NMPA clears HUTCHMED (HCM) drug ORPATHYS for MET-amplified gastric cancer

Rhea-AI Filing Summary

HUTCHMED (China) Limited reports that China’s National Medical Products Administration has granted conditional approval for ORPATHYS® (savolitinib) to treat locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with MET amplification after at least two prior systemic treatments.

ORPATHYS® is described as the first selective MET inhibitor approved in China for this MET‑amplified gastric cancer population, which the company cites as an estimated 4–6% of gastric cancer cases, or about 18,000 patients annually. The approval is based on a pivotal Phase II study that met its primary endpoint, with an independently reviewed objective response rate of 32.3% and a disease control rate of 63.1% as of the October 8, 2025 data cut‑off.

Positive

• NMPA conditional approval for new indication – ORPATHYS® receives conditional approval in China for MET‑amplified locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after at least two prior systemic treatments, opening access to an estimated 18,000 additional gastric cancer patients annually in this biomarker‑defined segment.

Negative

• None.

Insights

Biopharma & Regulatory Analyst

China’s conditional approval adds a new gastric cancer use for ORPATHYS®.

The NMPA’s conditional approval allows ORPATHYS® to be used in MET‑amplified advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior systemic treatments. This extends an already approved MET inhibitor into a difficult, late‑line setting with limited options.

The pivotal Phase II study showed an objective response rate of 32.3% and disease control rate of 63.1%, with median duration of response of 9.7 months and progression‑free survival of 4.0 months as of the October 8, 2025 cut‑off. Conditional status and further clinical results will influence future regulatory decisions and broader uptake.

Key Figures

Objective response rate: 32.3% Disease control rate: 63.1% Median duration of response: 9.7 months +4 more

7 metrics

Objective response rate 32.3% IRC-assessed ORR in Phase II gastric/GEJ MET-amplified study as of Oct 8, 2025

Disease control rate 63.1% IRC-assessed DCR in pivotal Phase II gastric/GEJ study

Median duration of response 9.7 months DoR in MET-amplified gastric/GEJ Phase II trial (95% CI: 3.7–18.5)

Median progression-free survival 4.0 months PFS in pivotal Phase II MET-amplified gastric/GEJ study (95% CI: 2.6–5.0)

Median time to response 1.4 months TTR in ORPATHYS MET-amplified gastric/GEJ Phase II trial

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

MET amplification prevalence 4–6% Estimated share of gastric cancer patients with MET amplification

Key Terms

NMPA, MET amplification, objective response rate, disease control rate, +2 more

6 terms

NMPA regulatory

"has been granted conditional approval by the China National Medical Products Administration (“NMPA”)"

China’s National Medical Products Administration is the government agency that reviews and approves medicines, medical devices and cosmetics, and enforces safety and quality rules. Think of it as a gatekeeper or traffic controller: its approvals and inspections determine whether a product can be sold, how quickly it reaches patients, and what safety or labeling rules apply—factors that directly affect a healthcare company’s sales, costs and regulatory risk for investors.

MET amplification medical

"gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China"

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.

objective response rate medical

"met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1"

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.

disease control rate medical

"Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

progression-free survival medical

"median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months"

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.

tyrosine kinase inhibitor medical

"ORPATHYS® (savolitinib) is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI)"

A tyrosine kinase inhibitor is a type of drug that blocks specific proteins in cells that act like on/off switches for growth and survival signals, often used to stop cancer cells from multiplying. For investors, these drugs matter because their clinical trial results, regulatory approvals, safety profiles, and patent status drive sales potential and company valuation—think of them as precision tools whose effectiveness and market exclusivity determine commercial success.

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

Form 6-K: How Foreign Companies Report to the SEC →

Available on EDGAR 07/02/2026 - 06:08 AM Accepted by SEC EDGAR 07/02/2026 - 06:08 AM Learn about SEC filing dates

FAQ

What did HUTCHMED (HCM) announce about ORPATHYS in this 6-K?

HUTCHMED announced that China’s NMPA granted conditional approval for ORPATHYS® (savolitinib) to treat locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with MET amplification after at least two prior systemic treatments, expanding its approved uses beyond existing indications in China.

For which gastric cancer patients is ORPATHYS now approved in China?

ORPATHYS® is approved for adults with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma whose tumors show MET amplification and who have already failed at least two prior systemic treatments, targeting a heavily pretreated and high‑risk population with limited options.

How common is MET-amplified gastric cancer according to HUTCHMED?

HUTCHMED cites research indicating MET amplification occurs in about 4–6% of gastric cancer patients. Based on epidemiology data referenced in the release, this corresponds to an estimated 18,000 new MET‑amplified gastric cancer cases each year in China, representing a meaningful niche population.

What key efficacy results supported ORPATHYS approval in gastric cancer?

The pivotal Phase II study in MET‑amplified gastric or gastroesophageal junction adenocarcinoma achieved an objective response rate of 32.3% and disease control rate of 63.1%. Median duration of response was 9.7 months and median progression‑free survival was 4.0 months, based on data to October 8, 2025.

Why is this ORPATHYS approval significant for HUTCHMED (HCM)?

This approval marks the third approved indication for ORPATHYS® in China and demonstrates HUTCHMED’s ability to advance an in‑house discovered, selective MET inhibitor into additional biomarker‑defined cancers, supporting its strategy in precision oncology alongside partner AstraZeneca.

What is ORPATHYS and how does it work in cancer treatment?

ORPATHYS® (savolitinib) is an oral, highly selective MET tyrosine kinase inhibitor. It blocks abnormal activation of the MET signaling pathway, which can be driven by mutations, gene amplification, or protein overexpression, thereby aiming to slow or stop growth of MET‑driven tumors such as certain lung and gastric cancers.

​

​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

​

​

FORM 6-K

​

​

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

​

For the Month of July 2026

​

Commission File Number: 001-37710

​

​

HUTCHMED (CHINA) LIMITED

(Translation of registrant’s name into English)

​

​

48th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong

(Address of principal executive offices)

​

​

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

​

Form 20-F  ⌧             Form 40-F  ◻

​

​

​

​

​

HUTCHMED (CHINA) LIMITED

​

Form 6-K

​

EXHIBIT INDEX

​

Exhibit No.	​ ​ ​	Description
​	​	​
Exhibit 99.1	​	Press release relating to NMPA approval for ORPATHYS® for the treatment of gastric cancer patients with MET amplification ​
​	​	​
​	​	​
​	​	​

2

​

​

SIGNATURE

​

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

​

​

​	HUTCHMED (CHINA) LIMITED
​	​	​
​	​	​
​	By:	/s/ Johnny Cheng
​	Name:	Johnny Cheng
​	Title:	Chief Financial Officer

​

​

Date: July 2, 2026

3

Exhibit 99.1

​

​

Press Release

​

HUTCHMED Announces NMPA Approval for ORPATHYS^® for the treatment of Gastric Cancer Patients with MET Amplification

​

— First selective MET inhibitor approved for patients with MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma in China —

​
Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 2, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (NDA) for ORPATHYS^® (savolitinib) has been granted conditional approval by the China National Medical Products Administration (“NMPA”) 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.

​

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 approval is supported by data from the pivotal Phase II registration study of ORPATHYS^® in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China (NCT04923932). The results were recently published in Nature Medicine and highlighted at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively.

​

“This milestone approval marks a critical leap forward for biomarker-driven precision medicine in gastrointestinal oncology,” said Professor Lin Shen of Peking University Cancer Hospital and leading Principal Investigator of the registration study. “The clinical data from our pivotal study, recently recognized and published by Nature Medicine, provided compelling evidence that identifying MET amplification through timely molecular testing can directly guide patients to a highly effective, targeted oral option. ORPATHYS^®’s entry into the MET-amplified gastric cancer clinical setting offers clinicians a powerful, precise new tool to interrupt this aggressive oncogenic driver.” ⁵

​

“The approval of ORPATHYS^® for MET-amplified advanced gastric cancer is an important achievement that underscores HUTCHMED’s enduring commitment to bringing in-house discovered innovations to patients,” said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. “This marks the third approved indication for ORPATHYS^® in China and further validates our proprietary R&D platform's ability to address deep unmet medical needs. Together with our partner AstraZeneca, we are proud to expand the clinical application of this highly selective MET inhibitor and look forward to accelerating its commercial availability to transform gastric cancer treatment landscapes in China.”

​

Ms Mary Guan, General Manager of AstraZeneca China Oncology Business, said: “Following its success in lung cancer, the approval of ORPATHYS^® in gastric cancer marks another pivotal chapter in our joint development journey with HUTCHMED. This regulatory milestone reinforces our shared vision of pairing the right treatments with the right patients through precision medicine. We look forward to maximizing the potential of this highly selective MET inhibitor and advancing its broader clinical lifecycle management to address the evolving unmet needs of cancer patients in China and beyond.”

​

About ORPATHYS^®

ORPATHYS^® (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.⁶ ORPATHYS^® 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.

ORPATHYS^® is approved in China and is marketed 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 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 therapeutic potential of ORPATHYS^®, the further clinical development for ORPATHYS^®, its expectations as to whether any studies on ORPATHYS^® 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. Forward-looking statements involve risks and uncertainties. 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 ORPATHYS^®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS^® for a targeted indication; and HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS^®, 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 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

​

______________

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 Peng Z, Liu T, Wang H. et al. Savolitinib in MET-amplified gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Nat Med. Published online June 1, 2026. doi:10.1038/s41591-026-04459-7

⁶ Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EX-99.1 28.2 KB