HUTCHMED (China) Limited American Depositary Shares - HCM STOCK NEWS

HUTCHMED has initiated a Phase Ib/II study in China for HMPL-453, a selective FGFR inhibitor, in combination with chemotherapy or toripalimab.

The trial aims to evaluate the safety and initial efficacy in patients with advanced solid tumors. The first patient was dosed on January 22, 2022. This multi-center study includes a dose escalation phase followed by a dose expansion phase targeting gastric cancer and other conditions. HUTCHMED retains all global rights to HMPL-453, which addresses key tumor growth factors and is currently involved in further clinical studies, including HMPL-453 monotherapy for intrahepatic cholangiocarcinoma.

HUTCHMED has initiated a Phase I clinical trial for HMPL-653, a selective CSF-1R inhibitor, in China as of January 18, 2022. This multicenter trial aims to evaluate the safety, tolerability, and preliminary efficacy in patients with advanced solid tumors and tenosynovial giant cell tumors (TGCT). Around 110 patients will be enrolled. With no CSF-1R inhibitors currently approved in China, this trial addresses a significant unmet medical need. HUTCHMED retains all worldwide rights to HMPL-653, furthering its commitment to innovative cancer therapies.

HUTCHMED announced that updated analysis of the ongoing Phase I/Ib trial of fruquintinib will be presented at the 2022 ASCO Gastrointestinal Cancers Symposium on January 22, 2022. The study focuses on patients with advanced solid tumors, specifically looking at the preliminary results of the dose expansion cohorts in refractory metastatic colorectal cancer. Colorectal cancer is a significant health issue worldwide, with an estimated 915,000 deaths in 2020. Fruquintinib, an oral VEGFR inhibitor, is already approved in China for metastatic CRC and is being studied for various combinations with other therapies.

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.