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. |
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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
| 標題： | 索凡替尼在中美患者中的藥代動力學特征及安全性比較 |
| 報告人： | 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. |
| 報告環節： | VPO.CT01 |
| 報告編號： | CT115 |
| 鏈接地址： | 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.
| 標題： | 關於索凡替尼聯合特瑞普利單抗治療晚期實體瘤患者的I期臨床研究 |
| 報告人： | 曹彥碩 |
| 作者： | 陸明1, 曹彥碩1, 龔繼芳1, 孫宇2, 李潔1, 沈琳1.
1北京大學腫瘤醫院惡性腫瘤發病機制及轉化研究教育部重點實驗室，消化道腫瘤科； 2北京大學腫瘤醫院惡性腫瘤發病機制及轉化研究教育部重點實驗室，病理科 |
| 報告環節： | VPO.CT01 |
| 報告編號： | CT142 |
| 報告編號： | 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
倫敦：2020年4月22日，星期三：和黃中國醫藥科技有限公司（簡稱「和黃醫藥」或「Chi-Med」 ）（納斯達克/倫敦證交所：HCM）今日宣佈將於2020年4月27日召開的美國癌症研究協會（AACR）網上年會（一）上公佈正在進行的索凡替尼研究的最新分析與更新後的分析結果。
報告詳情如下：
| 標題： | 關於索凡替尼聯合特瑞普利單抗治療晚期實體瘤患者的I期臨床研究 |
| 報告人： | 曹彥碩 |
| 作者： | 陸明1, 曹彥碩1, 龔繼芳1, 孫宇2, 李潔1, 沈琳1.
1北京大學腫瘤醫院惡性腫瘤發病機制及轉化研究教育部重點實驗室，消化道腫瘤科； 2北京大學腫瘤醫院惡性腫瘤發病機制及轉化研究教育部重點實驗室，病理科 |
| 報告環節： | VPO.CT01 |
| 報告編號： | CT142 |
| 鏈接地址： | 查看摘要 | 下載演示文稿 |
| 標題： | 索凡替尼在中美患者中的藥代動力學特征及安全性比較 |
| 報告人： | 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. |
| 報告環節： | VPO.CT01 |
| 報告編號： | CT115 |
| 鏈接地址： | 查看摘要 | 下載演示文稿 |
索凡替尼（surufatinib）是由和黃醫藥自主研發的一種新型的口服酪氨酸激酶抑製劑，具有抗血管生成和免疫調節雙重活性。索凡替尼可通過抑制血管內皮生長因子受體（VEGFR）和成纖維細胞生長因子受體（FGFR）以阻斷腫瘤血管生成，並可抑制集落刺激因子-1受體（CSF-1R），通過調節腫瘤相關巨噬細胞，促進機體對腫瘤細胞的免疫應答。因為具有抗腫瘤血管生成和免疫調節的雙重機制，索凡替尼可能非常適合與其他免疫療法聯合使用。
和黃醫藥目前擁有索凡替尼在全球範圍內的所有權利。
美國、歐洲與日本神經內分泌瘤研究：由於索凡替尼以神經內分泌瘤為適應症的兩項III期中國臨床試驗數據令人鼓舞，且美國Ib期臨床試驗進展順利（clinicaltrials.gov 註冊號NCT02549937 ），和黃醫藥正與美國、歐洲和日本的監管部門進行溝通，以確定索凡替尼的臨床開發和註冊路徑。在美國，索凡替尼於2020年4月被授予快速通道資格，用於治療胰腺和非胰腺神經內分泌瘤，並於2019年11月被授予「孤兒藥」資格認證，用於治療胰腺神經內分泌瘤。
中國非胰腺神經內分泌瘤研究：2019年11月，國家藥監局受理了索凡替尼用於治療非胰腺神經內分泌瘤的新藥上市申請（「NDA」），並於2019年12月納入優先審評。該NDA獲成功的SANET-ep研究數據支持。 SANET-ep是一項關於索凡替尼以晚期非胰腺神經內分泌瘤為適應症的中國III 期臨床試驗，而這些患者目前尚無有效治療方法。 2019年6月，該研究獨立數據監察委員會（「IDMC」）評估認為，共198名患者參與的中期分析成功達到無進展生存期（「PFS」）這一預設主要療效終點並提前終止研究。該項研究的積極結果於2019年舉行的歐洲腫瘤內科學會（ESMO）年會上以口頭報告的形式公佈（clinicaltrials.gov 註冊號NCT02588170）。
中國胰腺神經內分泌瘤研究：2016年，和黃醫藥在中國啟動了一項關鍵性III期註冊研究SANET-p，入組患者為低級別或中級別晚期胰腺神經內分泌瘤患者。 2020年1月，該IDMC評估中期分析已經成功達到PFS這一預設主要療效終點並建議提前終止研究（clinicaltrials.gov 註冊號NCT02589821）。和黃醫藥計劃提交索凡替尼的第二個NDA，用於治療晚期胰腺神經內分泌瘤，併計劃於隨後的學術會議上提交SANET-p 研究結果。
中國膽道癌研究：2019年3月，和黃醫藥啟動了一項IIb/III期臨床試驗，旨在對比索凡替尼和卡培他濱治療一線化療失敗晚期膽道癌患者的療效和安全性。該研究的主要終點為總生存率（OS）（clinicaltrials.gov 註冊號NCT03873532）。
免疫聯合療法：2018年11月及2019年9月，和黃醫藥達成了數個合作協議，以評估索凡替尼聯合PD-1單克隆抗體的安全性、耐受性和療效。其中包括與上海君實生物醫藥科技股份有限公司在全球共同開發索凡替尼與拓益®聯合療法的合作協議，及與信達生物製藥在全球共同開發達伯舒®聯合療法的合作協議。拓益®及達伯舒®均已在中國獲批。
和黃中國醫藥科技有限公司（簡稱「和黃醫藥」或「Chi-Med」）（納斯達克/ 倫敦證交所：HCM）是一家創新型生物醫藥公司，在過去20年間致力於發現和全球開發治療癌症和自身免疫性疾病的靶向藥物和免疫療法。目前，和黃醫藥共有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。
本新聞稿包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對索凡替尼用於治療神經內分泌瘤患者的治療潛力的預期、索凡替尼針對此適應症及其他適應症的進一步臨床研究計劃、對此類研究是否能達到其主要或次要終點的預期，以及對此類研究完成時間和結果發佈的預期。前瞻性陳述涉及風險和不確定性。此類風險和不確定性包括下列假設：支持索凡替尼獲批用於在中國治療胰腺或非胰腺神經內分泌瘤的新藥上市申請的數據充足性、在美國、歐洲和日本等其他地區獲得快速審批的潛力、索凡替尼的安全性、索凡替尼成為治療胰腺或非胰腺神經內分泌瘤患者治療新標準的潛力、實現及完成索凡替尼進一步臨床開發計劃的能力、在中國或其他地區推出上市的可能性及上市時間等。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本公告發佈當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會和AIM提交的文件。無論是否出現新信息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本新聞稿所含信息的義務。
投資者諮詢 |
|
| 李健鴻，資深副總裁 | +852 2121 8200 |
| 鄭嘉惠，副總裁 | +1 (973) 567 3786 |
媒體諮詢 |
|
| 美洲 | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340（手機） bmiles@troutgroup.com |
| 英國及歐洲 | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 （手機） / +44 7779 545 055（手機） Chi-Med@fticonsulting.com |
| 亞洲 | |
| 盧志倫, 博然思維集團 | +852 9850 5033（手機） jlo@brunswickgroup.com |
| 周怡, 博然思維集團 | +852 9783 6894（手機） yzhou@brunswickgroup.com |
任命保薦人 |
|
| Freddie 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
倫敦：2020年4月17日，星期五：和黃中國醫藥科技有限公司（簡稱「和黃醫藥」或「Chi-Med」）（納斯達克/倫敦證交所：HCM）今天宣佈，美國食品藥品監督管理局（「FDA」）已授予索凡替尼兩項快速通道資格，用於治療不適合手術的晚期和進展性胰腺和非胰腺神經內分泌瘤（「NET」）。
美國FDA快速通道資格旨在加速針對嚴重疾病的藥物開發和審批，以解決未獲滿足的醫療需求。獲得快速通道資格的新藥可能是針對特定嚴重疾病的首個療法，或與現有療法相比在臨床上具有顯著優勢。除此之外，這類新藥有可能擁有獨特的作用機制，或者可令對現有療法效果不佳或不耐受的患者獲益，從而解決未滿足的醫療需求。獲得快速通道資格的項目可以在藥物開發計劃上與美國FDA進行更頻繁的互動，並獲取加速審批、優先審評和滾動審評資格。[1]
索凡替尼（surufatinib）是由和黃醫藥自主研發的一種新型的口服酪氨酸激酶抑製劑，具有抗血管生成和免疫調節雙重活性。索凡替尼可通過抑制血管內皮生長因子受體（VEGFR）和成纖維細胞生長因子受體（FGFR）以阻斷腫瘤血管生成，並可抑制集落刺激因子-1受體（CSF-1R），通過調節腫瘤相關巨噬細胞，促進機體對腫瘤細胞的免疫應答。因為具有抗腫瘤血管生成和免疫調節的雙重機制，索凡替尼可能非常適合與其他免疫療法聯合使用。
和黃醫藥目前擁有索凡替尼在全球範圍內的所有權利。
美國、歐洲與日本神經內分泌瘤研究：由於索凡替尼以神經內分泌瘤為適應症的兩項III期中國臨床試驗數據令人鼓舞，且美國Ib期臨床試驗進展順利（clinicaltrials.gov 註冊號NCT02549937 ），和黃醫藥正與美國、歐洲和日本的監管部門進行溝通以確定索凡替尼的臨床開發和註冊路徑。除了上述被授予的兩項快速通道資格，索凡替尼亦於2019年11月被FDA授予「孤兒藥」資格認證，用於治療胰腺神經內分泌瘤。
中國非胰腺神經內分泌瘤研究：2019年11月，國家藥監局受理了索凡替尼用於治療非胰腺神經內分泌瘤的新藥上市申請，並於2019年12月納入優先審評。該新藥上市申請獲成功的SANET-ep研究數據支持。 SANET-ep是一項關於索凡替尼以晚期非胰腺神經內分泌瘤為適應症的中國III 期臨床試驗，而這些患者目前尚無有效治療方法。 2019年6月，該研究獨立數據監察委員會（IDMC）評估認為，共198名患者參與的中期分析成功達到無進展生存期（「PFS」）這一預設主要療效終點並提前終止研究。該項研究的積極結果於2019年舉行的歐洲腫瘤內科學會（ESMO）年會上以口頭報告的形式公佈（clinicaltrials.gov 註冊號NCT02588170）。
中國胰腺神經內分泌瘤研究：2016年，和黃醫藥在中國啟動了一項關鍵性III期註冊研究SANET-p，入組患者為低級別或中級別晚期胰腺神經內分泌瘤患者。 2020年1月，該研究獨立數據監察委員會（IDMC）評估中期分析已經成功達到PFS這一預設主要療效終點並建議提前終止研究（clinicaltrials.gov 註冊號NCT02589821）。和黃醫藥計劃提交索凡替尼的第二個新藥上市申請（NDA），用於治療晚期胰腺神經內分泌瘤，併計劃於隨後的學術會議上提交SANET-p 研究結果。
中國膽道癌研究：2019年3月，和黃醫藥啟動了一項IIb/III期臨床試驗，旨在對比索凡替尼和卡培他濱治療一線化療失敗晚期膽道癌患者的療效和安全性。該研究的主要終點為總生存率（OS）（clinicaltrials.gov 註冊號NCT03873532）。
免疫聯合療法：2018年11月及2019年9月，和黃醫藥達成了數個合作協議，以評估索凡替尼聯合PD-1單克隆抗體的安全性、耐受性和療效。其中包括與上海君實生物醫藥科技股份有限公司在全球共同開發索凡替尼與拓益®聯合療法的合作協議，及與信達生物製藥在全球共同開發達伯舒®聯合療法的合作協議。拓益®及達伯舒®均已在中國獲批。
神經內分泌瘤（NET）起源於與神經系統相互作用的細胞或產生激素的腺體。神經內分泌瘤可起源於體內很多部位，最常見於消化道或肺部，可為良性或惡性腫瘤。按照起源，神經內分泌瘤通常分為胰腺神經內分泌瘤和非胰腺神經內分泌瘤。獲批的靶向治療包括索坦®（蘋果酸舒尼替尼）和飛尼妥®（依維莫司），用於治療胰腺神經內分泌瘤或高度分化的非功能性胃腸道或肺神經內分泌瘤。
據Frost & Sullivan公司估計，2018年美國神經內分泌瘤新診斷病例為19,000例。值得關注的是，與其他腫瘤相比，神經內分泌瘤患者的生存期相對較長，因此，雖然神經內分泌瘤發病率相對不高，但患者人群相對較大。此外，據估計2018年美國神經內分泌瘤患者約141,000名，其中約有超九成，即132,000名患者，為非胰腺神經內分泌瘤患者。
在中國，2018年約有67,600例神經內分泌瘤新診斷病例。按照中國的發病率與流行率比例（incidence to prevalence ratio）估算，中國總共或有高達300,000名神經內分泌瘤患者2 。據估計在中國患有神經內分泌瘤的患者中約有八成是非胰腺神經內分泌瘤患者。
和黃中國醫藥科技有限公司（簡稱「和黃醫藥」或「Chi-Med」）（納斯達克/ 倫敦證交所: HCM）是一家創新型生物醫藥公司，在過去20年間致力於發現和全球開發治療癌症和自身免疫性疾病的靶向藥物和免疫療法。目前，和黃醫藥共有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。
本新聞稿包含1995年《美國私人證券訴訟改革法案》「安全港」條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對索凡替尼用於治療神經內分泌瘤患者的治療潛力的預期、索凡替尼針對此適應症及其他適應症的進一步臨床研究計劃、對此類研究是否能達到其主要或次要終點的預期，以及對此類研究完成時間和結果發佈的預期。前瞻性陳述涉及風險和不確定性。此類風險和不確定性包括下列假設：支持索凡替尼獲批用於在中國治療胰腺或非胰腺神經內分泌瘤的新藥上市申請的數據充足性、在美國、歐洲和日本等其他地區獲得快速審批的潛力、索凡替尼的安全性、索凡替尼成為治療胰腺或非胰腺神經內分泌瘤患者治療新標準的潛力、實現及完成索凡替尼進一步臨床開發計劃的能力、在中國或其他地區推出上市的可能性及上市時間等。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本公告發佈當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會和AIM提交的文件。無論是否出現新信息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本新聞稿所含信息的義務。
投資者諮詢 |
|
| 李健鴻，資深副總裁 | +852 2121 8200 |
| 鄭嘉惠，副總裁 | +1 (973) 567 3786 |
媒體諮詢 |
|
| 美洲 — | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340（手機） bmiles@troutgroup.com |
| 英國及歐洲 – | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 （手機） / +44 7779 545 055（手機） Chi-Med@fticonsulting.com |
| 亞洲 | |
| 盧志倫, 博然思維集團 | +852 9850 5033（手機） jlo@brunswickgroup.com |
| 周怡, 博然思維集團 | +852 9783 6894（手機） yzhou@brunswickgroup.com |
任命保薦人 |
|
| Freddie Crossley / Andrew Potts, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
倫敦：2020年3月31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）啟動了一項HMPL-453治療晚期惡性間皮瘤患者的II期臨床試驗。 HMPL-453是一種靶向成纖維細胞生長因子受體（「FGFR」）的新型小分子抑製劑。
該研究是一項單臂、多中心、開放標籤的臨床試驗，旨在評估HMPL-453在至少經過一線全身性治療失敗後的晚期惡性間皮瘤患者中的療效、安全性和藥代動力學特性。
該研究的主要結果指標為客觀緩解率（ORR）。次要結果指標包括初步療效，例如疾病控制率（DCR）、到達疾病緩解的時間（TTR）、緩解持續時間（DoR）、無進展生存期（PFS）和總生存期（OS）。該研究的主要研究者為上海交通大學附屬胸科醫院的陸舜教授。該項研究的其他詳情可登錄clinicaltrials.gov，檢索NCT04290325查閱。
FGFR是受體酪氨酸激酶的亞族之一。 FGFR信號通路的激活是數個生物過程的關鍵。正常生理情況下，FGF/FGF信號通路參與胚胎髮育（器官發生和形態發生）、組織修復、血管生成、神經內分泌和代謝平衡。鑑於其在許多重要生理過程中的複雜性和關鍵作用，已發現異常的FGFR信號傳導是腫瘤生長、促進血管生成以及抗腫瘤治療抗性產生的誘因。
HMPL 453是一種新型、強效且高選擇性的小分子成纖維細胞生長因子受體（FGFR） 1、2和3抑製劑。在臨床前研究中， HMPL 453較同類其他藥物相比表現出更強的效力、更高的激酶選擇性及更佳的安全性。在中國進行的HMPL-453 I期臨床試驗的劑量遞增階段已完成患者招募，詳細內容請登錄clinicaltrials.gov，檢索NCT03160833查閱。
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，請訪問：www.chi-med.com。
投資者諮詢 |
|
| 李健鴻，資深副總裁 | +852 2121 8200 |
| 鄭嘉惠，副總裁 | +1 (973) 567 3786 |
| David Dible, Citigate Dewe Rogerson |
+44 7967 566 919 （手機）david.dible@citigatedewerogerson.com |
| Xuan Yang, Solebury Trout |
+1 (415) 971 9412（手機） xyang@troutgroup.com |
媒體諮詢 |
|
| 英國及歐洲 – | |
| Anthony Carlisle, Citigate Dewe Rogerson | +44 7973 611 888（手機） anthony.carlisle@cdrconsultancy.co.uk |
| 美洲 — | |
| Brad Miles, Solebury Trout | +1 (917) 570 7340（手機） bmiles@troutgroup.com |
| 亞洲 – | |
| 盧志倫, 博然思維集團 | +852 9850 5033（手機） jlo@brunswickgroup.com |
| 周怡, 博然思維集團 | +852 9783 6894（手機） yzhou@brunswickgroup.com |
任命保薦人 |
|
| Freddie Crossley / Andrew Potts, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |
本新聞稿包含1995年《美國私人證券訴訟改革法案》“安全港”條款中定義的前瞻性陳述。這些前瞻性陳述反映了和黃醫藥目前對未來事件的預期，包括對HMPL-453臨床開發的預期、啟動HMPL-453進一步臨床研究計劃、對此類研究是否能達到其主要或次要終點的預期，以及對此類研究完成時間和結果發布的預期。前瞻性陳述涉及風險和不確定性。此類風險和不確定性包括下列假設：入組率、滿足研究入选和排除標準的受試者的時間和可用性、臨床方案或監管要求變更、非預期不良事件或安全性問題、候選藥物HMPL- 453達到研究的主要或次要終點的療效、獲得不同司法管轄區的監管批准、獲得監管批准後獲得上市許可、HMPL-453用於目標適應症的潛在市場和資金充足性等。當前和潛在投資者請勿過度依賴這些前瞻性陳述，這些陳述僅在截至本新聞稿發布當日有效。有關這些風險和其他風險的進一步討論，請查閱和黃醫藥向美國證券交易委員會和AIM提交的文件。無論是否出現新信息、未來事件或情況或其他因素，和黃醫藥均不承擔更新或修訂本新聞稿所含信息的義務。