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IIIb期研究数据于2024年欧洲肺癌大会(ELCC)上以口头报告的形式公布,研究在初治患者中的中位PFS13.7个月,中位OS尚未达到 —

— 若取得批准,将确2021年的附条件批准,并将适至更多患者 —

 

中国香港、上海和美国新西州:2024328日,星期四: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)今日宣布赛沃替尼用于治疗间质-上皮转化因子(“MET”) 外显子 14跳变的局部晚期或转移性非小细胞肺癌成人患者的新适应症上市申请已获中国国家药品监督管理局(“国家药监局”)受理。若取得批准,赛沃替尼在中国新的标签适应症将扩展至覆盖初治患者。

 

赛沃替尼早前已于中国获附条件批准,用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的非小细胞肺癌患者。赛沃替尼是中国首个获批的选择性MET抑制剂,我们的合作伙伴阿斯利康针对该患者群体以商品名沃瑞沙®(ORPATHYS®)将其推出市场及销售。中国肺癌患者人数占全世界肺癌患者总数的三分之一以上。在全球非小细胞肺癌患者中,约有2%-3%的患者伴有MET外显子14跳跃突变。

 

IIIb 期确证性研究(NCT04923945)的一线治疗队列的初步疗效和安全性数据已于 2023 年 9 月在国际肺癌研究协会(IASLC)主办的世界肺癌大会(WCLC)上公布。该IIIb 期确证性研究的最终数据已于2024年3月20日在欧洲肺癌大会公布。

 

这项研究的数据为赛沃替尼作为MET外显子14跳跃突变的初治及经治非小细胞肺癌患者的靶向治疗选择提供了确认性的证据。在初治患者中,独立审查委员会评估的客观缓解率(“ORR”)为62.1% [95% 置信区间(“CI”):51.0%至72.3%]、疾病控制率(“DCR”)为92.0%(95% CI:84.1%至96.7%)、中位缓解持续时间(“DoR”)为12.5个月(95% CI:8.3个月至15.2个月)。至中位随访时间20.8个月的中位无进展生存期(“PFS”)为13.7个月(95% CI:8.5个月至16.6个月)及中位总生存期(“OS”)尚未达到。在经治患者中,独立审查委员会评估的ORR为39.2%(95% CI:28.4%至50.9%)、DCR为92.4%(95% CI:84.2%至97.2%)、中位DoR为11.1个月(95% CI:6.6个月至未达到)。至中位随访时间12.5个月的中位PFS为11.0个月(95% CI:8.3个月至16.6个月)及中位OS尚未成熟。初治和经治患者均较早出现缓解(到达疾病缓解的时间1.4-1.6个月)。安全性特征可耐受,没有观察到新的安全信号。最常见的3级或以上药物相关治疗不良事件(5%或以上的患者)为肝功能异常(16.9%)、谷丙转氨酶升高(14.5%)、谷草转氨酶升高(12.0% )、外围水肿(6.0%)及γ-谷氨酰转移酶升高(6.0%)。

 

关于非小细胞肺癌及MET异常

肺癌是男性和女性癌症死亡的主要原因,约占所有癌症死亡人数的五分之一。1 肺癌通常分为非小细胞肺癌和小细胞肺癌(SCLC),其中80-85%为非小细胞肺癌。2 大部分(约75%)非小细胞肺癌患者在确诊时已是晚期,而美国和欧洲的非小细胞肺癌患者中约有10-25%存在EGFR突变,而亚洲患者中该比例高达30-40%。3,4,5,6

 

MET是一种受体酪氨酸激酶,在细胞的正常发育过程中发挥重要作用。7 MET过表达及/或扩增可导致肿瘤生长以及癌细胞的转移进展,且是EGFR突变的转移性非小细胞肺癌患者对EGFR TKI治疗产生获得性耐药的机制之一。7,8 约有2%-3%的患者伴有MET外显子14跳跃突变,这是一种特定的基因突变。9 在奥希替尼(osimertinib)治疗后出现疾病进展的患者中,MET异常的发生率为15-50%。10,11,12,13,14  MET异常的发生率可能因样品类型、检测方法和使用的测定阈值而异。15

 

关于赛沃替尼(中国商品名:沃瑞沙®

赛沃替尼是一种强效、高选择性的口服MET 酪氨酸激酶抑制剂,在晚期实体瘤中表现出临床活性。赛沃替尼可阻断因突变(例如外显子14跳跃突变或其他点突变)、基因扩增或蛋白质过表达而导致的MET受体酪氨酸激酶信号通路的异常激活。

 

赛沃替尼在中国获批并以商品名沃瑞沙®上市,用于治疗接受全身性治疗后疾病进展或无法接受化疗的MET外显子14跳跃突变的非小细胞肺癌患者。目前,赛沃替尼正作为单药疗法或与其他药物的联合疗法,开发用于治疗包括肺癌、肾癌和胃癌在内的多种肿瘤类型。沃瑞沙®自2023年3月1日起获纳入国家医保药品目录,用于治疗含铂化疗后疾病进展或不耐受标准含铂化疗的MET外显子14 跳跃突变的局部晚期或转移性非小细胞肺癌成人患者。

 

2011年,和黄医药与阿斯利康达成一项全球许可协议,旨在共同开发沃瑞沙®并促进其商业化。和黄医药与阿斯利康合作负责赛沃替尼的临床开发,在中国由和黄医药主导,在海外则由阿斯利康主导。此外,和黄医药负责赛沃替尼在中国的上市许可、生产和供应,而阿斯利康则负责实现沃瑞沙®在中国乃至全球范围内的商业化。赛沃替尼的销售收入将由阿斯利康确认。

 

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。集团旗下公司共有约5,000名员工,其中核心的肿瘤/免疫业务拥有约1,800人的团队。自成立以来,和黄医药致力于将自主发现的抗肿瘤候选药物带向全球患者,首三个药物现已在中国上市,其中首个药物亦于美国上市。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

稿包含1995年《美国私人诉讼改革法案》“安全港”条款中定的前瞻性述。些前瞻性述反映了和黄医目前未来事件的期,包括对赛沃替尼的治潜力沃替尼一步床研究此类研究是否能达到其主要或次要点的期,以及此类研究完成时间布的期。前瞻性述涉及风险和不确定性。此类风险和不确定性包括下列假率,足研究入和排除准的受者的时间和可用性,床方案或管要求更,非期不良事件或安全性问题沃替尼(包括作为联合治)达到研究的主要或次要点的效,得不同司法管区的管批准,并在管批准后得市接受,沃替尼用于目症的潜在市,以及金充足性等。当前和潜在投度依赖这些前瞻性述,在截至本新稿布当日有效。有关风险和其他风险一步讨论请查阅和黄医向美国券交易委会、香港合交易所有限公司以及AIM提交的文件。无是否出息、未来事件或情况或其他因素,和黄医均不承担更新或修本新稿所含息的义务

 

信息

本新稿所提到的品可能并未在所有国家上市,或可能以不同的商标进售,或用于不同的病症,或采用不同的量,或有不同的效力。本文中所包含的任何信息都不被看作是任何的申、推广或广告,包括那些正在研物。

 

参考资料

  1. World Health Organization. International Agency for Research on Cancer. All cancers fact sheet. Available at: https://gco.iarc.fr/today/­data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed November 2022.
  2. American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022.
  3. Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070.
  4. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
  5. Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48).
  6. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
  7. Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).
  8. Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63.
  9. Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer 2018; 123: 76-82.
  10. Soria JC, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-125.
  11. Mok TS, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017;376(7):629-640.
  12. Hartmaier R, et al. Tumor genomics in patients (pts) with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib therapy in the Phase II ORCHARD study. Cancer Res 15 June 2022; 82 (12_Supplement): LB078.
  13. Piotrowska, et al. MET amplification (amp) as a resistance mechanism to osimertinib. Journal of Clinical Oncology 2017 35:15_suppl, 9020-9020.
  14. Hartmaier, et al. Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study. Cancer Res (2019) 79 (13_Supplement): 4897.
  15. Coleman N, et al. Beyond epidermal growth factor receptor: MET amplification as a general resistance driver to targeted therapy in oncogene-driven non-small-cell lung cancer. ESMO Open. 2019;6(6).

 

联络方法

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媒体咨询
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周怡, 博然思维集团 +852 9783 6894 (手机) / HUTCHMED@brunswickgroup.com
龙肇怡/何芷晴, 纵横公关集团 +852 9282 4640 / +852 6198 4265 (手机) / SPRG_HUTCHMED@sprg.com.hk
任命保荐人
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500

 

股份過戶登記總處

Computershare Investor Services (Jersey) Limited
13 Castle Street, St. Helier
Jersey, Channel Islands JE1 1ES
電話: +44 (0)370 707 4040
傳真: +44 (0)370 873 5851

 

香港股份過戶登記分處

香港中央證券登記有限公司
香港灣仔皇后大道東183 號
合和中心17 樓1712至1716 室
電話: +852 2862 8628
傳真: +852 2865 0990

 

發佈公司通訊

和黃醫藥(中國)有限公司(「本公司」)根據適用規則[1]自2024 年3月25日起,就發佈公司通訊[2]實施進一步安排,詳情如下:

倘   閣下為本公司之香港登記股東,請參閱致香港登記股東之通知信函及適用之回條。

倘   閣下為本公司之香港非登記股東[3],請參閱致香港非登記股東之通知信函及適用之回條。

倘   閣下為本公司之英國登記股東,請參閱致英國登記股東之通知信函及適用之回條(僅提供英文版)。

如 閣下對上述有任何疑問,請致電+44 (0)370 707 4040或發送電郵至webqueries@computershare.co.uk 聯絡本公司股份過戶登記總處Computershare Investor Services (Jersey) Limited ;或致電 (852) 2862 8688或發送電郵至hutchmed.ecom@computershare.com.hk聯絡本公司香港股份過戶登記分處香港中央證券登記有限公司。

 

[1]      根據香港聯合交易所有限公司證券上市規則第2.07A條

[2]      公司通訊 指本公司刊發或將予刊發以供其任何證券持有人或投資大眾參照或採取行動之任何文件,其中包括但不限於:董事會報告、年度賬目連同核數師報告、中期報告、會議通告、上市文件、通函及代表委任表格。

[3]      非登記股東 指其本公司股份存放於中央結算及交收系統(CCASS),並透過香港中央結算有限公司不時向本公司發出通知,表示欲收取本公司之公司通訊的人士或公司。

中国香港、上海和美国新西州:2024322日,星期五: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)今日宣布在中国启动一项索乐匹尼布治疗温抗体型自身免疫性溶血性贫血(wAIHA)成人患者的II/III期研究的注册阶段。

 

在此之前,该研究的II期概念验证阶段取得了积极的数据,并与中国国家药品监督管理局(“国家药监局”)进行了沟通。 若研究取得积极结果,其数据有望用于支持于未来提交新药上市申请。温抗体型自身免疫性溶血性贫血是一种可导致贫血的自身免疫性疾病,治疗选择非常有限。研究III期阶段的首名受试者已于2024年3月20日接受首次给药治疗。

 

ESLIM-02研究是一项随机、双盲、安慰剂对照的II/III期临床试验。该研究的注册阶段旨在确认索乐匹尼布治疗温抗体型自身免疫性溶血性贫血成人患者的安全性和疗效。研究的主要终点为第24周时达到整体血红蛋白应答的患者比例。该研究目前已入组21名患者,并计划在注册阶段多纳入约90名患者。研究的牵头主要研究者为中国医学科学院血液病医院张凤奎医生、中国医学科学院北京协和医院韩冰医生和兰州大学第二医院张连生医生。该项研究的其他详情可登录clinicaltrials.gov,检索注册号NCT05535933查看。

 

关于索乐匹尼布

索乐匹尼布是一种探索性的新型、选择性的口服小分子脾酪氨酸激酶(“Syk”)抑制剂。Syk作为B细胞受体和Fc受体信号传导通路中的一个关键蛋白,是多种亚型的B细胞淋巴瘤及自身免疫疾病的成熟治疗靶点。和黄医药目前保留索乐匹尼布在全球的所有权利。

 

除了温抗体型自身免疫性溶血性贫血以外,索乐匹尼布治疗免疫性血小板减少症的研究亦正在进行中。索乐匹尼布治疗原发免疫性血小板减少症的随机、双盲、安慰剂对照的ESLIM-01 中国III期研究(NCT05029635)已达到所有终点。免疫性血小板减少症是一种导致出血风险增加的自身免疫疾病。索乐匹尼布获国家药监局纳入突破性治疗品种用于此适应症,其中国新药上市申请已于2024年1月获受理并获纳入优先审评。一项于美国开展的剂量探索研究正在计划中(NCT06291415)。

 

关于温抗体型自身免疫性溶血性贫血(wAIHA)和脾酪氨酸激酶(Syk)

自身免疫性溶血性贫血(AIHA)是一种自身免疫性疾病,是由于产生抗自身红细胞的抗体,而导致红细胞的破坏所造成的疾病。自身免疫性溶血性贫血的发病率估计为每年每十万成人中有0.8-3.0例,患病率估计为每十万成人中有17例,死亡率为8%-11%。[1],[2]  温抗体型自身免疫性溶血性贫血是最常见的自身免疫性溶血性疾病,[3] 占所有成人自身免疫性溶血性贫血病例的75-80%。[4]

 

携带免疫球蛋白Fc受体(“FcR”)的巨噬细胞加速清除被抗体包裹的红细胞被认为是温抗体型自身免疫性溶血性贫血的致病机制。[5]  FcR的激活与信号亚基FcRγ相关,FcRγ与其受体结合后发生磷酸化,并导致Syk的募集和激活。[6]  被激活的Syk会介导吞噬细胞中活化的FcR的下游信号传导,导致对红细胞的吞噬作用。[7]  此外,活化的Syk通过B细胞受体介导B淋巴细胞的激活并分化为能分泌抗体的浆细胞。[8]  因此,抑制Syk可抑制吞噬作用和减少抗体产生,并为温抗体型自身免疫性溶血性贫血的治疗带来潜在帮助。

 

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。集团旗下公司共有约5,000名员工,其中核心的肿瘤/免疫业务拥有约1,800人的团队。自成立以来,和黄医药致力于将自主发现的抗肿瘤候选药物带向全球患者,首三个药物现已在中国上市,其中首个药物亦于美国上市。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

稿包含1995年《美国私人诉讼改革法案》“安全港”条款中定的前瞻性述。些前瞻性述反映了和黄医目前未来事件的期,包括匹尼布用于治温抗体型自身免疫性溶血性患者的治潜力,以及索匹尼布在上述适症及其他适症中一步床研究划的期。前瞻性述涉及风险和不确定性。此类风险和不确定性包括下列假研究时间布的期、支持匹尼布于中国或其他地区用于治温抗体型自身免疫性溶血性或其他适症的新上市申的数据充足性、管部快速批或批的潜力,匹尼布效及安全性、和黄医药为匹尼布一步床开发计划及商化提供金并实现及完成的能力,以及此类事件生的时间等。当前和潜在投度依赖这些前瞻性述,在截至本新稿布当日有效。有关风险和其他风险一步讨论请查阅和黄医向美国券交易委会、香港合交易所有限公司以及AIM提交的文件。是否出息、未来事件或情况或其他因素,和黄医均不承担更新或修本新稿所含息的义务

 

信息

本新稿所提到的品可能并未在所有国家上市,或可能以不同的商标进售,或用于不同的病症,或采用不同的量,或有不同的效力。本文中所包含的任何信息都不被看作是任何的申、推广或广告,包括那些正在研物。

 

联络方法

投资者咨询 +852 2121 8200 /  ir@hutch-med.com
媒体咨询  

Ben Atwell / Alex Shaw,

FTI Consulting

+44 20 3727 1030 / +44 7771 913 902 (手机) / +44 7779 545 055 (手机)

HUTCHMED@fticonsulting.com

周怡,

博然思维集团

+852 9783 6894 (手机)

HUTCHMED@brunswickgroup.com

龙肇怡 / 何芷晴,

纵横公关集团

+852 9282 4640 / +852 6198 4265 (手机)

SPRG_HUTCHMED@sprg.com.hk

任命保荐人

Atholl Tweedie / Freddy Crossley/ Daphne Zhang,

Panmure Gordon

+44 (20) 7886 2500

 

参考

[1] Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB. Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007; 29 (1):1-9. doi: 10.1016/j.jaut.2007.05.002.

[2] Roumier M, Loustau V, Guillaud C, et al. Characteristics and outcome of warm autoimmune hemolytic anemia in adults: new insights based on a single-center experience with 60 patients. Am J Hematol. 2014; 89 (9):E150-5. doi: 10.1002/ajh.23767.

[3] Cotran Ramzi S, Kumar Vinay, Fausto Nelson, Nelso Fausto, Robbins Stanley L, Abbas Abul K. Robbins and Cotran pathologic basis of disease. St. Louis, Mo: Elsevier Saunders; 2005. p. 637.

[4] Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J Hematol. 2002; 69:258–271. doi: 10.1002/ajh.10062.

[5] Barros MM, Blajchman MA, Bordin JO. Warm autoimmune hemolytic anemia: recent progress in understanding the immunobiology and the treatment. Transfus Med Rev. 2010; 24(3):195‐210. doi: 10.1016/j.tmrv.2010.03.002.

[6] Braselmann S, Taylor V, Zhao H, et al. R406, an orally available spleen tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune complex‐mediated inflammation. J Pharmacol Exp Ther. 2006; 319(3):998‐1008. doi: 10.1124/jpet.106.109058.

[7] Barcellini W, Fattizzo B, Zaninoni A. Current and emerging treatment options for autoimmune hemolytic anemia. Expert Rev Clin Immunol. 2018; 14(10):857‐872. doi: 10.1080/1744666x.2018.1521722.

[8] Davidzohn N, Biram A, Stoler‐Barak L, Grenov A, Dassa B, Shulman Z. SYK degradation restrains plasma cell formation and promotes zonal transitions in germinal centers. J Exp Med. 2020; 217(3):e20191043. doi: 10.1084/jem.20191043.

Hong Kong, Shanghai, & Florham Park, NJ: Tuesday, March 14, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) announces that on March 14, 2024, it granted share options (“Share Options”) under the Share Option Scheme adopted by HUTCHMED in 2015 (the “Share Option Scheme”) and awards (“LTIP Awards”) under the Long Term Incentive Plan adopted by HUTCHMED in 2015 (“LTIP”).

Aimed at attracting and retaining top talent, the Remuneration Committee of HUTCHMED appointed an independent advisor to conduct compensation benchmarking research on a selected peer group of companies. As a result of this the Remuneration Committee has comprehensively reviewed the compensation and share-based incentives policies of HUTCHMED and its subsidiaries (the “Group”) and established an attractive policy to ensure the Group is able to recruit and retain top talent. In line with this review HUTCHMED has decided to make the following grant of Share Options and LTIP Awards.

 

1. Performance Related Share Options

HUTCHMED granted Share Options subject to the Performance Targets (defined below) under its Share Option Scheme to Dr Weiguo Su (Executive Director, Chief Executive Officer and Chief Scientific Officer), being a person discharging managerial responsibility (“PDMR”) under the UK Market Abuse Regulation to subscribe for a total of 1,359,561 ordinary shares with par value US$0.10 each in the share capital of the Company (“Ordinary Shares”) subject to the acceptance of the grantee. Details of such Share Options granted are as follows:

Date of grant : March 13, 2024
Exercise price of share options granted : HK$28.35 per Ordinary Share
Number of share options granted : 1,359,561 Ordinary Shares
Closing market price of Ordinary Shares at HKEX on the date of grant : HK$28.35 per Ordinary Share
Exercise period of the share options : From March 13, 2024 to March 12, 2034
Vesting period of the share options : Vesting will occur two business days after the date of announcement of the annual results of the Company for the financial year ending December 31, 2025 (the “2025 Results Announcement”).
Performance targets : The exercise of the share options is conditional upon the fulfilment of certain performance targets relating to the Group over the financial years 2023 to 2025 (the “Performance Targets”). The number of share options to be exercisable will be determined on the date of 2025 Results Announcement. The Performance Targets have been determined by the Board and specified in the grant letter of Dr Su. To the extent that the Performance Targets have not been met, the relevant number of share options granted to Dr Su will lapse.
Clawback mechanism : The share options may be subject to the clawback policy of the Company enabling the Company to recover incentive-based compensation paid to covered executive officers in the event of mis-statement of the financial statements of the Company resulting from material non-compliance with financial reporting requirements.

After the above grant of Share Options, the number of Share Options available for future grant under the scheme mandate of the Share Option Scheme is 11,678,982.

 

2. Non-performance-related LTIP Award (“Non-performance LTIP Award”) – a one-off cash amount was granted to each grantee and will be used by the trustee administering the LTIP (the “Trustee”) to purchase Ordinary Shares in HUTCHMED which will be subject to a vesting schedule over four years. HUTCHMED granted the following Non-performance LTIP Awards to the following Executive Director, being a PDMR under the UK Market Abuse Regulation:

Award Holder Award Holder Cash amount for the Non- Performance LTIP Awards
Dr Weiguo Su (Executive Director, Chief Executive Officer and Chief Scientific Officer) US$500,000

The non-performance-related LTIP Award was granted to Dr Su in recognition of his contribution to the Company in his dual role as Chief Executive Officer and Chief Scientific Officer.

Another employee of the Group has simultaneously been granted non-performance related LTIP Awards.

The notification in respect of share options granted to Dr Su in accordance with the requirements of the UK Market Abuse Regulation is set out below.

 

Dr Weiguo Su

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Dr Weiguo Su
2 Reason for the notification
a) Position/status Executive Director, Chief Executive Officer and Chief Scientific Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name HUTCHMED (China) Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)

Description of the financial instrument, type of instrument

Identification code

Share option over Ordinary Shares of US$0.10

 

Share option over Ordinary Share with DI ISIN: KYG4672N1016

b) Nature of the transaction Grant of options in respect of 1,359,561 Ordinary Shares under the Share Option Scheme.

The exercise of the share options is conditional upon the fulfilment of certain performance targets relating to the Group over the financial years 2023 to 2025 (the “Performance Targets”). The number of share options to be exercisable will be determined on the date of 2025 Results Announcement. The Performance Targets have been determined by the Board and specified in the grant letter of Dr Su. To the extent that the Performance Targets have not been met, the relevant number of share options granted to Dr Su will lapse.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 1,359,561
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2024-3-13
f) Place of the transaction Outside a trading venue

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 approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/​immunology. Since inception, it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S.. 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, on AIM and on HKEX. 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.

Contact

Investor Enquiries +852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com
Media Enquiries
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500

 

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, March 5, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; SEHK:13) announces that following the announcement of the 2023 annual results of HUTCHMED on February 28, 2024, the following awards granted under the Long Term Incentive Plan (“LTIP”) on March 26, 2021 to Dr Weiguo Su and Mr Johnny Cheng were vested on March 4, 2024:

 

Award Holder Number of American depositary shares (“ADS”)
Person Discharging Managerial Responsibilities
Dr Weiguo Su (Executive Director, Chief Executive Officer and Chief Scientific Officer) 93,545
Mr Johnny Cheng (Executive Director and Chief Financial Officer) 15,141
Total 108,686

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

 

(a) Dr Weiguo Su

 

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Dr Weiguo Su
2 Reason for the notification
a) Position/status Executive Director, Chief Executive Officer and Chief Scientific Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name HUTCHMED (China) Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)

Description of the financial instrument, type of instrument

Identification code

ADS each representing five Ordinary Shares of US$0.10

ADS ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on March 26, 2021 under HUTCHMED’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 93,545 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2024-03-04
f) Place of the transaction Outside a trading venue

 

(b) Mr Johnny Cheng

 

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Johnny Cheng
2 Reason for the notification
a) Position/status Executive Director and Chief Financial Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name HUTCHMED (China) Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)

Description of the financial instrument, type of instrument

 

Identification code

ADS each representing five Ordinary Shares of US$0.10

 

 

ADS ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on October 20, 2021 under HUTCHMED’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 15,141 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2024-03-04
f) Place of the transaction Outside a trading venue

 

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 approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.