Welcome to our dedicated page for Hutchmed (China) news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on Hutchmed (China) stock.
HUTCHMED (China) Limited (HCM) news covers the company’s ongoing work as a commercial-stage biopharmaceutical developer of targeted therapies and immunotherapies for cancer and immunological diseases. Press releases frequently describe progress across its in-house pipeline, regulatory milestones in China and abroad, and updates on marketed medicines such as ELUNATE® (fruquintinib), ORPATHYS® (savolitinib) and SULANDA® (surufatinib).
Investors and healthcare professionals following HUTCHMED news can expect detailed reports on clinical trial results, including Phase II and Phase III data in solid tumors and autoimmune hematologic diseases. Recent announcements have highlighted Phase III outcomes for savolitinib plus TAGRISSO® in EGFR-mutated non-small cell lung cancer, topline Phase III results for sovleplenib in warm antibody autoimmune hemolytic anemia, and initiation or expansion of studies such as the Phase II/III trial of surufatinib and camrelizumab in metastatic pancreatic ductal adenocarcinoma.
News items also address regulatory and reimbursement developments, such as New Drug Application acceptances with priority review for savolitinib in MET-amplified gastric cancer and fanregratinib in intrahepatic cholangiocarcinoma, as well as inclusion of HUTCHMED-associated medicines on China’s National Reimbursement Drug List and the National Commercial Health Insurance Innovative Drug List. These updates provide context on how the company’s therapies may reach broader patient populations.
Another recurring theme is platform and pipeline strategy, including announcements about the ATTC (Antibody-Targeted Therapy Conjugate) platform and first-in-human trials of HMPL-A251, as well as presentations at major scientific meetings such as ESMO, ASH and AACR-NCI-EORTC. For those tracking HCM, this news feed offers a centralized view of clinical data readouts, partnership activities, regulatory interactions and broader R&D progress. Bookmarking this page allows readers to follow how HUTCHMED’s oncology and immunology programs evolve over time.
HUTCHMED (Nasdaq/AIM: HCM) announced updates on its ongoing studies of HMPL-523 and HMPL-306, presented at the 63rd ASH Annual Meeting from December 11-14, 2021. Key presentations include clinical data on HMPL-523, focusing on its safety and preliminary efficacy for treating primary immune thrombocytopenia, and initial results from a Phase I study on HMPL-523 in lymphoma patients. Additionally, a Phase I trial of HMPL-306 for advanced hematological malignancies is in progress. Both compounds aim to address significant oncology challenges, with HMPL-523 retaining global rights by HUTCHMED.
HUTCHMED and AstraZeneca have launched the global Phase III study SAMETA to evaluate savolitinib combined with IMFINZI for treating patients with MET-driven advanced papillary renal cell carcinoma (PRCC). The trial aims to show improved efficacy compared to existing treatments, with initial doses administered on October 28, 2021. Previous studies, like SAVOIR and CALYPSO, showcased promising results, with CALYPSO reporting a 57% response rate in patients with MET alterations. The primary endpoint is median progression-free survival.
HUTCHMED has commenced a Phase III trial of HMPL-523, an investigational Syk inhibitor, for primary immune thrombocytopenia (ITP) in China. The trial began on October 27, 2021, enrolling approximately 180 adult patients. The study aims to evaluate the drug's efficacy, with the primary endpoint being the durable response rate. Previous Phase Ib data showed promising results, which will be further detailed at the upcoming American Society of Hematology Annual Meeting in December 2021. HUTCHMED retains global rights for HMPL-523, which is also being studied for other conditions.
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) has completed the sale of its indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (HBYS) for approximately US$169 million in cash. This valuation represents about 22 times HBYS' adjusted net profit of US$7.7 million for 2020. HUTCHMED has received around US$127 million, with the remaining US$42 million expected from future dividends. The sale allows HUTCHMED to direct resources toward enhancing its Oncology/Immunology investments in China and globally.
HUTCHMED presented new clinical data for surufatinib and fruquintinib at the 24th CSCO Annual Meeting. The Phase II study of surufatinib with toripalimab in advanced neuroendocrine carcinoma showed a median overall survival of 10.3 months and a confirmed response rate of 23.8%. Meanwhile, a study on fruquintinib plus sintilimab demonstrated a 100% response rate in treatment-naïve patients and a 32% response rate in pretreated patients with advanced endometrial cancer. Regulatory discussions for potential pivotal studies in China are ongoing for both therapies.
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.
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