London: Wednesday, April 29, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) announces that on April 28, 2020, in accordance with its new incentive policy outlined in its full year results announcement on March 3, 2020, it granted share options under the Share Option Scheme adopted by Chi-Med at its Annual General Meeting on April 24, 2015 (the “Share Option Scheme”). The scheme limit of the Share Option Scheme was refreshed on April 27, 2020.
In 2019, Chi-Med had conducted a comprehensive review of its compensation and share-based incentives policies, which included benchmarking research on peer group U.S. and China biotech companies. The Company has established a new competitive policy to ensure that it is able to attract and retain top talent.
Chi-Med granted share options under its Share Option Scheme to employees to subscribe for a total of 9,891,500 Ordinary Shares represented by 1,978,300 American Depositary Shares (“ADSs”) (each equating to five Ordinary Shares) subject to the acceptance of the grantees. Details of such share options granted prescribed are as follows:
| Date of grant | : | April 28, 2020 |
| Exercise price of share options granted | : | US$22.09 per ADS |
| Number of share options granted | : | 9,891,500 represented by 1,978,300 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS) |
| Closing market price of ADSs on the date of grant | : | US$22.09 per ADS |
| Validity period of the share options | : | From April 28, 2020 to April 27, 2030 |
Among the share options granted, a total of 2,483,300 share options represented by 496,660 ADSs were granted to Mr Christian Hogg, Dr Weiguo Su and Mr Johnny Cheng (Executive Directors of the Company), being persons discharging managerial responsibility under the EU Market Abuse Regulation as follows:-
| Grantee | Number of share options granted | |
| Mr Christian Hogg (Executive Director and Chief Executive Officer) | 1,291,700 Ordinary Shares represented by 258,340 ADSs | |
| Dr Weiguo Su (Executive Vice President and Chief Scientific Officer) | 789,700 Ordinary Shares represented by 157,940 ADSs | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | 401,900 Ordinary Shares represented by 80,380 ADSs |
The notification set out below is 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 |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
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| b) | Nature of the transaction |
Grant of options in respect of 1,291,700 Ordinary Shares (represented by 258,340 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
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| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2020-04-28 | ||||||
| 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 |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 789,700 Ordinary Shares represented by 157,940 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2020-04-28 | ||||||
| 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 |
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10) Option over American Depositary Share with ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 401,900 Ordinary Shares represented by 80,380 ADSs under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2020-04-28 | ||||||
| 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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+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
| 标题： | 索凡替尼在中美患者中的药代动力学特征及安全性比较 |
| 报告人： | Arvind Dasari |
| 作者： |
A Dasari1, S Paulson2, E Hamilton3, J Wang4, M Sung5, G Falchook6, C Tucci7, K Li7, C Chien7, J Kauh7, M Kania7, D Li8. 1 MD Anderson Cancer Center, Houston, TX, USA, 2 Baylor Sammons Cancer Center, Dallas, TX, MD Anderson Cancer Center, Houston, TX, USA, 3 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA, 4 Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA, 5 Mount Sinai Hospital, New York, NY, USA, 6 Sarah Cannon Research Institute at HealthONE, Denver, Co, USA, 7 Hutchison MediPharma International Inc., Florham Park, NJ, USA, 8 City of Hope Cancer Center, Duarte, CA, USA. |
| 报告环节： | VPO.CT01 |
| 报告编号： | CT115 |
| 链接地址： | 查看摘要 |
John Kauh. Hutchison MediPharma International Inc, Florham Park, NJ
J. Kauh: ; Hutchison MediPharma International Inc.
Introduction: Recently reported results from the SANET-ep study (NCT02588170) demonstrated superior efficacy of surufatinib (S) in Chinese patients (pts) with advanced extra-pancreatic neuroendocrine tumors (epNET) when compared to placebo (median progression free survival 9.2 vs. 3.8 months). S is an inhibitor of tyrosine kinases VEGFR1, 2, and 3, FGFR1, and CSF-1R. Trials in the US are ongoing, however genetic differences leading to disparate metabolism of S in different pt populations are unknown. We report a comparison of PK and safety across populations treated with S.
Methods: A phase I/II study of S, (NCT02267967), conducted in Chinese pts, and a similar study, (NCT02549937), conducted in US pts are compared to evaluate potential effects of race to surufatinib exposure. Both trials enrolled pts at the recommended phase 2 dose (RP2D) of 300 mg QD in three tumor types including Biliary Tract Cancer, epNET, and pancreatic neuroendocrine tumors (pNET).
Results: PK sampling was obtained on days 1 and 14 in 81 Chinese pts, and on days 1, 8, 15, and 29, in 39 US pts. Out of 39 US pts there were 29 Caucasian, 2 Asian, and 8 were not reported. Following a single dose of S 300 mg on day 1, geometric mean (percent coefficient of variation of geometric mean, %CV) Cmax and AUCtau were 376 (70%) ng/mL and 2770 (56%) hr*ng/mL, respectively, in Chinese pts, compared to 354 (61%) ng/mL and 3050 (56%) hr*ng/mL, respectively, in US pts. Following S to steady-state on day 14/15, Cmax and AUCtau were 487 (65%) ng/mL and 4810 (58%) hr*ng/mL, respectively, in Chinese pts, compared to 471 (59%) ng/mL and 5130 (50%) hr*ng/mL, respectively, in US pts. PK exposures on days 15 and 29 were similar.
In 81 Chinese pts, 100% of pts experienced a treatment-related adverse event (TRAE), and 79.5% of 39 US pts reported a TRAE. The most common TRAEs reported were proteinuria (81% and 12.8%), diarrhea (72% and 23.1%), and hypertension (60% and 35.9%) in Chinese and US pts respectively. The most commonly reported ≥ Grade 3 TRAE’s were: hypertension (33% and 23.1%), proteinuria (12% and 2.6%) and diarrhea (6% and 7.7%), in Chinese and US pts, respectively. Serious adverse events were reported in 27% of Chinese pts and 23.7% of US pts. The safety profile in the two populations appear to be similar at the RP2D.
In addition to a similar toxicity profile, the relative dose intensity in both trials were comparable. In Chinese and US pts, respectively, the relative mean dose intensity was 90%, and 84%, and the median intensity was 97% and 96%.
Conclusions Given the similar PK and toxicity profiles of S between Chinese and US pts, it can be concluded that race has minimal effect on S exposure. Further evaluations of safety and efficacy are being conducted in ongoing global studies.
| 标题： | 关于索凡替尼联合特瑞普利单抗治疗晚期实体瘤患者的I期临床研究 |
| 报告人： | 曹彦硕 |
| 作者： | 陆明1, 曹彦硕1, 龚继芳1, 孙宇2, 李洁1, 沈琳1.
1北京大学肿瘤医院恶性肿瘤发病机制及转化研究教育部重点实验室，消化道肿瘤科；2北京大学肿瘤医院恶性肿瘤发病机制及转化研究教育部重点实验室，病理科 |
| 报告环节： | VPO.CT01 |
| 报告编号： | CT142 |
| 链接地址： | 查看摘要 |
Ming Lu, Yanshuo Cao, Jifang Gong, Yu Sun, Jie Li, Lin Shen. Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China, Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China
M. Lu: None. Y. Cao: None. J. Gong: None. Y. Sun: None. J. Li: None. L. Shen: None.
Background: Surufatinib is a novel small-molecule inhibitor targeting vascular endothelial growth factor receptors 1, 2 and 3, fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor. Toripalimab (JS001) is a monoclonal humanized IgG4 PD-1 antibody. The potential synergistic antitumor activity of surufatinib and anti-PD-L1 combination regimen had been demonstrated in preclinical study (presented at 2017 AACR). Here, we report the safety and preliminary efficacy results from a phase I trial of surufatinib plus toripalimab in patients with advanced solid tumor (NCT03879057).
Methods: This study is an open-label, dose escalation and expansion study in solid tumor patients who had failed standard therapies or had no effective treatment. In dose escalation stage, 3 dose levels of surufatinib (200, 300 and 250 mg once daily) were evaluated in combination with a fixed dose of toripalimab 240 mg every 3 weeks until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) was reached, which ever occurred first. Additional patients were enrolled at dose expansion phase to further assess the efficacy, safety and pharmacokinetic (PK) profile.
Results: As of 2020-1-20, a total of 30 patients were enrolled. Tumor types include neuroendocrine tumor (NET) Grade (G) 1/2 (4), NET G3 (4), neuroendocrine carcinoma (NEC) (13), colorectal carcinoma (CRC) (4), gastric adenocarcinoma (GC) (2), esophageal squamous cell carcinoma (ESCC) (2) and metastatic squamous cell carcinoma with unknown primary (1). The RP2D was determined at surufatinib 250 mg daily plus toripalimab. One patient at 300 mg experienced dose-limiting toxicity, grade 3 hyperthyroidism. The most common grade 3/4 treatment emergent adverse events (TEAE, ≥5%) were transaminase elevation, bilirubin elevation, fatigue, hyponatremia, and vomit, with higher frequencies in the 300 mg cohort compared with lower dose cohorts. There was no treatment-related fatal serious adverse event. Preliminary PK analysis showed surufatinib exposure at steady state increased dose-proportionally. Individual PK profiles was comparable to those of surufatinib or toripalimab from previous monotherapy trials. By 2020-1-10, 25/30 patients across 3 cohorts were evaluable for tumor response: 1 complete response, 6 partial response (ORR=28%); in NET G1/2 (3), NEC (2), ESCC (1), and CRC (1). Twelve patients experienced stable disease for at least 6 weeks (DCR=76%). Most patients with negative or low PD-L1 expression achieved PR or CR. Of 21 evaluable neuroendocrine neoplasms (NENs) patients, the ORR and DCR were 23.8% and 81.0%, respectively. Four of 8 evaluable patients at RP2D achieved PR, and the ORR and DCR were 50% and 100%, respectively.
Conclusions: Surufatinib plus toripalimab were well tolerated with no unexpected safety signals observed, and showed encouraging antitumor activity in patients with advanced solid tumor, especially in NENs patients. The phase II trial (NCT04169672) has been initiated.
London: Monday, April 27, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that all ordinary resolutions and special resolutions put to its Annual General Meeting (“AGM”) held on April 27, 2020 were duly passed. The poll results of the resolutions were as follows:
| Number of Votes (%)* | ||||||
| Resolutions | For | Against | Withheld# | |||
| 1 | To consider and adopt the audited financial statements and the reports of the directors and independent auditor for the year ended 31 December 2019. |
622,475,006 (99.97825%) |
135,425 (0.02175%) |
209,095 | ||
| 2(A) | To re-elect Mr Simon To as a director. |
547,656,413 (93.79515%) |
36,229,215 (6.20485%) |
38,935,898 | ||
| 2(B) | To re-elect Mr Christian Hogg as a director. |
614,200,226 (98.61822%) |
8,605,840 (1.38178%) |
15,460
|
||
| 2(C) | To re-elect Mr Johnny Cheng as a director. |
612,394,636 (98.32808%) |
10,412,825 (1.67192%) |
14,065
|
||
| 2(D) | To re-elect Dr Weiguo Su as a director. |
612,400,256 (98.32849%) |
10,410,325 (1.67151%) |
10,945 | ||
| 2(E) | To re-elect Dr Dan Eldar as a director. |
612,014,066 (98.26647%) |
10,796,615 (1.73353%) |
10,845 | ||
| 2(F) | To re-elect Ms Edith Shih as a director. |
612,006,786 (98.26611%) |
10,798,775 (1.73389%) |
15,965 | ||
| 2(G) | To re-elect Mr Paul Carter as a director. |
620,440,741 (99.61989%) |
2,367,325 (0.38011%) |
13,460
|
||
| 2(H) | To re-elect Dr Karen Ferrante as a director. |
622,577,316 (99.96253%) |
233,365 (0.03747%) |
10,845 | ||
| 2(I) | To re-elect Mr Graeme Jack as a director. |
619,884,406 (99.53097%) |
2,921,135 (0.46903%) |
15,985 | ||
| 2(J) | To re-elect Professor Tony Mok as a director. |
622,805,231 (99.99912%) |
5,450 (0.00088%) |
10,845 | ||
| 3 | To re-appoint PricewaterhouseCoopers as the auditor of the Company and authorise the board of directors to fix the auditor’s remuneration. |
622,682,786 (99.97980%) |
125,795 (0.02020%) |
12,945 | ||
| 4 | Ordinary Resolution No. 4(A) | : | To grant a general mandate to the directors of the Company to issue additional shares. |
615,116,216 (98.76581%) |
7,686,590 (1.23419%) |
18,720 |
| Special Resolution No. 4(B) | : | To disapply pre-emption rights (general power). |
618,134,451 (99.25233%) |
4,656,435 (0.74767%) |
30,640 | |
| Special Resolution No. 4(C) | : | To disapply pre-emption rights (in connection with an equity raise). |
529,841,459 (86.65474%) |
81,598,207 (13.34526%) |
11,381,860 | |
| Ordinary Resolution No. 4(D) | : | To grant a general mandate to the directors of the Company to repurchase shares of the Company. |
622,786,026 (99.99584%) |
25,890 (0.00416%) |
9,610 | |
| 5 | Ordinary Resolution | : | To amend the 2015 Share Option Scheme and refresh the scheme mandate limit under the 2015 Share Option Scheme. |
501,381,220 (85.77268%) |
83,165,305 (14.22732%) |
38,275,001 |
| 6 | Special Resolution | : | To adopt a new memorandum and articles of association of the Company. |
622,545,861 (99.96014%) |
248,265 (0.03986%) |
27,400 |
* Percentages rounded to 5 decimal places
# A vote withheld is not a vote in law and is not counted in the calculation of the proportion of the votes for and against a resolution.
As at the date of the AGM, the number of issued shares of Chi-Med was 690,574,765, which was the total number of shares entitling the holders to attend and vote on the ordinary resolutions and special resolutions proposed at the AGM.
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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+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
伦敦：2020年4月22日，星期三：和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克/伦敦证交所：HCM）今日宣布将于2020年4月27日召开的美国癌症研究协会（AACR）线上年会（一）上公布正在进行的索凡替尼研究的最新分析与更新后的分析结果。
报告详情如下：
| 标题： | 关于索凡替尼联合特瑞普利单抗治疗晚期实体瘤患者的I期临床研究 |
| 报告人： | 曹彦硕 |
| 作者： | 陆明1, 曹彦硕1, 龚继芳1, 孙宇2, 李洁1, 沈琳1.
1北京大学肿瘤医院恶性肿瘤发病机制及转化研究教育部重点实验室，消化道肿瘤科；2北京大学肿瘤医院恶性肿瘤发病机制及转化研究教育部重点实验室，病理科 |
| 报告环节： | VPO.CT01 |
| 报告编号： | CT142 |
| 链接地址： | 查看摘要 | 下载演示文稿 |
| 标题： | 索凡替尼在中美患者中的药代动力学特征及安全性比较 |
| 报告人： | Arvind Dasari |
| 作者： |
A Dasari1, S Paulson2, E Hamilton3, J Wang4, M Sung5, G Falchook6, C Tucci7, K Li7, C Chien7, J Kauh7, M Kania7, D Li8. 1 MD Anderson Cancer Center, Houston, TX, USA, 2 Baylor Sammons Cancer Center, Dallas, TX, MD Anderson Cancer Center, Houston, TX, USA, 3 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA, 4 Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA, 5 Mount Sinai Hospital, New York, NY, USA, 6 Sarah Cannon Research Institute at HealthONE, Denver, Co, USA, 7 Hutchison MediPharma International Inc., Florham Park, NJ, USA, 8 City of Hope Cancer Center, Duarte, CA, USA. |
| 报告环节： | VPO.CT01 |
| 报告编号： | CT115 |
| 链接地址： | 查看摘要 | 下载演示文稿 |
索凡替尼（surufatinib）是由和黄医药自主研发的一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。索凡替尼可通过抑制血管内皮生长因子受体（VEGFR）和成纤维细胞生长因子受体（FGFR）以阻断肿瘤血管生成，并可抑制集落刺激因子-1受体（CSF-1R），通过调节肿瘤相关巨噬细胞，促进机体对肿瘤细胞的免疫应答。因为具有抗肿瘤血管生成和免疫调节的双重机制，索凡替尼可能非常适合与其他免疫疗法联合使用。
和黄医药目前拥有索凡替尼在全球范围内的所有权利。
美国、欧洲与日本神经内分泌瘤研究：由于索凡替尼以神经内分泌瘤为适应症的两项III期中国临床试验数据令人鼓舞，且美国Ib期临床试验进展顺利 （clinicaltrials.gov 注册号NCT02549937），和黄医药正与美国、欧洲和日本的监管部门进行沟通，以确定索凡替尼的临床开发和注册路径。在美国，索凡替尼于2020年4月被授予快速通道资格，用于治疗胰腺和非胰腺神经内分泌瘤，并于2019年11月被授予“孤儿药”资格认证，用于治疗胰腺神经内分泌瘤 。
中国非胰腺神经内分泌瘤研究：2019年11月，国家药监局受理了索凡替尼用于治疗非胰腺神经内分泌瘤的新药上市申请（“NDA”），并于2019年12月纳入优先审评。该NDA获成功的SANET-ep研究数据支持。SANET-ep是一项关于索凡替尼以晚期非胰腺神经内分泌瘤为适应症的中国III 期临床试验，而这些患者目前尚无有效治疗方法。2019年6月，该研究独立数据监察委员会（“IDMC”）评估认为，共198名患者参与的中期分析成功达到无进展生存期（“PFS”）这一预设主要疗效终点并提前终止研究。该项研究的积极结果于2019年举行的欧洲肿瘤内科学会（ESMO）年会上以口头报告的形式公布（clinicaltrials.gov 注册号NCT02588170）。
中国胰腺神经内分泌瘤研究：2016年，和黄医药在中国启动了一项关键性III期注册研究SANET-p，入组患者为低级别或中级别晚期胰腺神经内分泌瘤患者。2020年1月，该IDMC评估中期分析已经成功达到PFS这一预设主要疗效终点并建议提前终止研究（clinicaltrials.gov 注册号NCT02589821）。和黄医药计划提交索凡替尼的第二个NDA，用于治疗晚期胰腺神经内分泌瘤，并计划于随后的学术会议上提交SANET-p 研究结果。
中国胆道癌研究：2019年3月，和黄医药启动了一项IIb/III期临床试验，旨在对比索凡替尼和卡培他滨治疗一线化疗失败晚期胆道癌患者的疗效和安全性。该研究的主要终点为总生存率（OS）（clinicaltrials.gov 注册号NCT03873532）。
免疫联合疗法：2018年11月及2019年9月，和黄医药达成了数个合作协议，以评估索凡替尼联合PD-1单克隆抗体的安全性、耐受性和疗效。其中包括与上海君实生物医药科技股份有限公司在全球共同开发索凡替尼与拓益®联合疗法的合作协议，及与信达生物制药在全球共同开发达伯舒®联合疗法的合作协议。拓益®及达伯舒®均已在中国获批。
和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克 / 伦敦证交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。欲了解更多详情，请访问：www.chi-med.com。
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对索凡替尼用于治疗神经内分泌瘤患者的治疗潜力的预期、索凡替尼针对此适应症及其他适应症的进一步临床研究计划、对此类研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持索凡替尼获批用于在中国治疗胰腺或非胰腺神经内分泌瘤的新药上市申请的数据充足性、在美国、欧洲和日本等其他地区获得快速审批的潜力、索凡替尼的安全性、索凡替尼成为治疗胰腺或非胰腺神经内分泌瘤患者治疗新标准的潜力、实现及完成索凡替尼进一步临床开发计划的能力、在中国或其他地区推出上市的可能性及上市时间等。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本公告发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会和AIM提交的文件。无论是否出现新信息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含信息的义务。
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| 李健鸿，资深副总裁 | +852 2121 8200 |
| 郑嘉惠，副总裁 | +1 (973) 567 3786 |
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| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 （手机） / +44 7779 545 055（手机） Chi-Med@fticonsulting.com |
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| 卢志伦, 博然思维集团 | +852 9850 5033（手机） jlo@brunswickgroup.com |
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| Freddie Crossley / Andrew Potts, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
London: Tuesday, April 21, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) announces that on April 20, 2020, in accordance with the new incentive policy outlined in its full year results announcement on March 3, 2020, it granted conditional awards (“LTIP Awards”) under the Long Term Incentive Plan (“LTIP”) adopted by Chi-Med at its Annual General Meeting in 2015 and share options under the Share Option Scheme conditionally adopted by Chi-Med at its Annual General Meeting in 2015 (the “2015 HCML Share Option Scheme”).
In 2019, Chi-Med had conducted a comprehensive review of its compensation and share-based incentives policies, which included benchmarking research on peer group U.S. and China biotech companies. The Company has established a new competitive policy to ensure that it is able to attract and retain top talent.
A. Long Term Incentive Plan
The LTIP Awards grant participating directors, persons discharging managerial responsibilities (“PDMRs”) or employees a conditional right to a cash amount which is used to purchase shares in Chi-Med (“Shares”), on-market by an independent third party trustee (“Trustee”).
Two different types of LTIP Awards have been granted, namely:
1. Performance-related LTIP Award for the Chi-Med Financial Year 2020 (“Performance LTIP”) – award based on a maximum cash amount, which amount is determined by the achievement of performance targets for the financial year ending 31 December 2020. The performance targets will be determined by the Remuneration Committee of Chi-Med based on the strategic objectives of Chi-Med.
The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of performance targets, will then be held by the Trustee until the underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of Chi-Med for the financial year ending December 31, 2022. Vesting will also depend upon the continued employment of the award holder with the Chi-Med group and will otherwise be at the discretion of the Board of Directors of Chi-Med.
Chi-Med has granted the following LTIP Awards for the Performance LTIP to the following PDMRs:
| Award Holder | Maximum amount for the Performance LTIP | |
| Mr Christian Hogg (Executive Director and Chief Executive Officer) | US$1,580,193 | |
| Mr Johnny Cheng (Executive Director and Chief Financial Officer) | US$640,443 | |
| Dr Weiguo Su (Executive Vice President and Chief Scientific Officer) | US$1,407,120 |
An additional 331 employees of Chi-Med and its subsidiaries have simultaneously been granted LTIP Awards under the Performance LTIP.
2. Non-performance LTIP Award (“Non-performance LTIP”) – a one-off cash amount is granted to each grantee and will be used by the Trustee to purchase Shares which will be subject to a vesting period of four years. Chi-Med has granted the following Non-performance LTIP to the following PDMRs:
| Award Holder | Cash amount for the Non-performance LTIP | |
| Mr Simon To (Executive Director) | US$200,000 | |
| Dr Dan Eldar (Non-executive Director (“NED”)) | US$200,000 | |
| Ms Edith Shih (NED) | US$200,000 | |
| Mr Paul Carter (Independent Non-executive Director (“INED”)) | US$200,000 | |
| Dr Karen Ferrante (INED) | US$200,000 | |
| Mr Graeme Jack (INED) | US$200,000 | |
| Professor Tony Mok (INED) | US$200,000 |
The cash amount will be used by the Trustee to buy Shares which will be held by the Trustee until the underlying Non-performance LTIP Awards are vested. 25% of the Shares bought by the Trustee will vest on each anniversary of the grant of the Non-performance LTIP Awards for the next four years.
An additional two employees of Chi-Med and its subsidiaries have simultaneously been granted the Non-performance LTIP.
Further announcements will be made in due course at the time the Performance Awards and Non-performance Awards are vested, when the number of the Shares to which each Director and PDMR is entitled will be known. The above Directors and PDMRs additionally have the right to elect on acceptance of the grant of their awards to have part of their awards held (on behalf of the Director/PDMR by the trustee administering the LTIP) pending vesting in the form of cash in order to satisfy any tax liability in respect of their awards.
B. Share Option Scheme
Chi-Med granted a total of 2,855,000 share options under its 2015 HCML Share Option Scheme to eight senior employees to subscribe for Ordinary Shares subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:
| Date of grant | : | April 20, 2020 |
| Exercise price of share options granted | : | GBP3.34 per Ordinary Share |
| Number of share options granted | : | 2,855,000 (each share option shall entitle the holder thereof to subscribe for one Ordinary Share) |
| Closing market price of Ordinary Shares on the date of grant | : |
GBP3.34 per Ordinary Share
|
| Validity period of the share options | : | From April 20, 2020 to April 19, 2030 |
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.
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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+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
伦敦：2020年4月17日，星期五：和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克/伦敦证交所：HCM）今天宣布，美国食品药品监督管理局（“FDA”）已授予索凡替尼两项快速通道资格，用于治疗不适合手术的晚期和进展性胰腺和非胰腺神经内分泌瘤（“NET”）。
美国FDA快速通道资格旨在加速针对严重疾病的药物开发和审批，以解决未获满足的医疗需求。获得快速通道资格的新药可能是针对特定严重疾病的首个疗法，或与现有疗法相比在临床上具有显着优势。除此之外，这类新药有可能拥有独特的作用机制，或者可令对现有疗法效果不佳或不耐受的患者获益，从而解决未满足的医疗需求。获得快速通道资格的项目可以在药物开发计划上与美国FDA进行更频繁的互动，并获取加速审批、优先审评和滚动审评资格。1
索凡替尼（surufatinib）是由和黄医药自主研发的一种新型的口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。索凡替尼可通过抑制血管内皮生长因子受体（VEGFR）和成纤维细胞生长因子受体（FGFR）以阻断肿瘤血管生成，并可抑制集落刺激因子-1受体（CSF-1R），通过调节肿瘤相关巨噬细胞，促进机体对肿瘤细胞的免疫应答。因为具有抗肿瘤血管生成和免疫调节的双重机制，索凡替尼可能非常适合与其他免疫疗法联合使用。
和黄医药目前拥有索凡替尼在全球范围内的所有权利。
美国、欧洲与日本神经内分泌瘤研究：由于索凡替尼以神经内分泌瘤为适应症的两项III期中国临床试验数据令人鼓舞，且美国Ib期临床试验进展顺利 （clinicaltrials.gov 注册号NCT02549937），和黄医药正与美国、欧洲和日本的监管部门进行沟通以确定索凡替尼的临床开发和注册路径。除了上述被授予的两项快速通道资格，索凡替尼亦于2019年11月被FDA授予“孤儿药”资格认证，用于治疗胰腺神经内分泌瘤 。
中国非胰腺神经内分泌瘤研究：2019年11月，国家药监局受理了索凡替尼用于治疗非胰腺神经内分泌瘤的新药上市申请，并于2019年12月纳入优先审评。该新药上市申请获成功的SANET-ep研究数据支持。SANET-ep是一项关于索凡替尼以晚期非胰腺神经内分泌瘤为适应症的中国III 期临床试验，而这些患者目前尚无有效治疗方法。2019年6月，该研究独立数据监察委员会（IDMC）评估认为，共198名患者参与的中期分析成功达到无进展生存期（“PFS”）这一预设主要疗效终点并提前终止研究。该项研究的积极结果于2019年举行的欧洲肿瘤内科学会（ESMO）年会上以口头报告的形式公布（clinicaltrials.gov 注册号NCT02588170）。
中国胰腺神经内分泌瘤研究：2016年，和黄医药在中国启动了一项关键性III期注册研究SANET-p，入组患者为低级别或中级别晚期胰腺神经内分泌瘤患者。2020年1月，该研究独立数据监察委员会（IDMC）评估中期分析已经成功达到PFS这一预设主要疗效终点并建议提前终止研究（clinicaltrials.gov 注册号NCT02589821）。和黄医药计划提交索凡替尼的第二个新药上市申请（NDA），用于治疗晚期胰腺神经内分泌瘤，并计划于随后的学术会议上提交SANET-p 研究结果。
中国胆道癌研究：2019年3月，和黄医药启动了一项IIb/III期临床试验，旨在对比索凡替尼和卡培他滨治疗一线化疗失败晚期胆道癌患者的疗效和安全性。该研究的主要终点为总生存率（OS）（clinicaltrials.gov 注册号NCT03873532）。
免疫联合疗法：2018年11月及2019年9月，和黄医药达成了数个合作协议，以评估索凡替尼联合PD-1单克隆抗体的安全性、耐受性和疗效。其中包括与上海君实生物医药科技股份有限公司在全球共同开发索凡替尼与拓益联合疗法的合作协议，及与信达生物制药在全球共同开发达伯舒联合疗法的合作协议。拓益及达伯舒均已在中国获批。
神经内分泌瘤（NET）起源于与神经系统相互作用的细胞或产生激素的腺体。神经内分泌瘤可起源于体内很多部位，最常见于消化道或肺部，可为良性或恶性肿瘤。按照起源，神经内分泌瘤通常分为胰腺神经内分泌瘤和非胰腺神经内分泌瘤。获批的靶向治疗包括索坦®（苹果酸舒尼替尼）和飞尼妥®（依维莫司），用于治疗胰腺神经内分泌瘤或高度分化的非功能性胃肠道或肺神经内分泌瘤。
据Frost & Sullivan公司估计，2018年美国神经内分泌瘤新诊断病例为19,000例。值得关注的是，与其他肿瘤相比，神经内分泌瘤患者的生存期相对较长，因此，虽然神经内分泌瘤发病率相对不高，但患者人群相对较大。此外，据估计2018年美国神经内分泌瘤患者约141,000名，其中约有超九成，即132,000名患者，为非胰腺神经内分泌瘤患者。
在中国，2018年约有67,600例神经内分泌瘤新诊断病例。按照中国的发病率与流行率比例（incidence to prevalence ratio）估算，中国总共或有高达300,000名神经内分泌瘤患者2 。据估计在中国患有神经内分泌瘤的患者中约有八成是非胰腺神经内分泌瘤患者。
和黄中国医药科技有限公司（简称“和黄医药”或“Chi-Med”）（纳斯达克 / 伦敦证交所: HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。欲了解更多详情，请访问：www.chi-med.com。
本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对索凡替尼用于治疗神经内分泌瘤患者的治疗潜力的预期、索凡替尼针对此适应症及其他适应症的进一步临床研究计划、对此类研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持索凡替尼获批用于在中国治疗胰腺或非胰腺神经内分泌瘤的新药上市申请的数据充足性、在美国、欧洲和日本等其他地区获得快速审批的潜力、索凡替尼的安全性、索凡替尼成为治疗胰腺或非胰腺神经内分泌瘤患者治疗新标准的潜力、实现及完成索凡替尼进一步临床开发计划的能力、在中国或其他地区推出上市的可能性及上市时间等。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本公告发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会和AIM提交的文件。无论是否出现新信息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含信息的义务。
投资者咨询 |
|
| 李健鸿，资深副总裁 | +852 2121 8200 |
| 郑嘉惠，副总裁 | +1 (973) 567 3786 |
媒体咨询 |
|
| 美洲 — | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340（手机） bmiles@troutgroup.com |
| 英国及欧洲 – | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 （手机） / +44 7779 545 055（手机） Chi-Med@fticonsulting.com |
| 亚洲 | |
| 卢志伦, 博然思维集团 | +852 9850 5033（手机） jlo@brunswickgroup.com |
| 周怡, 博然思维集团 | +852 9783 6894（手机） yzhou@brunswickgroup.com |
任命保荐人 |
|
| Freddie Crossley / Andrew Potts, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |