China grants conditional OK to HUTCHMED (HCM) ATLED after 42.5% response

Rhea-AI Filing Summary

HUTCHMED (China) Ltd (HCM) reports that China’s National Medical Products Administration has granted conditional approval for ATLED® (fanregratinib, HMPL-453), a novel oral FGFR 1/2/3 inhibitor, to treat adult patients in China with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement after prior systemic therapy.

The approval is based on a pivotal Phase II/IIIb China study (NCT04353375) whose Phase II registration cohort achieved an IRC-assessed objective response rate of 42.5%, median duration of response 6.9 months, disease control rate 83.9%, median progression-free survival 6.9 months and median overall survival 16.6 months. HUTCHMED retains worldwide rights to fanregratinib, and a Phase IIIb confirmatory cohort began enrollment in January 2026.

Positive

• NMPA conditional approval in China for ATLED® (fanregratinib) in FGFR2-altered advanced intrahepatic cholangiocarcinoma, supported by a 42.5% objective response rate, 83.9% disease control rate and 16.6-month median overall survival, adds a new marketed product and expands HUTCHMED’s oncology portfolio.

Negative

• None.

Key Figures

Objective response rate (ORR): 42.5% Disease control rate (DCR): 83.9% Median duration of response (DoR): 6.9 months +5 more

8 metrics

Objective response rate (ORR) 42.5% IRC-assessed ORR in Phase II registration cohort of advanced ICC with FGFR2 fusions/rearrangements

Disease control rate (DCR) 83.9% Phase II registration cohort of ATLED in pretreated advanced ICC patients

Median duration of response (DoR) 6.9 months Phase II registration cohort, 95% CI: 5.6–8.5

Median progression-free survival (PFS) 6.9 months Phase II registration cohort, 95% CI: 4.1–8.2

Median overall survival (OS) 16.6 months Phase II registration cohort, 95% CI: 12.4–16.6

Median time to response 1.4 months Key secondary endpoint in Phase II registration cohort

ICC share of primary liver cancers 8.2–15.0% Share of primary liver cancers accounted for by intrahepatic cholangiocarcinoma

FGFR2 fusions/rearrangements prevalence in ICC 10–15% Approximate proportion of ICC patients globally with FGFR2 fusions or rearrangements

Key Terms

conditional approval, objective response rate, disease control rate, progression-free survival, +2 more

6 terms

conditional approval regulatory

"has been granted conditional approval by the China National Medical Products"

Conditional approval is a formal confirmation that a product or plan is permitted to proceed, provided certain specified requirements are met within a designated timeframe. For investors, it signals that approval is nearly complete but depends on the fulfillment of specific conditions, which could influence the final outcome or timeline. This status helps stakeholders assess the likelihood of success while identifying any remaining hurdles.

objective response rate medical

"demonstrating an Independent Review Committee (IRC)-assessed objective response"

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

"Median duration of response (DoR) was 6.9 months ... and disease control rate"

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

"the median progression-free survival (PFS) was 6.9 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.

fibroblast growth factor receptor medical

"with fibroblast growth factor receptor (“FGFR”) 2 fusion or rearrangement"

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.

Phase II/IIIb clinical trial medical

"pivotal Phase II/IIIb clinical trial of ATLED® in China (NCT04353375)"

FAQ

What did HUTCHMED (HCM) announce regarding ATLED (fanregratinib)?

HUTCHMED announced that China’s NMPA granted conditional approval for ATLED® (fanregratinib) to treat adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or rearrangement who have previously received systemic therapy.

For which patients is ATLED approved in China according to HCM’s 6-K?

ATLED® is approved for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma whose tumors have FGFR2 fusion or rearrangement and who have already received systemic therapy.

What were the key efficacy results for ATLED in HUTCHMED’s pivotal trial?

In the Phase II registration cohort, ATLED® achieved an IRC-assessed objective response rate of 42.5%, disease control rate 83.9%, median duration of response 6.9 months, median progression-free survival 6.9 months, and median overall survival 16.6 months.

What was the median time to response for ATLED reported by HCM?

HUTCHMED reported that ATLED® showed a median time to response of 1.4 months in pretreated patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements.

How common are FGFR2 alterations in intrahepatic cholangiocarcinoma, per HCM?

HUTCHMED cites that approximately 10–15% of intrahepatic cholangiocarcinoma patients globally have tumors with FGFR2 fusions or rearrangements, representing the target population for ATLED® (fanregratinib).

What confirmatory study is planned for ATLED according to HUTCHMED (HCM)?

The Phase IIIb portion of the ATLED® trial will serve as a confirmatory study to further validate clinical benefit and safety, with enrollment for this cohort initiated in January 2026.

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

Available on EDGAR 08/28/2026 - 08:45 AM Accepted by SEC EDGAR 08/28/2026 - 06:21 AM Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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

SECURITIES EXCHANGE ACT OF 1934

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For the Month of August 2026

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Commission File Number: 001-37710

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HUTCHMED (CHINA) LIMITED

(Translation of registrant’s name into English)

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

(Address of principal executive offices)

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

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Form 20-F  ⌧             Form 40-F  ◻

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HUTCHMED (CHINA) LIMITED

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Form 6-K

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EXHIBIT INDEX

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Exhibit No.	​ ​ ​	Description
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Exhibit 99.1	​	Press release relating to HUTCHMED announcing NMPA approval for ATLED® (Fanregratinib) for the treatment of patients with FGFR2-fusion/rearrangement intrahepatic cholangiocarcinoma ​
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SIGNATURE

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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.

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

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Date: August 28, 2026

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Exhibit 99.1

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Press Release

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HUTCHMED Announces NMPA Approval for ATLED^® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma

—Novel, highly potent oral selective FGFR 1/2/3 inhibitor approved for patients with advanced FGFR2-altered intrahepatic cholangiocarcinoma in China —

Hong Kong, Shanghai & Florham Park, NJ — Friday, August 28, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration (“NMPA”) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (“ICC”) with fibroblast growth factor receptor (“FGFR”) 2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED^®. 

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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

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The approval is supported by data from the Phase II registration cohort of the single-arm, multi-center, open-label, pivotal Phase II/IIIb clinical trial of ATLED^® in China (NCT04353375). The results were recently presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2026. The study met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated advanced ICC patients harboring FGFR2-fusions/rearrangements, representing a strong, clinically meaningful response.

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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).

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“As a major and devastating subtype of primary liver cancer, intrahepatic cholangiocarcinoma carries an immense disease burden with historically limited targeted options. We are thrilled by the NMPA approval of ATLED^®, which directly addresses this critical therapeutic gap in China,” said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. “This approval unlocks an important new treatment alternative for a substantial population of pretreated advanced ICC patients. We are fully prepared to leverage our established commercial infrastructure to bring this precision medicine to patients as rapidly as possible.”

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The Phase IIIb portion of the trial will serve as the confirmatory study to further validate the clinical benefits and safety of ATLED^® in this setting. Enrollment for this confirmatory cohort was initiated in January 2026.

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About ATLED^®

ATLED^® (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.

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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 four 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.

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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 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. 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 fanregratinib, 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 fanregratinib for a targeted indication; and 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.

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.

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CONTACTS

Investor Enquiries	+852 2121 8200 / ir@hutch-med.com
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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
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Panmure Liberum	Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden	+44 20 7886 2500
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Cavendish	Joint Broker
Geoff Nash / Nigel Birks	+44 20 7220 0500
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Deutsche Numis	Joint Broker
Duncan Monteith / Ramin Naji	+44 20 7545 8000

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REFERENCES

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.

Filing Exhibits & Attachments

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