# EDGAR Filing Document

**Accession Number:** 0001648257
**File Stem:** 0001648257-23-000002
**Filing Date:** 2023-1
**Character Count:** 12465
**Document Hash:** 0c405767302b3dfb58c8ee07466344b9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001648257-23-000002.hdr.sgml**: 20230103

**ACCESSION NUMBER**: 0001648257-23-000002

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20230103

**FILED AS OF DATE**: 20230103

**DATE AS OF CHANGE**: 20230103

**FILER**: 

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

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37710
- **FILM NUMBER:** 23500033

**BUSINESS ADDRESS:**
- **STREET 1:** 48TH FLOOR, CHEUNG KONG CENTER
- **STREET 2:** 2 QUEEN'S ROAD CENTRAL
- **CITY:** HONG KONG
- **STATE:** K3
- **ZIP:** 00000
- **BUSINESS PHONE:** 852-2121-3888

**MAIL ADDRESS:**
- **STREET 1:** 48TH FLOOR, CHEUNG KONG CENTER
- **STREET 2:** 2 QUEEN'S ROAD CENTRAL
- **CITY:** HONG KONG
- **STATE:** K3
- **ZIP:** 00000

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

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**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 January 2023**

**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 ◻

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ◻

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ◻

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

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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 completion of patient enrollment of ESLIM-01, a Phase III trial of sovleplenib in primary immune thrombocytopenia in China |

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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: January 3, 2023

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## Exhibit 99.1

**Exhibit 99.1**

&nbsp;&nbsp;![GRAPHIC](hcm-20230103xex99d1001.jpg)<br>

**Press Release**

#### HUTCHMED Completes Patient Enrollment of ESLIM-01, a Phase III Trial of Sovleplenib in Primary Immune Thrombocytopenia in China
**Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 3, 2023:** HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM, HKEX:13) today announces that it has completed patient enrollment of ESLIM-01, a pivotal Phase III clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia ("ITP") in China. The last patient was enrolled on December 31, 2022.

The ESLIM-01 study, initiated in October 2021, is a randomized, double blinded, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of sovleplenib in treating adult patients with ITP. The primary endpoint of the study is the durable response rate. Secondary and exploratory endpoints include overall response rate (ORR), incidence of treatment emergent adverse events, and patient quality of life improvement. A total of 188 patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635.

Topline results from the ESLIM-01 trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical congress. If positive, HUTCHMED would initiate plans to apply for marketing authorization of sovleplenib by the China National Medical Products Administration (NMPA).

#### About Sovleplenib
Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.

HUTCHMED currently retains all rights to sovleplenib worldwide. In addition to ITP, sovleplenib is also being studied in warm antibody autoimmune hemolytic anemia (NCT05535933), indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies in China, the U.S. and Europe (NCT02857998; NCT03779113).

#### About ITP and Syk
ITP is an autoimmune disorder characterized by immunologic destruction of platelets and decreased platelet production. Patients with ITP exhibit symptoms of petechiae, purpura, and gastrointestinal and/or urinary mucosal tract bleeding.<sup>1</sup> ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life, across domains of emotional, functional and reproductive health, and work or social life.<sup>2,3,4,5,6</sup> The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults.<sup>7</sup>

Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem. Many patients develop resistance to treatment and thereby are prone to relapse.<sup>8</sup> Thus, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of new treatments.

As platelet destruction in ITP is mediated by Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition represents a promising approach to management of ITP.<sup>9</sup>

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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. It has more than 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception HUTCHMED has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. 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 U.S. 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 sovleplenib for patients, its expectations as to whether any studies on sovleplenib 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 sovleplenib, including as a combination therapy, 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 market of sovleplenib for a targeted indication; the sufficiency of funding; and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. 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, 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**

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| | |
|:---|:---|
| **Investor Enquiries** |  |
| &nbsp;&nbsp;&nbsp;Mark Lee, Senior Vice President | +852 2121 8200 |
| &nbsp;&nbsp;&nbsp;Annie Cheng, Vice President | +1 (973) 567 3786 |
| **Media Enquiries** |  |
| &nbsp;&nbsp;&nbsp;**Americas** – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) / <u>bmiles@soleburystrat.com</u> |
| &nbsp;&nbsp;&nbsp;**Europe** – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / <u>HUTCHMED@fticonsulting.com</u>  |
| &nbsp;&nbsp;&nbsp;**Asia** – Zhou Yi, Brunswick  | +852 9783 6894 (Mobile) / <u>HUTCHMED@brunswickgroup.com</u> |
| **Nominated Advisor** |  |
| &nbsp;&nbsp;&nbsp;Atholl Tweedie / Freddy Crossley, Panmure Gordon | +44 (20) 7886 2500 |

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<sup>1</sup> Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia (ITP). J. Clin. Med. 2017, 6(2), 16.

<sup>2</sup> McMillan R, Bussel JB, et al. Self-reported health-related quality of life in adults with chronic immune thrombocytopenic purpura. Am J Hematol. 2008 Feb;83(2):150-4.

<sup>3</sup> Snyder CF, Mathias SD, Cella D, et al. Health-related quality of life of immune thrombocytopenic purpura patients: results from a web-based survey. Curr Med Res Opin. 2008 Oct;24(10):2767-76.

<sup>4</sup> Doobaree IU, Nandigam R, Bennett D, et al. Thromboembolism in adults with primary immune thrombocytopenia: a systematic literature review and meta-analysis. Eur J Haematol. 2016 Oct;97(4):321-30.

<sup>5</sup> Sarpatwari A, Bennett D, Logie JW, et al. Thromboembolic events among adult patients with primary immune thrombocytopenia in the United Kingdom General Practice Research Database. Haematologica. 2010 Jul;95(7):1167-75.

<sup>6</sup> Sarpatwari A, Watson S, Erqou S, et al. Health-related lifestyle in adults and children with primary immune thrombocytopenia (ITP). Br J Haematol. 2010 Oct;151(2):189-91.

<sup>7</sup> Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.

<sup>8</sup> Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817.

<sup>9</sup> Crowley MT, Costello PS, Fitzer-Attas CJ et al. A critical role for Syk in signal transduction and phagocytosis mediated by Fcγ receptors on macrophages. J. Exp. Med. 186(7), 1027–1039 (1997).

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