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 |
||||||
| 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. |
||||||
| 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
| Title: | Comparison of Pharmacokinetic Profiles and Safety of Surufatinib in Patients from China and the United States |
| Presenter: | Arvind Dasari |
| Authors: |
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. |
| Session: | VPO.CT01 |
| Number: | CT115 |
| Link: | View Abstract |
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.
| Title: | A Phase I Trial of Surufatinib Plus Toripalimab in Patients with Advanced Solid Tumors |
| Presenter: | Yanshuo Cao |
| Authors: |
M Lu1, Y Cao1, J Gong1, Y Sun2, J Li1, L Shen1. 1 Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China; 2 Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China |
| Session: | VPO.CT01 |
| Number: | CT142 |
| Link: | View Abstract |
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
London: Wednesday, April 22, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that new and updated analyses on the ongoing studies of surufatinib will be presented at the upcoming American Association for Cancer Research (AACR) Virtual Annual Meeting I, taking place on April 27, 2020.
Further details of the presentations are as follows:
| Title: | A Phase I Trial of Surufatinib Plus Toripalimab in Patients with Advanced Solid Tumors |
| Presenter: | Yanshuo Cao |
| Authors: |
M Lu1, Y Cao1, J Gong1, Y Sun2, J Li1, L Shen1. 1 Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China; 2 Department of Pathology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China |
| Session: | VPO.CT01 |
| Number: | CT142 |
| Link: | View Abstract | Download Presentation |
| Title: | Comparison of Pharmacokinetic Profiles and Safety of Surufatinib in Patients from China and the United States |
| Presenter: | Arvind Dasari |
| Authors: |
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. |
| Session: | VPO.CT01 |
| Number: | CT115 |
| Link: | View Abstract | Download Presentation |
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
Chi-Med currently retains all rights to surufatinib worldwide.
Neuroendocrine tumors (“NET”) in the U.S., Europe and Japan: We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration, based on the encouraging data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019.
Non-pancreatic neuroendocrine tumors in China: In November 2019, a New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee (“IDMC”) to determine that the study met the pre-defined primary endpoint of progression-free survival (“PFS”) and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).
Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended that registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).
Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi®, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt®, approved in China by Innovent Biologics, Inc.
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 press release 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 reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development of surufatinib in this and other indications, its expectations as to whether clinical studies of surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support NDA approval of surufatinib for the treatment of patients with NET in China, its potential to gain expeditious approvals for surufatinib in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of surufatinib, the potential for surufatinib to become a new standard of care for NET patients, its ability to implement and complete its further clinical development plans for surufatinib, its potential commercial launch of surufatinib in China and other jurisdictions and the timing of these events. 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 press release, 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
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
London: Friday, April 17, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted two Fast Track Designations for the development of surufatinib, for the treatment of both advanced and progressive pancreatic neuroendocrine tumors (“NET”) and extra-pancreatic (non-pancreatic) NET in patients who are not amenable for surgery.
The FDA Fast Track Designation is one of several approaches utilized by the U.S. FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the U.S. FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.[1]
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (“VEGFR”) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
Chi-Med currently retains all rights to surufatinib worldwide.
Neuroendocrine tumors in the U.S., Europe and Japan: We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration, based on the encouraging data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In addition to the aforementioned grants of Fast Track Designation in pancreatic and non-pancreatic NET in the U.S., surufatinib was granted Orphan Drug Designation for pancreatic NET in November 2019.
Non-pancreatic neuroendocrine tumors in China: In November 2019, an NDA for surufatinib for the treatment of patients with advanced extra-pancreatic (non-pancreatic) neuroendocrine tumors was accepted for review by the China NMPA and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee (“IDMC”) to determine that the study met the pre-defined primary endpoint of progression-free survival (“PFS”) and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).
Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended that registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).
Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi®, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt®, approved in China by Innovent Biologics, Inc.
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. Approved targeted therapies include Sutent® and Afinitor® for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.
According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.
In China, there were approximately 67,600 newly diagnosed neuroendocrine tumor patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country[2]. It is estimated that approximately 80% of the patients living with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor patients.
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 press release 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 reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development of surufatinib in this and other indications, its expectations as to whether clinical studies of surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support NDA approval of surufatinib for the treatment of patients with NET in China, its potential to gain expeditious approvals for surufatinib in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of surufatinib, the potential for surufatinib to become a new standard of care for NET patients, its ability to implement and complete its further clinical development plans for surufatinib, its potential commercial launch of surufatinib in China and other jurisdictions and the timing of these events. 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 press release, 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