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.

中国香港、上海和美国新泽西州：2022年6月1日，星期二：和黄医药（中国）有限公司（简称”和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM；香港交易所：13）今日宣布， 达唯珂^®（TAZVERIK^®，通用名：他泽司他/ tazemetostat）的临床急需进口药品申请获海南省卫生健康委员会和海南省药品监督管理局批准，于海南博鳌乐城国际医疗旅游先行区（简称“海南先行区”）使用，用于治疗某些上皮样肉瘤和滤泡性淋巴瘤患者，与美国食品药品监督管理局（“FDA”）已批准的标签一致。国务院于2013年批准设立海南先行区，汇聚全球科技创新并成为国际医疗旅游目的地。2020年，海南先行区接待医疗旅客达8.39万人次。

达唯珂^®是由Epizyme, Inc.（“Epizyme”）开发的EZH2^[i]甲基转移酶抑制剂，已分别于2020年1月和2020年6月获FDA批准用于治疗某些上皮样肉瘤患者和某些滤泡性淋巴瘤的患者。

和黄医药首席执行官兼首席科学官苏慰国博士表示：“此次达唯珂^®在海南先行区获批，令患者得以及早获得这种全球首创的EZH2抑制剂。和黄医药致力为有需要的患者带来创新药物。除了海南先行区以外，根据我们和Epizyme的合作协议，我们亦计划在中国开展进一步的注册性研究，帮助更多患者获得更便捷的治疗。”

2021年8月，和黄医药与Epizyme开展合作，在中国大陆、香港、澳门和台湾进行达唯珂^®的研究、开发、生产以及商业化。

关于滤泡性淋巴瘤和上皮样肉瘤

滤泡性淋巴瘤（FL）是非霍奇金淋巴瘤的一种亚型。滤泡性淋巴瘤约占非霍奇金淋巴瘤的17%。2020年，中国和美国估计分别新增16,000例和13,000例滤泡性淋巴瘤患者。^[2],[3],[4]

上皮样肉瘤（ES）是一种罕见的、生长缓慢的软组织癌。根治性肿瘤切除术是上皮样肉瘤患者的主要治疗方法。然而，上皮样肉瘤容易发生局部复发和远处转移。由于治疗选择非常有限，上皮样肉瘤患者的存活率一般并不理想。^[5]

关于达唯珂^®（TAZVERIK^®，通用名：他泽司他/ tazemetostat）

达唯珂^®是甲基转移酶抑制剂，在美国获批用于治疗以下患者：

• 患有不符合完全切除条件的转移性或局部晚期上皮样肉瘤的成人及16岁及以上的儿童患者。
• 复发或难治性滤泡性淋巴瘤的成人患者，其肿瘤经FDA批准的试验检测呈EZH2突变阳性，并且之前已经接受至少两种全身治疗。
• 复发或难治性滤泡性淋巴瘤的成人患者，惟并无任何理想的替代治疗方案。

上述适应症根据客观缓解率（ORR）及和缓解持续时间（DOR）获美国FDA加速审批后获得批准。根据这些适应症继续授予的批准可能取决于确证性试验中的临床疗效验证和描述。

请按此处查看美国完整处方资料：www.tazverik.com。

关于他泽司他在中国的其他临床开发计划

和黄医药及Epizyme正在大中华区开发他泽司他用于治疗多种血液肿瘤及实体瘤，其中和黄医药主导Epizyme的SYMPHONY-1研究的中国部分。和黄医药还计划与Epizyme合作开展其他全球研究。

SYMPHONY-1研究（原称EZH-302） 是一项全球、多中心、随机、双盲、活性对照、三阶段、生物标志物富集的确证性Ib/III期研究，旨在评估他泽司他和R²方案联合疗法治疗既往接受过至少一线治疗后复发或难治性滤泡性淋巴瘤患者的安全性和疗效（clinicaltrials.gov 注册号：NCT04224493）。

我们计划启动一项滤泡性淋巴瘤的桥接研究，以支持他泽司他在中国的注册，以及启动他泽司他与和黄医药其他药物的多项联合疗法研究。

关于和黄医药

和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。集团旗下公司共有超过4,600名员工，其中核心的肿瘤/免疫业务拥有约1,700人的团队。自成立以来，和黄医药已将自主发现的12个候选癌症药物推进到在全球开展临床研究，其中首三个创新肿瘤药物现已在中国获批上市。欲了解更多详情，请访问：www.hutch‑med.com或关注我们的领英专页。

前瞻性陈述的警告性说明

本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对达唯珂^®（TAZVERIK^®）治疗上皮样肉瘤或滤泡性淋巴瘤患者的治疗潜力的预期、达唯珂^®在该适应症及其他适应症的进一步临床开发、在海南先行区使用达唯珂^®的相关风险（包括未来可能因各种原因而停止使用）、对和黄医药正在开展及未来计划开展的达唯珂^®的研究是否能达到其主要或次要终点或保证与监管机构会面、在加速批准程序下向政府部门提交监管审评或批准，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：监管部门批准的假设（包括加速批准）、开展临床试验或销售产品（包括持续在海南先行区，以及中国大陆、香港、澳门及台湾等其他地区提供达唯珂^®）、临床前研究或早期研究对未来研究（包括正在进行的确证性试验）结果具有预测性的预期、达唯珂^®的安全性、达唯珂^®成为上皮样肉瘤或滤泡性淋巴瘤患者治疗新标准的潜力、和黄医药及Epizyme开展和完成达唯珂^®进一步临床开发计划的能力、达唯珂^®在中国和其他司法管辖区就已获批适应症的潜在商业上市、各公司应对可预见及不可预见的运营费用和资本支出的资金充足性、上述事件的时间，以及新冠肺炎全球大流行对和黄医药的业务、运营结果及财务状况以及整体经济、监管及政治状况带来的影响等。此外，由于部分研究可能依赖于达唯珂^®与其他候选药物联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。和黄医药预期随后的事件和发展可能会令其观点改变。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、AIM以及香港联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.

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