Core Viewpoint - Hutchison China MediTech Limited (HCM) has initiated global Phase I clinical development for HMPL-A251, a first-in-class PI3K/PIKK-HER2 antibody-drug conjugate (ATTC) designed to target HER2-expressing tumors [1][2]. Group 1: Clinical Development - The Phase I/IIa trial is an open-label, multicenter study aimed at evaluating the safety and efficacy of HMPL-A251 in adult patients with unresectable, HER2-expressing advanced or metastatic solid tumors [2]. - The study consists of two phases: the Phase I dose escalation phase and the Phase IIa dose expansion and optimization phase, focusing on determining the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) [2]. - Primary endpoints include safety, tolerability, and preliminary efficacy, while secondary endpoints encompass initial anti-tumor activity, pharmacokinetics, and immunogenicity of HMPL-A251 [2]. Group 2: Drug Characteristics - HMPL-A251 is the first candidate from HCM's new generation ATTC platform, utilizing a potent and selective PI3K/PIKK inhibitor as the payload [2]. - The drug is designed to precisely target HER2-expressing tumor cells, potentially overcoming systemic toxicity and narrow therapeutic windows associated with traditional PI3K/PIKK inhibitors [2]. - The strategy aims to enhance overall tolerability while achieving more effective and sustained pathway inhibition [2]. Group 3: Preclinical Data - Preclinical data for HMPL-A251 was presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targeted Therapy and Cancer [3]. - These data support the translational potential of the ATTC platform and the ongoing global clinical evaluation of HMPL-A251 [3]. - The combination of PI3K/PIKK inhibitors with linker-payload technology shows promise for developing a series of future ATTC candidates [3].

Core Insights - Hutchison China MediTech Limited (HCM) has announced the initiation of global Phase I clinical development for HMPL-A251, a first-in-class PI3K/PIKK-HER2 antibody-drug conjugate (ADC) [1][2] - The study aims to evaluate the safety and efficacy of HMPL-A251 in adult patients with unresectable, HER2-expressing advanced or metastatic solid tumors [1] Group 1: Clinical Development - HMPL-A251 is the first candidate from HCM's next-generation ADC platform to enter clinical development [2] - The clinical trial will be conducted in the United States and China, with the first patient dosed on December 16, 2025 [1] - The study consists of a Phase I dose-escalation stage and a Phase IIa dose-expansion and optimization stage, focusing on safety, tolerability, and preliminary efficacy [1] Group 2: Mechanism and Innovation - HMPL-A251 utilizes a highly selective and potent PI3K/PIKK inhibitor as the payload, coupled with a humanized anti-HER2 IgG1 antibody via a cleavable linker [1][2] - This innovative approach aims to target HER2-expressing tumor cells precisely, potentially overcoming systemic toxicity and narrow therapeutic windows associated with traditional PI3K/PIKK inhibitors [2] - Preclinical data supporting the potential of the ADC platform were presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targeted Therapy and Cancer [2]

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]

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 ...

Core Insights - HUTCHMED has initiated a global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy Conjugate, with the first patient dosed on December 16, 2025 [1][2] Group 1: Clinical Development - The Phase I/IIa study evaluates HMPL-A251 monotherapy in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors, focusing on safety, tolerability, and determining maximum tolerated doses [2][3] - The study is divided into two parts: Phase I for dose escalation and Phase IIa for dose expansion and optimization, with primary outcomes including safety and preliminary efficacy [2][3] Group 2: Product Details - HMPL-A251 is derived from HUTCHMED's next-generation ATTC platform, designed to deliver targeted pathway inhibition directly into HER2-expressing tumor cells, potentially overcoming systemic toxicity associated with traditional PI3K/PIKK inhibitors [3][4] - The ATTC platform combines monoclonal antibodies with small-molecule inhibitor payloads, aiming for synergistic anti-tumor activity and improved safety profiles compared to traditional therapies [5][6] Group 3: Mechanism of Action - The PI3K/AKT/mTOR (PAM) pathway is critical for cell growth and survival, with alterations linked to poor prognosis in various cancers; HMPL-A251 aims to address challenges faced by existing PAM-targeted drugs [7][8] - The innovative design of HMPL-A251 enhances targeted delivery to tumor cells, maximizing therapeutic benefits while minimizing systemic exposure [9]

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]

Core Viewpoint - Hutchison China MediTech Limited (Chi-Med) announced that its drugs ELUNATE, ORPATHYS, and SULANDA will continue to be included in the updated National Medical Insurance Drug List effective from January 1, 2026, following a renewal agreement with the National Healthcare Security Administration of China. Additionally, TAZVERIK has been included in the inaugural National Commercial Health Insurance Innovative Drug List [1]. Group 1 - Chi-Med's drugs ELUNATE, ORPATHYS, and SULANDA will remain in the National Medical Insurance Drug List starting January 1, 2026 [1]. - The renewal agreement with the National Healthcare Security Administration ensures continued access to these medications for patients [1]. - TAZVERIK has been added to the first version of the National Commercial Health Insurance Innovative Drug List [1].

Group 1 - The core point of the article is that Hutchison China MediTech has successfully renewed three of its drugs, which will continue to be included in the updated National Medical Insurance Drug List effective from January 1, 2026 [2] - The three drugs mentioned are Aiyoute, Vorinostat, and Sutai Da, indicating the company's ongoing commitment to maintaining its product offerings in the healthcare market [2] - Additionally, the drug Daviq has successfully entered the first edition of the National Commercial Health Insurance Innovative Drug List, expanding the company's market access [2]

Core Viewpoint - Hutchison China MediTech Limited (00013) announced the renewal of its medical insurance agreements with the National Healthcare Security Administration of China, ensuring the continued inclusion of ELUNATE®, ORPATHYS®, and SULANDA® in the updated National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List effective from January 1, 2026 [1] Group 1 - ELUNATE®, ORPATHYS®, and SULANDA® will remain included in the National Medical Insurance Drug List starting January 1, 2026 [1] - TAZVERIK® has been included in the inaugural National Commercial Health Insurance Innovative Drug List [1]

Group 1 - The core announcement is that Hutchison China MediTech Limited (和黄医药) has successfully negotiated with the National Healthcare Security Administration of China to include its drugs, Elunate (爱优特), Orpathys (沃瑞沙), and Sulanda (苏泰达), in the new version of the National Medical Insurance Drug List effective from January 1, 2026 [1] - Tazverik (达唯珂) has been included in the inaugural National Commercial Health Insurance Innovative Drug List, indicating a significant step for the company's product portfolio in the commercial insurance sector [1]