Hong Kong, Shanghai & Florham Park, NJ –– Thursday, January 20, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I trial in China of HMPL-653, an investigational novel, highly selective, and potent colony-stimulating factor 1 receptor (“CSF-1R”) inhibitor. The first patient received their first dose on January 18, 2022.

The Phase I trial is a multicenter, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-653 in the treatment of patients with advanced or metastatic solid tumors and tenosynovial giant cell tumors (“TGCT”). Approximately 110 patients are expected to be enrolled in the dose escalation and expansion phase of this study. The primary endpoints are dose limiting toxicity, safety, tolerability, recommended phase II dose and maximum tolerated dose. The secondary endpoints include pharmacokinetics, objective response rate, progression free survival, disease control rate, and overall survival. The lead principal investigator is Dr Cheng Ying of the Jilin Cancer Hospital, which is the lead institution for this study.

About HMPL-653

HMPL-653 is an investigational novel, highly selective, and potent CSF-1R inhibitor designed to target malignant driven tumors as a monotherapy or in combination with other drugs.

CSF-1R is usually expressed on the surface of macrophages and can promote growth and differentiation of macrophages after binding with its ligand, CSF-1. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate the tumor microenvironment, relieve tumor immunosuppression, and synergize with other anti-cancer therapies such as immune checkpoint inhibitors to achieve tumor inhibition. It has been demonstrated in several clinical studies that other CSF-1R inhibitors, by inhibiting CSF-1R activity, could be used to treat TGCT, and to treat a variety of malignancies through combination with immuno-oncology and/or other therapeutic agents. Currently no CSF-1R inhibitor has been approved in China.

HUTCHMED currently retains all rights to HMPL-653 worldwide.

About TGCT

TGCT is a very rare type of soft tissue tumor caused by abnormal proliferation and inflammation of giant cells, monocytes and inflammatory cells. These tumors are mainly characterized by the expression of CSF-1. Targeting CSF-1R has become an effective therapeutic strategy for TGCT. The incidence of TGCT is approximately between 1.8 and 50 per 1 million people.^[1] Surgery is the standard treatment for TGCT patients. However, among patients with diffuse or recurrent/refractory TGCT, tumors are wrapped in peripheral organs such as bone, tendon, ligament and joint, which makes removal by surgery difficult. The recurrence rate of diffuse-type cases is estimated to be 21% to 50%.^[2] There is a high unmet need for effective and safe treatment for these patients.

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 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies 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 HMPL-653 for patients, its expectations as to whether any studies on HMPL-653 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 HMPL-653, 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 HMPL-653 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.

[1] Rockberg J, Bach BA, Amelio J, et al. J Bone Joint Surg Am. 2015;97:1756-66.
[2] Gouin F, Noailles T. Orthop Traumatol Surg Res. 2017;103(1S):S91-S97.

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Hong Kong, Shanghai & Florham Park, NJ — Wednesday, January 19, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that updated analysis of the ongoing international Phase I/Ib trial of fruquintinib will be presented at the upcoming 2022 ASCO Gastrointestinal Cancers Symposium, taking place on January 20-22, 2022.  The meeting will be held virtually and in person at the Moscone Center in San Francisco, California, US.

Further details of the presentation are as follows:

About Colorectal Cancer (“CRC”)

CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.^[1] In the U.S., an estimated 150,000 people were diagnosed with CRC and 53,000 people died from CRC in 2021.^[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.^[2] In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.^[2]

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China

Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE^®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE^® is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study^[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy

The safety and efficacy of fruquintinib for the following investigational uses 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:

Gastric Cancer (“GC”) in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction (“GEJ”) adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival (OS). Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT^® in China).

• Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer (“TNBC”) and endometrial cancer (“EMC”). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).
• Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer (“NSCLC”). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.
• Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced EMC, cervical cancer, CRC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).

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. It has more than 4,500 personnel across all its companies, at the center of which is a team of over 1,400 in oncology/immunology. Since inception it has advanced 11 cancer drug candidates from in-house discovery into clinical studies 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 fruquintinib for the treatment of patients with advanced CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support New Drug Application approval of fruquintinib for the treatment of patients with advanced CRC in the U.S., Europe, Japan, Australia or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as paclitaxel, tislelizumab and sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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 AIM and on The Stock Exchange of Hong Kong Limited. 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.

[1] The Global Cancer Observatory.  Accessed September 21, 2021.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer Institute.  https://seer.cancer.gov/statfacts/html/colorect.html.  Accessed September 21, 2021.
[3] Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.

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Hong Kong, Shanghai & Florham Park, NJ –– Wednesday, January 12, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Admin­istration (“NMPA”) has granted Break­through Therapy Designation (“BTD”) to HMPL-523, a novel, investiga­tional spleen tyrosine kinase (“Syk”) inhibitor, for the treat­ment of chronic adult primary immune thrombo­cytopenia (“ITP”) patients who have received at least one prior therapy.

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advan­tages over existing therapies. Drug cand­idates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

Christian Hogg, Chief Executive Officer of HUTCHMED, said, “ITP is an autoimmune bleeding disorder that can often be serious and can have a significant, multifaceted impact on patients’ health and quality of life. The granting of BTD to HMPL-523 in ITP highlights the unmet need in this treatment setting and the promis­ing clinical value of this novel oral Syk inhibitor. With this designation, we are hopeful that can accelerate the development of HMPL-523 in China.”

The BTD is supported by the encouraging results from the Phase Ib study of HMPL-523, which were presented at the 63^rd American Society of Hema­tology (ASH) Annual Meeting in December 2021. The data also supported the initiation of a Phase III trial, ESLIM-01, in China of HMPL-523 in adult patients with ITP in October 2021. Approximately 180 patients are expected to be enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635.

About HMPL-523

HMPL-523 is a novel, investigational, selective small molecule inhibitor for oral admin­istration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell 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 HMPL-523 worldwide. The ESLIM-01 Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in treating adult patients with primary ITP, an auto­immune disorder that can lead to increased risk of bleeding. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635. HMPL-523 is also being studied in indolent non-Hodgkin’s lymphoma and multiple subtypes of B-cell malignancies in China (NCT02857998), the U.S. and Europe (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.^[1] 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.^{[2][3][4][5][6]} The incidence of primary ITP in adults is estimated to be 3.3 per 100,000 adults per year with a prevalence of 9.5 per 100,000 adults.^[7]

Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treat­ments are infrequently curative. Despite the 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.^[8] 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 the management of ITP.^[9]

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 4,500 personnel across all its companies, at the center of which is a team of over 1,400 in oncology/​immunology. Since inception it has advanced 11 cancer drug cand­idates from in-house discovery into clinical studies 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 HMPL-523 for patients with ITP and other indications, its expectations as to whether any studies on HMPL-523 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 HMPL-523, 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 HMPL-523 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.

[1] Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia (ITP). J. Clin. Med. 2017, 6(2), 16.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.
[8] 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.
[9] 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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— HMPL-760 is the eleventh innovative potential oncology drug candidate discovered in-house by HUTCHMED —

— HMPL-760 is HUTCHMED’s fifth candidate in clinical development for hematological malignancies, including amdizalisib and HMPL-523 that also target the B-cell receptor (“BCR”) signaling pathway, and tazemetostat and HMPL-306 —

Hong Kong, Shanghai & Florham Park, NJ — Monday, January 10, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) has initiated a Phase I study in China of HMPL-760, a highly potent, selective, and reversible inhibitor with long target engagement against Bruton’s tyrosine kinase (“BTK”), including wild-type and C481S-mutated BTK. The first patient received their first dose on January 4, 2022.

The clinical study is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy profile of HMPL-760. The study is enrolling patients with previously treated chronic lymphocytic leukemia/​small lymphocytic lymphoma (CLL/SLL) or other types of Non-Hodgkin Lymphoma (“NHL”), including patients treated with a prior regimen containing a BTK inhibitor, whose disease carries either wild-type BTK or acquired resistance to first generation BTK inhibitors due to additional mutations to BTK.

An initial dose escalation stage to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (“RP2D”) is planned, to be followed by a dose expansion phase where patients will receive HMPL‑760 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Approximately 100 patients are expected to be enrolled.

HMPL-760 is HUTCHMED’s fifth investigational drug candidate targeting hematological malignancies in clinical development. Amdizalisib (HMPL-689, targeting the delta isoform of phosphoinositide 3-kinase or PI3K delta) and HMPL-523 (targeting spleen tyrosine kinase or Syk) are also being studied in several Phase II trials against B-cell dominant malignancies. Phase II registration studies are underway in China for amdizalisib in patients with follicular lymphoma (FL), for which it has been granted Breakthrough Therapy Designation in China, and marginal zone lymphoma (MZL).

In addition to the three BCR inhibitors, for hematological malignancies HUTCHMED is also developing its in-house discovered drug candidate HMPL-306, a dual-inhibitor of mutant isocitrate dehydrogenase 1 and 2, and tazemetostat, a methyl­transferase inhibitor of EZH2 (being developed in Greater China by HUTCHMED pursuant to a strategic collaboration with Epizyme).

About BTK and Non-Hodgkin Lymphoma

BTK is a key component of the B-cell receptor signaling pathway and is an important regulator of cell prolifera­tion and cell survival in various lymphomas. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hemato­logical cancers, which represent approximately 85% of all NHL cases.^[1] BTK is considered a validated target for drugs that aim to treat certain hemato­logical cancers, however C481S mutation of BTK is a known resistance mechanism for first and second generation BTK inhibitors. In 2020, approximately 93,000 new cases of NHL are estimated to have been diagnosed in China.^[2]

About HMPL-760

HMPL-760 is an investigational, highly selective, non-covalent, third-generation inhibitor of BTK, both wild-type and C481S mutant enzymes, with pre-clinical data suggesting high target specificity and higher potency versus first generation BTK inhibitors. BTK C481S mutation plays an important role in resistance to certain BTK inhibitors.^[3],[4]

HMPL-760 is HUTCHMED’s eleventh innovative potential oncology drug candidate to enter clinical develop­ment. HUTCHMED currently retains all rights to HMPL-760 worldwide.

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 4,500 personnel across all its companies, at the center of which is a team of over 1,400 in oncology/​immunology. Since inception it has advanced 11 cancer drug candidates from in-house discovery into clinical studies 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 HMPL-760, amdizalisib, HMPL-523, HMPL-306 and tazemetostat for patients, its expectations as to whether any studies on HMPL-760, amdizalisib, HMPL-523, HMPL-306 and tazemetostat 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 HMPL-760, amdizalisib, HMPL-523, HMPL-306 and tazemetostat, 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 HMPL-760, amdizalisib, HMPL-523, HMPL-306 and tazemetostat  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.

[1]  American Cancer Society (2019, January 29). Types of B-cell Lymphoma. https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed January 5, 2022.
[2] The Global Cancer Observatory, China fact sheet. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.  Accessed November 17, 2021.
[3]  Woyach JA, Ruppert AS, Guinn D, et al. BTKC^481S-Mediated Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol. 2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282.
[4]  Woyach JA, Huang Y, Rogers K, et al.  Resistance to Acalabrutinib in CLL is Mediated Primarily by BTK Mutations. Blood.  2019;134 (Supplement_1): 504.  doi:10.1182/blood-2019-127674.

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