— 在约180名患者中进行的单臂研究，以客观缓解率为主要终点—

— 复发性/难治性滤泡性淋巴瘤和边缘区淋巴瘤约占所有非霍奇金淋巴瘤的25% —

— HMPL-689针对这两种以及其他非霍奇金淋巴瘤亚型的试验也正于

美国、欧洲和中国进行中 —

中国香港、上海和美国新泽西州：2021 年4 月29日，星期四：和黄中国医药科技有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM）在中国启动了一项其高选择性和强效PI3Kδ抑制剂 — HMPL-689的II期注册意向临床试验，用于治疗复发性或难治性滤泡性淋巴瘤（”FL”）和边缘区淋巴瘤（”MZL”）患者。FL及MZL均属非霍奇金淋巴瘤（”NHL”）的亚型。首批受试者已于今天接受给药治疗。

该研究是一项多中心、单臂、开放标签的临床试验，旨在评估HMPL-689单药每日一次口服治疗在约100例复发性/难治性滤泡性淋巴瘤患者及约80例复发性/难治性边缘区淋巴瘤患者中的疗效和安全性。复发性/难治性的定义为：患者在最新一个全身性治疗方案后未达到缓解（包括完全缓解或部分缓解），或达到缓解后疾病进展或复发。主要终点是客观缓解率（ORR），次要终点包括完全缓解率（CRR）、无进展生存期（PFS）、缓解时间（TTR）和缓解持续时间（DoR）。 该研究正在中国超过35个临床中心开展。 该项研究的其他详情可登录clinicaltrials.gov，检索注册号NCT04849351查看。

此次启动II期研究是基于在中国正在进行中的Ib期扩展研究取得的令人鼓舞的初步结果。其结果显示HMPL-689耐受性良好，并表现出与剂量成比例的药代动力学（PK）、可控的毒性特征以及在复发性/难治性B细胞淋巴瘤患者中的单药临床活性。该项研究的其他详情可登录clinicaltrials.gov，检索注册号NCT03128164 查看。

关于PI3Kδ和NHL

PI3Kδ，磷酸肌醇-3激酶δ异构体，是一种脂质激酶，控制着几种重要信号蛋白的激活。当抗原与B细胞受体结合后，PI3Kδ可通过Lyn和Syk信号传导通路被激活。B细胞受体信号传导异常激活与B细胞血液癌症的发生密切相关，B细胞血液癌约占所有非霍奇金淋巴瘤病例的85%。因此，PI3Kδ被认为是在预防或治疗血液癌症领域极具前景的药物靶点。

滤泡性淋巴瘤约占非霍奇金淋巴瘤的17%，边缘区淋巴瘤约占非霍奇金淋巴瘤的8%。在美国，2020年估计新增13,000例滤泡性淋巴瘤和6,000例边缘区淋巴瘤。在中国， 2020年估计分别新增16,000例滤泡性淋巴瘤和7,000例边缘区淋巴瘤[1]^,[2]^,[3]。

关于HMPL-689

HMPL-689是一种新型、选择性的强效口服PI3Kδ异构体抑制剂。在临床前药代动力学研究中，证实HMPL-689具有良好的口服吸收、适度的组织分布和低清除率，表明HMPL-689的药物蓄积以及药物间相互作用的风险较低。由于其高度的靶点选择性和优越的药代动力学特征，HMPL-689有潜力成为同类药物中具优越收益风险特征的药物。

和黄医药已经启动了大规模、面向全球的HMPL-689临床开发计划。除了目前在中国正在进行的II期临床试验和支持性I期临床试验外，HMPL-689于美国和欧洲的I/Ib期临床试验亦在进行中，用于治疗复发或难治性非霍奇金淋巴瘤患者。

和黄医药目前拥有HMPL-689在全球范围内的所有权利。

关于和黄医药

和黄医药（纳斯达克/伦敦证交所：HCM）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。超过1,200人的专业团队已将自主发现的10个候选癌症药物推进到在全球开展临床研究，其中首两个创新肿瘤药物现已获批并上市。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

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HMPL-689临床开发的预期，HMPL-689的进一步临床研究计划，对此类研究是否能达到其主要或次要终点的预期，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：入组率、满足研究入选和排除标准的受试者的时间和可用性、临床方案或监管要求变更、非预期不良事件或安全性问题、候选药物HMPL-689（包括作为联合治疗）达到研究的主要或次要终点的疗效、获得不同司法管辖区的监管批准、获得监管批准后获得上市许可、HMPL-689用于目标适应症的潜在市场和资金充足性等。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公告发布当日有效。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和AIM提交的文件。无论是否出现新信息、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信息的义务。

联系方式

[1] 资料来源: NCCN^® – https://www.nccn.org

[2] 资料来源: SEER – https://seer.cancer.gov/statfacts/html/follicular.html

[3] 资料来源: GLOBOCAN https://gco.iarc.fr/

Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, April 28, 2021: Hutchison China MediTech Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM) today announces that all ordinary resolutions and special resolutions put to its Annual General Meeting (“AGM”) held on April 28, 2021 were duly passed.  The poll results of the resolutions were as follows:

*  Percentages rounded to 4 decimal places

^# A vote withheld is not a vote in law and is not counted in the calculation of the proportion of the votes for and against a resolution.

The change of name will be effective once the Register of Companies has issued a certificate of incorporation on change of name.

As at the date of the AGM, the number of issued shares of HUTCHMED was 744,515,660, which was the total number of shares entitling the holders to attend and vote on the ordinary resolutions and special resolutions proposed at the AGM.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) 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. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Hong Kong, Shanghai & Florham Park, NJ: Friday, April 23, 2021: Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) announces that the non-performance based awards granted under the Long Term Incentive Plan (“LTIP”) on April 20, 2020 to the following persons discharging managerial responsibilities were vested on April 20, 2021:-

Notes:

1. Similar to the arrangement for his Director’s fees, these ADSs were not received by Mr Simon To, but were received by or for the account of his employer, Hutchison Whampoa (China) Limited.
2. Similar to the arrangement for her Director’s fees, these ADSs were not received by Ms Edith Shih, but were received by or for the account of her employer, Hutchison International Limited.

The notifications set out below are provided in accordance with the requirements of the EU Market Abuse Regulation.

(a) Dr Dan Eldar

(b) Mr Paul Carter

(c) Dr Karen Ferrante

(d) Mr Graeme Jack

(e) Professor Tony Mok

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) 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. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements involve risks and uncertainties.  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 and on AIM.  HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Hong Kong, Shanghai, & Florham Park, NJ: Wednesday, April 14, 2021:  Hutchison China MediTech Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) was notified that CK Hutchison Holdings Limited (“CK Hutchison”) shareholding^[1] in HUTCHMED remains unchanged, at 332,478,770 ordinary shares of par value US$0.10 each in the capital of HUTCHMED (“Shares”). Each American Depositary Share (“ADS”) represents five Shares.  As announced on April 8, 2021, HUTCHMED issued a total of 16,393,445 Shares (equivalent to 3,278,689 ADSs) to funds affiliated with Baring Private Equity Asia.  HUTCHMED was notified on April 14, 2021 that this issuance diluted CK Hutchison’s holding^[1] to 44.66 per cent of the total number of voting rights of HUTCHMED.  The date on which the notification threshold was crossed was April 14, 2021.

^[1] Held through CK Hutchison’s indirect wholly-owned subsidiary Hutchison Healthcare Holdings Limited.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) 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. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

CONTACTS

AACR 2021: ctDNA Analysis in the Savolitinib Phase II Study in NSCLC Patients Harboring METex14 Skipping Alterations

Presenter/Authors: Yongfeng Yu, Yongxin Ren, Jian Fang, Lejie Cao, Zongan Liang, Qisen Guo, Sen Han, Zimei Ji, Ye Wang, Yulan Sun, Yuan Chen, Xingya Li, Hua Xu, Jianying Zhou, Liyan Jiang, Ying Cheng, Zhigang Han, Jianhua Shi, Gongyan Chen, Rui Ma, Yun Fan, Sanyuan Sun, Longxian Jiao, Xiaoyun Jia, Linfang Wang, Puhan Lu, Jing Li, Qian Xu, Xian Luo, Weiguo Su, Shun Lu.

Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China, Hutchison MediPharma Limited, Shanghai, China, Peking University Cancer Hospital & Institute, Beijing, China, Anhui Provincial Hospital,The First Affiliated Hospital of USTC, Hefei, China, West China Hospital of Sichuan University, Chengdu, China, Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China, The First Affiliated Hospital of Zhengzhou University,, Zhengzhou, China, The Second Affiliated Hospital of Nanchang University, Nanchang, China, The First Affiliated Hospital of Zhejiang University, Hangzhou, China, Shanghai Chest Hospital,Shanghai JiaoTong University, Shanghai, China, Jilin Cancer Hospital, Changchun, China, The Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China, Linyi Cancer Hospital, Linyi, China, Cancer Hospital of Harbin Medical University, Harbin, China, Liaoning Cancer Hospital, Shenyang, China, Zhejiang Cancer Hospital, Hangzhou, China, Xuzhou Central Hospital, Xuzhou, China

Abstract

Background: Savolitinib is a potent and selective MET tyrosine kinase inhibitor. It demonstrated clinical efficacy and a manageable safety profile in Chinese NSCLC pts with METex14 alterations in a phase 2 study (NCT028997479). Here, we report the post-hoc ctDNA analysis of METex14 at baseline and clearance upon treatment and the association of these findings with clinical outcome. In addition, concurrent gene alterations in ctDNA samples from the patients treated with savolitinib and impact on clinical efficacy is explored.

Methods: Plasma samples were prospectively collected pre-dose and at tumor assessment visits, until disease progression or end of treatment. MET and other somatic gene alterations in the ctDNA samples were detected by next generation sequencing (425-gene panel, Geneseeq).

Results: Sixty-six pts provided baseline plasma samples, of which METex14 ctDNA was detectable in 46 (70%) and undetectable in the remaining 20 pts (30%). Among the 46 ctDNA detectable pts, 19 were pulmonary sarcomatoid carcinoma (19/22, 86%) and 27 were other NSCLC (27/44, 61%), respectively. Of the 46 baseline-detectable pts, 24 were clearance evaluable and 22 had no qualified post baseline samples for clearance evaluation. Of the 24 clearance evaluable pts, 14 achieved ctDNA clearance (undetectable) with a median time to clearance of 1.4 months of treatment (Min 1.4 m, Max 4.2 m). The PFS and OS were compared for pts based on their METex14 ctDNA status at baseline and upon treatment. As shown in the table, METex14 baseline undetectable or clearance pts demonstrated significantly longer mPFS and mOS. Furthermore, in 21 pts with analyzable ctDNA samples at baseline and at disease progression, additional gene alterations were observed such as KRAS, NRAS, BRAF, PIK3CA as well as secondary MET mutations and FGF19 amplification in 12 pts (57%). These alterations might be associated with treatment resistance.

Conclusions: The results suggest that ctDNA METex14 undetectable at baseline or clearance upon savolitinib treatment may define favorable treatment outcome. Confirmation of this finding and the predictive value of the ctDNA with larger sample size is desirable.

CI, confidence interval; HR, hazard ratio; NC, non-calculable

Disclosures:

Y. Yu: None. Y. Ren: ; Hutchison MediPharma Limited.. J. Fang: None. L. Cao: None. Z. Liang: None. Q. Guo: None. S. Han: None. Z. Ji: None. Y. Wang: None. Y. Sun: None. Y. Chen: None. X. Li: None. H. Xu: None. J. Zhou: None. L. Jiang: None. Y. Cheng: None. Z. Han: None. J. Shi: None. G. Chen: None. R. Ma: None. Y. Fan: None. S. Sun: None. L. Jiao: ; Hutchison MediPharma Limited. X. Jia: ; Hutchison MediPharma Limited. L. Wang: ; Hutchison MediPharma Limited. P. Lu: ; Hutchison MediPharma Limited. J. Li: ; Hutchison MediPharma Limited. Q. Xu: ; Hutchison MediPharma Limited. X. Luo: ; Hutchison MediPharma Limited. W. Su: ; Hutchison MediPharma Limited. S. Lu: ; Hutchison MediPharma. ; Astra Zeneca. ; BMS. ; Heng Rui. ; Beigene. ; Hansoh. ; Roche. ; Pfizer. ; BoehringerIngelheim. ; Simcere. ; Zai Lab. ; GenomiCare. ; Yuhan Corporation. ; PrIME Oncology. ; Menarini.

本公告全部或部分内容，不得于或向或从任何视此等举措属违反当地有关法律的司法管辖区发布、刊发或派发。 (本文件的中文本为翻译稿，仅供参考用。本文件的英文及中文版本如有歧义，概以英文版本为准。)

中国香港、上海和美国新泽西州：2021年4月8日，星期四：和黄中国医药科技有限公司（简称“和黄医药”或“HUTCHMED”）（纳斯达克/伦敦证交所：HCM）今天宣布与霸菱亚洲投资基金（简称 “霸菱亚洲”）达成一项最终协议，通过定向增发向霸菱亚洲的关联基金发行1 亿美元新股，发行价相当于每股美国存托股份30.5美元。

和黄医药首席执行官贺隽先生（Mr. Christian Hogg）表示：“随着爱优特^®和苏泰达^®的上市销售以及可能成为中国首个选择性c-MET抑制剂的赛沃替尼有望获批上市以带动肿瘤业务收入加速增长，我们预计今年业务将会取得显著增长。我们正在迅速扩展全部由和黄医药自主发现的十种创新肿瘤药物的全球开发，并计划于2021年内启动8至10项注册和注册意向研究。霸菱亚洲在支持全球性的创新型业务方面拥有悠久的历史，我们欢迎霸菱亚洲成为我们的股东。我们期待在新的发展阶段与霸菱亚洲携手合作。”

霸菱亚洲创始人及首席执行官庄佳诚先生（Mr. Jean Eric Salata）表示：“本次战略投资彰显了霸菱亚洲对和黄医药作为亚洲生物制药领域正在崛起的头部企业的长期支持。中国医疗健康行业是霸菱亚洲的核心投资领域之一。和黄医药正为世界各地的患者研发并提供高度差异化的肿瘤疗法。我们期待与公司首席执行官及管理团队合作，并将支持和黄医药的创新和全球发展愿景。”

霸菱亚洲成立于1997年，是亚洲最大且最成熟的独立私募股权公司之一，管理约230亿美元的资产。霸菱亚洲在医疗健康行业方面拥有良好的投资往绩，在各领域拥有多元化的投资组合，为行业领导者提供战略资金并与之紧密合作，以支持其长期发展。

和黄医药于此次定向增发中获得相当于3,278,689股美国存托股份的全部资金，以为其正在进行的研究和临床开发提供资金，并支持和黄医药在中国和全球范围内进一步加强其商业化能力。

股本及证券规例说明

和黄医药已同意以定向增发的方式，发行 16,393,445 股票面价值0.10美元的普通股（简称“股份”）。此等股份将于发行时缴足，并将在所有方面与和黄医药现有普通股享有同等权利。每股美国存托股份代表五股普通股。

将于定向增发中出售的证券将不会根据1933年美国证券法（经修订）（“证券法”） 或任何州份或其他适用司法管辖区的证券法律登记，而在并无登记或获证券法及适用州份或其他司法管辖区证券法律的适用登记规定豁免下，不得在美国提呈发售或出售。在满足某些条件的前提下，和黄医药已同意向美国证券交易委员会提交登记声明，登记转售在定向增发中出售的股份，以便霸菱亚洲日后进行转售。根据转售登记声明提呈发售任何证券将仅可通过招股书进行。

本公告（包括本公告内作为参考而加入或并入的任何信息）仅供参考，并不构成或属于出售该等证券的要约或招揽购买该等证券的要约的一部分，且不应被诠释为有关要约或招揽，亦不得在进行有关要约、招揽或发售即属违法的任何司法管辖区进行邀约、招揽或发售任何该等证券。本公告所述证券将不会在美国或其他地方公开发售。

本公告载有依法规（欧盟）第596/2014 号（由于其构成《2018年退出欧盟法案》所界定保留欧盟法例的一部分）第7 条所规定的内幕消息。

纳入伦敦证券交易所AIM市场及完成后的已发行股份

和黄医药将申请将股份纳入伦敦证券交易所经营的AIM市场（“纳入”）。预期纳入将于2021年4月14日英国夏令时间上午八时正生效。

股份获纳入在AIM交易后，和黄医药的已发行股本将包括 744,515,660 股每股面值为0.10美元的普通股，每股普通股附带一项投票权，且并无持作库存股份。股数 744,515,660 可由股东用作计算的分母，从而厘定其是否须根据英国金融行为监管局的披露指引及透明度规则知会其于和黄医药的权益或权益变更。

仅供说明之用，如 744,515,660 股普通股全部予以转换，将相等于 148,903,132 股在纳斯达克交易的美国存托股份（每股美国存托股份相等于五股普通股）。

关于霸菱亚洲投资基金

霸菱亚洲投资基金（“霸菱亚洲”）是亚洲最具规模的私募投资公司之一，旗下所管理资产约230亿美元。基金专注于私募股权投资，聚焦亚太市场，提供资金协助目标企业进行业务扩张和兼并收购，并在全球投资有潜力在亚太地区扩展的公司。霸菱亚洲亦管理私募房地产及私募信贷专项基金。霸菱亚洲成立至今24年，团队遍及中国香港、中国内地、印度、日本、新加坡、澳大利亚及美国设有办事处，总计超过195名。旗下基金目前在亚洲投资企业超过39家，员工总人数超过230,000人，总收入接近320亿美元。欲了解更多详情，请访问：www.bpeasia.com。

关于和黄医药

和黄医药（纳斯达克/伦敦证交所：HCM）是一家处于商业化阶段的创新型生物医药公司，在过去二十年间致力于发现和全球开发治疗癌症和免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有十个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。欲了解更多详情，请访问：www.hutch-med.com。

前瞻性陈述

本公告包含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，包括对使用交易所得款项的预期，以及和黄医药对其候选药物的临床开发和监管计划以及和黄医药的整体业务战略的预期。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：和黄医药未来临床开发计划所需资金的充足性，入组率、满足研究入选和排除标准的受试者的时间和可用性，临床方案或监管要求变更，非预期不良事件或安全性问题，和黄医药为持续运营需要筹集更多资金的时间和能力，以及新冠肺炎全球大流行对整体经济、监管及政治状况带来的影响等。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公告发布当日有效。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和AIM提交的文件。无论是否出现新信息、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公告所含信息的义务。

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