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

HUTCHMED announces that its partner Takeda has received European Commission (EC) approval for FRUZAQLA® (fruquintinib) to treat metastatic colorectal cancer (CRC).

This approval is based on positive results from the Phase III FRESCO-2 trial.

FRUZAQLA® is the first novel targeted therapy for CRC in the EU in over a decade, regardless of biomarker status.

Fruquintinib is indicated for adult CRC patients who have been previously treated with standard therapies and have either progressed or are intolerant to trifluridine-tipiracil or regorafenib.

This milestone marks the first product from HUTCHMED's research to be approved in Europe.

HUTCHMED announced that the Phase III ESLIM-01 trial results for sovleplenib, targeting primary immune thrombocytopenia (ITP), have been published in The Lancet Haematology. The study, involving 188 adult ITP patients in China, demonstrated a 48.4% durable response rate with sovleplenib versus 0% with placebo. Significant improvements were seen regardless of prior therapies or TPO/TPO-RA exposure. Regulatory submissions in China were accepted in January 2024. Additionally, HUTCHMED presented these findings at the European Hematology Association 2024 Hybrid Congress. The safety profile of sovleplenib was consistent with earlier studies, with most adverse events being mild or moderate. The China National Medical Products Administration has granted Breakthrough Therapy status and accepted the New Drug Application for sovleplenib with Priority Review.

HUTCHMED has commenced a Phase I clinical trial for its menin inhibitor, HMPL-506, targeting hematological malignancies in China. The trial, starting on May 31, 2024, involves a multicenter, open-label study designed to assess the safety, pharmacokinetics, and efficacy of HMPL-506. It consists of two parts: dose escalation and dose expansion, with plans to enroll at least 60 patients. Leading the study are Dr. Jianxiang Wang and Dr. Hui Wei from the Chinese Academy of Medical Sciences Blood Diseases Hospital. More information is available on clinicaltrials.gov under identifier NCT06387082.

HUTCHMED announced the publication of Phase III FRUTIGA trial results for fruquintinib in combination with paclitaxel for second-line advanced gastric cancer in Nature Medicine. Highlighted at ASCO 2024, the trial showed statistically significant improvement in progression-free survival (PFS) with median PFS of 5.6 months versus 2.7 months for paclitaxel alone. While overall survival (OS) improved (9.6 months vs. 8.4 months), it was not statistically significant. Fruquintinib was well-tolerated with consistent safety profiles. Additional subgroup analyses revealed particular efficacy in intestinal-type and lymph node metastasis patients. The findings support fruquintinib as a viable treatment option.

HUTCHMED (China) announced it will present new and updated data from several studies at the 2024 ASCO Annual Meeting. Key highlights include the Phase II study of fruquintinib combined with sintilimab in endometrial cancer patients, showing an objective response rate (ORR) of 35.6%, disease control rate (DCR) of 88.5%, and median progression-free survival (PFS) of 9.5 months. The study supported a New Drug Application (NDA) in China. Additionally, updated data from the Phase III FRUTIGA study in gastric cancer, and data from the FRESCO and FRESCO-2 studies in colorectal cancer will be presented. Other presentations include studies on surufatinib and the ERK1/2 inhibitor HMPL-295.

The ASCO Annual Meeting will take place from May 31 to June 4, 2024, in Chicago, IL, and online.

HUTCHMED (HCM) announced key changes in its leadership on May 17, 2024. Mr. Simon To retired from his role as Chairman and Executive Director after 23 years with the company, citing personal and health reasons. Dr. Dan Eldar, a Non-executive Director since 2016 with over 30 years of experience in various sectors, has been appointed as the new Chairman. These changes will take effect immediately. Dr. Eldar will also join the Nomination and Technical Committees, while Ms. Edith Shih will join the Remuneration Committee. Mr. To will remain a Strategic Advisor to HUTCHMED. The board expressed deep gratitude to Mr. To for his significant contributions.

HUTCHMED announced that key data from the Phase III ESLIM-01 study of sovleplenib and other hematological malignancy treatments will be presented at EHA2024. The ESLIM-01 study showed a 48.4% durable response rate for sovleplenib in primary ITP patients, significantly higher than the placebo. Safety profiles showed comparable TEAEs between sovleplenib (25.4%) and placebo (24.2%). Additional Phase II data on sovleplenib for wAIHA showed a 43.8% overall response rate in the first 8 weeks. Presentation details include various other investigational therapies like HMPL-306, HMPL-760, and tazemetostat.

HUTCHMED has commenced a Phase II/III trial exploring the efficacy of a combination therapy involving surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The trial began on May 8, 2024, and aims to enroll 500 patients after an initial safety run-in stage, with the primary endpoint being overall survival (OS). Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and safety. PDAC is a particularly aggressive cancer with a five-year survival rate of less than 10%, and existing treatments have not shown significant improvement in patient outcomes.

HUTCHMED has initiated a Phase III clinical trial of HMPL-306 for relapsed/refractory acute myeloid leukemia (AML) patients with IDH1/IDH2 mutations in China. The trial, named RAPHAEL, started dosing the first patient on May 11, 2024. HMPL-306 is a dual-inhibitor targeting both IDH1 and IDH2 mutations, potentially overcoming resistance seen with single inhibitors. The trial aims to enroll around 320 patients and will compare HMPL-306's effectiveness and safety to current chemotherapy regimens. Key endpoints include overall survival, event-free survival, and complete remission rates. Previous Phase I data showed promising results, with more data expected in June 2024.