12月16日于中国接受首次给药治疗。 这项首个人体试验是一项I/IIa期、开放标签、多中心临床研究,旨在评估HMPL-A251单药用于治疗不 可切除、伴有HER2表达的晚期或转移性实体瘤成人患者。研究分为两个阶段:I期剂量递增阶段和IIa期 剂量扩展及优化阶段。研究的主要指标为HMPL-A251的安全性和耐受性,在I期部分确定最大耐受剂量 (MTD)和/或剂量扩展推荐剂量(RDE),并进一步评估RDE下的安全性和初步疗效,及在IIa期部分确定II 期(RP2D)或III期(RP3D)临床试验推荐剂量。次要指标包括初步抗肿瘤活性、药代动力学特征以及 HMPL-A251的免疫原性。 HMPL-A251是和黄医药新一代ATTC平台旗下首个进入临床开发 ...
和黄医药(00013.HK):启动ATTC候选药物HMPL-A251用于治疗实体瘤的全球临床开发
Ge Long Hui· 2025-12-17 00:11
Core Viewpoint - Hutchison China MediTech Limited (00013.HK) has announced the initiation of global Phase I clinical development for HMPL-A251, a first-in-class PI3K/PIKK-HER2 antibody-drug conjugate (ATTC) [1] Group 1 - HMPL-A251 is composed of a highly selective and potent PI3K/PIKK inhibitor as the payload and a humanized anti-HER2 IgG1 antibody linked by a cleavable linker [1] - The clinical study will be conducted in both the United States and China [1] - The first patient received the initial dose of treatment on December 16, 2025, in China [1]
和黄医药(00013) - 自愿性公告 - 和黄医药启动ATTC候选药物HMPL-A251用於治疗实...

2025-12-17 00:01
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) 和黃醫藥啓動ATTC候選藥物HMPL-A251用於治療實體瘤的全球臨床開發 — 新一代 ATTC 平台下候選藥物首次進入人體臨床試驗 ― ― 中國與全球同步臨床開發策略,加速推進研發進程 ― 和黃醫藥(中國)有限公司(簡稱「和黃醫藥」或 「HUTCHMED」)今日宣佈啟動HMPL-A251的全球I期臨床開發 項目。 HMPL-A251 是一款全球首創的PI3K/PIKK- HER2抗體靶向偶聯藥物(「ATTC」),由高選擇性、強效的 PI3K/PIKK抑制劑作為有效載荷(payload)和人源化抗HER2 IgG1抗體通過可裂解的連接子(linker)偶聯而成。 研究將於美國和中國開展。首名患者已於2025年12月16日於中國接受首次給藥治療。 這項首個人體試驗是一項 I/IIa 期、開放標簽、多 ...
HUTCHMED Initiates Global Clinical Development of ATTC Candidate HMPL-A251 in Patients with Solid Tumors
Globenewswire· 2025-12-17 00:00
— First-in-human trial of candidate from the next-generation ATTC platform — — Simultaneous China and global clinical development strategy to expedite development process — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy Conjugate (“ATTC”) comprising a highl ...
行业ESG周报:中法进一步加强气候与环境合作,我国人为碳排放总量增幅显著收窄-20251212
GUOTAI HAITONG SECURITIES· 2025-12-12 09:13
Investment Rating - The report does not explicitly provide an investment rating for the industry Core Insights - The report highlights the strategic cooperation between China and France in addressing global climate and environmental challenges, emphasizing the importance of multilateralism and the implementation of international agreements such as the Paris Agreement [5][6][9] - The report indicates that China's carbon emissions growth has significantly slowed, with a 0.6% increase in 2024 compared to 2023, which is lower than the global average of 0.8% [17][19] - The establishment of a green foreign debt pilot program in Shanghai aims to support "dual carbon" key enterprises, with over 300 million RMB in financing for green technology projects [20][22] Policy Developments - China and France issued a joint statement on climate cooperation during President Macron's visit, reaffirming their commitment to international climate agreements and cooperation in various areas such as carbon pricing and methane reduction [5][6][7] - The China Securities Regulatory Commission (CSRC) is seeking public opinion on a draft regulation aimed at enhancing corporate governance and investor protection in listed companies [11][12][13] Industry Trends - The Ministry of Ecology and Environment released the "2025 China Mobile Source Environmental Management Annual Report," indicating that mobile sources are a significant contributor to air pollution, with total emissions reaching 18.582 million tons in 2024 [14][15][16] - The "2024 China Greenhouse Gas Bulletin" shows that China's anthropogenic carbon emissions increased by approximately 0.6% in 2024, reflecting effective implementation of carbon reduction commitments [17][19] - The Shanghai branch of the State Administration of Foreign Exchange has initiated a green foreign debt pilot program, with three key enterprises signing agreements to raise over 300 million RMB for green projects [20][22] International Events - The United Nations Environment Programme (UNEP) released the 2025 Climate Adaptation Gap Report, highlighting a significant funding gap for climate adaptation in developing countries [24][25] - Former President Trump announced plans to roll back fuel economy standards, which could impact environmental progress in the U.S. automotive industry [26][27][28] - Germany's government has agreed to construct hydrogen-compatible gas power plants, potentially delaying the coal phase-out process [29] Corporate Developments - China Gas and EVE Energy have entered a strategic partnership to collaborate on energy storage and green energy projects [30][31] - Hutchison Whampoa has been recognized as an "ESG Leading Company" for three consecutive years, reflecting its commitment to sustainability and responsible governance [32][33]
2025年医保谈判结果点评:医保平稳商保可期,国产创新药龙头胜出
Orient Securities· 2025-12-10 00:45
Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry, indicating an expected return that is stronger than the market benchmark by over 5% [5]. Core Insights - The National Medical Insurance Administration is strongly encouraging the high-quality development of innovative drugs, with clear policies supporting the payment side for innovative drugs. Domestic leading innovative drug companies are entering a commercial realization phase [3][7]. - The 2025 National Medical Insurance Drug List includes 127 products, with 114 successfully added, of which 50 are innovative drugs, marking a historical high. The overall negotiation success rate reached 90%, the highest in nearly seven years [7]. - The report highlights that the domestic innovative drug market is becoming increasingly concentrated, with leading companies like Heng Rui and Xin Da Biotech significantly benefiting from the new insurance policies [7]. Summary by Sections Investment Recommendations and Targets - Recommended stocks include Heng Rui Pharmaceutical (600276, Buy), Ke Lun Pharmaceutical (002422, Buy), Xin Li Tai (002294, Hold), Ao Sai Kang (002755, Buy), Jing Xin Pharmaceutical (002020, Buy), and others [3]. Market Dynamics - The report notes that the introduction of the commercial insurance directory marks the beginning of a "new golden decade" for Chinese innovative drugs, with a focus on high clinical efficacy and value innovation [7]. - The report emphasizes that the competition in the GLP-1 market remains clear, with the entry of new drugs not significantly altering the competitive landscape for existing treatments [7].
港股公告掘金 | 果下科技拟全球发售3385.29万股H股 引入惠开香港等基石投资者
Zhi Tong Cai Jing· 2025-12-08 15:25
Major Events - GuoXia Technology (02655) plans to conduct an IPO from December 8 to December 11, offering 33.85 million H-shares and introducing cornerstone investors such as Huikai Hong Kong [1] - Basilea Pharmaceutica AG (02616) has its drug Pujihua® (Pralsetinib Capsules) included in the National Medical Insurance Directory for 2025 [1] - Four Seasons Pharmaceutical (00460) sees its innovative drug XuanYueNing® included in the National Basic Medical Insurance Drug List for the first time [1] - Shanghai Pharmaceuticals (02607) successfully negotiates and includes Amisulpride Orally Disintegrating Tablets in the National Medical Insurance Directory [1] - Hansoh Pharmaceutical (03692) has its innovative drug Amelotex® approved for two new indications in the updated 2025 National Medical Insurance Directory [1] - Xiansheng Pharmaceutical (02096) sees EnzeShu® and EnDu® included in the updated National Medical Insurance Drug List [1] - Hutchison China MediTech (00013) has its drug Tazverik® included in the first edition of the National Commercial Health Insurance Innovative Drug List [1] - XuanZhu Biotechnology (02575) has its innovative drug XuanYueNing® included in the National Basic Medical Insurance Drug List for the first time [1] - Yino Pharmaceutical (02591) has its H-shares included in the list of eligible securities for the Shanghai-Hong Kong and Shenzhen-Hong Kong Stock Connect [1] - China Metallurgical Group (01618) and its subsidiaries plan to sell non-core business assets for approximately 60.68 billion yuan, focusing on core businesses in metallurgical engineering, non-ferrous metals, and mining engineering [1] - Cambridge Technology (06166) intends to invest a total of 405 million yuan to acquire and subscribe for shares in the Yangzhong Happiness Home Venture Capital Partnership Fund [1] Operating Performance - Dongfeng Motor Group (00489) reports cumulative automobile sales of 1.697 million units in the first 11 months, a year-on-year decrease of approximately 0.3% [2] - New天绿色能源 (00956) achieves a cumulative power generation of 1,336.89 million MWh in the first 11 months, an increase of 8.04% year-on-year [2] - Longyuan Power (00916) reports a cumulative power generation of approximately 6,909.64 million MWh in the first 11 months, a year-on-year growth of 0.41% [2] - Baolong Real Estate (01238) records a total contract sales of approximately 6.666 billion yuan in the first 11 months, a year-on-year decline of 43.2% [2]
和黄医药:达唯珂 (TAZVERIK )获纳入首版国家商业健康保险创新药品目录
Zhi Tong Cai Jing· 2025-12-08 09:48
分时图 日K线 周K线 月K线 21.96 -0.04 -0.18% 1.82% 1.23% 0.59% 0.00% 0.59% 1.23% 1.82% 21.60 21.73 21.87 22.00 22.13 22.27 22.40 09:30 10:30 12:00/13:00 14:00 16:10 0 3万 7万 10万 和黄医药(00013)发布公告,经过与中国国家医疗保障局(国家医保局)的医保续约,爱优特(ELUNATE)、 沃瑞沙(ORPATHYS)和苏泰达(SULANDA)将继续获纳入自2026年1月1日起生效的新版《国家基本医疗 保险、工伤保险和生育保险药品目录》(国家医保药品目录)。此外,达唯珂(TAZVERIK)获纳入首版国 家商业健康保险创新药品目录(简称商保创新药目录)。 和黄医药 ...
和黄医药:达唯珂 获纳入首版国家商业健康保险创新药品目录
Zheng Quan Shi Bao Wang· 2025-12-08 09:48
和黄医药公告称,其三款药品(爱优特、沃瑞沙和苏泰达)已成功续约,将继续被纳入2026年1月1日生效 的新版国家医保药品目录。同时,达唯珂还成功进入首版国家商业健康保险创新药品目录。 和黄医药 分时图 日K线 周K线 月K线 21.96 -0.04 -0.18% 1.82% 1.23% 0.59% 0.00% 0.59% 1.23% 1.82% 21.60 21.73 21.87 22.00 22.13 22.27 22.40 09:30 10:30 12:00/13:00 14:00 16:10 0 3万 7万 10万 ...