Welcome to our dedicated page for Hutchmed (China) news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on Hutchmed (China) stock.
HUTCHMED (China) Limited (HCM) news covers the company’s ongoing work as a commercial-stage biopharmaceutical developer of targeted therapies and immunotherapies for cancer and immunological diseases. Press releases frequently describe progress across its in-house pipeline, regulatory milestones in China and abroad, and updates on marketed medicines such as ELUNATE® (fruquintinib), ORPATHYS® (savolitinib) and SULANDA® (surufatinib).
Investors and healthcare professionals following HUTCHMED news can expect detailed reports on clinical trial results, including Phase II and Phase III data in solid tumors and autoimmune hematologic diseases. Recent announcements have highlighted Phase III outcomes for savolitinib plus TAGRISSO® in EGFR-mutated non-small cell lung cancer, topline Phase III results for sovleplenib in warm antibody autoimmune hemolytic anemia, and initiation or expansion of studies such as the Phase II/III trial of surufatinib and camrelizumab in metastatic pancreatic ductal adenocarcinoma.
News items also address regulatory and reimbursement developments, such as New Drug Application acceptances with priority review for savolitinib in MET-amplified gastric cancer and fanregratinib in intrahepatic cholangiocarcinoma, as well as inclusion of HUTCHMED-associated medicines on China’s National Reimbursement Drug List and the National Commercial Health Insurance Innovative Drug List. These updates provide context on how the company’s therapies may reach broader patient populations.
Another recurring theme is platform and pipeline strategy, including announcements about the ATTC (Antibody-Targeted Therapy Conjugate) platform and first-in-human trials of HMPL-A251, as well as presentations at major scientific meetings such as ESMO, ASH and AACR-NCI-EORTC. For those tracking HCM, this news feed offers a centralized view of clinical data readouts, partnership activities, regulatory interactions and broader R&D progress. Bookmarking this page allows readers to follow how HUTCHMED’s oncology and immunology programs evolve over time.
HUTCHMED announces the launch of FRUZAQLA® (fruquintinib) in Japan by Takeda following approval from the Japanese Ministry of Health, Labour and Welfare. The drug is indicated for treating advanced or recurrent colorectal cancer (CRC) that has progressed after chemotherapy. This marks the first novel oral targeted therapy approval for metastatic CRC in Japan in over a decade. CRC is Japan's most prevalent cancer, with an estimated 161,000 new cases and 54,000 deaths in 2023. The launch triggers a milestone payment to HUTCHMED from Takeda, who holds exclusive worldwide rights outside mainland China, Hong Kong, and Macau.
HUTCHMED (Nasdaq/AIM:HCM, HKEX:13) has appointed Dr Chaohong Hu (Dr Mary Hu) as an Independent Non-executive Director and member of the Technical Committee, effective November 21, 2024. Dr Hu brings over 20 years of experience in therapeutic antibodies, antibody-drug conjugates, and vaccines development. She is currently Chief Operating Officer of D Biotherapeutics and principal consultant of Lakebio Consulting. Her annual compensation includes US$76,000 as Director and US$8,000 as Technical Committee member. Dr Hu's expertise spans from early-stage discovery to clinical development, commercialization, and strategic partnerships.
HUTCHMED announced new data presentations at the 2024 ASH Annual Meeting and ESMO Asia Congress. The key highlight is the long-term safety and efficacy data from the ESLIM-01 Phase III study of sovleplenib in adult patients with chronic primary immune thrombocytopenia (ITP) in China. The study showed that 81% of patients achieved overall response, with durable response rates of 51.4% and long-term durable response of 59.8%. Among 179 treated patients, 55.3% remained on treatment with a median exposure of 56.6 weeks. The treatment demonstrated effectiveness in maintaining platelet counts and showed a favorable safety profile consistent with previous studies.
HUTCHMED will receive a US$20 million milestone payment from Takeda after FRUZAQLA® (fruquintinib) achieved over US$200 million in sales for metastatic colorectal cancer treatment. Takeda reported US$203 million in net sales of FRUZAQLA® in the nine months ended September 2024. This marks HUTCHMED's first commercial milestone payment. The drug has received approval in multiple regions including the US, EU, Switzerland, Canada, Japan, UK, Argentina, Australia, and Singapore, with more regulatory applications in progress.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announced positive results from the SAVANNAH Phase II trial, showing that TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) demonstrated a high, clinically meaningful, and durable objective response rate (ORR) in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with high levels of MET overexpression and/or amplification. The combination targets MET-driven resistance in EGFR-mutated lung cancer patients who progressed on TAGRISSO® treatment.
Key findings include:
- 62% of screened patients had tumors with MET overexpression and/or amplification
- 34% met the high MET level cut-off upon clinical progression
- The combination received Fast Track designation from the FDA in 2023
- Safety profile was consistent with known profiles of the combination and individual treatments
The global SAFFRON Phase III trial will further assess the combination versus chemotherapy in this patient population.
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.