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HUTCHMED China Ltd, formerly known as Hutchison China Meditech Ltd, is a prominent player in the healthcare sector, focusing primarily on the manufacturing and sale of pharmaceuticals. The company is engaged in the development, production, and commercialization of therapies targeting oncology and immunological diseases. HUTCHMED operates through three main business segments: Innovation Platform, Commercial Platform, and Production.
Within the Innovation Platform, HUTCHMED dedicates extensive resources to research and development, aiming to discover novel drug candidates and advance them through clinical trials. The Commercial Platform includes the marketing and distribution aspects, where the company leverages its significant presence in China to bring its products to market. The Production segment focuses on the manufacturing of these drugs, following stringent quality standards.
HUTCHMED has achieved several milestones, including the development of its flagship products such as Savolitinib and Sulfatinib, which are undergoing various stages of clinical trials. Recent updates indicate promising subgroup efficacy and improved quality of life data, as presented at ASCO 2024. These advancements underline the company's commitment to addressing unmet medical needs and enhancing patient care.
Financially, HUTCHMED maintains a robust pipeline of projects and collaborations with global pharmaceutical giants, bolstering its position in the market. The company's strategic partnerships and alliances play a crucial role in expanding its research capabilities and accelerating drug development processes.
Overall, HUTCHMED China Ltd stands as a noteworthy entity in the pharmaceutical industry, continually striving to innovate and improve its product offerings to meet the growing healthcare demands in China and beyond.
HUTCHMED announces that its partner Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA® (fruquintinib) for previously treated metastatic colorectal cancer (CRC). FRUZAQLA® is the first novel targeted therapy approved in Japan for metastatic CRC, regardless of biomarker status, in over a decade.
CRC is the most prevalent cancer in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023. The approval was based on results from the global Phase III FRESCO-2 trial. Fruquintinib is already approved in several regions including the United States, Europe, and China.
Takeda has the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. FRUZAQLA® was approved in the US in November 2023 and in Europe in June 2024.
HUTCHMED (HCM) announces upcoming presentations at the 2024 World Conference on Lung Cancer (WCLC24) in San Diego and the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. Key results include the FLOWERS study, a Phase II trial of osimertinib with or without savolitinib for first-line treatment in EGFRm, MET-aberrant advanced NSCLC patients. As of May 28, 2024, the median follow-up was 8.2 months. Cohort 2 (osimertinib + savolitinib) showed a 90.5% ORR and 95.2% DCR, compared to Cohort 1's (osimertinib) 60.9% ORR and 87% DCR. Median PFS was 9.3 months in Cohort 1 and 19.6 months in Cohort 2. Safety profiles were manageable. Additional presentations cover studies of surufatinib and fruquintinib in various cancers at ESMO 2024.
HUTCHMED has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib in combination with paclitaxel for second-line advanced gastric cancer treatment. This decision follows discussions with the National Medical Products Administration of China (NMPA) and an internal review of the data package from the Phase III FRUTIGA study.
While the study showed statistically significant improvements in progression-free survival (PFS) and other endpoints, the overall survival (OS) improvement was not statistically significant. The high proportion of patients receiving subsequent therapies confounded the OS effect, although favorable trends were observed. HUTCHMED remains optimistic about fruquintinib's potential in gastric cancer treatment and will evaluate new paths forward.
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.
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