HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) reported pivotal Phase II data for fanregratinib in pretreated advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements.

The single-arm trial (53 sites in China) showed IRC-assessed ORR 42.5%, DCR 83.9%, median DoR 6.9 months, PFS 6.9 months, and OS 16.6 months. An NDA received priority review in China.

Positive

• Priority review granted in December 2025 for fanregratinib NDA in advanced ICC with FGFR2 fusions/rearrangements
• IRC-assessed objective response rate of 42.5% (95% CI: 30.0%–53.6%) in Phase II ICC study
• Disease control rate of 83.9% (95% CI: 74.5%–90.9%) in treated patient population
• Median duration of response 6.9 months and median progression-free survival 6.9 months
• Median overall survival of 16.6 months (95% CI: 12.4–16.6)
• Low treatment discontinuation due to drug-related adverse events at 2.2% and no treatment-related deaths

Negative

• Grade 3 or higher drug-related adverse events reported in 48.3% of patients, including liver enzyme elevations and PPES

News Market Reaction – HCM

+0.19%

+0.19% Session close to close

In the Jun 25 session, HCM gained 0.19%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights pivotal Phase II data for fanregratinib in FGFR2-altered ICC, including...

Analysis

This announcement highlights pivotal Phase II data for fanregratinib in FGFR2-altered ICC, including an ORR of 42.5% and median OS of 16.6 months. With China priority review already granted, key risks include safety tolerability and eventual regulatory outcomes.

Key Figures

Objective response rate: 42.5% ORR (95% CI: 30.0%–53.6%) Time to response: 1.4 months Duration of response: 6.9 months (95% CI: 5.6–8.5) +5 more

8 metrics

Objective response rate 42.5% ORR (95% CI: 30.0%–53.6%) Pivotal Phase II fanregratinib ICC trial, IRC-assessed primary endpoint

Time to response 1.4 months Median time to response in Phase II fanregratinib ICC study

Duration of response 6.9 months (95% CI: 5.6–8.5) Median DoR in treated ICC patients with FGFR2 fusion/rearrangement

Disease control rate 83.9% (95% CI: 74.5%–90.9%) Phase II fanregratinib ICC trial key secondary endpoint

Progression-free survival 6.9 months (95% CI: 4.1–8.2) Median PFS in pivotal Phase II fanregratinib ICC study

Overall survival 16.6 months (95% CI: 12.4–16.6) Median OS for advanced ICC patients in fanregratinib trial

Grade ≥3 adverse events 48.3% of patients Drug-related Grade 3 or greater AEs in fanregratinib ICC study

Treatment discontinuation 2.2% of patients Discontinuations due to drug-related AEs; no treatment-related deaths

Previous Clinical trial Reports

5 past events · Latest: Jun 11 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 11	Phase III data	Positive	+2.6%	Phase III sovleplenib wAIHA data with NDA under priority review in China.
May 21	Clinical data preview	Positive	-0.4%	Upcoming ASCO presentations including pivotal savolitinib Phase II meeting ORR endpoint.
Mar 22	Trial initiation	Positive	+0.4%	Start of registrational Phase III HMPL-760 trial in relapsed/refractory DLBCL in China.
Jan 13	Phase III publication	Positive	+2.3%	Lancet publication of SACHI Phase III confirming savolitinib plus osimertinib efficacy.
Jan 06	Topline Phase III	Positive	+6.6%	Positive topline Phase III ESLIM-02 sovleplenib results in wAIHA with planned NDA.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial announcements for HUTCHMED have typically led to modestly positive next-day price moves.

Key Terms

objective response rate, progression-free survival, overall survival, new drug application (nda), +2 more

6 terms

objective response rate medical

"The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6)"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

new drug application (nda) regulatory

"a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

priority review regulatory

"has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA)"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

palmar-plantar erythrodysesthesia syndrome medical

"with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES)"

A painful skin reaction that causes redness, swelling, blistering or peeling on the palms of the hands and soles of the feet, often triggered by certain chemotherapy or targeted cancer drugs. It matters to investors because it can force dose reductions, treatment interruptions or extra medical care, which can slow a drug’s uptake, affect clinical trial outcomes and increase costs—similar to a car needing frequent repairs that limit how much it can be used.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

— Registration-enabling study demonstrated high clinically meaningful objective responses, achieving rapid and durable disease control —

— Fanregratinib holds promise as a new treatment option for pretreated advanced ICC patients harboring FGFR2-fusions/rearrangements —

HONG KONG and FLORHAM PARK, N.J., June 25, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma (“ICC”) will be presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor (“FGFR”) 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

“The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure,” said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. “The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology.”

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title:	Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author:	Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session:	Rapid oral session on innovation
Presentation Number:	343RO
Date & Time:	Saturday, July 4, 2026, 9:00 am CEST
Location:	Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fanregratinib, the further clinical development for fanregratinib, its expectations as to whether any studies on fanregratinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fanregratinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fanregratinib for a targeted indication, and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

Investor Enquiries	+852 2121 8200 / ir@hutch-med.com
Media Enquiries
FTI Consulting –	+44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Tim Stamper	+44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)
Brunswick – Zhou Yi	+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Panmure Liberum	Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden	+44 20 7886 2500
Cavendish	Joint Broker
Geoff Nash / Nigel Birks	+44 20 7220 0500
Deutsche Numis	Joint Broker
Duncan Monteith / Ramin Naji	+44 20 7545 8000

FAQ

What Phase II results did HUTCHMED (HCM) report for fanregratinib in FGFR2-positive intrahepatic cholangiocarcinoma?

HUTCHMED reported that fanregratinib achieved an IRC-assessed objective response rate of 42.5% in advanced FGFR2-fusion/rearrangement intrahepatic cholangiocarcinoma. According to HUTCHMED, disease control rate reached 83.9%, with median duration of response 6.9 months and progression-free survival 6.9 months.

How strong were the survival outcomes for fanregratinib in HUTCHMED’s Phase II ICC trial?

The fanregratinib trial showed median overall survival of 16.6 months in treated patients. According to HUTCHMED, median progression-free survival was 6.9 months, and the median duration of response was also 6.9 months, indicating prolonged benefit for responding patients.

What safety profile did HUTCHMED report for fanregratinib in the Phase II ICC study?

Fanregratinib showed what HUTCHMED describes as a manageable safety profile consistent with selective FGFR inhibitors. According to HUTCHMED, Grade 3 or higher drug-related adverse events occurred in 48.3% of patients, but treatment discontinuation was 2.2% with no treatment-related deaths.

Has fanregratinib received regulatory priority review in China, and what does it cover for HCM?

Yes, fanregratinib received priority review from China’s NMPA for advanced ICC with FGFR2 fusions/rearrangements. According to HUTCHMED, the NDA, accepted in December 2025, covers adults with metastatic or unresectable disease previously treated with systemic therapy.

What patient population was included in HUTCHMED’s pivotal fanregratinib Phase II trial for ICC?

The trial enrolled adults with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. According to HUTCHMED, all patients had received at least one prior systemic therapy line, all had prior chemotherapy, and 72% had prior immunotherapy exposure.

When and where will HUTCHMED present the fanregratinib Phase II data at ESMO GI 2026?

The fanregratinib Phase II data will be presented on July 4, 2026, at 9:00 am CEST. According to HUTCHMED, the rapid oral session (presentation 343RO) will take place in Room 13a at the ESMO Gastrointestinal Cancers Congress in Munich.