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新聞中心及演示文稿

London: Wednesday, March 25, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/ AIM: HCM) today announces that its 2019 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy (“AGM Materials”) have been posted to Shareholders of Chi-Med (“Shareholders”).  The documents can be accessed from the website of Chi-Med (www.chi-med.com).

Due to travel restrictions resulting from the novel coronavirus outbreak, the 2020 Annual General Meeting (“AGM”) will be held at the 47th Floor, Cheung Kong Center, 2 Queen’s Road Central, Hong Kong on Monday, April 27, 2020 at 6:00 pm Hong Kong Time (11:00 am London Time).

To safeguard the health and safety of Shareholders, Chi-Med encourages Shareholders to exercise their right to vote at the AGM by appointing the Chairman of the AGM as their proxy instead of attending the AGM in person. Shareholders will be able to view a live webcast of the AGM through the website of the Company at https://www.hutch-med.com/agm2020/. Along with the AGM Materials, all registered Shareholders will also receive a letter containing log in details and information on how to access the webcast. Please note that webcast participation does not constitute formal attendance at the AGM nor would Shareholders be able to vote electronically. Shareholders would need to submit their form of proxy ahead of the AGM in accordance with the instructions printed thereon if they wish to cast their votes.

 

About Chi-Med

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.

 

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

Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com

Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com


Nominated Advisor

Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500

Contents

Corporate Information

Chairman’s Statement

2019 Operating Highlights

2019 Financial Highlights

Financial Review

Operations Review

Innovation Platform

Commercial Platform

Use of Non-GAAP Financial Measures and Reconciliation

Biographical Details Of Directors

Report of the Directors

Corporate Governance Report

Form 20-F (Including Financial Statements)

Information For Shareholders

日期:2020年4月27日
時間:香港時間下午6時 (倫敦時間上午11時)
地址:香港中環皇后大道中2號長江中心47樓

線上投資者會議

線上投資者會議
時間: 08:30 pm HKT(08:30 am EDT/12:30 pm GMT )

 

Cinney Zhang
czhang429@bloomberg.net

Sam Fazeli
mfazeli@bloomberg.net

Louise Chen
+1 212 915 1794
Louise.Chen@cantor.com

Brandon Folkes
+1 212 294 8081
Brandon.Folkes@cantor.com

Jennifer Kim
+1 212 829 4860
Jennifer.Kim@cantor.com

Carvey Leung
+1 212 915 1917
Carvey.Leung@cantor.com

>> 相關報道

The previously reported SANET-ep trial (clinicaltrials.gov identifier NCT02588170) demonstrated that surufatinib significantly improves progression-free survival (“PFS”) in patients with advanced extrapancreatic (non-pancreatic) neuroendocrine tumors compared to placebo, with a median PFS of 9.2 months versus 3.8 months, respectively (hazard ratio = 0.334, 95% CI 0.223 to 0.499, p<0.0001).  This presented analysis evaluated the safety profile and adverse events of special interest (“AESI”) of surufatinib from SANET-ep data.  93.8% of patients in the surufatinib group and 73.5% of patients in the placebo group had at least one treatment-emergent AESI.

The analysis concluded that AESIs of Grade 3 or higher hypertension and proteinuria occurred more frequently with surufatinib than with placebo, with the most common (at least 3% of patients) grade 3 or greater AESIs being hypertension (40.3% with surufatinib vs. 16.2% with placebo), proteinuria (23.3% vs. 0) and hemorrhage (3.1% vs. 2.9%).  It also concluded that AESIs leading to treatment discontinuation were uncommon, with AESIs leading to dose discontinuation in at least 1% of patients being proteinuria (3.9% with surufatinib vs. 0 with placebo), hemorrhage (1.6% vs 1.5%), and hepatic failure (0.8% vs 1.5%).  Surufatinib has a manageable safety profile in patients with advanced extra-pancreatic neuroendocrine tumors.

 

Title:      Safety Profile and Adverse Events of Special Interest for Surufatinib in Chinese Patients with Advanced Extra-Pancreatic Neuroendocrine Tumors: Analysis of the Phase 3 SANET-ep Trial

Authors: Jie Li, Jianming Xu, Zhiwei Zhou, Chunmei Bai, Yihebali Chi, Zhiping Li, Nong Xu, Enxiao Li, Tianshu Liu, Yuxian Bai, Sha Guan, Lin Shen

Abstract: #2914

Introduction The previously reported SANET-ep trial (NCT02588170) demonstrated surufatinib significantly improves progression-free survival (PFS) in patients (pts) with advanced extrapancreatic neuroendocrine tumors (epNETs) compared to placebo; median PFS (9.2 vs. 3.8 months; HR = 0.334, 95% CI 0.223 to 0.499, p<0.0001).

Aims The present analysis evaluates the safety profile and adverse events of special interest (AESIs) of surufatinib from SANET-ep data.

Patients and Methods Pts were randomized (2:1) to receive surufatinib (300 mg once daily continuously) or placebo. Treatment-related AESIs and time-to-first occurrence of AESIs were summarized. Predefined AESIs included hepatic failure (HF), proteinuria (P), hypertension (HTN), haemorrhage (H), and acute renal failure (ARF), which were searched with narrow MedDRA Standardized MedDRA Query (SMQ).

Results A total of 121/129 (93.8%) pts in the surufatinib group and 50/68 (73.5%) in the placebo group had ≥ 1 treatment-emergent AESI; the mean relative dose intensity was 86.42% and 96.78%, respectively. The most commonly reported (>10% of pts) AESIs were P (84.5% vs 57.4%), HTN (68.2% vs 30.9%), and H (55.8% vs 27.9%). The most common (≥3% of pts) grade ≥3 AESIs were HTN (40.3% vs 16.2%), P (23.3% vs 0) and H (3.1% vs 2.9%); the median time-to-onset of these events in the surufatinib group was 13.5, 28, and 32 days, respectively. AESIs (≥1% of pts) leading to dose discontinuation were P (3.9% vs 0), H (1.6% vs 1.5%), and HF (0.8% vs 1.5%).

Conclusions The AESIs of Grade ≥ 3 HTN and P occurred more frequently with surufatinib; however, AESIs leading to treatment discontinuation were uncommon. Surufatinib has a manageable safety profile in pts with advanced epNETs.

Keywords extra-pancreatic, neuroendocrine tumors, safety

London: Monday, March 9, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) announces that following the announcement of the 2019 annual results of Chi-Med on March 3, 2020, the following awards granted under the Long Term Incentive Plan (“LTIP”) on March 15, 2017 to Mr Christian Hogg, Mr Johnny Cheng and Dr Weiguo Su were vested on March 6, 2020:

Award Holders   Number of American depositary shares (“ADS”)
Person Discharging Managerial Responsibilities
Mr Christian Hogg (Executive Director and Chief Executive Officer) 14,975
Mr Johnny Cheng (Executive Director and Chief Financial Officer) 5,857
Dr Weiguo Su (Executive Director and Chief Scientific Officer) 10,475
Total 31,307

 

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

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 five Ordinary Shares of US$0.10

ADS ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 14,975 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction  2020-03-06
f) Place of the transaction  Outside a trading venue

 

 

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 five Ordinary Shares of US$0.10

ADS ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 5,857 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction  2020-03-06
f) Place of the transaction  Outside a trading venue

 

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 five Ordinary Shares of US$0.10

ADS ISIN: US44842L1035

b) Nature of the transaction Vesting of awards granted on March 15, 2017 under Chi-Med’s LTIP
c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 10,475 ADS
d) Aggregated information

Aggregated volume
Price
N/A
e) Date of the transaction  2020-03-06
f) Place of the transaction  Outside a trading venue

 

About Chi-Med

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.

 

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.

 

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

Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com

Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com


Nominated Advisor

Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500

公告發佈: 8pm HKT (12 noon GMT / 7am EST)
 >> 查看公告 <<
簡報會網絡直播及電話會議:9pm HKT (1pm GMT / 8am EST)
觀看網絡直播回放

To participate by phone, please use one of the following numbers. Participant Access Code is “413486“.

United Kingdom (Local) 020 3936 2999
China (Local): 010 5387 5828
United States (Local): 1 845 213 3398
Hong Kong (Local): 5808 4954
All other locations: +44 20 3936 2999

 

注:本文件的中文本為翻譯稿,僅供參考用。本文件的英文及中文版本如有歧義,概以英文版本為準。完整版本(僅備英文版)請參閱此處

 

倫敦,202033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/ AIM: HCM) 是一家處於商業化階段的生物製藥公司,目前在全球範圍內共有8個抗癌類候選藥物在開發中,並在中國具有廣泛的商業網絡。和黃醫藥今日發布截至2019年12月31日止年度之經審計財務業績,並報告關鍵臨床項目及商業平台方面的最新進展。

和黃醫藥主席杜志強表示:「2019年是我們為和黃醫藥開創新紀元奠定基礎的一年。我們首個上市的藥物愛優特®最近被納入中國國家醫保藥品目錄(NRDL),有望在今年讓更多患者受惠。我們首個具有全球專利和權益、用於治療非胰腺神經內分泌瘤的抗癌候選藥物索凡替尼(surufatinib)有望在年底上市。我們正在擴大自己的腫瘤商業化團隊為其上市做好充分準備。此外,我們即將提交另外兩項新藥上市申請(NDA),其中一項為沃利替尼(savolitinib)用於治療肺癌,另一項為索凡替尼用於治療胰腺神經內分泌瘤,均預計可在2021年上市。」

「基於大量臨床數據,我們計劃於今年開始對呋喹替尼 (fruquintinib)和索凡替尼開展多項全球註冊研究, 而沃利替尼的全球註冊研究也有望展開。此外,一些抗血液惡性腫瘤藥物在中國的註冊研究也在籌劃中。」

「我們相信,多個有望上市的全新抗腫瘤藥物,將解決廣泛未被滿足的醫療需求並令廣大患者受益,進而推動和黃醫藥快速發展。」

 

近期營運亮點

以下為和黃醫藥2019年至今的營運亮點。如欲了解更多詳細資料,請參閱英文版公告全文有關 「Operations Review」的部分。

沃利替尼–全球 

 

索凡替尼 – 中國 

 

呋喹替尼 – 中國 

其他正在研發的候選藥物 – 中國 

全球臨床開發 

 

公司組織 

  1. EGFR:抗表皮生长因子受体;TKI::酪氨酸激酶抑制剂
  2. MET:间充质上皮转化因子
  3. EGFRm:表皮生长因子受体突变
  4. ORR:客观缓解率
  5. PFS:无进展生存期
  6. PD-L1:程序性死亡受体配体1
  7. OS:总生存期
  8. Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388–1405. doi: 10.1158/2159-8290.CD-19-0442
  9. PD-1:程序性死亡受体1
  10. 由礼来提供的未经审计的爱优特®销售予第三方的销售数据

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 / AIM: 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8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。欲了解更多詳情,請瀏覽:www.chi-med.com