# EDGAR Filing Document

**Accession Number:** 0001648257
**File Stem:** 0001648257-25-000071
**Filing Date:** 2025-10
**Character Count:** 22226
**Document Hash:** 76ff9dbc307c98afeee30a3246977ba5
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001648257-25-000071.hdr.sgml**: 20251014

**ACCESSION NUMBER**: 0001648257-25-000071

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 5

**CONFORMED PERIOD OF REPORT**: 20251014

**FILED AS OF DATE**: 20251014

**DATE AS OF CHANGE**: 20251014

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** HUTCHMED (China) Ltd
- **CENTRAL INDEX KEY:** 0001648257
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** E9

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37710
- **FILM NUMBER:** 251389289

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 48TH FLOOR, CHEUNG KONG CENTER
- **STREET 2:** 2 QUEEN'S ROAD CENTRAL
- **CITY:** HONG KONG
- **PROVINCE COUNTRY:** K3
- **BUSINESS PHONE:** 852-2121-3888

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 48TH FLOOR, CHEUNG KONG CENTER
- **STREET 2:** 2 QUEEN'S ROAD CENTRAL
- **CITY:** HONG KONG
- **PROVINCE COUNTRY:** K3

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Hutchison China MediTech Ltd
- **DATE OF NAME CHANGE:** 20150716

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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**

**For the Month of October 2025**

**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.

Form 20-F ⌧ &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form 40-F ◻

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**HUTCHMED (CHINA) LIMITED**

**Form 6-K**

<u>EXHIBIT INDEX</u>

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| Exhibit 99.1 | Press release relating to FRUSICA-2 registration trial data to be presented at the 2025 ESMO Congress<br>|
| Exhibit 99.2<br>| Announcement relating to appointment of Independent Non-Executive Director and member of board committee |

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**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.

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

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Date: October 14, 2025

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## Exhibit 99.1

**Exhibit 99.1**

![Graphic](hcm-20251014xex99d1001.gif)

**Press Release**

**HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress**

— The fruquintinib and sintilimab combination demonstrated significant PFS improvements in advanced renal cell carcinoma patients after progression on first-line therapies —

**Hong Kong, Shanghai & Florham Park, NJ — Monday, October 13, 2025:** HUTCHMED (China) Limited ("<u>HUTCHMED</u>") (Nasdaq/AIM:HCM; HKEX:13) announces results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma. Results of the Phase III part of the study will be presented on Friday, October 17, 2025 during the European Society for Medical Oncology ("ESMO") Congress in Berlin, Germany.

FRUSICA-2 is a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma (<u>NCT05522231</u>). A total of 234 patients were randomized into a group that received fruquintinib plus sintilimab combination therapy, or into a group that received axitinib or everolimus monotherapy. As of the progression free survival ("PFS") final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months.

The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank *p*<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, *p*<0.0001), and the median duration of response (DoR) was 23.7 vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria.

The safety profile of the fruquintinib and sintilimab combination was tolerable and consistent with the known profiles of each individual treatment. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8% for patients in the axitinib/everolimus group.

"The FRUSICA-2 trial results provide compelling evidence that fruquintinib and sintilimab may offer a valuable new treatment option for patients with advanced renal cell carcinoma," said **Professor Dingwei Ye of Fudan University Shanghai Cancer Center** and the co-leading Principal Investigator of the FRUSICA-2 study. "These findings show the combination's potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups."

"The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma," said **Professor Zhisong He of Peking University First Hospital** and the co-leading Principal Investigator of the FRUSICA-2 study. "These results point to the combination's potential to enhance clinical outcomes, providing a new option for managing this challenging disease."

Supported by data from FRUSICA-2, a New Drug Application (NDA) for the combination of fruquintinib and sintilimab in patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA).

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**About Kidney Cancer and Renal Cell Carcinoma**

It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.<sup>1</sup> In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.<sup>2</sup> Approximately 90% of kidney tumors are renal cell carcinoma.

*The safety and efficacy of fruquintinib for the investigational uses discussed above have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.*

**About Fruquintinib** 

Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition.<sup>3</sup>

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE<sup>®</sup>. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. The combination of fruquintinib and sintilimab has received conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA<sup>®</sup>.

**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: <u>www.hutch-med.com</u> or follow us on <u>LinkedIn</u>.

***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 fruquintinib, the further clinical development for fruquintinib, its expectations as to whether any studies on fruquintinib 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 fruquintinib, 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 fruquintinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. 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**

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| | |
|:---|:---|
| **Investor Enquiries** | +852 2121 8200 / <u>ir@hutch-med.com</u> |
| **Media Enquiries** |  |
| FTI Consulting – | +44 20 3727 1030 / <u>HUTCHMED@fticonsulting.com</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;Ben Atwell / Alex Shaw | &nbsp;&nbsp;&nbsp;&nbsp;+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) |
| Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / <u>HUTCHMED@brunswickgroup.com</u> |
| **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 The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf. Accessed February 19, 2025.

2 The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed February 19, 2025.

3 Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. *Cancer Biol Ther*. 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087.

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## Exhibit 99.2

**Exhibit 99.2**

![Graphic](hcm-20251014xex99d2001.gif)

#### HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committee
**Hong Kong, Shanghai & Florham Park, NJ — Tuesday, October 14, 2025:** HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM:HCM, HKEX:13) today announces that Professor Tan Shao Weng, Daniel (Chen Shaowen) is appointed as an Independent Non-executive Director and a member of the Technical Committee of the Company with effect from October 15, 2025.

Professor Tan, aged 47, has over 20 years of experience in oncology, with his main research interests focusing on thoracic, head and neck malignancies, and drug development. He is the head of the Division of Clinical Trials and Epidemiological Sciences and a senior consultant in the Division of Medical Oncology at the National Cancer Centre Singapore ("NCCS"). He is a professor at Duke-NUS Medical School and serves as a senior clinician-scientist at the Genome Institute of Singapore.

Dr Dan Eldar, Chairman of HUTCHMED, said "On behalf of the Board, I would like to extend a warm welcome to Professor Tan. Professor Tan has a proven track record in early phase clinical trials of novel therapeutics, and we believe that his expertise in targeted therapies, biomarker development and clinical oncology will strongly support the strategic growth of the Company and drive continued innovation in cancer drug development."

Professor Tan currently leads the Experimental Cancer Therapeutics Unit (ECRU) at the NCCS, one of Asia's largest Phase I units, which runs approximately 30–40 trials at any time. He is also the Principal Investigator of the Cancer Therapeutics Research Laboratory at NCCS focused on developing representative patient-derived preclinical models to study drug response and resistance, complementing his leadership in multiple biomarker-driven early-phase and first-in-human clinical trials. He currently serves as the principal investigator of the National Medical Research Council ("NMRC") Lung Cancer Large Collaborative Grant in Singapore (2025-2029 and previously 2019–2023) and chairs the Asian Thoracic Oncology Research Group, a regional platform for translational research and clinical trials.

Professor Tan's research focuses on applying "omics" technologies to understand drug resistance and accelerate the development of novel therapies and biomarkers. His work has earned numerous accolades, including the International Association for the Study of Lung Cancer (IASLC) Daniel C. Idhe Lectureship Award for Medical Oncology, the American Society of Clinical Oncology (ASCO) Young Investigator Award, and the SingHealth Group Chief Executive Officer Outstanding Clinician-Researcher Award. He is a three-time recipient of the NMRC Clinician-Scientist Award.

He has published extensively, contributing to over 200 peer-reviewed articles including those in leading journals such as Nature, Nature Medicine, New England Journal of Medicine, and The Lancet Oncology. Professor Tan has held leadership roles in global oncology forums, including Chair of the IASLC Education Committee and Co-Chair of the World Conference on Lung Cancer (WCLC). He currently serves as Associate Editor for the Journal of Thoracic Oncology, Scientific Editor for Cancer Discovery and Senior Editor for Clinical Cancer Research. He is a member of the American Association of Cancer Research (AACR), ASCO, the European Society for Medical Oncology (ESMO), IASLC and the Singapore Society of Oncology of which he was also a past secretary.

Professor Tan holds a Bachelor of Science degree with first class honors in tumor biology from University College London, University of London; a Bachelor of Medicine and Bachelor of Surgery from St Bartholomew's and the Royal London School of Medicine and Dentistry; and a PhD from the National University of Singapore. He is a member of the Royal College of Physicians of the United Kingdom.

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**Additional Disclosure Pursuant to the AІM Rules for Companies and the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited ("HK Listing Rules")**

Professor Tan is currently a director of Epoch Biosciences Pte. Ltd. Save for this appointment, Professor Tan has held no other directorships or partnerships during the period of five years prior to his appointment as a director of HUTCHMED. He does not have any relationship with any Directors, senior management or substantial or controlling shareholders of HUTCHMED. Professor Tan has confirmed (a) his independence as regards each of the factors for independence referred to in Rule 3.13(1) to (8) of the HK Listing Rules; (b) that he had no past or present financial or other interest in the business of the Company or its subsidiaries or any connection with any core connected person (as defined in the HK Listing Rules) of the Company; and (c) that there are no other factors that may affect his independence at the time of his appointment.

The initial term of the appointment of Professor Tan as an Independent Non-executive Director of the Company shall end at the next following annual general meeting of the Company, subject to retirement in accordance with the Articles of Association of the Company and applicable legal and regulatory requirements, and thereafter for successive periods of 12 months, unless he is not re-elected at the next following annual general meeting or his appointment is otherwise terminated earlier by either party in writing. The director's fees of Professor Tan as an Independent Non-executive Director and member of the Technical Committee of the Company under his appointment letter are US$76,000 and US$8,000 per annum respectively, which were determined by the Board with reference to the director's duties and responsibilities and prevailing market conditions. Such fees are subject to review from time to time and proration for any incomplete year of service.

Professor Tan does not have any interest in any shares of the Company within the meaning of Part XV of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong).

Save for the information disclosed above, there is no other information in relation to Professor Tan that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AІM Rules for Companies or Rule 13.51(2) of the HK Listing Rules, and there are no other matters concerning the appointment of Professor Tan that are required to be brought to the attention of the shareholders of HUTCHMED.

#### About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED 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 announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to HUTCHMED's board of directors are not eﬀective in their respective positions, the diﬀiculty in locating and recruiting suitable candidates for its board of directors and the management diﬀiculties which may arise from changes in HUTCHMED's board of directors. 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 U.S. Securities and Exchange Commission, on AІM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.*

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**CONTACTS**

---

| | |
|:---|:---|
| **Investor Enquiries** | +852 2121 8200 / <u>ir@hutch-med.com</u> |
| **Media Enquiries** |  |
| FTI Consulting – | +44 20 3727 1030 / <u>HUTCHMED@fticonsulting.com</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;Ben Atwell / Alex Shaw | &nbsp;&nbsp;&nbsp;&nbsp;+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) |
| Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / <u>HUTCHMED@brunswickgroup.com</u> |
| **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 |

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