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.

CONTACTS

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.

CONTACTS

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.

中國香港、上海和美國新澤西州：2022年6月1日，星期三：和黃醫藥（中國）有限公司（簡稱「和黃醫藥」或「HUTCHMED」）（納斯達克/倫敦證交所：HCM；香港交易所：13）今日宣佈，達唯珂^®（TAZVERIK^®，通用名：他澤司他/tazemetostat）的臨床急需進口藥品申請獲海南省衛生健康委員會和海南省藥品監督管理局批准，於海南博鰲樂城國際醫療旅遊先行區（簡稱「海南先行區」）使用，用於治療某些上皮樣肉瘤和濾泡性淋巴瘤患者，與美國食品藥品監督管理局（「FDA」）已批准的標籤一致。國務院於2013年批准設立海南先行區，匯聚全球科技創新並成為國際醫療旅遊目的地。2020年，海南先行區接待醫療旅客達8.39萬人次。

達唯珂^®是由Epizyme, Inc.（「Epizyme」）開發的EZH2[1]甲基轉移酶抑制劑，已分別於2020年1月和2020年6月獲FDA批准用於治療某些上皮樣肉瘤患者和某些濾泡性淋巴瘤的患者。

和黃醫藥首席執行官兼首席科學官蘇慰國博士表示：「此次達唯珂^®在海南先行區獲批，令患者得以及早獲得這種全球首創的EZH2抑制劑。和黃醫藥致力為有需要的患者帶來創新藥物。除了海南先行區以外，根據我們和Epizyme的合作協議，我們亦計劃在中國開展進一步的註冊性研究，幫助更多患者獲得更便捷的治療。」

2021年8月，和黃醫藥與Epizyme開展合作，在中國大陸、香港、澳門和台灣進行達唯珂^®的研究、開發、生產以及商業化。

關於濾泡性淋巴瘤和上皮樣肉瘤

濾泡性淋巴瘤（FL）是非霍奇金淋巴瘤的一種亞型。濾泡性淋巴瘤約佔非霍奇金淋巴瘤的17%。2020年，中國和美國估計分別新增16,000例和13,000例濾泡性淋巴瘤患者。[2]^,[3]^,[4]

上皮樣肉瘤（ES）是一種罕見的、生長緩慢的軟組織癌。根治性腫瘤切除術是上皮樣肉瘤患者的主要治療方法。然而，上皮樣肉瘤容易發生局部復發和遠處轉移。由於治療選擇非常有限，上皮樣肉瘤患者的存活率一般並不理想。[v]

關於達唯珂^®（TAZVERIK^®，通用名：他澤司他/ tazemetostat）

達唯珂^®是甲基轉移酶抑制劑，在美國獲批用於治療以下患者：

• 患有不符合完全切除條件的轉移性或局部晚期上皮樣肉瘤的成人及16歲及以上的兒童患者。
• 復發或難治性濾泡性淋巴瘤的成人患者，其腫瘤經FDA批准的試驗檢測呈EZH2突變陽性，並且之前已經接受至少兩種全身治療。
• 復發或難治性濾泡性淋巴瘤的成人患者，惟並無任何理想的替代治療方案。

上述適應症根據客觀緩解率（ORR）及和緩解持續時間（DOR）獲美國FDA加速審批後獲得批准。根據這些適應症繼續授予的批准可能取决於確證性試驗中的臨床療效驗證和描述。

請按此處查看美國完整處方資料：www.tazverik.com。

關於他澤司他在中國的其他臨床開發計劃

和黃醫藥及Epizyme正在大中華區開發他澤司他用於治療多種血液腫瘤及實體瘤，其中和黃醫藥主導Epizyme的SYMPHONY-1研究的中國部分。和黃醫藥還計劃與Epizyme合作開展其他全球研究。

SYMPHONY-1研究（原稱EZH-302） 是一項全球、多中心、隨機、雙盲、活性對照、三階段、生物標誌物富集的確證性Ib/III期研究，旨在評估他澤司他和R²方案聯合療法治療既往接受過至少一線治療後復發或難治性濾泡性淋巴瘤患者的安全性和療效（clinicaltrials.gov 註冊號：NCT04224493）。

我們計劃啟動一項濾泡性淋巴瘤的橋接研究，以支持他澤司他在中國的註冊，以及啟動他澤司他與和黃醫藥其他藥物的多項聯合療法研究。

關於和黃醫藥

和黃醫藥（納斯達克/倫敦證交所：HCM；香港交易所：13）是一家處於商業化階段的創新型生物醫藥公司，致力於發現、全球開發和商業化治療癌症和免疫性疾病的靶向藥物和免疫療法。集團旗下公司共有超過4,600名員工，其中核心的腫瘤/免疫業務擁有約1,700人的團隊。自成立以來，和黃醫藥已將自主發現的12個候選癌症藥物推進到在全球開展臨床研究，其中首三個創新腫瘤藥物現已在中國獲批上市。欲了解更多詳情，請訪問：www.hutch‑med.com或關注我們的LinkedIn專頁。

前瞻性陳述的警告性說明

本新聞稿包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對達唯珂^®（TAZVERIK^®）治療上皮樣肉瘤或濾泡性淋巴瘤患者的治療潛力的預期、達唯珂^®在該適應症及其他適應症的進一步臨床開發、在海南先行區使用達唯珂^®的相關風險（包括未來可能因各種原因而停止使用）、對和黃醫藥正在開展及未來計劃開展的達唯珂^®的研究是否能達到其主要或次要終點或保證與監管機構會面、在加速批准程序下向政府部門提交監管審評或批准，以及對此類研究完成時間和結果發佈的預期。前瞻性陳述涉及風險和不確定性。此類風險和不確定性包括下列假設：監管部門批准的假設（包括加速批准）、開展臨床試驗或銷售產品（包括持續在海南先行區，以及中國大陸、香港、澳門及台灣等其他地區提供達唯珂^®）、臨床前研究或早期研究對未來研究（包括正在進行的確證性試驗）結果具有預測性的預期、達唯珂^®的安全性、達唯珂^®成為上皮樣肉瘤或濾泡性淋巴瘤患者治療新標準的潛力、和黃醫藥及Epizyme開展和完成達唯珂^®進一步臨床開發計劃的能力、達唯珂^®在中國和其他司法管轄區就已獲批適應症的潛在商業上市、各公司應對可預見及不可預見的運營費用和資本支出的資金充足性、上述事件的時間，以及新冠肺炎全球大流行對和黃醫藥的業務、運營結果及財務狀況以及整體經濟、監管及政治狀況帶來的影響等。此外，由於部分研究可能依賴於達唯珂^®與其他候選藥物聯合使用，因此此類風險和不確定性包括有關這些治療藥物的安全性、療效、供應和監管批准的假設。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本新聞稿發佈當日有效。和黃醫藥預期隨後的事件和發展可能會令其觀點改變。無論是否出現新訊息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本新聞稿所含訊息的義務。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會、AIM以及香港聯合交易所有限公司提交的文件。

[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.

聯絡方法