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

HUTCHMED (Nasdaq/AIM: HCM; SEHK:13) will announce its interim financial results for the first half of 2024 on July 31, 2024, at 7:00 am EDT. The announcement will be followed by a conference call and audio webcast presentation at 8:00 am EDT, including a Q&A session hosted by HUTCHMED management. An additional Chinese (Putonghua) webcast will be held on August 1, 2024, at 8:30 am HKT. Both webcasts will be accessible live via the company's website, where presentation materials will be available for download beforehand. A replay of the events will be available shortly after the live sessions.

HUTCHMED has announced an R&D update event to be held on July 9, 2024, in Shanghai and via a live webcast. The event will feature presentations from senior management, providing insights into the company's R&D strategy and updates on key programs. These include Phase III ESLIM-01 and Phase II/III ESLIM-02 studies of the Syk inhibitor sovleplenib for immune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (wAIHA). Additionally, updates on surufatinib for metastatic pancreatic ductal adenocarcinoma (PDAC) and the Phase III RAPHAEL study of HMPL-306 for acute myeloid leukemia (AML) will be presented. The in-person event is invitation-only, while the live webcast is publicly accessible. The English webcast is scheduled for 8:30 p.m. HKT / 8:30 a.m. EDT / 1:30 p.m. BST, with replays available for 90 days afterward.

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.