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 develops and commercializes targeted therapies and immunotherapies for cancer and immunological diseases through a China-based commercial organization and a global clinical pipeline. News for HCM centers on marketed oncology products such as FRUZAQLA and ELUNATE for fruquintinib, ORPATHYS for savolitinib, China regulatory actions, and partner-driven commercialization outside China.
Recurring updates also cover pipeline compounds including sovleplenib, HMPL-760 and HMPL-A580, clinical data presented at oncology meetings, and the company’s Antibody-Targeted Therapy Conjugate platform. Corporate items include annual results, product-license updates such as TAZVERIK in China, board and committee changes, and disclosures tied to HUTCHMED’s Nasdaq, AIM and HKEX listings and ADR structure.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that the NMPA has granted Breakthrough Therapy Designation to HMPL-523, a novel oral Syk inhibitor, for treating chronic adult primary immune thrombocytopenia (ITP). This designation is given to therapies that address serious conditions with unmet needs. CEO Christian Hogg emphasized the potential of HMPL-523 to improve patient health and expedite its development in China. The BTD is based on positive results from a Phase Ib study, supporting the initiation of a Phase III trial with expected enrollment of approximately 180 patients.
HUTCHMED has initiated a Phase I clinical study of HMPL-760, a third-generation Bruton’s tyrosine kinase (BTK) inhibitor, on January 4, 2022. This investigational drug targets both wild-type and C481S-mutated BTK, aiming to treat patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma. The study will enroll approximately 100 patients to assess safety, tolerability, and efficacy. HMPL-760 is the fifth candidate for hematological malignancies from HUTCHMED, which currently has 11 oncology candidates in clinical development.
HUTCHMED has been added to the FTSE Global Equity Index Series as announced on December 19, 2021, effective December 20, 2021. This inclusion highlights HUTCHMED’s standing as a notable player in the global equity market. FTSE Russell, a leader in global indices, provides a comprehensive benchmarking framework that includes over 16,000 securities from various markets. HUTCHMED is focused on developing targeted therapies for cancer and immunological diseases with over 1,400 personnel in oncology and immunology.
HUTCHMED announced new analyses of HMPL-523 at the 63rd American Society for Hematology’s Annual Meeting, highlighting the ongoing Phase I and Ib studies. In the Phase Ib trial for primary immune thrombocytopenia (ITP), 68.8% of patients on the recommended dose responded positively compared to 9.1% on placebo. Safety data demonstrated no treatment-related serious adverse events, with 73% experiencing treatment-related adverse events. A Phase III trial (ESLIM-01) is underway for HMPL-523 after positive outcomes. The drug targets Syk kinase, crucial for treating several B-cell malignancies.
HUTCHMED (HCM) presented new analyses of surufatinib combined with toripalimab during the ESMO Immuno-Oncology Congress 2021. Two studies were highlighted: one focused on advanced small cell lung cancer (SCLC) and the other on advanced gastric and gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, and neuroendocrine carcinoma. Surufatinib, an oral angio-immuno kinase inhibitor, has shown promising results in clinical trials, demonstrating a significant progression-free survival advantage in various indications. HUTCHMED retains worldwide rights to surufatinib.
HUTCHMED has successfully completed patient enrollment for the FRESCO-2 Phase III study of fruquintinib, targeting metastatic colorectal cancer, ahead of schedule with 687 participants. Conducted across 150 sites in 14 countries, this trial aims to confirm the drug's clinical benefits observed in earlier studies. Topline results are expected in H2 2022. If successful, HUTCHMED plans to seek FDA, EMA, and PMDA marketing authorizations. Notably, the FDA granted Fast Track Designation for fruquintinib in June 2020, highlighting its potential as a treatment option.
HUTCHMED (HCM) announced that starting January 1, 2022, its drug ELUNATE® remains on China's National Reimbursement Drug List (NRDL), while SULANDA® is newly included. ELUNATE® targets metastatic colorectal cancer, a prevalent condition in China with approximately 450,000 to 550,000 new cases annually. SULANDA® treats advanced neuroendocrine tumors, with 71,300 new cases diagnosed in 2020. HUTCHMED's ORPATHYS® was excluded from the NRDL update, which will be reassessed next year. The NRDL aims to improve drug affordability for patients under various insurance schemes.
HUTCHMED and AstraZeneca announced the initiation of the SACHI Phase III trial in China, studying ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib) for EGFR mutation-positive NSCLC patients with MET amplification. The trial, which began on November 22, 2021, aims to assess the combination's efficacy against standard chemotherapy. Primary endpoint: median progression-free survival. This follows earlier promising results from TATTON studies. Savolitinib is already approved in China for specific NSCLC cases.
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.