Welcome to our dedicated page for HUTCHMED (China) American Depositary Shares news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on HUTCHMED (China) American Depositary Shares stock.
HUTCHMED China Ltd, formerly known as Hutchison China Meditech Ltd, is a prominent player in the healthcare sector, focusing primarily on the manufacturing and sale of pharmaceuticals. The company is engaged in the development, production, and commercialization of therapies targeting oncology and immunological diseases. HUTCHMED operates through three main business segments: Innovation Platform, Commercial Platform, and Production.
Within the Innovation Platform, HUTCHMED dedicates extensive resources to research and development, aiming to discover novel drug candidates and advance them through clinical trials. The Commercial Platform includes the marketing and distribution aspects, where the company leverages its significant presence in China to bring its products to market. The Production segment focuses on the manufacturing of these drugs, following stringent quality standards.
HUTCHMED has achieved several milestones, including the development of its flagship products such as Savolitinib and Sulfatinib, which are undergoing various stages of clinical trials. Recent updates indicate promising subgroup efficacy and improved quality of life data, as presented at ASCO 2024. These advancements underline the company's commitment to addressing unmet medical needs and enhancing patient care.
Financially, HUTCHMED maintains a robust pipeline of projects and collaborations with global pharmaceutical giants, bolstering its position in the market. The company's strategic partnerships and alliances play a crucial role in expanding its research capabilities and accelerating drug development processes.
Overall, HUTCHMED China Ltd stands as a noteworthy entity in the pharmaceutical industry, continually striving to innovate and improve its product offerings to meet the growing healthcare demands in China and beyond.
HUTCHMED has launched the SURTORI-01 Phase III clinical trial to assess the efficacy and safety of surufatinib in combination with toripalimab for treating advanced neuroendocrine carcinoma (NEC). The first patient was dosed on September 18, 2021. The study aims to enroll approximately 200 patients and evaluate outcomes including overall survival and progression-free survival. Preliminary Phase II data revealed a 20% objective response rate and a 70% disease control rate, indicating potential for this treatment combination.
HUTCHMED announced the initiation of a Japan registration-enabling bridging study for surufatinib on September 15, 2021, aimed at treating advanced neuroendocrine tumors (NETs). This study follows the drug's previous approvals in China and regulatory progress in the U.S. and Europe. The study will recruit approximately 34 patients, assessing safety, tolerability, and efficacy. The NDA will include results from pivotal studies in Japan, complementing data from studies in the U.S. and China. Surufatinib is marketed in China as SULANDA®.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that China's NMPA granted Breakthrough Therapy Designation to amdizalisib (HMPL-689), a selective PI3Kδ inhibitor, for treating relapsed or refractory follicular lymphoma (FL). This designation fast-tracks drug development and review, potentially leading to expedited approval for addressing unmet medical needs. Preliminary Phase Ib study results show that amdizalisib has a manageable toxicity profile and clinical activity in patients. Further data will be presented at the upcoming ESMO Congress on September 20, 2021.
HUTCHMED and AstraZeneca have launched the SANOVO Phase III study in China, evaluating the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for first-line treatment in non-small cell lung cancer (NSCLC) patients with EGFR mutations and MET overexpression. The trial aims to compare the efficacy and safety of the combination against TAGRISSO alone, focusing on progression-free survival (PFS). This initiative follows significant results from previous studies, underscoring the potential of savolitinib in treating advanced solid tumors.
HUTCHMED (Nasdaq/AIM: HCM) announced that new analyses of its drug candidates will be presented at the 2021 ESMO Virtual Congress, taking place from September 16-21, 2021. Key studies include:
- Amdizalisib: Phase Ib results for relapsed/refractory lymphoma, presented on September 20, 2021.
- Savolitinib: Interim analysis of a biomarker-directed Phase II study in advanced non-small cell lung cancer available from September 13, 2021.
- Fruquintinib: Phase Ib/II study in advanced triple-negative breast cancer, also available from September 13, 2021.
HUTCHMED (HCM) announces its inclusion in the Shanghai-Hong Kong and Shenzhen-Hong Kong Stock Connect programs, effective September 6, 2021. This inclusion allows qualified Mainland Chinese investors direct access to HUTCHMED shares. The company is also now part of the Hang Seng Composite Index, a prerequisite for Stock Connect participation. CEO Christian Hogg expressed optimism about the new access for investors, which could enhance the trading volume and visibility of HUTCHMED's shares in the mainland market.
HUTCHMED has initiated a Phase Ib/II study of fruquintinib combined with tislelizumab for patients with advanced triple negative breast cancer (TNBC) and advanced endometrial cancer (EC). The first patient was dosed on August 24, 2021. The trial evaluates safety and efficacy, with a focus on enhancing immune checkpoint inhibition. Fruquintinib is designed to block tumor angiogenesis and has previously shown potential in treating metastatic colorectal cancer in China. The company holds all rights to fruquintinib outside China.
HUTCHMED has been selected as a constituent stock of various indexes by Hang Seng Indexes, including the Hang Seng Composite Index, effective September 6, 2021. This inclusion signifies HUTCHMED's representation in the top 95th percentile of market capitalization on the Hong Kong Stock Exchange. Additionally, the company will be part of six cross-market indexes, including the Hang Seng Stock Connect China 500 Index, which tracks the largest Chinese companies. HUTCHMED is committed to developing cancer therapies and has advanced multiple drug candidates into clinical studies.
HUTCHMED and Epizyme announced a collaboration to develop TAZVERIK® in Greater China. Epizyme will receive an upfront payment of $25 million, potential milestones of up to $285 million, and tiered royalties. HUTCHMED gains development and commercial rights in China. TAZVERIK®, an EZH2 inhibitor FDA-approved for certain cancers, aims to accelerate clinical trials in various malignancies. HUTCHMED plans to lead trials in combination with other therapies and commercialize the drug upon approval.
Epizyme and HUTCHMED announced a collaboration to develop and commercialize TAZVERIK® in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan. TAZVERIK® is an FDA-approved EZH2 methyltransferase inhibitor for certain patients with epithelioid sarcoma and follicular lymphoma. Epizyme will receive a $25 million upfront payment, with potential milestone payments of up to $285 million, plus royalties. HUTCHMED will lead clinical trials and commercialization in the region, aiming to expand TAZVERIK®'s reach and potential applications.
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