This section highlights FDA-related milestones and regulatory updates for drugs developed by HUTCHMED (HCM).
Over the past two years, HUTCHMED has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Fruquintinib, FRUSICA-2, HMPL-453, savolitinib, TAZVERIK®, and TYVYT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Fruquintinib - FDA Regulatory Timeline and Events
Fruquintinib is a drug developed by HUTCHMED for the following indication: Advanced solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Fruquintinib
- Announced Date:
- December 3, 2024
- Indication:
- Advanced solid tumors
Announcement
HUTCHMED (China) Limited and Innovent Biologics, Inc announce that the New Drug Application ("NDA") for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient ("pMMR") tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.
AI Summary
HUTCHMED (China) Limited and Innovent Biologics, Inc. announced that their New Drug Application for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China. This approval is specifically for treating patients with advanced endometrial cancer who have Mismatch Repair proficient (pMMR) tumors, have not responded to previous systemic therapy, and are not candidates for curative surgery or radiation.
The conditional approval followed a priority review by China’s National Medical Products Administration and was supported by data from the Phase II FRUSICA-1 study. The trial showed promising results including an objective response rate of 35.6%, a disease control rate of 88.5%, and rapid treatment benefits. This milestone marks a significant advancement by combining targeted therapy and immunotherapy to address an unmet need for advanced endometrial cancer patients.
Read Announcement- Drug:
- Fruquintinib
- Announced Date:
- August 30, 2024
- Indication:
- Advanced solid tumors
Announcement
HUTCHMED (China) Limited announces that it has voluntarily withdrawn its supplemental New Drug Application ("NDA") in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward.
AI Summary
HUTCHMED (China) Limited announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for the combination of fruquintinib with paclitaxel. This application was intended for use as a second-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma. In a recent review, HUTCHMED found that the current data package, derived from the Phase III FRUTIGA study, is unlikely to support regulatory approval in China at this time. Although the study showed a statistically significant improvement in progression-free survival, the observed overall survival benefit did not reach statistical significance. The company noted that while the combination demonstrated a tolerable safety profile and clinical benefits in several endpoints, further evaluation and a new approach will be needed to move forward with the treatment option for patients.
Read Announcement- Drug:
- Fruquintinib
- Announced Date:
- April 26, 2024
- Indication:
- Advanced solid tumors
Announcement
HUTCHMED (China) Limited announces that its partner Takeda received notification that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has recommended the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer ("CRC").
Read Announcement
FRUSICA-2 - FDA Regulatory Timeline and Events
FRUSICA-2 is a drug developed by HUTCHMED for the following indication: Advanced Renal Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FRUSICA-2
- Announced Date:
- March 18, 2025
- Indication:
- Advanced Renal Cell Carcinoma
Announcement
Innovent Biologics, Inc and HUTCHMED (China) Limited jointly announce that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR).
AI Summary
Innovent Biologics, Inc. and HUTCHMED (China) Limited announced encouraging results from the FRUSICA-2 Phase II/III clinical trial in China. This study evaluated the combination of sintilimab and fruquintinib as a second-line treatment for patients with locally advanced or metastatic renal cell carcinoma (RCC). The trial successfully met its primary endpoint of progression free survival (PFS), as determined by a blinded independent central review using RECIST 1.1 criteria. In addition to improved PFS, the combination therapy also showed promising results in key secondary endpoints, including the objective response rate and duration of response. These outcomes suggest that the sintilimab and fruquintinib regimen could offer a new and effective treatment alternative for advanced RCC patients who have not responded adequately to previous therapies. The companies anticipate sharing further detailed findings at an upcoming scientific conference.Read Announcement
HMPL-453 - FDA Regulatory Timeline and Events
HMPL-453 is a drug developed by HUTCHMED for the following indication: For Intrahepatic Cholangiocarcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HMPL-453
- Announced Date:
- March 6, 2025
- Indication:
- For Intrahepatic Cholangiocarcinoma
Announcement
HUTCHMED (China) Limited announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma ("IHCC") patients with fibroblast growth factor receptor ("FGFR")2 fusion/rearrangement.
AI Summary
HUTCHMED (China) Limited has announced that it has successfully completed enrollment for its Phase II clinical trial of fanregratinib (HMPL-453). This trial targets patients with intrahepatic cholangiocarcinoma (IHCC) who have FGFR2 fusion/rearrangement. The study is a single-arm, multi-center, open-label registration trial designed to evaluate the drug’s efficacy, safety, and pharmacokinetics in treating advanced IHCC. The primary goal of the trial is to determine the objective response rate (ORR), while secondary measures include progression-free survival, disease control rate, duration of response, and overall survival. A total of 87 patients were enrolled, with the first dose administered in March 2023. HUTCHMED expects to announce the topline results by the end of 2025, which may support a New Drug Application submission to China’s National Medical Products Administration if the findings are positive.
Read Announcement
savolitinib - FDA Regulatory Timeline and Events
savolitinib is a drug developed by HUTCHMED for the following indication: Tyrosine kinase inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- savolitinib
- Announced Date:
- June 1, 2025
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces primary results from the interim analysis of the SACHI Phase III study.
AI Summary
HUTCHMED (China) Limited shared the primary results from the interim analysis of the SACHI Phase III trial. The study focused on patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification who had seen disease progression after initial EGFR inhibitor treatment. The trial compared an all-oral combination of savolitinib and osimertinib against chemotherapy. Results showed that the savolitinib plus osimertinib group had a median progression-free survival (PFS) of 8.2 months versus 4.5 months in the chemotherapy group, with a significant hazard ratio of 0.34. The combination also led to a higher objective response rate of 58% compared to 34% with chemotherapy. In addition to strong efficacy, the treatment demonstrated a favorable safety profile, marking a promising advancement for a chemotherapy-free, patient-friendly option in treating this challenging form of lung cancer.
Read Announcement- Drug:
- savolitinib
- Announced Date:
- May 22, 2025
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology ("ASCO") Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA.
AI Summary
HUTCHMED (China) Limited announced that new data from several studies on its compounds—savolitinib, ranosidenib, fruquintinib, and surufatinib—will be shared at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 30 to June 3, 2025. These studies highlight the potential of the compounds in treating various cancers. For instance, savolitinib, when combined with osimertinib, has shown promising results in patients with EGFR mutation-positive non-small cell lung cancer, particularly in cases with MET amplification. Additionally, early data from a Phase I study of ranosidenib has indicated that the treatment is well tolerated, showing target inhibition and positive responses in certain patients. Overall, these presentations underline HUTCHMED’s commitment to advancing cancer therapies through innovative targeted treatments and robust clinical research.
Read Announcement- Drug:
- savolitinib
- Announced Date:
- April 21, 2025
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification.
AI Summary
HUTCHMED (China) Limited announced that it has completed enrollment of the registration phase of its Phase II clinical trial for savolitinib in gastric cancer patients with MET amplification. The trial is a single-arm, multi-center, open-label study designed to assess the efficacy, safety, and tolerability of savolitinib in patients with gastric or gastroesophageal junction adenocarcinoma who have MET amplification. A total of 64 patients have been enrolled. The primary goal of the trial is to measure the objective response rate, while secondary goals include evaluating progression-free survival and tracking adverse events.
Early results presented at the American Association for Cancer Research Annual Meeting showed promising activity with a 45% objective response rate overall and a 50% response rate in patients with high MET gene copy numbers. These findings may support future applications for marketing authorization in China later this year.
Read Announcement- Drug:
- savolitinib
- Announced Date:
- January 13, 2025
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") with MET exon 14 skipping alteration.
AI Summary
HUTCHMED (China) Limited announced that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application for ORPATHYS® (savolitinib). This approval expands the drug’s label to include adult patients with locally advanced or metastatic non‐small cell lung cancer (NSCLC) with MET exon 14 skipping alterations, whether they are treatment-naïve or have been previously treated. The previous conditional approval for patients who had received prior treatment has now been converted into full approval. The decision was based on promising results from a confirmatory Phase IIIb clinical trial, which demonstrated high tumor response and disease control rates among patients. This milestone is an important step in offering an effective and targeted treatment option for NSCLC patients with this specific genetic alteration, reflecting HUTCHMED’s ongoing commitment to addressing unmet medical needs in lung cancer care.
Read Announcement- Drug:
- savolitinib
- Announced Date:
- January 2, 2025
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration ("NMPA"). ORPATHYS® is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI").
AI Summary
HUTCHMED (China) Limited announced that its New Drug Application (NDA) for the combination treatment of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) has been accepted and granted priority review by the China National Medical Products Administration (NMPA). This combination is being developed for patients with locally advanced or metastatic EGFR mutation-positive non‐small cell lung cancer (NSCLC) with MET amplification after progression on first-line EGFR inhibitor therapy. ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor, while TAGRISSO® is a third-generation, irreversible EGFR TKI. The application is supported by positive findings from the SACHI Phase III trial, which met its primary endpoint of progression-free survival in an interim analysis. This regulatory progress underscores the commitment to tackling MET-driven resistance and offering an all-oral, chemotherapy-free treatment option for NSCLC patients.Read Announcement
- Drug:
- savolitinib
- Announced Date:
- December 12, 2024
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation‑positive non‑small cell lung cancer ("NSCLC") with MET amplification after disease progression on EGFR inhibitor therapy.
Read Announcement- Drug:
- savolitinib
- Announced Date:
- November 28, 2024
- Indication:
- Tyrosine kinase inhibitor
Announcement
HUTCHMED (China) Limited announces that following the contract renewal with the China National Healthcare Security Administration ("NHSA"), the updated National Reimbursement Drug List ("NRDL") effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement.
AI Summary
HUTCHMED (China) Limited has renewed its contract with the China National Healthcare Security Administration (NHSA), ensuring that the updated National Reimbursement Drug List (NRDL), effective January 1, 2025, will continue to include ORPATHYS® (savolitinib) under the same conditions as the current two-year agreement. ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor approved in China for treating certain non-small cell lung cancer patients with MET exon 14 skipping alterations. This renewal means that the drug remains accessible under the NRDL, which supports the government’s commitment to improving drug affordability for the nearly 1.33 billion people covered by basic medical insurance. The consistent terms reinforce the company's ongoing efforts to provide innovative and affordable treatments in oncology while maintaining its focus on meeting the needs of patients with specific genetic profiles.Read Announcement
TAZVERIK® (tazemetostat) - FDA Regulatory Timeline and Events
TAZVERIK® (tazemetostat) is a drug developed by HUTCHMED for the following indication: for the Treatment of Relapsed or Refractory Follicular Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAZVERIK® (tazemetostat)
- Announced Date:
- March 21, 2025
- Indication:
- for the Treatment of Relapsed or Refractory Follicular Lymphoma
Announcement
HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory ("R/R") follicular lymphoma ("FL") with EZH2 mutation who have received at least two prior systemic therapies.
AI Summary
HUTCHMED (China) Limited announced that its New Drug Application for TAZVERIK® (tazemetostat) has received conditional approval from China’s National Medical Products Administration (NMPA). TAZVERIK® is a first-in-class EZH2 inhibitor approved for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have an EZH2 mutation and have already received at least two prior systemic therapies. This approval, granted after a priority review, is based on data from a multicenter Phase II bridging study conducted in China and additional global clinical studies. The study primarily evaluated the drug’s objective response rate, along with secondary endpoints such as duration of response and progression‐free survival. This significant milestone marks HUTCHMED’s first approval in the area of hematological malignancies and offers new hope to FL patients who face limited treatment options.
Read Announcement
TYVYT - FDA Regulatory Timeline and Events
TYVYT is a drug developed by HUTCHMED for the following indication: for the Treatment of Advanced Endometrial Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TYVYT
- Announced Date:
- December 3, 2024
- Indication:
- for the Treatment of Advanced Endometrial Cancer
Announcement
Innovent Biologics, Inc and HUTCHMED (China) Limited announce that the New Drug Application (NDA) for the combination of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.
AI Summary
Innovent Biologics, Inc. and HUTCHMED (China) Limited announced that their new drug application for the combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been conditionally approved in China. This treatment is designed for patients with advanced endometrial cancer that have mismatch repair proficient (pMMR) tumors. It is specifically for those who have not benefited from previous systemic therapies and are not candidates for curative surgery or radiation. The decision was backed by priority review and breakthrough therapy designations from China’s National Medical Products Administration. Data from the FRUSICA-1 Phase II study showed promising results, with a 35.6% objective response rate and an 88.5% disease control rate, along with a quick median time to response of about 1.6 months. This approval marks a significant step in offering new treatment options to patients facing limited alternatives in advanced endometrial cancer.
Read Announcement
