- Hutchmed
- | 公告及新聞稿
London: Friday, June 30, 2017: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at June 30, 2017, the issued share capital of Chi-Med consisted of 60,737,204 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 60,737,204 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.
For illustrative purposes only, the 60,737,204 ordinary shares would be equivalent to 60,737,204 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 121,474,408 American depositary shares (each equating to one-half of one ordinary share) which are traded on Nasdaq.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
| 阿斯利康製藥（“阿斯利康”） (LON/STO/NYSE: AZN) |
和黃中國醫藥科技有限公司 （簡稱 “和黃醫藥”） |
2017 年6 月29 日：和黃醫藥今日宣布將與阿斯利康聯手啟動沃利替尼治療c-MET 異常乳頭狀腎細胞癌的開放標籤隨機多中心全球III 期關鍵性註冊臨床試驗，沃利替尼是一種高選擇性口服c-Met（也被稱作間充質上皮轉移因子）受體酪氨酸激酶抑製劑。這是首個以c-MET 異常乳頭狀腎細胞癌為適應症的關鍵性研究，也是首個以腎細胞癌為適應症以生物標誌物篩選患者的臨床試驗。
和黃中國醫藥科技有限公司首席執行官賀雋表示：“ SAVOIR試驗旨在為藥品在美國和歐洲的產品註冊提供支持，該試驗的啟動將進一步推動我們向全球主要市場提供創新藥品的策略。”基於II期臨床研究的數據，我們相信沃利替尼有潛力為c-MET異常表達的乳頭狀腎細胞癌患者帶來有意義的臨床獲益。也希望通過使用我們最新研發的同伴診斷分析方法，通過流行病學分析進一步解析c-MET突變與患者的治療效果之間的關係。
阿斯利康腫瘤創新藥物部負責人，資深副總裁Susan Galbraith表示：“我們非常高興看到沃利替尼研發進程中這一里程碑式的進展。早期研究數據十分鼓舞人心，沃利替尼有潛力成為治療c-MET異常表達的各種癌症（包括腎癌，肺癌和胃癌）的一種重要方案。“
此次III期臨床試驗的順利啟動，根據和黃醫藥和阿斯利康2011年簽訂的授權合作協議（已修訂的），阿斯利康將向和黃醫藥支付500萬美元的里程碑付款。
除了SAVOIR，合作雙方正以腎癌，肺癌和胃癌為適應症進行一系列Ib 期和II期臨床研究。這些研究或以沃利替尼作為單一療法，或將其與其他靶向療法，例如Tagrisso ®（奧希替尼）或Iressa ®（吉非替尼）聯合進行治療。與Imfinzi ®（durvalumab ）及Taxotere ®（多西他賽）聯合進行治療的研究也正在進行中。
關於“ SAVOIR” 研究
SAVOIR是一項開放標籤隨機對照全球III期臨床試驗，旨在評估與舒尼替尼相比，沃利替尼治療c-MET異常且腫瘤不可切除的局部晚期或轉移性乳頭狀腎細胞癌患者的療效和安全性。約180名患者將在分佈於五至十個國家的50至75家研究中心接受隨機分組。通過專門為沃利替尼開發的新型靶向下一代測序法（NGS）驗證c-MET狀態。隨後患者將以1：1的比例隨機分組，或接受沃利替尼的持續治療，每日一次口服600 mg沃利替尼（400 mg，如果體重<50 kg），或接受舒尼替尼的間歇性治療，每日一次口服舒尼替尼50 mg（服藥4週/停藥2週），6週為一個治療週期。
該研究的主要目標是評估沃利替尼與舒尼替尼相比的主要療效終點無進展生存期（“PFS”），次要終點包括總生存期，客觀緩解率（“ORR”），緩解持續時間，腫瘤大小的最佳百分比變化，疾病控制率以及安全性和耐受性。也將評估沃利替尼與舒尼替尼相比對疾病症狀和生活質量的影響以及沃利替尼的藥代動力學特性。該研究詳情可登陸clinicaltrials.gov，檢索NCT03091192 查看。
關於沃利替尼
沃利替尼是一種高選擇性口服c-Met（也被稱作間充質上皮轉移因子）受體酪氨酸激酶抑製劑，研究發現這種酪氨酸激酶在多種實體瘤中表現異常。沃利替尼作為一種強效的高選擇性口服抑製劑，旨在克服第一代c-Met抑製劑在臨床研究中出現的問題，比如腎毒性。
根據此前的合作協議，沃利替尼由和黃醫藥和阿斯利康合作開發。目前，雙方正在全球展開沃利替尼以多種腫瘤類型為適應症的臨床研究，包括腎癌，肺癌和胃癌，沃利替尼作為單一療法或與其他靶向和免疫治療藥物聯合治療。
關於c-MET 異常乳頭狀腎細胞癌
每年全球新診斷的腎癌病例約為366,000例。腎細胞癌約佔全部腎癌的80-85%，且包括數種組織學亞型，其遺傳和生化特性各異。乳頭狀腎細胞癌是最常見的非透明細胞腎癌，約佔腎細胞癌的10-15%。根據數個實驗的歷史數據，c-Met異常乳頭狀腎細胞癌估計佔全部乳頭狀腎細胞癌的40-70% 。
目前還沒有專門用於治療乳頭狀腎細胞癌的藥品獲批，乳頭狀腎細胞癌患者正在使用以腎細胞癌為適應症的獲批藥品進行治療，例如舒尼替尼。這些腎細胞癌藥品的大部分研究是基於數量龐大的腎透明細胞癌患者，乳頭狀腎細胞癌患者的預後及治療效果明顯不及腎透明細胞癌患者。美國國家綜合癌症網絡指南現建議乳頭狀腎細胞癌患者參加臨床試驗。
沃利替尼治療乳頭狀腎細胞癌
2017年2月，沃利替尼治療晚期乳頭狀腎細胞癌的全球II期多中心臨床研究結果在2017年美國臨床腫瘤學會泌尿生殖道腫瘤研討會上公佈，結果顯示沃利替尼作為單藥治療c-MET異常的患者療效明確。c-MET異常組的中位無進展生存期為6.2個月，而c-MET正常的對照組為1.4個月（雙側p<0.0001）。c-MET異常組的客觀緩解率為18.2%，對照組則為0% （雙側p=0.002）。沃利替尼在治療受試者的過程中提供了持續有效的緩解並顯示出了良好的安全特性。
在c-MET異常的胃癌和肺癌中開展的研究表明，c-MET 擴增和/或過度表達可能是疾病進展的陰性預後。在2017年期間，和黃醫藥和阿斯利康也正在對大約300例乳頭狀腎細胞癌患者樣本進行全面的分子流行病學研究，以進一步解析c-MET突變與患者治療效果之間的相關性，包括預測性生物標誌物的關聯。
London: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | Hutchison China MediTech Limited |
| 2. | Name of scheme: | Hutchison China MediTech Limited Share Option Schemes |
| 3. | Period of return: | From December 29, 2016 to June 28, 2017 |
| 4. | Balance under scheme from previous return: | 1,361,308 ordinary shares of US$1 each |
| 5. | The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return: | Nil |
| 6. | Number of securities issued/allotted under scheme during period: | 31,381 ordinary shares of US$1 each |
| 7. | Balance under scheme not yet issued/allotted at end of the period: | 1,329,927 ordinary shares of US$1 each |
| 8. | Number and class of securities originally listed and the date of admission: | 2,560,606 ordinary shares of US$1 each admitted on June 26, 2007 |
| 9. | Total number of securities in issue at the end of the period: | 60,737,204 ordinary shares of US$1 each |
| Name of contact: | Christian Hogg | |
| Address of contact: | 21/F., Hutchison House, 10 Harcourt Road, Hong Kong | |
| Telephone number of contact: | +852 2121 8200 |
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) will be announcing its interim results for the six months ended June 30, 2017 on Monday, July 31, 2017 at 7:00 am British Summer Time (BST).
An analyst presentation will be held at 9:00 am BST (4:00 pm Hong Kong Time) on the same day at Panmure Gordon & Co, One New Change, London EC4M 9AF, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.
For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (2:00 pm BST).
Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Toni K. Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y.C. Heng, Thomas Powles, Melanie M. Frigault, Edwin A. Clark, Amir A. Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, and Sumanta Kumar Pal
Abstract
Purpose
Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status.
Patients and Methods
Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily. MET-driven PRCC was defined as any of the following: chromosome 7 copy gain, focal MET or HGF gene amplification, or MET kinase domain mutations. Efficacy was assessed according to MET status. Safety, toxicity, and patient-reported health-related quality-of-life outcomes were assessed in all patients.
Results
Of 109 patients treated, PRCC was MET driven in 44 (40%) and MET independent in 46 (42%); MET status was unknown in 19 (17%). MET-driven PRCC was strongly associated with response; there were eight confirmed partial responders with MET-driven disease (18%), but none with MET-independent disease (P = .002). Median progression-free survival for patients with MET-driven and MET-independent PRCC was 6.2 months (95% CI, 4.1 to 7.0 months) and 1.4 months (95% CI, 1.4 to 2.7 months), respectively (hazard ratio, 0.33; 95% CI, 0.20 to 0.52; log-rank P < .001). The most frequent adverse events associated with savolitinib were nausea, fatigue, vomiting, and peripheral edema.
Conclusion
These data show activity and tolerability of savolitinib in the subgroup of patients with MET-driven PRCC. Furthermore, molecular characterization of MET status was more predictive of response to savolitinib than a classification based on pathology. These findings justify investigating savolitinib in MET-driven PRCC.
Citations and Links
Please follow the DOI link to access the publication:
J Clin Oncol. 2017 Jun 23:JCO2017722967
DOI link: 10.1200/JCO.2017.72.2967
Intercontinental, Boston, MA, USA
2017年6月22日：和黃醫藥近日在中國啟動HMPL-453的I/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）的新型高選擇性小分子抑製劑。2017年6月19日首位受試者接受給藥治療。該試驗是今年早先在澳大利亞展開的I期臨床試驗的一項補充研究。
該試驗是一項多中心單臂開放標籤的兩階段研究，旨在評估HMPL ‑ 453作為單一療法在治療攜帶FGFR基因突變的實體瘤患者中的安全性，耐受性，藥代動力學特性和初步療效。劑量爬升階段將招募局部晚期或轉移性實體瘤的患者，這些患者缺乏標準療法或標準療法被證實為無效或不耐受，但暫不考慮FGFR基因表達狀態，旨在確定最大耐受劑量和臨床II期研究的推薦劑量。
劑量爬升之後的劑量擴展階段將進一步評估臨床II期研究推薦劑量的安全性，耐受性和藥代動力學特性以及初步的抗腫瘤功效。這一階段將主要招募有FGFR異常表達的癌症患者，包括晚期膀胱癌，晚期膽管癌等實體腫瘤。第二階段研究的主要終點是客觀緩解率（ORR），次要終點包括緩解持續時間（DoR ），疾病控制率(DCR)，無進展生存期(PFS)，總生存期(OS)和安全性。該研究的詳細信息請登陸clinicaltrials.gov，檢索NCT03160833查看。
關於膀胱癌和膽管癌
膀胱癌佔尿路上皮癌的約90％。膀胱癌是美國第六大，也是中國第九大最常見的惡性腫瘤，兩國每年各有約80,000例新發病例。在美國，疾病已轉移的患者五年生存率約為5％。儘管局部晚期或轉移性尿路上皮癌的治療取得了一定進步，但患者的預後仍然很差，需要更多的治療方案。
作為在世界範圍內未得到滿足的醫療需求,膽管癌佔全球胃腸癌的3％左右，是膽道（肝，膽囊和膽管的聯合系統）最常見的惡性腫瘤。膽管癌根據解剖位置分為肝內或肝外，研究表明肝內膽管癌的發生率有明顯的上升。目前膽管癌預後不佳，5年生存率低於5％。
關於FGFR
FGFR是受體酪氨酸激酶的亞家族。FGFR信號通路的激活是數個生物過程的關鍵。在正常生理情況下，FGF / FGFR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，異常的FGFR信號傳導被發現是腫瘤增長，促進血管生成以及針對抗腫瘤治療產生抗性的驅動力。目前還沒有專門針對FGFR信號通路的療法獲批。
關於HMPL-453
HMPL ‑ 453是一種靶向成纖維細胞生長因子受體FGFR 1，2，3的新型高選擇性小分子抑製劑。在臨床前研究中，HMPL ‑ 453與同類其他藥物相比表現出藥效強，激酶選擇性高及安全性更佳的特點。和黃醫藥正在澳大利亞展開HMPL-453的一項I期臨床研究，詳細內容請登陸clinicaltrials.gov，檢索NCT02966171查看。
Mandarin Oriental, Hong Kong
London: Friday, June 16, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has received notifications that:-
- Dynamic Drive Limited, a person closely associated (“PCA”) with Mr Simon To, Executive Director and Chairman, purchased a total of 11,158 American Depositary Shares of the Company (“ADSs”, each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med (“Ordinary Share”)) between June 13 and 15, 2017 at an average price of US$21.18 per ADS. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust (the “DDT”) which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor;
- Wencheng Capital Limited (“WCL”), a PCA with Mr To, purchased a total of 25,669 ADSs between June 13 and 15, 2017 at an average price of US$21.15 per ADS. WCL is controlled by the trustee of Wencheng Trust (“WT”) which has been established for the benefit of Mr To’s family member, of which Mr To is the settlor;
- Mr To transferred a total of 70,000 ADSs from an account in his own name to WCL on June 14, 2017; and
- Ms Edith Shih, Non-executive Director and Company Secretary, purchased a total of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS.
Following the above purchase of a total of 36,827 ADSs and transfer of 70,000 ADSs, Mr To is interested in 106,827 ADSs (in DDT and WT of which his family members are the beneficiaries) and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in DDT of which his family members are the beneficiaries), representing in aggregate approximately 0.38% of the current issued share capital of Chi-Med.
Following the above purchase, Ms Shih is interested in 76,144 ADSs and 60,000 Ordinary Shares, representing approximately 0.16% of the current issued share capital of Chi-Med.
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 | Dynamic Drive Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) | Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 11,158 ADSs in the name of Dynamic Drive Limited which holds the ADSs for a family trust (Dynamic Drive Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.18 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 11,158 Price information: US$21.18 |
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| e) | Date of the transaction | 2017-06-13 – acquisition of 6,780 ADSs 2017-06-14 – acquisition of 500 ADSs 2017-06-15 – acquisition of 3,878 ADSs |
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| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Wencheng Capital Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) | Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,669 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.15 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,669 Price information: US$21.15 |
||||||||
| e) | Date of the transaction | 2017-06-13 – acquisition of 16,958 ADSs 2017-06-14 – acquisition of 1,300 ADSs 2017-06-15 – acquisition of 7,411 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | ||||||||
| a) | Name | Mr Simon To | |||||||
| 2 | Reason for the notification | ||||||||
| a) | Position/status | Executive Director and Chairman | |||||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
|||||||
| b) | Nature of the transaction | Disposal of 70,000 ADSs from Mr Simon To to Wencheng Capital Limited which holds the ADSs for a trust (Wencheng Trust), established for the benefit of Mr To’s family members, of which Mr To is the settlor on June 14, 2017 | |||||||
| c) | Price(s) and volume(s) |
|
|||||||
| d) | Aggregated information
|
N/A | |||||||
| e) | Date of the transaction | 2017-06-14 | |||||||
| f) | Place of the transaction | Outside a trading venue | |||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Wencheng Capital Limited | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Acquisition of 70,000 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor on June 14, 2017 | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2017-06-14 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Ms Edith Shih | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Non-executive Director and Company Secretary | ||||||||
| 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 Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,403 Price information: US$21.17 |
||||||||
| e) | Date of the transaction | 2017-06-14 – Acquisition of 24,445 ADSs 2017-06-15 – Acquisition of 958 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
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Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
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+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
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Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
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+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
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+44 (20) 7886 2500
– 國家食品藥品監督管理局已受理申請，並將由藥品審評中心作技術審核–
–將收到來自禮來共計3080萬人民幣的里程碑付款–
2017年6月12日：和黃醫藥今日宣布藥物呋喹替尼治療晚期結直腸癌的新藥上市申請已獲國家食品藥品監督管理局（CFDA）的正式受理，美國禮來因此將向和黃醫藥支付共計人民幣3080萬（450萬美元）的里程碑付款。此次新藥上市申請是基於和黃醫藥呋喹替尼治療416名晚期或轉移性結直腸癌患者的關鍵臨床III 期註冊試驗“ FRESCO”的成功，其試驗數據已於2017年6月5日在美國臨床腫瘤協會年會上做了口頭報告。
關於結直腸癌
結直腸癌是中國第二大最常見的惡性腫瘤，根據全國腫瘤登記中心數據顯示，每年新增病例約為38萬例。
根據諮詢公司Frost & Sullivan的數據，2015年全球新增結直腸癌病例約為150萬例，至2020年預計增至170萬例。
關於呋喹替尼
呋喹替尼是一種新型的高選擇性小分子候選藥物，臨床研究證實：通過一日一次的口服劑量即可有效的抑制血管內皮生長因子受體（VEGFR），且脫靶毒性低於其他靶向療法。從藥物的耐受性，以及根據目前顯示出的無藥物相互作用的特性來看，呋喹替尼或能夠與其他癌症療法進行聯合用藥，例如當前正在進行的臨床試驗中，呋喹替尼聯合化療及其他靶向療法治療不同的腫瘤。
癌症進入到晚期，腫瘤會分泌大量的蛋白配體-血管內皮生長因子(VEGF)，以促進腫瘤組織周圍過度的脈管系統的生成(血管生成)，為腫瘤細胞的生長提供更多的血流，氧氣和營養。VEGF和其受體VEGFR在腫瘤的血管生成中起到了至關重要的作用，因此，對VEGF/VEGFR相關通路的抑制就成為了阻斷新生血管形成，防止腫瘤增長和侵入的一種重要的治療策略。
根據此前的合作協議，呋喹替尼由和黃醫藥和美國禮來在中國范圍內合作開發。2017年3月3日，合作的雙方共同宣布呋喹替尼以結直腸癌為適應症的III期臨床試驗“FRESCO”的研究結果。此外，呋喹替尼以非小細胞肺癌為適應症的III期臨床試驗被命名為“FALUCA”，目前正在中國展開研究，另有一項II期臨床試驗以呋喹替尼聯合易瑞沙（吉非替尼）治療一線晚期或轉移性非小細胞肺癌也正在進行中。與紫杉醇聯合用藥治療胃癌的中國III期臨床研究，在美國的數項新研究，以及與其他腫瘤藥物聯合用藥的多項探索性研究也正在計劃中，將於今後逐漸展開。
2017年6月5日：和黃醫藥宣佈在今天於美國芝加哥舉行的美國臨床腫瘤學會（ASCO）年會上就其自主研發的高選擇性血管細胞內皮生長因子受體（VEGFR）抑製劑的關鍵III期臨床研究結果進行了口頭報告。“ FRESCO”是呋喹替尼以局部晚期或轉移性結直腸癌為適應症的一項隨機雙盲安慰劑對照的多中心中國III期臨床研究，結果表明其達到了所有主要和次要終點，顯著提高了總生存期和無進展生存期，與其他靶向療法相比，具有可管理的安全性及更低的脫靶毒性。
同濟大學附屬上海東方醫院腫瘤醫學部主任李進教授表示，“416名受試者的試驗數據顯示，呋喹替尼在治療既往至少經過2 輪治療失敗的轉移性結直腸癌患者過程中，為受試者帶來了顯著的統計學及臨床意義的生存獲益，且不良事件可管理和可控。特別令人鼓舞的是，與其他靶向療法相比，呋喹替尼引起的肝功能異常發生率更低且更輕微。”
“ 總體的安全性和藥效數據表明呋喹替尼為疾病持續進展的結直腸癌患者提供了一種重要的新治療方案。”李進教授總結道。
藥效結果
呋喹替尼的III期臨床試驗“FRESCO” 為隨機雙盲安慰劑對照的多中心臨床試驗，目標受試者為至少經過2 輪化療／治療 （包括奧沙利鉑和氟尿嘧啶類藥物及伊立替康）失敗的轉移性結直腸癌患者。在中國，經2 輪治療失敗的結直腸癌患者，最佳支持治療是一般護理標準。受試者招募於2016年5月全部完成，共篩選了519名患者。416名意向治療人群受試者以2: 1的比例隨機接受每天口服一次5毫克的呋喹替尼（服藥三週/停藥一周為一周期）聯合最佳支持治療（278名患者）或安慰劑聯合最佳支持治療（138名患者）。以此前患者接受的抗VEGF治療及K- Ras 基因狀態為依據進行隨機分層。該試驗於2017年1月17日全部完成。
總生存期（OS）是FRESCO研究的主要終點，呋喹替尼治療組的中位OS 為9.30個月（95％CI 8.18-10.45），而安慰劑組為6.57個月（95％CI 5.88-8.11），風險比為0.65 [95％CI：0.51-0.83；雙側p<0.001] 。
中位無進展生存期（PFS）為次要終點，在呋喹替尼組中為3.71個月（95％CI 3.65-4.63），而安慰劑組為1.84個月（95％CI 1.81- 1.84），風險比為0.26 [95％CI：0.21-0.34；雙側p<0.001] 。
其他次要終點也有顯著效益：呋喹替尼組病情控制率（DCR）為62.2％，而安慰劑組為12.3％（p<0.001）；呋喹替尼組的總體緩解率（ORR）為4.7％，而安慰劑組為0％（p=0.012）。
安全性及耐受性結果
結果表明，與其他靶向治療相比，呋喹替尼具有可控的安全性，較低的靶外毒性，並沒有顯示針對結直腸癌的其他靶向藥所觀察到的偶爾但嚴重且致命的肝毒性。
最常見的與呋喹替尼相關的≥3 級不良事件包括：高血壓（21.2％），手足皮膚反應（10.8％），蛋白尿（3.2％）和腹瀉（2.9％），均與VEGFR靶點抑制有關。接受呋喹替尼治療的人群中，其他≥3 級不良事件不超過1.4％，包括肝功能不良事件，如膽紅素升高（1.4％），丙氨酸氨基轉移酶（ALT） （0.7％）或天冬氨酸氨基轉移酶（AST）（0.4％）。
呋喹替尼組的劑量調整或減少發生率僅為35.3%及24.1%，僅有15.1%的受試者中止治療，安慰劑組則為5.8% 。
關於“FRESCO”研究的詳細信息，可在clinicaltrials.gov搜索NCT02314819查看。詳細報告請點擊chi-med.com/ wp -content/uploads/2017/06/pre170605-013asco.pdf。
和黃醫藥將於近期完成向國家食品藥品監督管理總局遞交呋喹替尼的新藥上市申請。同時將於2017年年內啟動呋喹替尼在美國的臨床研究。
關於呋喹替尼
呋喹替尼是一種新型的高選擇性小分子候選藥物，臨床研究證實：通過一日一次的口服劑量即可有效的抑制血管內皮生長因子受體（VEGFR），且脫靶毒性低於其他靶向療法。其良好的耐受性加上被證明的無藥物相互作用的特性，使得呋喹替尼可以與其他抗癌藥物聯合使用，例如在正進行的臨床試驗中，聯合化療／靶向藥物與呋喹替尼一起治療各種癌症。
癌症進入到晚期，腫瘤會分泌大量的蛋白配體-血管內皮生長因子(VEGF)，以促進腫瘤組織周圍過度的脈管系統的生成(血管生成)，為腫瘤細胞的生長提供更多的血流，氧氣和營養。VEGF和其受體VEGFR在腫瘤的血管生成中起到了至關重要的作用，因此，對VEGF/VEGFR相關通路的抑制就成為了阻斷新生血管形成，防止腫瘤增長和侵入的一種重要的治療策略。
根據此前的合作協議，呋喹替尼由和黃醫藥和美國禮來在中國范圍內合作開發。2017年3月3日，合作的雙方共同宣布呋喹替尼以結直腸癌為適應症的III期臨床試驗“FRESCO”的研究結果。此外，呋喹替尼以非小細胞肺癌為適應症的III期臨床試驗被命名為“FALUCA”，目前正在中國展開研究，另有一項II期臨床試驗以呋喹替尼聯合易瑞沙（吉非替尼）治療一線晚期或轉移性非小細胞肺癌也正在進行中。與紫杉醇聯合用藥治療胃癌的中國III期臨床研究，在美國的數項新研究，以及與其他腫瘤藥物聯合用藥的多項探索性研究也正在計劃中，將於今後逐漸展開。
A randomized, double-blind, placebo-controlled, multi-centered phase III trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, IL
Abstract #: 3508
Presenter: Dr. Jin Li, Oncologist and Director of the Tumor Department, Shanghai East Hospital, Tongji University School of Medicine
Authors: J Li, S Qin, RH Xu, J Xu, L Shen, Y Bai, Y Deng, L Yang, ZD Chen, H Zhong, H Pan, W Guo, Y Shu, Y Yuan, J Zhou
Session: Gastrointestinal (Colorectal) Cancer – Oral Abstract Session
Date & Time: Monday, June 5, 2017, 5:24 PM CDT
Location: Hall D2
A phase II multicenter trial of the multitargeted kinase inhibitor sulfatinib in advanced medullary thyroid cancer (MTC) and radioiodine (RAI)-refractory differentiated thyroid cancer (DTC)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, USA
Abstract #: 6037
Authors: J Chen, Q Ji, J Cao, D Ji, C Bai, Y Lin, B Pan, G Sun, J Li, C Qi, Y Hua
Session: Head and Neck Cancer
Date & Time: Monday, June 5, 2017, 1:15 PM CDT
Location: Hall A