HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Savolitinib for the treatment of Gastric Cancer Patients with MET Amplification

Rhea-AI Summary

HUTCHMED (Nasdaq/AIM: HCM) announced that the China NMPA accepted the NDA for savolitinib to treat locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma with MET amplification and granted priority review on Dec 30, 2025.

The NDA is supported by a single-arm, multi-center Phase II registration study in Chinese patients that met its primary endpoint of objective response rate (ORR) by IRC (RECIST 1.1). Savolitinib previously received Breakthrough Therapy designation in 2023. MET amplification is estimated at 4–6% of gastric cancer cases, with an annual incidence of roughly 18,000 patients in China.

Positive

• NMPA accepted NDA and granted priority review
• Phase II study met primary endpoint (ORR by IRC)
• Breakthrough Therapy designation (2023) supports expedited review
• Potential to be first selective MET inhibitor in China for this indication

Negative

• Pivotal evidence is from a single-arm Phase II study (no randomized control)
• Target population is limited: 4–6% of gastric cancer (~18,000 annual cases in China)

News Market Reaction

-1.49%

1 alert

-1.49% News Effect

On the day this news was published, HCM declined 1.49%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MET amplification share: 4–6% MET-amplified incidence: 18,000 patients Prior treatments required: At least 2 prior systemic treatments +5 more

8 metrics

MET amplification share 4–6% Proportion of gastric cancer patients with MET amplification in China

MET-amplified incidence 18,000 patients Estimated annual incidence of MET-amplified gastric cancer in China

Prior treatments required At least 2 prior systemic treatments Eligibility criteria for savolitinib NDA population

Breakthrough Therapy year 2023 Year NMPA granted Breakthrough Therapy Designation for savolitinib in this indication

Current price $13.4 Latest price before NDA acceptance news

52-week high $19.5 Pre-news 52-week high for HCM

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

Phase II endpoint Objective response rate (ORR) Primary endpoint met by IRC per RECIST 1.1

Market Reality Check

Price: $14.76 Vol: Volume 29,882 is 23% abov...

normal vol

$14.76 Last Close

Volume Volume 29,882 is 23% above 20-day average 24,276. normal

Technical Price 13.4 is trading below 200-day MA at 15.25, well under the 52-week high 19.5.

Peers on Argus

Peers showed mixed, modest moves: INDV +0.76%, PBH +0.98%, while BHC -0.7%, KNSA...

Peers showed mixed, modest moves: INDV +0.76%, PBH +0.98%, while BHC -0.7%, KNSA -2.09%, SUPN -0.58%, suggesting today’s move in HCM is stock-specific rather than a coordinated sector shift.

Historical Context

5 past events · Latest: Dec 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 16	Clinical development start	Positive	+0.5%	Initiation of global Phase I/IIa trial for ATTC candidate HMPL-A251.
Dec 07	Reimbursement update	Positive	-1.3%	NRDL renewal and inclusion in China commercial insurance drug list.
Nov 26	Clinical data previews	Positive	+0.7%	Upcoming presentations of multiple clinical datasets at ESMO Asia and ASH.
Nov 04	Phase III enrollment	Positive	+0.5%	Completion of enrollment in SAFFRON global Phase III ORPATHYS+TAGRISSO trial.
Nov 02	R&D pipeline update	Positive	+4.3%	R&D event highlighting ATTC platform and strong late-stage oncology data.

Pattern Detected

Recent pipeline and clinical updates have generally led to modestly positive price reactions, with one divergence on reimbursement/access news.

Recent Company History

Over the past two months, HUTCHMED has reported several pipeline and market-access milestones. These include global development initiation for HMPL-A251 (Dec 16, 2025), expanded coverage on China’s NRDL and a new commercial insurance list (effective Jan 1, 2026), and multiple clinical data updates at ESMO Asia and ASH 2025. Enrollment was completed in the global Phase III SAFFRON trial of ORPATHYS plus TAGRISSO. Today’s NDA acceptance and priority review for savolitinib in MET‑amplified gastric cancer fits this pattern of advancing late‑stage assets.

Market Pulse Summary

This announcement details NMPA acceptance of HUTCHMED’s NDA for savolitinib in MET‑amplified gastric...

Analysis

This announcement details NMPA acceptance of HUTCHMED’s NDA for savolitinib in MET‑amplified gastric or gastroesophageal junction cancer with priority review, supported by a Phase II study that met its ORR primary endpoint under RECIST 1.1. The target group is a biologically defined subset, estimated at 4–6% of gastric cancers, or about 18,000 annual cases in China. Investors may track review progress, any additional data disclosures, and how this indication complements the company’s broader late‑stage oncology portfolio.

Key Terms

nda, met amplification, gastroesophageal junction, objective response rate, +4 more

8 terms

nda regulatory

"the New Drug Application (“NDA”) for savolitinib for the treatment of"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

met amplification medical

"adenocarcinoma patients with MET amplification who have failed at least"

MET amplification is a genetic change where extra copies of the MET gene cause cells to make too much of a growth-promoting protein, which can drive some cancers to grow and spread. For investors, it matters because cancers with this change may respond to targeted drugs or diagnostic tests, affecting the commercial potential of therapies, clinical trial outcomes, and the value of companies developing treatments or tests for MET-driven tumors.

gastroesophageal junction medical

"gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients"

The gastroesophageal junction is the physical spot where the tube that brings food from the mouth (the esophagus) meets the stomach. Think of it as a doorway between two rooms that needs to open and close properly; problems there can cause reflux, ulcers, or cancers that require drugs, devices, or surgery. Investors care because diseases or procedures tied to this location drive clinical trials, regulatory decisions, and market demand for treatments and medical devices.

objective response rate medical

"met its primary endpoint of objective response rate (ORR) by the Independent"

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.

recist 1.1 medical

"objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1)."

RECIST 1.1 is a standardized set of rules used in cancer clinical trials to measure how solid tumors respond to treatment by tracking changes in size on medical scans. Think of it as a consistent ruler and scorecard that tells doctors and regulators whether a drug is shrinking tumors, keeping them stable, or allowing them to grow. Investors care because RECIST-based results are common primary endpoints that influence regulatory decisions, trial success, and a therapy’s commercial prospects.

breakthrough therapy designation regulatory

"follows Breakthrough Therapy Designation granted in 2023 — — Savolitinib"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

single-arm medical

"data from a single-arm, multi-center, open-label, Phase II registration study"

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

open-label medical

"single-arm, multi-center, open-label, Phase II registration study of savolitinib"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

AI-generated analysis. Not financial advice.

— NDA supported by positive Phase II registration study data in Chinese patients; follows Breakthrough Therapy Designation granted in 2023 —

— Savolitinib has the potential to become the first selective MET inhibitor in China for MET-amplified gastric cancer —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 30, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces 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 who have failed at least two prior systemic treatments has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

This NDA is supported by data from a single-arm, multi-center, open-label, Phase II registration study of savolitinib in gastric cancer patients with MET amplification in China. The study has met its primary endpoint of objective response rate (ORR) by the Independent Review Committee (IRC) (RECIST 1.1). Additional details may be found at clinicaltrials.gov using identifier NCT04923932.

Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis.¹ It is estimated that MET amplification accounts for approximately 4-6% of gastric cancer patients.^2,3 The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.⁴  

The NMPA has granted Breakthrough Therapy Designation to savolitinib for this potential indication in 2023. The NMPA granted this designation to this new treatment that could target a serious condition where clinical evidence demonstrates substantial advantages over existing therapies.

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an essential role in normal cell development.⁵ Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is approved in China and is marketed under the brand name ORPATHYS^® by our partner, AstraZeneca, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

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 savolitinib for the treatment of gastric cancer with the NMPA and the timing of such review, therapeutic potential of savolitinib for the treatment of patients with gastric cancer and the further development of savolitinib 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 savolitinib for the treatment of patients with gastric cancer 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 savolitinib, HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for savolitinib 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.

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 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

_____________________

REFERENCES

¹ Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070. doi:10.1002/cncr.30437
² Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044
³ Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter Phase II Study of AMG 337 in Patients with MET-Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337
⁴ Global Cancer Observatory. China Fact Sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed April 7, 2025.
⁵ Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).

FAQ

What did HUTCHMED (HCM) announce on December 30, 2025 about savolitinib?

HUTCHMED said the China NMPA accepted the NDA for savolitinib in MET‑amplified GC/GEJ and granted priority review.

What clinical evidence supports HCM's savolitinib NDA in China?

The NDA is supported by a single‑arm, multi‑center Phase II registration study in Chinese patients that met its primary endpoint (ORR by IRC, RECIST 1.1).

Does savolitinib have any expedited designations for MET‑amplified gastric cancer in China?

Yes, savolitinib was granted Breakthrough Therapy designation in 2023 by the NMPA for this potential indication.

How large is the addressable MET‑amplified gastric cancer population in China for HCM's savolitinib?

MET amplification is estimated at 4–6% of gastric cancer cases, with an annual incidence of about 18,000 patients in China.

Will priority review speed up HCM's savolitinib approval timeline in China?

Priority review indicates the NMPA will review the NDA on an expedited track, potentially shortening review time compared with standard review.