Research analysts who have asked questions during HUTCHMED (China) earnings calls.
Recent press releases and 8-K filings for HCM.
HUTCHMED Highlights Publication of Positive Phase III SACHI Trial Results
HCM
Product Launch
New Projects/Investments
- HUTCHMED (China) Limited announced on January 14, 2026, the publication of Phase III SACHI trial results in The Lancet.
- The SACHI trial confirmed the efficacy of the savolitinib and osimertinib combination for treating patients with advanced non-small cell lung cancer (NSCLC) with acquired MET amplification after progression on prior EGFR-TKI treatment.
- Based on interim data from the SACHI trial, this combination was granted regulatory approval in China in June 2025.
- The study met its primary endpoint of progression-free survival (PFS) in an interim analysis in January 2025, showing an investigator-assessed median PFS of 8.2 months for the combination arm compared to 4.5 months for chemotherapy.
Jan 14, 2026, 11:06 AM
HUTCHMED Announces Positive Phase III Results for Sovleplenib in wAIHA
HCM
Product Launch
New Projects/Investments
- HUTCHMED (China) Limited announced positive topline results from the Phase III part of its ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China.
- The trial met its primary endpoint of durable hemoglobin response rate within weeks 5 to 24 of treatment.
- The company plans to submit a New Drug Application (NDA) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026.
- An NDA resubmission for sovleplenib for second-line immune thrombocytopenia (ITP) is also planned for the first half of 2026.
Jan 7, 2026, 11:04 AM
HUTCHMED Initiates Phase III Stage of Pancreatic Cancer Trial
HCM
New Projects/Investments
- HUTCHMED (China) Limited has initiated the Phase III stage of its ongoing Phase II/III trial for a combination therapy involving surufatinib as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) in China.
- The first patient in the Phase III part received treatment on December 30, 2025, with plans to enroll approximately 400 additional patients.
- Results from the Phase II part demonstrated a median progression-free survival (PFS) of 7.20 months for the combination therapy (S+C+AG) compared to 5.52 months for the control arm (AG), showing a 50.1% reduction in the risk of progression or death.
- Key secondary efficacy endpoints, including an objective response rate (ORR) of 67.7% and a disease control rate (DCR) of 93.5%, also showed consistent benefits for the S+C+AG regimen.
Jan 5, 2026, 11:05 AM
HUTCHMED Initiates Phase III Trial for Pancreatic Cancer Treatment
HCM
New Projects/Investments
- HUTCHMED has initiated the Phase III part of a clinical trial in China for a combination therapy (surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The first patient was dosed on December 30, 2025.
- The Phase III trial plans to enroll approximately 400 additional patients to evaluate the efficacy and safety of the combination versus standard treatment, with overall survival (OS) as the primary endpoint.
- Results from the Phase II part, presented at the 2025 ESMO Asia Congress, demonstrated the combination regimen achieved a median progression-free survival (PFS) of 7.20 months compared to 5.52 months for the control arm, indicating a 50.1% reduction in the risk of progression or death.
- The Phase II data also showed improved objective response rate (ORR) of 67.7% versus 41.9% and disease control rate (DCR) of 93.5% versus 71.0% for the combination regimen, with a manageable safety profile.
Jan 5, 2026, 12:00 AM
HUTCHMED Announces NDA Acceptance and Priority Review for Savolitinib in Gastric Cancer
HCM
Product Launch
New Projects/Investments
- HUTCHMED (China) Limited announced that the New Drug Application (NDA) for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification has been accepted and granted priority review by the China National Medical Products Administration (NMPA).
- The NDA is supported by positive Phase II registration study data in Chinese patients, which met its primary endpoint of objective response rate (ORR).
- If approved, savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer, a condition estimated to affect approximately 18,000 patients annually in China.
- The NMPA had previously granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023.
Dec 30, 2025, 11:02 AM
HUTCHMED's Savolitinib NDA Accepted with Priority Review in China for Gastric Cancer
HCM
Product Launch
New Projects/Investments
- HUTCHMED (China) Limited announced that its New Drug Application (NDA) for savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification has been accepted and granted priority review by the China National Medical Products Administration (NMPA).
- The NDA is supported by positive Phase II registration study data in Chinese patients, which met its primary endpoint of objective response rate (ORR).
- Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer, a condition with an estimated annual incidence of 18,000 patients in China.
- The NMPA had previously granted Breakthrough Therapy Designation for savolitinib for this potential indication in 2023.
Dec 30, 2025, 10:00 AM
HUTCHMED Announces NDA Acceptance with Priority Review for Fanregratinib in China
HCM
Product Launch
New Projects/Investments
- HUTCHMED (China) Limited announced that its New Drug Application (NDA) for fanregratinib (HMPL-453) has been accepted and granted priority review by the China National Medical Products Administration (NMPA).
- The NDA seeks approval for fanregratinib to treat adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) with fibroblast growth factor receptor (FGFR) 2 fusion/rearrangement, who have previously received systemic therapy.
- Fanregratinib is a novel, selective, oral inhibitor targeting FGFR 1/2/3, and the NDA is supported by data from a Phase II registration study in China which met its primary endpoint of objective response rate (ORR).
- ICC is the second most common form of liver cancer, with approximately 10-15% of patients globally having tumors harboring FGFR2 fusions or rearrangements.
Dec 29, 2025, 8:35 AM
HUTCHMED Initiates Global Clinical Development for HMPL-A251
HCM
New Projects/Investments
Product Launch
- HUTCHMED (China) Limited has initiated the global Phase I clinical development program for its first-in-class ATTC candidate, HMPL-A251, in patients with solid tumors.
- The first patient was dosed on December 16, 2025, in China, as part of a Phase I/IIa, open-label, multicenter clinical study conducted in both the US and China.
- HMPL-A251 is the first clinical-stage candidate from HUTCHMED's next-generation ATTC platform, designed to deliver a targeted PI3K/PIKK inhibitor payload directly to HER2-expressing tumor cells, aiming to enhance efficacy and reduce systemic toxicity.
Dec 17, 2025, 11:04 AM
HUTCHMED Announces Expanded Drug Coverage in China
HCM
Product Launch
Revenue Acceleration/Inflection
- HUTCHMED (China) Limited announced that ELUNATE®, ORPATHYS®, and SULANDA® will continue to be included in China's National Reimbursement Drug List (NRDL), effective January 1, 2026.
- TAZVERIK® has been included in the first edition of the National Commercial Health Insurance Innovative Drug List in China.
- The NRDL coverage for ELUNATE® was expanded to include advanced endometrial cancer and renewed for metastatic colorectal cancer.
- The new Commercial Insurance Drug List focuses on innovative medicines with high clinical value, such as high-cost oncology drugs, gene therapies, and rare disease therapies, enabling reimbursement through commercial health insurance products.
Dec 8, 2025, 11:02 AM
HUTCHMED Updates on Commercial Products, Pipeline, and Financial Outlook
HCM
Guidance Update
New Projects/Investments
Product Launch
- HUTCHMED has been profitable since 2023 and highlights its globally commercialized products, including FRUZAQLA (colorectal cancer drug with half-year sales of about $160 million) and ORPATHYS (lung cancer drug partnered with AstraZeneca).
- The company's 2025 oncology revenue guidance was recently revised down due to an increasingly competitive landscape and a restructuring of its sales infrastructure in China, though sequential sales improvements were observed in June and July.
- HUTCHMED is advancing its Antibody Targeted Therapy Conjugate (ATTC) platform, described as "chemo-free" with significant potential, and expects to start Phase 1 human trials in China and the US within two to three weeks.
- Key upcoming milestones include the Phase 3 data readout for ORPATHYS in the first half of next year (2026) with potential US approval in 2027, China approval for FRUZAQLA in kidney cancer around mid-2026, and the SYK inhibitor for ITP targeting China approval and launch in 2027.
Nov 17, 2025, 3:30 PM
Quarterly earnings call transcripts for HUTCHMED (China).
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