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]

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].

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]

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]