中國香港、上海和新澤西州:2020年7月30日,星期四:和黃中國醫藥科技有限公司(簡稱「和黃醫藥」或「Chi-Med」)(納斯達克/倫敦證交所:HCM)是一家處於商業化階段的創新型生物醫藥公司。和黃醫藥今日公佈截至2020年6月30日六個月的未經審計財務業績,並公佈關鍵臨床項目和商業化發展的最新進展。
和黃醫藥主席杜志強先生表示:「2020年上半年,我們繼續致力於中國建立由研發到生產及商業化和銷售的高度一體化業務,並專注於腫瘤領域。索凡替尼和沃利替尼的新藥上市申請目前正在中國國家藥品監督管理局(「國家藥監局」)的審評過程中,我們現正通過新成立的專注於腫瘤的商業化團隊緊密籌備多項潛在產品上市,並將覆蓋中國大陸的所有省份。」
他補充道:「我們也是為數不多的致力於將中國本土創新候選藥物帶向世界舞台的生物科技公司之一。我們目前擁有9個處於臨床階段的創新候選藥物,其中多個均具有全球發展潛力。此外我們還有5個創新藥物正在新藥臨床試驗(「IND」)申請階段。」
「在過去3年中,我們的國際發展版圖迅速擴張,並在2020年上半年確定了索凡替尼和呋喹替尼的全球註冊策略,而我們與阿斯利康的全球合作也將推動實現沃利替尼全球註冊。此外,和黃醫藥的研發管線亦獨立擁有多個處於早期研發階段的腫瘤藥物。其中最值得關注的是我們的脾酪氨酸激酶(「Syk」)和磷酸肌醇-3激酶δ異構體(「PI3Kδ」)藥物,目前全球開發進展順利;另外我們的異檸檬酸脫氫酶(「IDH」)1/2抑制劑,預計將於今年在美國啟動I期臨床試驗。」
「我們期望在未來的12至18個月內會有多個創新腫瘤藥物推向市場,相信可以解決廣泛未滿足的醫療需求,令全球各地的廣大患者受益,並推動和黃醫藥進入新的發展階段。」
以下是和黃醫藥2020年至今的一些營運亮點。如欲瞭解更多詳細資料,請參閱英文版公告 「業務回顧(Operations Review)」部分。
沃利替尼 – 中國新藥上市申請已提交,有潛力成為中國首個上市的選擇性間充質上皮轉化因子(「MET」)抑制劑:
索凡替尼 – 已提交兩項新藥上市申請,並計於于2020年底於中國首次上市用於治療神經內分泌瘤(「NET」):
呋喹替尼 – 愛優特®(呋喹替尼膠囊)的商業化進展:
建立自有的腫瘤商業化團隊 – 團隊已為即將到來的新腫瘤藥上市做好準備:
[1] 根據禮來提供的未經審計的愛優特®銷售予協力廠商的銷售數據
索凡替尼 – 美國新藥上市申請籌備中:
呋喹替尼 – 全球III期結直腸癌(CRC)註冊研究正在進行中:
沃利替尼 – 與阿斯利康合作在肺癌和腎癌方面取得進展:
中國:高度一體化的中國腫瘤業務 | ||
呋喹替尼 |
|
|
索凡替尼 |
|
|
沃利替尼 |
|
|
早期創新藥物 |
|
全球:發揮和黃醫藥創新腫瘤藥物的全球潛力 | ||
呋喹替尼 |
|
|
索凡替尼 |
|
|
沃利替尼 |
|
|
早期創新藥物 |
|
以下各項是截至2020年6月30日止六個月的部分財務數據。除非另有說明,所有單位均以美元表示。欲了解更多詳細資料,請參閱英文版公告 「財務回顧(Financial Review)」、「業務回顧(Operations Review)」和「中期未經審計的簡明合併財務報表(Interim Unaudited Condensed Consolidated Financial Statements)」部分。
集團整體表現:
研發創新平台(我們的研發營運):
商業平台(我們的商業營運):
和黃中國醫藥科技有限公司(簡稱「和黃醫藥」或「Chi-Med」)(納斯達克/倫敦證交所:HCM)是一家創新型、商業階段的生物醫藥公司,在過去20年間致力於發現和全球開發治療癌症和自身免疫性疾病的靶向藥物和免疫療法。目前,和黃醫藥共有9個抗癌類候選藥物正在全球開發中,並在中國本土市場擁有廣泛的商業網絡。欲瞭解更多詳情,請訪問:www.chi-med.com。
本公告所載本集團之業績和經營狀況屬歷史性質,且過往業績並不保證本集團之未來狀況。本公告包含符合1995年《美國私人證券訴訟改革法案》中「安全港」條款定義的前瞻性陳述。該等前瞻性陳述可以用諸如「將會「、「期望」、「預期」、「未來」、「打算」、「計畫」、「相信」、「估計」、「籌備」、「可能」、「潛在」、「首個」、「旨在」、「目標」、「指導」、「追求」或類似術語,或通過對潛在候選藥物、潛在候選藥物適應症的明示或暗示討論,或通過討論戰略、計畫、預期或意圖來識別。閣下請勿過分倚賴這些前瞻性陳述。該等前瞻性陳述反映了和黃醫藥管理層目前對未來事件的預期,並受到已知及未知風險與不確定性的影響。如若該等風險或不確定性中的一項或多項出現,或者基本假設被證明屬不正確,則實際結果可能與前瞻性陳述中所載之結果有重大出入。和黃醫藥不能保證其任何候選藥物均將會在任何市場上獲准銷售,或者在任何特定時間獲得批准,或者任何候選藥物將達到任何特定的收入或淨收入水平。和黃醫藥管理層的預期可能會受到以下因素的影響:意料之外的監管行動或延遲或一般性的政府監管;研究與開發中固有的不確定性,包括無法滿足關鍵的關於受試者的註冊率、時機和可用性的研究假設,其要符合研究的納入及排除標準以及資金要求;臨床方案的變更、意外不利事件或安全性、質量或生產方面的問題;候選藥物無法滿足研究的主要或次要評估指標;新冠肺炎疫情或其他健康危機在中國或全球的影響;候選藥物無法獲得不同司法管轄區的監管批准或獲得監管批准後無法獲得商業認可;全球醫療成本遏制趨勢,包括持續的價格壓力;實際和潛在法律程序的不確定性,其中包括實際或潛在產品責任訴訟、有關銷售和營銷的訴訟和調查、知識產權糾紛以及政府調查;以及經濟和工業狀況,包括許多國家持續疲弱的經濟和金融環境影響的不確定性以及未來全球匯率的不確定性。有關前述各項和其他風險的進一步討論,請參閱和黃醫藥向美國證券交易委員會和AIM提交的文件。 和黃醫藥在本公告中提供之訊息截至本公告日期,並且不承擔因新的訊息、未來事件或其他原因而更新任何前瞻性陳述的義務。
此外,本公告還包含和黃醫藥從行業出版物和第三方市場研究公司生成的報告中獲得的統計數據和估計。儘管和黃醫藥認為該等出版物、報告和調查研究是可靠的,但是和黃醫藥尚未獨立驗證該等數據,不能保證該等數據的準確性或完整性。請閣下注意不要過度考慮該等數據。該等數據涉及風險和不確定性,並可能根據各種因素(包括前述因素)有所更改。
投資者諮詢 |
|
李健鴻,資深副總裁 | +852 2121 8200 |
鄭嘉惠,副總裁 | +1 (973) 567 3786 |
媒體諮詢 |
|
美洲 | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手機) bmiles@troutgroup.com |
英國及歐洲 | |
Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (手機) / +44 7779 545 055(手機) Chi-Med@fticonsulting.com |
亞洲 | |
盧志倫, 博然思維集團 | +852 9850 5033(手機) jlo@brunswickgroup.com |
周怡, 博然思維集團 | +852 9783 6894(手機) yzhou@brunswickgroup.com |
中國大陸 | |
張瑞丹, 愛德曼公關公司 | +86 139 1694 1712(手機) fay.zhang@edelman.com |
任命保薦人 |
|
Freddie Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
公告發佈:香港時間晚上7點(12 noon BST/ 7am EDT) |
>> 查看公告 << |
簡報會網絡直播及電話會議: 香港時間晚上8點(1pm BST/ 8am EDT) |
To participate by phone, please use one of the following numbers. Participant Access Code is “54962123#“.
United Kingdom (Toll-Free) | 0800 026 1542 |
United Kingdom (Toll) | +44 203 194 0569 |
United States (Toll-Free) | 1 855 824 5644 |
United States (Toll) | +1 646 722 4977 |
Mainland China (Toll-Free) | 800 988 0563 |
Mainland China (Toll) | 400 821 0637 |
Hong Kong SAR | +852 3027 6500 |
Singapore (Toll-Free) | 800 120 6853 |
Switzerland (Toll-Free) | 0800 800 732 |
香港、上海和新澤西:2020年7月28日,星期二:和黃中國醫藥科技有限公司(簡稱「和黃醫藥」或「Chi-Med」)(納斯達克/倫敦證交所:HCM)今日宣佈中國國家藥品監督管理局(「國家藥監局」)將沃利替尼(savolitinib)用於治療間充質上皮轉化因子(「MET」)外顯子14跳躍突變的非小細胞肺癌(「NSCLC」)的新藥上市申請納入優先審評。這是沃利替尼在全球範圍內的首個新藥上市申請,也是中國首個選擇性MET抑制劑新藥上市申請。
中國每年新增肺癌病例超過77.4萬例,佔全球肺癌新增病例的37%。[1] 大約80-85%的肺癌屬於非小細胞肺癌。[2] 據估計,有2-3%的非小細胞肺癌患者會發生MET外顯子14跳躍突變,伴有此類突變的患者預後普遍較差。[3] 在中國,每年約新增12,000至20,000例MET外顯子14跳躍突變的非小細胞肺癌新增病例。
優先審評是國家藥監局為鼓勵研究和創製具有明確臨床價值的潛在新藥、臨床急需的藥品或疫苗、防治重大傳染病和罕見疾病等疾病的藥品,以及兒童用藥新品種或劑型等而制定。潛在的新藥可能具有明確的臨床價值,用於防治嚴重危及生命或嚴重影響生活品質的疾病。納入優先審評資格的新藥上市申請可獲國家藥監局在審評審批的過程中優先配置資源。[4]
沃利替尼是一種強效、高選擇性的口服小分子MET抑制劑。而MET是一種在許多類型實體瘤中表現出功能異常的受體酪氨酸激酶,其作用包括促進腫瘤生長、血管新生和腫瘤轉移。迄今為止,沃利替尼已在全球範圍內逾1,000名患者中開展研究。臨床試驗顯示,沃利替尼在多種MET基因異常的腫瘤中均表現出了良好的臨床療效,並且具有可接受的安全性特徵。
和黃醫藥於2011年與阿斯利康(LSE,STO,NYSE:AZN)就沃利替尼簽訂了全球專利許可、合作開發和商業化協議。 沃利替尼的全球開發計畫包括非小細胞肺癌與腎癌,並且正在探索用於治療其他MET驅動的腫瘤。
MET 外顯子14突變的 NSCLC II 期臨床研究 (NCT02897479) – 2020年5月,一項進行中的開放標籤II期註冊研究資料於美國臨床腫瘤學會2020年網上年會(「ASCO 2020」)中公佈。沃利替尼治療MET 外顯子14跳躍突變NSCLC療效可評估的患者中,客觀緩解率(「ORR」)為49.2%,疾病控制率(DCR)為93.4%,緩解持續時間(DoR)為9.6個月。該研究中,36%的患者屬於NSCLC中更具侵略性的肺肉瘤樣癌(PSC)亞型患者。緩解持續時間、無進展生存期(PFS)和總生存期(OS)數據尚未成熟。臨床資料表明,沃利替尼具有可接受的安全性,因不良事件(AE)而中止治療的比例僅為14.3%。2020年5月,中國新藥上市申請基於上述數據獲受理。
SAVANNAH II 期臨床研究:沃利替尼聯合泰瑞沙®用於因 MET 擴增或過表達引起的泰瑞沙®治療後進展的患者 (NCT03778229) – SAVANNAH 研究是一項針對接受過泰瑞沙®治療的伴有MET擴增或過表達的表皮生長因子受體(EGFR)突變陽性的 NSCLC 患者的單臂、開放標籤研究。泰瑞沙®是阿斯利康的一種表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI)。
MET驅動的乳頭狀腎細胞癌 (NCT03091192) – 2020年5月, 在MET驅動的乳頭狀腎細胞癌患者中比較沃利替尼單藥治療與舒尼替尼單藥治療的SAVOIR全球研究中60名患者的研究資料於ASCO 2020網上年會發表。 沃利替尼表現出令人鼓舞的療效,ORR為27%,而舒尼替尼的ORR則為7%。至數據截止時,對沃利替尼有反應的患者均未出現疾病進展,總生存期的風險比(HR)為0.51(95% 置信區間:0.21–1.17; p=0.110),中位生存期尚未到達。基於這些資料,阿斯利康和和黃醫藥正在積極評估進一步開展沃利替尼單藥治療乳頭狀腎細胞癌臨床研究的可能性。
CALYPSO II 期臨床研究:沃利替尼聯合英飛凡® PD-L1 抑制劑用於治療腎細胞癌 (NCT02819596) – CALYPSO 研究是一項由研究者發起的開放標籤的 I/II 期沃利替尼與英飛凡®聯合治療研究,英飛凡®是阿斯利康的一種PD-L1抗體。該研究旨在評估沃利替尼/英飛凡®聯合治療乳頭狀腎細胞癌患者和腎透明細胞癌患者的安全性和療效。
通過研究者發起的臨床試驗,沃利替尼在包括胃癌和結直腸癌在內的其他多種MET驅動的腫瘤中的應用潛力也在繼續探索中。
和黃中國醫藥科技有限公司(簡稱「和黃醫藥」或「Chi-Med」)(納斯達克 / 倫敦證交所: HCM)是一家創新型生物醫藥公司,在過去20年間致力於發現和全球開發治療癌症和自身免疫性疾病的靶向藥物和免疫療法。目前,和黃醫藥共有9個抗癌類候選藥物正在全球開發中,並在中國本土市場擁有廣泛的商業網絡。欲瞭解更多詳情,請瀏覽:www.chi-med.com。
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,包括對沃利替尼用於治療非小細胞肺癌患者的治療潛力的預期、沃利替尼針對此適應症及其他適應症的進一步臨床研究計畫、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:支援沃利替尼獲批用於在中國治療非小細胞肺癌的新藥上市申請的資料充足性、沃利替尼在美國、歐洲和日本等其他地區獲得快速審批的潛力、沃利替尼的安全性、沃利替尼成為治療非小細胞肺癌患者治療新標準的潛力、實現及完成沃利替尼進一步臨床開發計畫的能力、在中國或其他地區推出上市沃利替尼的可能性及上市時間,以及新冠肺炎全球大流行對整體經濟、監管及政治狀況帶來的影響等。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和AIM提交的文件。無論是否出現新資訊、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資訊的義務。
投資者諮詢 |
|
李健鴻,資深副總裁 | +852 2121 8200 |
鄭嘉惠,副總裁 | +1 (973) 567 3786 |
媒體諮詢 |
|
美洲 | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手機) bmiles@troutgroup.com |
歐洲 | |
Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (手機) / +44 7779 545 055(手機) Chi-Med@fticonsulting.com |
亞洲 | |
盧志倫, 博然思維集團 | +852 9850 5033(手機) jlo@brunswickgroup.com |
周怡, 博然思維集團 | +852 9783 6894(手機) yzhou@brunswickgroup.com |
中國大陸 | |
張瑞丹, 愛德曼公關公司 | +86 139 1694 1712(手機) fay.zhang@edelman.com |
任命保薦人 |
|
Freddie Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
[1] Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[2] 美國癌症協會. www.cancer.org/cancer/lung-cancer/about/what-is.html.
[3] Awad M et al. 火MET Exon 14 Mutations in Non–Small-Cell Lung Cancer Are Associated With Advanced Age and Stage-Dependent MET Genomic Amplification and c-Met Overexpression.” Journal of Clinical Oncology 2016;34(7):721-730. doi:10.1200/JCO.2015.63.4600.
[4] 國家藥品監督管理局,《藥品上市許可優先審評審批工作程式(試行)》 http://www.nmpa.gov.cn/WS04/CL2138/378606.html.
— HMPL-306是和黃醫藥自主研發的第9個腫瘤候選藥物 —
香港、上海和新澤西:2020年7月24日,星期五:和黃中國醫藥科技有限公司(簡稱 「和黃醫藥」 或 「Chi-Med」)(納斯達克/倫敦證交所:HCM)在中國啟動了一項HMPL-306治療惡性血液腫瘤患者的I期臨床試驗。HMPL-306是一種靶向異檸檬酸脫氫酶(「IDH」)1和2突變的新型雙重小分子抑制劑,靶向選擇性高。首名患者已於今日接受給藥治療。
該試驗是一項多中心研究 ,旨在評估HMPL-306在伴有IDH1和/或IDH2突變的復發性或難治性惡性血液腫瘤患者中的安全性、藥代動力學、藥效學和療效。在研究的第一階段,每組患者將接受遞增劑量的口服HMPL-306治療,以確定最大耐受劑量和/或II期推薦劑量(「RP2D」)。該研究的第二階段是劑量擴展階段,患者將分成3組隊列接受HMPL-306 治療,以進一步評估RP2D的安全性、耐受性和臨床療效。該項研究的其他詳情可登錄clinicaltrials.gov,檢索註冊號NCT04272957查看。
HMPL-306是和黃醫藥自主研發的第9個腫瘤創新藥物。已有臨床資料表明,當使用單一靶向IDH1突變或靶向IDH2突變的抑制劑時,細胞質的IDH1突變和線粒體的IDH2突變會相互轉化。通過同時抑制IDH1和IDH2突變,該候選藥物有望為具有IDH突變的癌症患者提供治療效益,並可能解決因亞型轉化導致的IDH抑制獲得性耐藥問題。
IDH是一類重要的代謝酶,參與分解營養物質並為細胞提供能量。發生突變的IDH會產生一種能改變細胞遺傳程式的分子,阻止細胞成熟。IDH1或IDH2突變是各種類型的血液腫瘤和實體瘤中常見的基因變異,急性髓系白血病(「AML」)患者中約有20%伴有IDH基因突變,在骨髓增生異常綜合症(MDS)、骨髓增生性腫瘤(MPN)和低級別神經膠質瘤和肝內膽管癌中也有一定的發生率。IDH突變亞型轉化,是對IDH抑制劑產生獲得性耐藥的主要機制之一,無論是由細胞質的IDH1突變轉為線粒體的IDH2突變,或反之亦然。[1],[2],[3]
根據美國國家癌症研究所(NCI)的資料,2020年美國將有大約20,000例AML新增病例,而五年相對存活率為28.7%。[4]目前,美國食品藥品監督管理局(FDA)已批准一種靶向於IDH1突變的藥物以及一種靶向於IDH2突變的藥物,但尚無可同時靶向IDH1和IDH2突變的雙重抑制劑獲批。據估計,2018年中國有19,700例AML新增病例,預計到2030年將達到24,200例。[5]在中國,目前尚未有IDH抑制劑獲批。
和黃中國醫藥科技有限公司(簡稱「和黃醫藥」或「Chi-Med」)(納斯達克/倫敦證交所:HCM)是一家創新型生物醫藥公司,在過去20年間致力於發現和全球開發治療癌症和自身免疫性疾病的靶向藥物和免疫療法。目前,和黃醫藥共有9個抗癌類候選藥物正在全球開發中,並在中國本土市場擁有廣泛的商業網絡。欲瞭解更多詳情,請瀏覽:www.chi-med.com。
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HMPL-306臨床開發的預期及HMPL-306對伴有IDH突變患者的潛在效益。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:臨床試驗入組率、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、候選藥物HMPL-306作為單藥或聯合療法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,以及獲得監管批准後取得商業認可的能力、HMPL-306用於目標適應症的潛在市場和資金充足性以及新冠肺炎全球大流行對整體經濟、監管及政治狀況帶來的影響等。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和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資訊的義務。
投資者諮詢 |
|
李健鴻,資深副總裁 | +852 2121 8200 |
鄭嘉惠,副總裁 | +1 (973) 567 3786 |
媒體諮詢 |
|
美洲 | |
Brad Miles, Solebury Trout | +1 (917) 570 7340(手機) bmiles@troutgroup.com |
英國及歐洲 | |
Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (手機) / +44 7779 545 055(手機) Chi-Med@fticonsulting.com |
亞洲 | |
盧志倫, 博然思維集團 | +852 9850 5033(手機) jlo@brunswickgroup.com |
周怡, 博然思維集團 | +852 9783 6894(手機) yzhou@brunswickgroup.com |
中國大陸 | |
張瑞丹, 愛德曼公關公司 | +86 139 1694 1712(手機) fay.zhang@edelman.com |
任命保薦人 |
|
Freddie Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
[1]. S Choe S et al. Blood 2019;134(Supplement_1):545. doi:10.1182/blood-2019-122671.
[2]. Harding JJ et al. Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition. Cancer Discov. 2018;8(12):1540-1547. doi:10.1158/2159-8290.CD-18-0877.
[3]. Delahousse J et al. Circulating oncometabolite D-2-hydroxyglutarate enantiomer is a surrogate marker of isocitrate dehydrogenase-mutated intrahepatic cholangiocarcinomas. Eur J Cancer. 2018;90:83-91. doi:10.1016/j.ejca.2017.11.024.
[4]. 资料来源: National Cancer Institute – seer.cancer.gov/statfacts/html/amyl.html.
[5]. Lin J et al. IDH1 and IDH2 mutation analysis in Chinese patients with acute myeloid leukemia and myelodysplastic syndrome. Ann Hematol. 2012;91(4):519-525. doi:10.1007/s00277-011-1352-7.
NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: | Hutchison China MediTech Limited; Legal Entity Identifier: 2138006X34YDQ6OBYE79 |
|||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
Non-UK issuer | X | |||||
2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
An acquisition or disposal of voting rights | X | |||||
An acquisition or disposal of financial instruments | ||||||
An event changing the breakdown of voting rights | ||||||
Other (please specify)iii: | ||||||
3. Details of person subject to the notification obligation | ||||||
Name | Mitsui & Co., Ltd. | |||||
City and country of registered office (if applicable) | Tokyo, Japan | |||||
4. Full name of shareholder(s) (if different from 3.)v | ||||||
Name | ||||||
City and country of registered office (if applicable) | ||||||
5. Date on which the threshold was crossed or reached: | 06/07/2020 | |||||
6. Date on which issuer notified (DD/MM/YYYY): | 08/07/2020 | |||||
7. Total positions of person(s) subject to the notification obligation | ||||||
% of voting rights attached to shares (total of 8. A) | % of voting rights through financial instr-uments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
Resulting situation on the date on which threshold was crossed or reached | 2.92% | 2.92% | 710,574,765 | |||
Position of previous notification (if applicable) | 3.96% (dated 12 December 2018) | – | 3.96% | |||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
A: Voting rights attached to shares | |||||||||
Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
||||||
Ordinary Shares (KYG4672N1016) and American Depositary Shares (US44842L1035) | 20,742,325 | – | 2.92% | – | |||||
SUBTOTAL 8. A | 20,742,325 | 2.92% | |||||||
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
SUBTOTAL 8. B 1 | |||||||
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
SUBTOTAL 8.B.2 |
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | X | |||
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
||||
Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
10. In case of proxy voting, please identify: | ||||
Name of the proxy holder | ||||
The number and % of voting rights held | ||||
The date until which the voting rights will be held | ||||
11. Additional informationxvi | ||||
The warrants in Box B 2 have not been exercised, in part or whole, as of the below “Date of completion.” Accordingly, the “Total number of voting rights of issuer” in Box 7 do not account for any issuance of the new voting shares, in part or whole, from the exercise of the warrants. Once the warrants are exercised in full, assuming no other changes in the interests or the voting shares in the meantime, the “Total number of voting rights of issuer” in Box 7 will become 727,241,435. On that basis, the ownership ordinary shares would represent 2.75%, the ownership of warrants would represent 2.29%, and the combined ownership of the ordinary shares and warrants would represent 5.04%. |
||||
Place of completion | Tokyo, Japan |
Date of completion | 08 July 2020 |
日期:2020年8月12日(星期三) |
時間:香港時間晚上8點30分 (08:30 am EDT/01:30 pm BST) |
NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: | Hutchison China MediTech Limited | |||||
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
Non-UK issuer | X | |||||
2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
An acquisition or disposal of voting rights | X | |||||
An acquisition or disposal of financial instruments | X | |||||
An event changing the breakdown of voting rights | ||||||
Other (please specify)iii: | ||||||
3. Details of person subject to the notification obligation | ||||||
Name | General Atlantic Singapore HCM Pte. Ltd. | |||||
City and country of registered office (if applicable) | Singapore | |||||
4. Full name of shareholder(s) (if different from 3.)v | ||||||
Name | ||||||
City and country of registered office (if applicable) | ||||||
5. Date on which the threshold was crossed or reached: | 06/07/2020 | |||||
6. Date on which issuer notified (DD/MM/YYYY): | 06/07/2020 | |||||
7. Total positions of person(s) subject to the notification obligation | ||||||
% of voting rights attached to shares (total of 8. A) | % of voting rights through financial instr-uments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
Resulting situation on the date on which threshold was crossed or reached | 2.81% | 2.35% | 5.16% | 710,574,765 | ||
Position of previous notification (if applicable) | ||||||
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
A: Voting rights attached to shares | |||||||||
Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
||||||
Ordinary Shares (KYG4672N1198) |
20,000,000 | 2.81% | |||||||
SUBTOTAL 8. A | 20,000,000 | 2.81% | |||||||
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
SUBTOTAL 8. B 1 | |||||||
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
Warrants over Ordinary Shares | January 3, 2022 | At any time after July 2, 2020 | Physical | 16,666,670 | 2.35% | ||
SUBTOTAL 8.B.2 | 16,666,670 | 2.35% |
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | ||||
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
X | |||
Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
GAP (Bermuda) Limited | 5.16% | |||
General Atlantic LLC | 5.16% | |||
General Atlantic GenPar (Bermuda), L.P. | 5.16% | |||
General Atlantic (Lux) S.à r.l. | 5.16% | |||
General Atlantic GenPar (Lux) SCSp, L.P. | 5.16% | |||
General Atlantic Part- ners (Bermuda) IV, L.P. | 5.16% | |||
General Atlantic Part- ners (Bermuda) EU, L.P. | 5.16% | |||
General Atlantic Part- ners (Lux) SCSp, L.P. | 5.16% | |||
GAP Coinvestments III, LLC | 5.16% | |||
GAP Coinvestments IV, LLC | 5.16% | |||
GAP Coinvestments V, LLC | 5.16% | |||
GAP Coinvestments CDA, L.P. | 5.16% | |||
General Atlantic Singa- pore Interholdco Ltd. | 5.16% | |||
General Atlantic Singa- pore Fund Pte. Ltd. | 5.16% | |||
General Atlantic Singa- pore HCM Pte. Ltd. | 5.16% | |||
10. In case of proxy voting, please identify: | ||||
Name of the proxy holder | ||||
The number and % of voting rights held | ||||
The date until which the voting rights will be held | ||||
11. Additional informationxvi | ||||
The warrants in Box B 2 have not been exercised, in part or whole, as of the below “Date of completion.” Accordingly, the “Total number of voting rights of issuer” in Box 7 do not account for any issuance of the new voting shares, in part or whole, from the exercise of the warrants. Once the warrants are exercised in full, assuming no other changes in the interests or the voting shares in the meantime, the “Total number of voting rights of issuer” in Box 7 will become 727,241,435. On that basis, the ownership ordinary shares would represent 2.75%, the ownership of warrants would represent 2.29%, and the combined ownership of the ordinary shares and warrants would represent 5.04%. |
||||
Place of completion | Hong Kong, China |
Date of completion | July 6, 2020 |
London: Tuesday, July 7, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) was notified that CK Hutchison Holdings Limited (“CK Hutchison”) shareholding1 in Chi-Med remains unchanged, at 332,478,770 ordinary shares of par value US$0.10 each in the capital of Chi-Med (“Shares”).
Each American Depositary Share (“ADS”) represents five Shares. As announced on June 25, 2020, Chi-Med issued a total of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic. Chi-Med was notified on July 6, 2020 that this issuance diluted CK Hutchison’s holding1 to 46.79 per cent of the total number of voting rights of Chi-Med. The date on which the notification threshold was crossed was July 3, 2020.
About CK Hutchison
Listed on The Stock Exchange of Hong Kong Limited, CK Hutchison is a renowned multinational conglomerate committed to innovation and technology with businesses spanning the globe. With operations in about 50 countries and over 300,000 employees worldwide, CK Hutchison has five core businesses – ports and related services, retail, infrastructure, energy and telecommunications.
CK Hutchison reported turnover of approximately HK$440 billion (US$56 billion) for the year ended 31 December 2019.
For more information, please visit www.ckh.com.hk.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
[1] Held through CK Hutchison’s indirect wholly-owned subsidiary Hutchison Healthcare Holdings Limited.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500