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IIIb期研究數據於2024年歐洲肺癌大會(ELCC)上以口頭報告的形式公佈,研究顯示在初治患者中的中位PFS13.7個月,中位OS則尚未達到 — 

— 若取得批准,將確認2021年的附條件批准,並將適應症擴展至更多患者 —

 

中國香港、上海和美國新澤西州:2024328日,星期四: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)今日宣佈賽沃替尼用於治療間質-上皮轉化因子(「MET」) 外顯子 14跳變的局部晚期或轉移性非小細胞肺癌成人患者的新適應症上市申請已獲中國國家藥品監督管理局(「國家藥監局」)受理。若取得批准,賽沃替尼在中國新的標籤適應症將擴展至覆蓋初治患者。

 

賽沃替尼早前已於中國獲附條件批准,用於治療接受全身性治療後疾病進展或無法接受化療的MET外顯子14跳躍突變的非小細胞肺癌患者。賽沃替尼是中國首個獲批的選擇性MET抑製劑,我們的合作夥伴阿斯利康針對該患者群體以商品名沃瑞沙®(ORPATHYS®)將其推出市場及銷售。中國肺癌患者人數佔全世界肺癌患者總數的三分之一以上。在全球非小細胞肺癌患者中,約有2%-3%的患者伴有MET外顯子14跳躍突變。

 

IIIb 期確證性研究(NCT04923945)的一線治療隊列的初步療效和安全性數據已於 2023 年 9 月在國際肺癌研究協會(IASLC)主辦的世界肺癌大會(WCLC)上公佈。該IIIb 期確證性研究的最終數據已於2024年3月20日在歐洲肺癌大會公佈。

 

這項研究的數據為賽沃替尼作為MET外顯子14跳躍突變的初治及經治非小細胞肺癌患者的靶向治療選擇提供了確認性的證據。在初治患者中,獨立審查委員會評估的客觀緩解率(「ORR」)為62.1% [95% 置信區間(「CI」):51.0%至72.3%]、疾病控制率(「DCR」)為92.0%(95% CI:84.1%至96.7%)、中位緩解持續時間(「DoR」)為12.5個月(95% CI:8.3個月至15.2個月)。至中位隨訪時間20.8個月的中位無進展生存期(「PFS」)為13.7個月(95% CI:8.5個月至16.6個月)及中位總生存期(「OS」)尚未達到。在經治患者中,獨立審查委員會評估的ORR為39.2%(95% CI:28.4%至50.9%)、DCR為92.4%(95% CI:84.2%至97.2%)、中位DoR為11.1個月(95% CI:6.6個月至未達到)。至中位隨訪時間12.5個月的中位PFS為11.0個月(95% CI:8.3個月至16.6個月)及中位OS尚未成熟。初治和經治患者均較早出現緩解(到達疾病緩解的時間1.4-1.6個月)。安全性特徵可耐受,沒有觀察到新的安全信號。最常見的3級或以上藥物相關治療不良事件(5%或以上的患者)為肝功能異常(16.9%)、谷丙轉氨酶升高(14.5%)、谷草轉氨酶升高(12.0% )、週邊水腫(6.0%)及γ-谷氨酰轉移酶升高(6.0%)。

 

關於非小細胞肺癌及MET異常

肺癌是男性和女性癌症死亡的主要原因,約佔所有癌症死亡人數的五分之一。1 肺癌通常分為非小細胞肺癌和小細胞肺癌(SCLC),其中80-85%為非小細胞肺癌。2 大部分(約75%)非小細胞肺癌患者在確診時已是晚期,而美國和歐洲的非小細胞肺癌患者中約有10-25%存在EGFR突變,而亞洲患者中該比例高達30-40%。3,4,5,6

 

MET是一種受體酪氨酸激酶,在細胞的正常發育過程中發揮重要作用。7 MET過表達及/或擴增可導致腫瘤生長以及癌細胞的轉移進展,且是EGFR突變的轉移性非小細胞肺癌患者對EGFR TKI治療產生獲得性耐藥的機制之一。7,8 約有2%-3%的患者伴有MET外顯子14跳躍突變,這是一種特定的基因突變。9 在奧希替尼(osimertinib)治療後出現疾病進展的患者中,MET異常的發生率為15-50%。10,11,12,13,14  MET異常的發生率可能因樣品類型、檢測方法和使用的測定閾值而異。15

 

關於賽沃替尼(中國商品名:沃瑞沙®

賽沃替尼是一種強效、高選擇性的口服MET 酪氨酸激酶抑制劑,在晚期實體瘤中表現出臨床活性。賽沃替尼可阻斷因突變(例如外顯子14跳躍突變或其他點突變)、基因擴增或蛋白質過表達而導致的MET受體酪氨酸激酶信號通路的異常激活。

 

賽沃替尼在中國獲批並以商品名沃瑞沙®上市,用於治療接受全身性治療後疾病進展或無法接受化療的MET外顯子14跳躍突變的非小細胞肺癌患者。目前,賽沃替尼正作為單藥療法或與其他藥物的聯合療法,開發用於治療包括肺癌、腎癌和胃癌在內的多種腫瘤類型。沃瑞沙®自2023年3月1日起獲納入國家醫保藥品目錄,用於治療含鉑化療後疾病進展或不耐受標準含鉑化療的MET外顯子14 跳躍突變的局部晚期或轉移性非小細胞肺癌成人患者。

 

2011年,和黃醫藥與阿斯利康達成一項全球許可協議,旨在共同開發沃瑞沙®並促進其商業化。和黃醫藥與阿斯利康合作負責賽沃替尼的臨床開發,在中國由和黃醫藥主導,在海外則由阿斯利康主導。此外,和黃醫藥負責賽沃替尼在中國的上市許可、生產和供應,而阿斯利康則負責實現沃瑞沙®在中國乃至全球範圍內的商業化。賽沃替尼的銷售收入將由阿斯利康確認。

 

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。集團旗下公司共有約5,000名員工,其中核心的腫瘤/免疫業務擁有約1,800人的團隊。自成立以來,和黃醫藥致力於將自主發現的抗腫瘤候選藥物帶向全球患者,首三個藥物現已在中國上市,其中首個藥物亦於美國上市。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

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,包括對賽沃替尼的治療潛力,賽沃替尼進一步臨床研究計劃,對此類研究是否能達到其主要或次要終點的預期,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:入組率,滿足研究入選和排除標準的受試者的時間和可用性,臨床方案或監管要求變更,非預期不良事件或安全性問題,賽沃替尼(包括作為聯合治療)達到研究的主要或次要終點的療效,獲得不同司法管轄區的監管批准,並在獲得監管批准後獲得市場接受,賽沃替尼用於目標適應症的潛在市場,以及資金充足性等。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。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、香港聯合交易所有限公司以及AIM提交的文件。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。

 

醫療信息

本新聞稿所提到的産品可能並未在所有國家上市,或可能以不同的商標進行銷售,或用於不同的病症,或採用不同的劑量,或擁有不同的效力。本文中所包含的任何信息都不應被看作是任何處方藥的申請、推廣或廣告,包括那些正在研發的藥物。

 

參考資料

  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).

 

聯絡方法

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媒體諮詢
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龍肇怡/何芷晴, 縱橫公關集團 +852 9282 4640 / +852 6198 4265 (手機) / SPRG_HUTCHMED@sprg.com.hk
任命保薦人
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。

中國香港、上海和美國新澤西州:2024年3月22日,星期五: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)今日宣佈在中國啟動一項索樂匹尼布治療溫抗體型自身免疫性溶血性貧血(wAIHA)成人患者的II/III期研究的註冊階段。

 

在此之前,該研究的II期概念驗證階段取得了積極的數據,並與中國國家藥品監督管理局(「國家藥監局」)進行了溝通。 若研究取得積極結果,其數據有望用於支持於未來提交新藥上市申請。溫抗體型自身免疫性溶血性貧血是一種可導致貧血的自身免疫性疾病,治療選擇非常有限。研究III期階段的首名受試者已於2024年3月20日接受首次給藥治療。

 

ESLIM-02研究是一項隨機、雙盲、安慰劑對照的II/III期臨床試驗。該研究的註冊階段旨在確認索樂匹尼布治療溫抗體型自身免疫性溶血性貧血成人患者的安全性和療效。研究的主要終點為第24週時達到整體血紅蛋白應答的患者比例。該研究目前已入組21名患者,並計劃在註冊階段多納入約90名患者。研究的牽頭主要研究者為中國醫學科學院血液病醫院張鳳奎醫生、中國醫學科學院北京協和醫院韓冰醫生和蘭州大學第二醫院張連生醫生。該項研究的其他詳情可登錄clinicaltrials.gov,檢索註冊號NCT05535933查看。

 

關於索樂匹尼布

索樂匹尼布是一種探索性的新型、選擇性的口服小分子脾酪氨酸激酶(「Syk」)抑製劑。Syk作為B細胞受體和Fc受體信號傳導通路中的一個關鍵蛋白,是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。和黃醫藥目前保留索樂匹尼布在全球的所有權利。

除了溫抗體型自身免疫性溶血性貧血以外,索樂匹尼布治療免疫性血小板減少症的研究亦正在進行中。索樂匹尼布治療原發免疫性血小板減少症的隨機、雙盲、安慰劑對照的ESLIM-01 中國III期研究(NCT05029635)已達到所有終點。免疫性血小板減少症是一種導致出血風險增加的自身免疫疾病。索樂匹尼布獲國家藥監局納入突破性治療品種用於此適應症,其中國新藥上市申請已於2024年1月獲受理並獲納入優先審評。一項於美國開展的劑量探索研究正在計劃中(NCT06291415)。

 

關於溫抗體型自身免疫性溶血性貧血(wAIHA)和脾酪氨酸激酶(Syk)

自身免疫性溶血性貧血(AIHA)是一種自身免疫性疾病,是由於產生抗自身紅細胞的抗體,而導致紅細胞的破壞所造成的疾病。自身免疫性溶血性貧血的發病率估計為每年每十萬成人中有0.8-3.0例,患病率估計為每十萬成人中有17例,死亡率為8%-11%。[1],[2]  溫抗體型自身免疫性溶血性貧血是最常見的自身免疫性溶血性疾病,[3] 佔所有成人自身免疫性溶血性貧血病例的75-80%。[4]

攜帶免疫球蛋白Fc受體(「FcR」)的巨噬細胞加速清除被抗體包裹的紅細胞被認為是溫抗體型自身免疫性溶血性貧血的致病機制。[5]  FcR的激活與信號亞基FcRγ相關,FcRγ與其受體結合後發生磷酸化,並導致Syk的募集和激活。[6]  被激活的Syk會介導吞噬細胞中活化的FcR的下游信號傳導,導致對紅細胞的吞噬作用。[7]  此外,活化的Syk通過B細胞受體介導B淋巴細胞的激活並分化為能分泌抗體的漿細胞。[8]  因此,抑制Syk可抑制吞噬作用和減少抗體產生,並為溫抗體型自身免疫性溶血性貧血的治療帶來潛在幫助。

 

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。集團旗下公司共有約5,000名員工,其中核心的腫瘤/免疫業務擁有約1,800人的團隊。自成立以來,和黃醫藥致力於將自主發現的抗腫瘤候選藥物帶向全球患者,首三個藥物現已在中國上市,其中首個藥物亦於美國上市。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

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,包括對索樂匹尼布用於治療溫抗體型自身免疫性溶血性貧血患者的治療潛力,以及索樂匹尼布在上述適應症及其他適應症中進一步臨床研究計劃的預期。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:對研究時間和結果發佈的預期、支持索樂匹尼布於中國或其他地區獲批用於治療溫抗體型自身免疫性溶血性貧血或其他適應症的新藥上市申請的數據充足性、獲得監管部門快速審批或審批的潛力,索樂匹尼布的療效及安全性、和黃醫藥為索樂匹尼布進一步臨床開發計劃及商業化提供資金並實現及完成的能力,以及此類事件發生的時間等。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。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、香港聯合交易所有限公司以及AIM提交的文件。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。

 

醫療信息

本新聞稿所提到的産品可能並未在所有國家上市,或可能以不同的商標進行銷售,或用於不同的病症,或採用不同的劑量,或擁有不同的效力。本文中所包含的任何信息都不應被看作是任何處方藥的申請、推廣或廣告,包括那些正在研發的藥物。

 

聯絡方法

投資者諮詢 +852 2121 8200 /  ir@hutch-med.com
媒體諮詢  

Ben Atwell / Alex Shaw,

FTI Consulting

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

HUTCHMED@fticonsulting.com

周怡,

博然思維集團

+852 9783 6894 (手機)

HUTCHMED@brunswickgroup.com

龍肇怡 / 何芷晴,

縱橫公關集團

+852 9282 4640 / +852 6198 4265 (手機)

SPRG_HUTCHMED@sprg.com.hk

任命保薦人

Atholl Tweedie / Freddy Crossley/ Daphne Zhang,

Panmure Gordon

+44 (20) 7886 2500

 

 

 

 

 

參考資料

 

[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.