Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announces an expert call on immune thrombocytopenia (ITP) treatment on August 28, 2024, at 7:00 p.m. HKT. The webcast, featuring a professor and key opinion leader, will be in Chinese with an English transcript available later. This investor-focused event follows the successful Phase III ESLIM-01 trial of HUTCHMED's novel drug candidate sovleplenib for primary ITP in China.

The trial met all endpoints, with results published in The Lancet Haematology and presented at the European Hematology Association Congress. HUTCHMED filed a New Drug Application in China for sovleplenib in January 2024, marking a significant step in advancing ITP treatment options.

HUTCHMED reported financial results for the six months ending June 30, 2024, with significant updates on clinical and commercial developments.

Key Highlights:

• Revenue: $305.7 million, down from $532.9 million in H1 2023.
• Net Income: $25.8 million.
• Oncology Product Revenue: Increased by 59% to $127.8 million.

Key Product Updates:

• FRUZAQLA®: $130.5 million in US sales since its November 2023 launch.
• ELUNATE®: Revenue increased by 8% to $61 million in China.

Other Financial Metrics:

• Cash Balance: $802.5 million as of June 30, 2024.
• R&D Expenses: Reduced by 34% to $95.3 million.

Future Outlook:

• Potential US NDA filing for savolitinib by year-end.
• EU launch preparations for FRUZAQLA® post-European Commission approval in June 2024.

HUTCHMED (Nasdaq/AIM: HCM) has announced that its New Drug Application (NDA) for tazemetostat, aimed at treating adult patients with relapsed or refractory follicular lymphoma (R/R FL), has been accepted for review by the China National Medical Products Administration (NMPA) with Priority Review status. Tazemetostat, developed by Epizyme (an Ipsen company), is a first-in-class EZH2 methyltransferase inhibitor already approved by the FDA for specific patients with R/R FL and advanced epithelioid sarcoma (ES). The NDA acceptance in China is backed by a multicenter, open-label Phase II bridging study in China and global clinical studies by Epizyme. This drug was previously approved in the Hainan Pilot Zone, Macau, and Hong Kong. HUTCHMED has a strategic collaboration to develop, manufacture, and commercialize tazemetostat in Greater China.

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.