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2019329日,中國上海 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)在中國啟動了一項有註冊性潛力的IIb/III期臨床試驗,旨在對比索凡替尼(HMPL-012或sulfatinib)和卡培他濱治療一線化療後進展的晚期膽道癌(BTC)的療效和安全性。BTC是一類異質性的罕見惡性腫瘤,起源於膽道上皮和膽囊,存在巨大的未被滿足的醫療需求。2019年3月22日,首名患者開始接受索凡替尼的治療。

該研究是一項隨機、開放標籤、活性對照、多中心研究,旨在對比索凡替尼與化療藥物卡培他濱作為二線療法治療不可切除或轉移性BTC患者的療效和安全性。索凡替尼是一種小分子口服抗血管生成-免疫逃逸激酶抑制劑,可同時阻斷腫瘤血管生成和免疫逃逸。該研究的主要終點為總生存期(OS)。次要終點包括腫瘤控制相關指標,如無進展生存期(PFS)、客觀緩解率(ORR)、疾病控制率(DCR)、緩解持續時間(DOR)、生活品質、腫瘤標誌物以及安全性等。該研究的主要研究者為中國人民解放軍總醫院第五醫學中心胃腸腫瘤科徐建明教授。該研究詳情可登陸clinicaltrials.gov,檢索NCT03873532查看。

該研究是在兩項臨床試驗的基礎上對索凡替尼治療BTC的進一步探索,這兩項臨床試驗包括一項在中國以BTC為適應症的Ib/II期概念驗證研究(clinicaltrials.gov 註冊號NCT02966821),以及一項在美國以BTC和胰腺神經內分泌腫瘤(NET)為適應症的Ib期臨床試驗(clinicaltrials.gov 註冊號NCT02549937)。其中,中國Ib/II期概念驗證BTC臨床試驗的研究結果預計將於2019年提交發表。

關於索凡替尼

索凡替尼是一種新型的口服抗血管生成-免疫逃逸激酶抑制劑,可通過抑制VEGFR和成纖維細胞生長因子受體(FGFR)來抑制血管生成,索凡替尼也可抑制集落刺激因子-1受體(CSF-1R),通過抑制CSF-1R可調節腫瘤相關巨噬細胞,促進機體對腫瘤細胞的免疫應答。因為具有這種同時抑制血管生成和腫瘤免疫逃逸的作用機制,索凡替尼可能非常適合與其他免疫療法聯用。除了此次啟動的BTC研究,索凡替尼目前正在美國和中國開展多項概念驗證研究,並在中國開展了多項後期臨床試驗。

中國胰腺NET研究:2016年,和黃醫藥在中國啟動了一項關鍵性III期註冊研究SANET-p,入組患者為低級別或中級別晚期胰腺NET患者。主要研究終點為PFS。和黃醫藥計畫於2019年年底開展一項中期分析,並在2020年完成患者入組工作(clinicaltrials.gov 註冊號NCT02589821)。

中國非胰腺NET研究:2015年12月,和黃醫藥在中國啟動了索凡替尼關鍵性III期臨床試驗SANET-ep,入組患者為低級別或中級別晚期非胰腺NET患者。主要研究終點為PFS 。和黃醫藥計畫於2019年中開展一項中期分析,並在2020年完成患者入組工作(clinicaltrials.gov 註冊號NCT02588170)。

美國與歐洲胰腺NET研究:由於索凡替尼以胰腺NET為適應症的II期中國臨床試驗資料令人鼓舞(clinicaltrials.gov 註冊號NCT02267967),且美國Ib期臨床試驗進展順利,和黃醫藥決定將計畫開展索凡替尼在胰腺NET患者中的註冊性研究。

免疫聯合療法:2018年11月,和黃醫藥達成了兩項合作協定,以評估索凡替尼聯合免疫檢查點抑制劑的安全性、耐受性和療效,包括:一項與上海君實生物醫藥科技股份有限公司在全球共同開發索凡替尼與拓益®(特瑞普利單抗,JS001)聯合療法的合作協定,以及一項與泰州翰中生物醫藥有限公司在中國共同開發索凡替尼與HX008聯合療法的合作協定。拓益®為上海君實生物醫藥科技股份有限公司研發的一種PD-1單克隆抗體,已於 2018年年底在中國獲批。HX008為泰州翰中生物醫藥有限公司的在研PD-1單克隆抗體。相關安全性研究目前已經啟動/處於計畫階段,以確定呋喹替尼與拓益®或HX008組成的聯合療法的安全有效的劑量方案。

關於Chi-Med

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,致力於藥品的研究、開發、生產和銷售。和記黃埔醫藥(上海)有限公司是Chi-Med的創新藥研發平臺,現有一支約420人的研發團隊,專注於研發和商業開發治療癌症和自身免疫性疾病的靶向創新藥物和免疫療法,目前共有8個抗癌類候選藥物進入臨床階段,正在全球開展臨床研究。Chi-Med的商業平臺負責處方藥和健康類消費品在中國的生產和行銷,銷售網路覆蓋中國廣大地區醫院。

總部位於中國香港,在倫敦證券交易所(AIM)和美國納斯達克全球精選市場均已上市,由長江和記實業有限公司(SEHK:1)持有多數股權。瞭解更多詳情請訪問:www.chi-med.com

聯繫方式

投資者咨詢

李健鴻,資深副總裁,企業融資及發展 +852 2121 8200
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (手提電話)david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412(手提電話)
xyang@troutgroup.com

媒體咨詢

英國及歐洲 –
Anthony Carlisle, Citigate Dewe Rogerson  +44 7973 611 888(手提電話)
anthony.carlisle@cdrconsultancy.co.uk
美洲 —
Brad Miles, Solebury Trout +1 (917) 570 7340(手提電話)
bmiles@troutgroup.com
中國香港及亞洲其他地區 (不含中國大陸地區) –
Joseph Chi Lo, Brunswick
Zhou Yi, Brunswick
+852 9850 5033(手提電話)
jlo@brunswickgroup.com+852 9783 6894(手提電話)
yzhou@brunswickgroup.com
中國大陸地區 –
Sam Shen, Edelman
+86 136 7179 1029 (手提電話)
sam.shen@edelman.com

任命保薦人

Richard Gray / Andrew Potts,  Panmure Gordon (UK) Limited +44 (20) 7886 2500

2019328日,中國上海 — 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)將於2019年3月31日-4月3日在美國佐治亞州亞特蘭大市召開的美國癌症研究協會(AACR)年會上分享沃利替尼治療肺癌的相關專案的更新資料。

一項在中國開展的沃利替尼單藥II期臨床試驗的初步療效和安全性資料將於大會上公佈,這項研究入組的患者為既往系統治療失敗或不能接受化療的攜帶MET外顯子14跳變的肺肉瘤樣癌以及其他類型非小細胞肺癌(NSCLC)患者。(摘要號 #CT031, clinicaltrials.gov 註冊號 NCT02897479

另外,多篇沃利替尼聯合泰瑞莎®(奧希替尼)的Ib/II 期TATTON臨床研究相關摘要也將公佈。摘要關注的患者人群為表皮生長因子受體(EGFR)突變陽性且MET擴增的NSCLC患者,入組患者需既往接受過EGFR酪氨酸激酶抑制劑(TKI)治療後進展(clinicaltrials.gov 註冊號 NCT02143466)。其中,一篇摘要主要關注既往接受過第一代或第二代EGFR-TKI治療且未接受過第三代EGFR-TKI治療的患者(摘要號 #CT032)。另外一篇摘要則主要關注接受過第三代EGFR-TKI治療後仍然出現疾病進展的患者(摘要號 #CT033)。第三篇則關注MET相關EGFR-TKI耐藥性檢測手段,也將以壁報形式公佈(摘要號 #4897/20),作為對以上兩篇摘要的補充。

TATTON研究的初步結果已於2017年10月在日本橫濱舉行的第18屆世界肺癌大會(WCLC)上以口頭報告的形式公佈。[1] 基於TATTON研究的結果,一項探索沃利替尼與泰瑞莎®聯合療法治療既往服用泰瑞莎®後出現MET相關EGFR-TKI耐藥患者的II期臨床試驗SAVANNAH也已經開展(clinicaltrials.gov 註冊號 NCT03778229)。

 

報告詳情如下:

報告環節: Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It?
NSCLC耐藥性能否被攻克?
環節分類: 臨床試驗主會環節
環節編號: CTPL02
日期及時間: 3月31日(周日) 3:00 PM-5:15 PM
報告地點: Marcus Auditorium, Building A, Georgia World Congress Center

 

 

報告1 Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations
沃利替尼治療MET外顯子14跳變肺肉瘤樣癌及其他類型NSCLC患者的初步療效和安全性結果
主要作者: 上海交通大學附屬胸科醫院  陸舜  教授
摘要號及連結: CT031 – 美國東部時間2019年3月29日3 PM後公佈摘要
時間: 3:05 PM-3:30 PM

 

 

報告2 TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
TATTON Ib期擴展隊列:奧希替尼聯合沃利替尼治療既往第一代/第二代表皮生長因子受體(EGFR)酪氨酸激酶抑制劑(TKI)治療後進展的EGFR突變且MET擴增NSCLC患者
主要作者: 紀念斯隆-凱特琳癌症中心腫瘤內科學家 Helena A. Yu
摘要號及連結: CT032 – 報告時公佈摘要
時間: 3:40 PM-3:55 PM

 

 

報告3 TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
TATTON Ib期擴展隊列:奧希替尼聯合沃利替尼治療既往第三代表皮生長因子受體(EGFR)酪氨酸激酶抑制劑(TKI)治療後進展的EGFR突變且MET擴增NSCLC患者
主要作者: 哈佛醫學院副教授、麻省總醫院癌症早期檢測創新中心主任  Lecia V. Sequist
摘要號及連結: CT033 – 報告時公佈摘要
時間: 3:55 PM-4:15 PM

 

 

報告環節: Novel Strategies for Biomarker Identification and Use in Cancer 3
生物標記物檢測與應用新策略-3
壁報題目: Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study
MET導致EGFR酪氨酸激酶抑制劑(TKI)耐藥NSCLC的檢測:TATTON研究生物標記物分析
主要作者: Ryan J. Hartmaier,阿斯利康
摘要號及連結: 4897 / 20 – 摘要已公布
日期及時間: 2019年4月3日,8:00 AM – 12:00 PM
報告地點: Section 19, Building B, Georgia World Congress Center (佐治亞世界會議中心B幢19區)

 

關於沃利替尼

沃利替尼有潛力成為全球首創c-MET受體酪氨酸激酶抑制劑,c-MET已被證明在多種實體瘤中功能異常。和黃醫藥對沃利替尼進行了成功地設計,使其成為能夠強效、高選擇性靶向c-MET的口服抑制劑,並通過對其化學結構的修飾來避免導致其他多種c-MET抑制劑研發中斷的代謝相關腎毒性問題。截止至目前為止,共計超過900名癌症患者接受了沃利替尼的治療,沃利替尼在多種c-MET基因異常實體瘤中均展現出了令人鼓舞的臨床療效和較好的安全性。和黃醫藥目前正在與合作夥伴阿斯利康聯合開展沃利替尼單藥和聯合療法在多種實體瘤中的數項Ib/II期臨床試驗。

 

關於Chi-Med

和黃中國醫藥科技有限公司(Chi-Med)(AIM/Nasdaq:HCM)是一家創新型生物醫藥公司,致力於藥品的研究、開發、生產和銷售。和記黃埔醫藥(上海)有限公司是Chi-Med的創新藥研發平臺,現有一支約420人的研發團隊,專注於研發和商業開發治療癌症和自身免疫性疾病的靶向創新藥物,目前共有8個抗癌類候選藥物進入臨床階段,正在全球開展臨床研究。Chi-Med的商業平臺負責處方藥和健康類消費品在中國的生產和行銷,銷售網路覆蓋中國廣大地區醫院。

總部位於中國香港,在倫敦證券交易所(AIM)和美國納斯達克全球精選市場均已上市,由長江和記實業有限公司(SEHK:1)持有多數股權。瞭解更多詳情請訪問:www.chi-med.com

 

聯繫方式

投資者咨詢

李健鴻,資深副總裁,企業融資及發展 +852 2121 8200

David Dible, Citigate Dewe Rogerson

 

+44 7967 566 919 (手提電話)david.dible@citigatedewerogerson.com

Xuan Yang, Solebury Trout

 

+1 (415) 971 9412(手提電話)
xyang@troutgroup.com

媒體咨詢

英國及歐洲 –
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888(手提電話)
anthony.carlisle@cdrconsultancy.co.uk
美洲 —
Brad Miles, Solebury Trout
+1 (917) 570 7340(手提電話)
bmiles@troutgroup.com
中國香港及亞洲其他地區 (不含中國大陸地區) –

Joseph Chi Lo, Brunswick

Zhou Yi, Brunswick

+852 9850 5033(手提電話)
jlo@brunswickgroup.com
+852 9783 6894(手提電話)
yzhou@brunswickgroup.com
中國大陸地區 –

Sam Shen, Edelman

 

+86 136 7179 1029 (手提電話)
sam.shen@edelman.com

任命保薦人

Richard Gray / Andrew Potts,  Panmure Gordon (UK) Limited +44 (20) 7886 2500

 

地址: 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN, UK
時間:上午11時

 

地址:香港港麗酒店

地址:摩根士丹利香港辦公室

London: Monday, March 25, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that following the publication of the 2018 annual report of Chi-Med on March 21 2019, the following awards granted under the Long Term Incentive Plan (“LTIP”) on October 19, 2015 to Mr Christian Hogg, Mr Johnny Cheng and Dr Weiguo Su were vested on March 22, 2019:-

Award Holders  

Number of American depositary shares (“ADS”)

Person Discharging Managerial Responsibilities
Mr Christian Hogg (Executive Director and Chief Executive Officer)

8,234

Mr Johnny Cheng (Executive Director and Chief Financial Officer)

2,540

Dr Weiguo Su (Executive Director and Chief Scientific Officer)

3,008

Total

13,782

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

 

(a) Mr Christian Hogg

1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Christian Hogg
2 Reason for the notification
a) Position/status Executive Director and Chief Executive Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech 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 one half of one Ordinary Share of US$1.00ADS

ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 8,234 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2019-03-22
f) Place of the transaction Nasdaq Stock Market

 

(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 Hutchison China MediTech 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 one half of one Ordinary Share of US$1.00ADS

ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 2,540 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2019-03-22
f) Place of the transaction Nasdaq Stock Market

 

(c) 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 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 Hutchison China MediTech 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 one half of one Ordinary Share of US$1.00ADS

ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on October 19, 2015 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 3,008 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction 2019-03-22
f) Place of the transaction Nasdaq Stock Market

 

About Chi-Med

Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

 

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 Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM.  Chi-Med 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.

London: Thursday, March 21, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that its 2018 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders.  The documents can be accessed from the website of Chi-Med (www.chi-med.com).

 

About Chi-Med

Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

Contents

Corporate Information

2018 Key Highlights

Highlights

Chairman’s Statement

Financial Review

Operations Review

Biographical Details Of Directors

Report of the Directors

Corporate Governance Report

Form 20-F (Including Financial Statements)

Information For Shareholders

London: Monday, March 11, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today published the Form 20-F for the financial year ended December 31, 2018. This is available for viewing at http://www.rns-pdf.londonstockexchange.com/rns/4831S_1-2019-3-11.pdf and also on the website of the Company at www.chi-med.com.

About Chi-Med

Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

London: Monday, March 11, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces its audited financial results for the year ended December 31, 2018 and provides updates on key clinical programs.

Video webcast presentation at 9:00 a.m. GMT and additional conference call at 9:00 a.m. EDT.

“With the launch of Elunate® underway and doing well, and with its financial prospects enhanced by the recent Lilly amendment, we are focused on our broader late-stage clinical development program with multiple important opportunities being pursued in parallel,” said Simon To, Chairman, Chi-Med. “We took a big step in 2018 to expand our U.S. development capability in order that we can take full advantage of the global potential of our assets. We also entered the immuno oncology arena through multiple development collaborations combining PD-1 antibodies with our highly selective small molecules. The increased investment in all these activities is partially offset by robust income from our commercial operation in China, which also serves as a very powerful platform for future product launches.”

“Looking ahead, we target multiple NDAs in the coming two or three years, covering savolitinib, surufatinib and fruquintinib, as well as registration studies with our hematological cancer assets. We believe that these activities will address a broad range of unmet medical needs and benefit a large number of patients.”

Financial Highlights

The items below are selected financial data for the year ended December 31, 2018. All dollars are expressed in US dollar currency unless otherwise stated. For more details, please refer to “Financial Review”, “Operations Review” and “Audited Consolidated Financial Statements” below.

OVERALL GROUP:    in-line with our most recent guidance

INNOVATION PLATFORM: increased investment in R&D driven by expansion of our operations and progress on our clinical development pipeline

COMMERCIAL PLATFORM: continued solid net income growth amid shift in revenue model and over-the-counter (“OTC”) logistics divestment

U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. GMT (5:00 p.m. HKT) – at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, U.K. Investors may participate in the call at +44 20 3003 2666 (800 900 476 toll free in Hong Kong), or access a live video webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.

U.S. Conference Call Scheduled Today at 9:00 a.m. EDT – to participate in the call from the U.S., please dial 1 866 966 5335.

Additional dial-in numbers are also available at Chi-Med’s website. For both calls please use conference ID “Chi-Med.”

Innovation Platform — Operating HIGHLIGHTS

The points below summarize some of the pipeline development highlights during 2018 and to-date in 2019. For more details, please refer to “Operations Review – Innovation Platform” below.

FRUQUINTINIB – Highly selective tyrosine kinase inhibitor (“TKI”) of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3 – focus on maximizing commercial potential of our first approved drug:

SAVOLITINIB – Highly selective TKI of MET:

SURUFATINIB (HMPL-012 or sulfatinib) – unique angio-immuno kinase inhibitor of VEGFR, fibroblast growth factor receptor (“FGFR”) 1, and colony stimulating factor-1 receptor (“CSF-1R”):

Further progress in early/proof-of-concept clinical trials, including:

Expansion of U.S. and international operations, and recruitment of key personnel: established new office in New Jersey to support our multiple unpartnered compounds through proof-of-concept and registration trials outside of Asia.

Innovation Platform — KEY EVENTS IN 2019

Commercial Platform — Operating Highlights

The points below summarize some of the operational and financial highlights of our Commercial Platform during 2018. For more details, please refer to “Operations Review — Commercial Platform” below.

Large-scale, high-performance drug marketing and distribution platform covering ~320 cities/towns in China with approximately 3,400 sales personnel. Targeting multiple indications with several household-name brands:

FINANCIAL GUIDANCE

We provide streamlined Financial Guidance for 2019.

The ramp-up of manufacturing and royalty revenues from Lilly on Elunate® is expected to significantly benefit the Company’s financial results in years to come, with a gradual start in 2019 – the product’s first full year on the market. On the broader Innovation Platform, we plan to continue to increase our investment in R&D particularly on clinical development of our main assets in the U.S. and Europe as well as in China (as discussed in the “Product pipeline progress” section below).

On the Commercial Platform, we expect to continue to generate cash flow directly through our subsidiaries and via dividends from our joint ventures.  Two government reforms, the Two-Invoice System and the 4+7 Quality Consistency Evaluation (“QCE”) System, could narrow growth rates this year before having a positive mid- to long-term impact for Chi-Med (both reforms are discussed in detail the “Commercial Platform,” section below).

  2019 Guidance
Research & Development Expenses $(160) – (200) million
Adjusted (non-GAAP) Group Net Cash Flow excluding financing activities $(120) – (150) million

2019 U.S. dollar guidance takes into account the weakening of the RMB, which is down 5% relative to the first half average last year due to global macroeconomic factors.

Use of Non-GAAP Financial Measures – References in this announcement to adjusted R&D expenses, adjusted consolidated net income attributable to Chi-Med from our Commercial Platform, adjusted consolidated operating profit from our Commercial Platform, adjusted consolidated net income attributable to Chi-Med from our Prescription Drugs business, adjusted revenues of HBYS and non-consolidated joint ventures, adjusted service fees for Seroquel®, adjusted Group net cash flows and adjusted Group net cash flows excluding financing activities are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively. 

FINANCIAL STATEMENTS

Chi-Med will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.

ANNUAL GENERAL MEETING

The Annual General Meeting of Chi-Med will be held at 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN on Wednesday, April 24, 2019 at 11:00 a.m.

About Chi-Med

Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 420 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.

Dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market, Chi-Med is headquartered in Hong Kong and majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 1). For more information, please visit: www.chi-med.com.

CONTACTS

Investor Enquiries

Mark Lee, Senior Vice President, Corporate Finance & Development

+852 2121 8200

Annie Cheng, Vice President, Corporate Finance & Development

+1 (973) 567 3786

David Dible, Citigate Dewe Rogerson

+44 7967 566 919 (Mobile)

david.dible@citigatedewerogerson.com

Xuan Yang, Solebury Trout

+1 (415) 971 9412 (Mobile)

xyang@troutgroup.com

Media Enquiries

UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson

+44 7973 611 888 (Mobile)

anthony.carlisle@cdrconsultancy.co.uk

Americas – Brad Miles, Solebury Trout

+1 (917) 570 7340 (Mobile)

bmiles@troutgroup.com

Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick

+852 9850 5033 (Mobile)

jlo@brunswickgroup.com

Hong Kong & Asia ex-China – Zhou Yi, Brunswick

+852 9783 6894 (Mobile)

yzhou@brunswickgroup.com

Mainland China – Sam Shen, Edelman

+86 1367 179 1029 (Mobile)

sam.shen@edelman.com

Nominated Advisor

Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500

References

Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med Group,” “we,” “us,” and “our,” mean Hutchison China MediTech Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. 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. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “believe,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that Chi-Med obtained from industry publications and reports generated by third-party market research firms. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

The content above is a copy of the first section of the announcement. For the remainder, including Financial Review, Operations Review, Non-GAAP Financial Measures and Reconciliation, and Consolidated Financial Statements, please download the Full Announcement.

Announcement released: 7am BST (3pm HKT / 3am EDT)
>> See announcement here
Presentation webcast & call: 9am BST (5pm HKT / 5am EDT)
>> Click here for the webcast
US conference call: 9am EDT (1pm BST/9pm HKT)

To participate by phone, please use one of the following numbers. The conference ID for the calls is “Chi-Med“.

UK Toll Free 0808 109 0700
USA Toll Free 1 866 966 5335
   
China Toll Free 4001 200558
Hong Kong Toll Free 800 900 476
Italy Toll Free 800 986 477
Singapore Toll Free 800 120 4789
Switzerland Toll Free 0800 800 038
    
New York City Local Access +1 646 843 4608
London/Other International +44 (0) 20 3003 2666