HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM: HCM) announced that the New Drug Application for fanregratinib (HMPL-453) in second-line intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement has been accepted and granted priority review by the China NMPA on Dec 29, 2025. Fanregratinib is an oral selective FGFR 1/2/3 inhibitor.

The NDA is supported by a single-arm, multi-center Phase II registration study in China (clinicaltrials.gov identifier NCT04353375) that met its primary endpoint of objective response rate; secondary endpoints (PFS, DCR, DoR, OS) also supported the primary findings. ICC accounts for roughly 8.2–15.0% of primary liver cancers and has an approximate 5-year overall survival of 9%; ~10–15% of ICC tumors harbor FGFR2 fusions/rearrangements.

Positive

• NMPA acceptance and priority review for fanregratinib
• Phase II study met primary endpoint of objective response rate
• Secondary endpoints (PFS, DCR, DoR, OS) support primary findings

Negative

• Registration data from a single-arm Phase II study, not randomized
• No detailed efficacy numbers (ORR, PFS, OS) disclosed in announcement

News Market Reaction

-2.69%

1 alert

-2.69% News Effect

On the day this news was published, HCM declined 2.69%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ICC share of liver cancers: 8.2–15.0% 5-year overall survival: approximately 9% FGFR2 alteration rate: 10–15% +5 more

8 metrics

ICC share of liver cancers 8.2–15.0% Proportion of primary liver cancers accounted for by ICC

5-year overall survival approximately 9% 5-year OS rate for intrahepatic cholangiocarcinoma

FGFR2 alteration rate 10–15% ICC patients globally with tumors harboring FGFR2 fusions/rearrangements

Trial phase Phase II Single-arm, multi-center, open-label registration study in China

Trial identifier NCT04353375 ClinicalTrials.gov identifier for fanregratinib Phase II study

Current price $13.77 Price before impact of NDA acceptance news

52-week high $19.50 Pre-news 52-week high level for HCM

52-week low $11.505 Pre-news 52-week low level for HCM

Market Reality Check

Price: $15.00 Vol: Volume 27,605 vs 20-day a...

normal vol

$15.00 Last Close

Volume Volume 27,605 vs 20-day average 23,707 (relative volume 1.16x). normal

Technical Price 13.77 is trading below the 200-day MA 15.26, indicating a weaker longer-term trend.

Peers on Argus

Peers show mixed, mostly small moves (e.g., INDV +0.11%, BHC +0.35%, KNSA -1.13%...

Peers show mixed, mostly small moves (e.g., INDV +0.11%, BHC +0.35%, KNSA -1.13%), suggesting this is stock-specific rather than a sector-wide move.

Historical Context

5 past events · Latest: 2025-12-16 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2025-12-16	Clinical development	Positive	+0.5%	Initiation of global Phase I/IIa trial for ATTC candidate HMPL-A251.
2025-12-07	Reimbursement update	Positive	-1.3%	Expanded NRDL and commercial insurance coverage for several oncology drugs.
2025-11-26	Data presentations	Positive	+0.7%	Announcement of multiple new and updated datasets for pipeline assets at ESMO Asia and ASH.
2025-11-04	Phase III milestone	Positive	+0.5%	Completion of enrollment in SAFFRON global Phase III ORPATHYS+TAGRISSO trial.
2025-11-02	R&D update event	Positive	+4.3%	R&D day highlighting new ATTC platform and strong late-stage efficacy data.

Pattern Detected

Recent news, mainly clinical and pipeline updates, has typically led to modest single-digit price moves, with one notable divergence on positive reimbursement news.

Recent Company History

Over the past few months, HUTCHMED has focused on clinical and commercial execution. Events include ATTC candidate HMPL-A251 entering global Phase I/IIa on 2025-12-16, expanded reimbursement and commercial insurance coverage in China on 2025-12-07, and multiple data presentations at ESMO Asia and ASH in early December. Enrollment completion of the SAFFRON Phase III trial was reported on 2025-11-04, alongside broader R&D and late‑stage pipeline updates on 2025-11-02. Today’s NDA acceptance with priority review for fanregratinib fits into this ongoing registrational and commercialization push.

Market Pulse Summary

This announcement details NDA acceptance and priority review for fanregratinib in second-line FGFR2‑...

Analysis

This announcement details NDA acceptance and priority review for fanregratinib in second-line FGFR2‑positive intrahepatic cholangiocarcinoma, supported by a Chinese Phase II registration study that met its primary ORR endpoint and showed consistent secondary outcomes. It follows a series of recent clinical and reimbursement milestones, reinforcing HUTCHMED’s late‑stage oncology focus. Investors may watch for the full Phase II dataset, NMPA review progress, and how this candidate complements other assets like ORPATHYS and the emerging ATTC platform.

Key Terms

new drug application, priority review, intrahepatic cholangiocarcinoma, fibroblast growth factor receptor, +4 more

8 terms

new drug application regulatory

"the New Drug Application (“NDA”) for fanregratinib (HMPL-453) for the treatment"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

priority review regulatory

"has been accepted and granted priority review by the China National Medical"

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.

intrahepatic cholangiocarcinoma medical

"unresectable intrahepatic cholangiocarcinoma (“ICC”) with fibroblast growth factor"

A rare form of liver cancer that starts in the small bile ducts inside the liver; think of it as a blockage or corrosion in the organ’s internal plumbing. Investors pay attention because its severity and limited treatment options drive demand for new drugs, diagnostics and clinical trials, which can significantly affect the value and future revenue prospects of healthcare and biotech companies developing therapies.

fibroblast growth factor receptor medical

"with fibroblast growth factor receptor (“FGFR”) 2 fusion/rearrangement who have"

A fibroblast growth factor receptor (FGFR) is a protein on a cell’s surface that acts like a light switch: when it binds specific signaling molecules, it turns on pathways that control cell growth, division and blood-vessel formation. Changes or overactivity in FGFRs are linked to cancer and other diseases, so drugs that block or modify these receptors are important development targets and can significantly affect the value of biotech and pharmaceutical investments.

objective response rate medical

"The study has met its primary endpoint of objective response rate (ORR)."

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

"secondary endpoints including progression-free survival (PFS), disease control rate"

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.

duration of response medical

"disease control rate (DCR), duration of response (DoR) and overall survival (OS)"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

overall survival medical

"duration of response (DoR) and overall survival (OS) also support the primary"

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.

AI-generated analysis. Not financial advice.

— NDA supported by results from a Phase II registration trial in China —

— Second most common form of liver cancer after hepatocellular carcinoma, with generally poorer long-term survival in comparison —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for fanregratinib (HMPL-453) for the treatment of 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 has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Fanregratinib (HMPL-453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.¹ Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.^2,3

This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study in China. The study has met its primary endpoint of objective response rate (ORR). Results from the secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS) also support the primary endpoint findings. Full results will be submitted for presentation at an upcoming scientific conference. Additional details may be found at clinicaltrials.gov using identifier NCT04353375.

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 its expectations regarding the review of a NDA for fanregratinib for the treatment of ICC with the NMPA and the timing of such review, therapeutic potential of fanregratinib for the treatment of patients with ICC and the further development of fanregratinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of fanregratinib for the treatment of patients with ICC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the safety profile of fanregratinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fanregratinib and the timing of these events. 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.

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 7421 898 348 (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
Freddie Barnfield / Jeffrey Wong / Duncan Monteith	+44 20 7260 1000

¹ Expert consensus on precision detection of intrahepatic cholangiocarcinoma (2024 edition). Chin J Clin Med. 2025;32(1):1-18.
² Arai Y, Totoki Y, Hosoda F, et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology. 2014;59:1427–34.
³ Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of biliary tract cancer. Nat Genet. 2015;47:1003–10.

FAQ

What did HUTCHMED (HCM) announce about fanregratinib on December 29, 2025?

HUTCHMED announced NMPA acceptance and priority review of the NDA for fanregratinib in second-line FGFR2-positive ICC.

What clinical evidence supports HUTCHMED's NDA for fanregratinib (HCM)?

A single-arm, multi-center Phase II registration study in China (NCT04353375) that met its primary endpoint of objective response rate.

Does the announcement include fanregratinib efficacy numbers for HCM?

No; the release states the Phase II study met ORR and that secondary endpoints supported the findings, but it does not disclose numeric ORR, PFS, DoR, or OS values.

What percentage of intrahepatic cholangiocarcinoma patients have FGFR2 fusions relevant to HUTCHMED (HCM)?

Approximately 10–15% of ICC patients globally have tumors with FGFR2 fusions or rearrangements.

Where can investors find the clinical trial record for fanregratinib (HCM)?

The study is listed on clinicaltrials.gov under identifier NCT04353375.