Hong Kong, Shanghai, & Florham Park, NJ — Wednesday, June 29, 2022: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX: 13) announces the following blocklisting six monthly return:

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 over 1,700 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.

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Hong Kong, Shanghai & Florham Park, NJ — Monday, June 27, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its interim results for the six months ended June 30, 2022 on Monday, August 1, 2022 at 7:00 am Eastern Daylight Time (EDT) / 12:00 noon British Summer Time (BST) / 7:00 pm Hong Kong Time (HKT).

Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.

The conference call and audio webcast will take place at 8:00 am EDT / 1:00 pm BST / 8:00 pm HKT on Monday, August 1, 2022 and will be webcast live via the company website at www.hutch-med.com/event/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website.  A replay will also be available on the website shortly after the event.

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 over 1,700 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.

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Macquarie Capital, New York, U.S.

Surufatinib in U.S. patients with soft tissue sarcoma

Authors

Sujana Movva, Alexander I. Spira, Erika P. Hamilton, Judy S. Wang, Allen Lee Cohn, James F. Strauss, Silvia Stacchiotti, Chris Tucci, John Kauh, Shivani Nanda, Marek K. Kania, Shreyaskumar Patel

Organizations

Memorial Sloan Kettering Cancer Center, New York, NY, Virginia Health Specialists, Fairfax, VA, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, Florida Cancer Specialists, Sarasota, FL, Rocky Mountain Cancer Center, Denver, CO, Mary Crowley Cancer Research Center, Dallas, TX, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, HUTCHMED International Corporation, Florham Park, NJ, HUTCHMED International, Florham Park, NJ, The University of Texas MD Anderson Cancer Center, Houston, TX

Background:

Surufatinib is an inhibitor of VEGFR1, 2, & 3, FGFR1, and CSF-1R. A manageable safety profile, and statistically significant improvement in progression-free survival (PFS) in patients (pts) treated with surufatinib have previously been demonstrated in pts with advanced NETs of extrapancreatic (epNET) and pancreatic (pNET) origin in 2 phase 3 randomized trials conducted in China (SANET-ep; NCT02588170 & SANET-p; NCT02589821). Similar safety and efficacy were demonstrated in this phase 1 study (NCT02549937) in pts with NETs. Here we report the results of surufatinib in pts with soft tissue sarcoma.

Methods:

This study is a phase 1, dose escalation (ESC)/expansion (EXP) study to evaluate the safety and efficacy of surufatinib in the US and Europe (EXP only). ESC previously reported the recommended phase 2 dose as 300mg once daily. Enrollment into advanced, adult, soft tissue sarcoma EXP cohorts is ongoing. The primary endpoint is PFS rate at 4 months (mo). Soft tissue sarcoma histological subtypes include: angiosarcoma (AS), epithelioid sarcoma (ES), leiomyosarcoma (LMS), pigmented villonodular synovitis (PVNS), synovial sarcoma (SS) and undifferentiated pleomorphic sarcoma (UPS).

Results:

32 adults with soft tissue sarcoma were enrolled (2 each AS and ES; 10 LMS; 1 PVNS; 9 SS; 8 UPS). The median age across all subtypes was 56.5 years (range 26-77), and the majority of pts were female (68.8%). 59.3% of pts received ≥ 3 prior lines of therapy (Tx) (median lines of Tx: 3 [range 1-6]). As of 15 Nov 2021, 1 pt (PVNS) remained on Tx. The PFS rate at 4 mo was 17.5%. The median PFS was 2.56 mo (95% CI; 0.92-2.92). The median duration on treatment (mDoT) for all pts was 11.2 weeks (wks) (0.4-39.0). The mDoT for LMS pts was 11.6 wks (3.1-36.0), mDoT for SS pts was 11.9 wks (0.4-27.9), and mDoT for UPS pts was 8.2 wks (2.7-27.9). Of 29 pts with ≥ 1 post baseline assessment, 6 pts (20.7%) achieved stable disease of ≥ 8.0 wks from start of Tx. No pts achieved a partial or complete response. The safety profile of surufatinib remains consistent with previously completed trials. All pts (n = 32) reported ≥ 1 adverse event (AE), and 21 pts (65.6%) reported AEs ≥ grade 3. The most common AEs of any grade were fatigue (53.1%), hypertension (43.8%), diarrhea (40.6%), anemia (25.0%), blood bilirubin increase (25.0%), headache (21.9%), and proteinuria (21.9%). The most commonly reported AEs ≥ grade 3 in > 1 pt were hypertension (21.9%), fatigue (12.5%), and anemia (9.4%). AEs leading to Tx discontinuation occurred in 9.4% of pts.

Conclusions:

Surufatinib demonstrated minimal antitumor activity as a single agent in heavily pretreated pts across various types of soft tissue sarcoma. The safety profile in pts with soft tissue sarcoma remains consistent with previously reported and ongoing studies with surufatinib. Clinical trials are ongoing with surufatinib globally, with active recruitment in PD-L1 combination studies. Clinical trial information: NCT02549937.

A pooled analysis of surufatinib safety from phase 3 trials in advanced NETs

Authors

Jie Li, Jianming Xu, Lin Shen, Chunmei Bai, Zhiwei Zhou, Zhiping Li, Yihebali Chi, Xianjun Yu, Enxiao LI, Nong Xu, Tianshu Liu, Wenhui Lou, Yuxian Bai, Xianglin Yuan, Xiuwen Wang, Ying Yuan, Jia Chen, Tao Zhang, Dianrong Xiu, Weiguo Su

Organizations:

Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China, Department of Oncology, Peking Union Medical College Hospital, Beijing, China, Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China, Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China, Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xian, China, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China, Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China, Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China, Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Department of Medical oncology, Qilu Hospital of Shandong University, Jinan, China, Department of Medical Oncology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China, Cancer Centre, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Department of General Surgery, Peking University Third Hospital, Beijing, China, HUTCHMED Limited, Shanghai, China

Background:

Surufatinib is a small-molecule inhibitor of VEGFR1, 2, & 3, FGFR1, and CSF-1R. Surufatinib demonstrated prolonged PFS and tolerable safety in two phase 3 studies in advanced neuroendocrine tumors (NETs) of pancreatic (SANET-p; NCT02589821) and extrapancreatic (SANET-ep; NCT02588170) origin (Xu, 2020 Lancet Oncology). Detailed outcomes on safety from these 2 studies are reported here as a pooled analysis.

Methods:

Data is pooled from SANET-p and SANET-ep studies which have similar designs including a 2:1 randomization of surufatinib to placebo in patients ≥18 years with advanced, well differentiated NETs, progressing on or after ≤2 prior therapies. Surufatinib 300 mg or placebo, was administered once daily until disease progression or unacceptable toxicity. Safety outcomes for each pooled treatment group are reported as treatment-emergent adverse events (TEAE) assessed by NCI-CTC 4.03. Patients were included if they had received study treatment during the double-blinded phase of the studies.

Results:

As of 30th June 2020, 396 patients were assigned to the surufatinib (n = 263) and placebo (n = 133) groups. Median treatment duration was longer with surufatinib 7.4 months (range 0.1–41.4) compared with placebo 4.6 months (range 0.1–39.9). 29% of patients reached more than 12 months of treatment with surufatinib group compared to 11% with placebo. The mean relative dose intensity was 87.56% in the surufatinib group and 97.01% in the placebo group. Most common TEAEs (surufatinib vs placebo) were proteinuria 68.8% vs 54.9%, hypertension 68.4% vs 27.1%, and diarrhea 49% vs 22.6%. Most common grade ≥3 TEAE were hypertension 38.8% vs 13.5%, proteinuria 14.8% vs 0.8% and hypertriglyceridaemia 5.3% vs 0%. Deaths due to TEAEs were comparable between groups 2.7% vs 2.3%. TEAEs led to dose reductions in 43.0% vs 6.8% of patients and dose interruptions in 47.1% vs 29.3% of patients. The majority of patients (83.3% vs 93.2%) were managed without discontinuation because of TEAE. Median onset of proteinuria and hypertension were < 1 month in both groups. Median (range) onset was 0.95 months (0.16–30.36) vs 0.95 months (0.23–16.95) for proteinuria and 0.49 months (0.03–31.18) vs 0.89 months (0.03–14.75) for hypertension. Among patients with hypertension, 59% (n = 111) vs 28% (n = 11) received antihypertensive medication.

Conclusions:

Surufatinib was generally well tolerated in this pooled analysis and the safety profile was consistent with its previously reported data. The monitoring and management of hypertension and proteinuria are important for patients receiving surufatinib. Clinical trial information: NCT02589821; NCT02588170.

Hong Kong, Shanghai & Florham Park, NJ — Wednesday, June 1, 2022: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that TAZVERIK^® (tazemetostat) has been approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (“Hainan Pilot Zone”), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma (“ES”) and follicular lymphoma (“FL”) consistent with the label as approved by the U.S. Food and Drug Administration (“FDA”). Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data.

TAZVERIK^® is a methyltransferase inhibitor of EZH2^[1] developed by Epizyme, Inc. (“Epizyme”). It is approved by the FDA for the treatment of certain patients with ES and certain patients with FL under FDA accelerated approval granted in January and June 2020, respectively.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: “The approval of TAZVERIK^® in the Hainan Pilot Zone allows patients to gain early access to this first-in-class EZH2 inhibitor in China, as part of our commitment to bringing innovative medicines to people in need. In addition to its use in the Hainan Pilot Zone, we also plan to initiate further registration-enabling studies in China under the terms of our agreement with Epizyme to facilitate wider and easier patient access.”

In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize TAZVERIK^® in China, Hong Kong, Macau and Taiwan.

About FL and ES

Follicular lymphoma (FL) is a subtype of non-Hodgkin’s lymphoma (“NHL”). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. ^[2],[3],[4]

Epithelioid sarcoma (ES) is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.^[5]

About TAZVERIK^® (tazemetostat)

TAZVERIK^® is a methyltransferase inhibitor indicated in the United States for the treatment of:

• Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
• Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
• Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

View the U.S. Full Prescribing Information here: www.tazverik.com

About Tazemetostat Clinical Development in China

HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.

SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R² in patients with relapsed or refractory FL after at least one prior line of therapy(clinicaltrials.gov identifier: NCT04224493).

We intend to initiate a bridging study in FL to support registration of tazemetostat in China, as well as several combination studies of tazemetostat with HUTCHMED assets.

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 1,700 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.

Cautionary Note on 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 TAZVERIK^® for the treatment of patients with ES or FL, the further clinical development of TAZVERIK^® in this and other indications, risks associated with the use of TAZVERIK^® in the Hainan Pilot Zone, including that it could be discontinued in the future for a variety of reasons, the risk that ongoing or future clinical trials conducted by HUTCHMED for TAZVERIK^® may not meet their primary or secondary endpoints or will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process and 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 regulatory approvals, including accelerated approval, to conduct trials or to market products (including to continue offering TAZVERIK^® in the Hainan Pilot Zone or elsewhere in China, Hong Kong, Macau and Taiwan), its expectations that preclinical studies or earlier clinical studies are predictive of the results of future trials, such as the ongoing confirmatory trials, the safety profile of TAZVERIK^®, the potential for TAZVERIK^® to become a new standard of care for ES or FL patients, HUTCHMED’s and Epizyme’s ability to implement and complete its further clinical development plans for TAZVERIK^®, the potential commercial launch of TAZVERIK^® in China and other jurisdictions in the approved indications, the sufficiency of each company’s cash resources to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the timing of these events, and the impact of the COVID-19 pandemic on HUTCHMED’s business, results of operations and financial condition and on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug candidates as combination therapeutics with TAZVERIK^®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and regulatory approval of such drug candidates. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. HUTCHMED anticipates that subsequent events and developments may cause its views to change; however, HUTCHMED does not undertake any 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. For a further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited.

[1] EZH2 = Enhancer of Zeste Homolog 2
[2] Source: NCCN^® – https://www.nccn.org
[3] Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html
[4] Source: GLOBOCAN https://gco.iarc.fr/
[5] Sobanko JF, Meijer L, Nigra TP. Epithelioid sarcoma: a review and update. J Clin Aesthet Dermatol. 2009;2(5):49-54.

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