…access to treatment options. [4] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead…
…placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4. [5] Xu J, Shen L, Bai C, et al. Surufatinib in advanced…
…line with guidance Group revenue up 12% to $241.2 million (2016: $216.1m); Net loss attributable to Chi-Med $26.7 million (2016: Net profit $11.7m), including $88.0 million in research and development…
…and immune evasion. Five other sulfatinib clinical trials are underway in China and the U.S., including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study…
…in May 2020 and subsequent grant of Priority Review status in July 2020. Surufatinib – Two NDAs with first China launch in NET planned for late 2020: Progressed non-pancreatic NET…
…$126.6 million (H1 2016: $104.5m). Net income attributable to Chi-Med of $1.7 million (H1 2016: $0.5m), including $37.5 million in research and development expenses on an as adjusted basis (H1…
…Society for Medical Oncology Congress (“ESMO”) (Abstract Number 1156O). This is the second NDA acceptance for surufatinib. The first NDA for non-pancreatic NET was accepted by the NMPA in November…
…Hutchison China MediTech Limited (“Chi-Med”) Reports Final Results for the Year Ended December 31 , 2016 and Updates Shareholders on Key Clinical Programs Group: Record revenue, net income and…
…(2017: $241.2m). N et loss attributable to Chi‑Med of $74.8 million (2017: net loss $26.7m). Adjusted Group net cash flow (non-GAAP) was -$57.3 million in 2018. Cash from our Commercial…
…another two NDA3 submissions are imminent, one with savolitinib in lung cancer and a second with surufatinib in pancreatic NET, with launches anticipated for 2021.” “Based on extensive clinical data,…
…Chairman, Chi-Med. “All major clinical readouts in the first half were encouraging, with the stand-out results being surufatinib’s positive Phase III outcome in non-pancreatic NET and savolitinib’s preliminary data in…
…104% to $178.2 million (2014: $87.3m). Net profit from operations attributable to Chi-Med of $8.0 million (2014: net loss -$7.3m), including our booking of $3.1 million in one-time preparation costs…
…that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support…
…SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission. The FDA granted…
…to $ 8 2 .3 million ( H1 201 5: $55.6m); Total sales of non-consolidated joint ventures up 9% to $249.6 million (H1 2015: $229.8m); Total net income attributable to…
…tumours. A U.S. Phase II study in NET is expected to be initiated based on the conclusion of this Phase I dose escalation study. Sulfatinib is an oral drug candidate…
…(SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4. [3] According to Frost & Sullivan. In 2018,…
…Chi‑Med of $32.7 million (H1 2017: net profit $1.7m). Cash resources of $416.9 million at Group level as of June 30, 2018 ($479.6m as of December 31, 2017), including cash…
…– – Preparations underway for the potential submission of surufatinib New Drug Application (“NDA”) by year end 2019 for non-pancreatic NET tumors in China – – Treatment options are limited…
…NET was accepted for review by the NMPA, and the U.S. Food and Drug Administration granted Orphan Drug designation to surufatinib for the treatment of pancreatic NET. About Surufatinib…
…placebo-controlled, multi-centre Phase III sulfatinib registration study to treat pathologically low or intermediate grade NET patients whose disease has progressed, locally advanced or distant metastasised and for whom there is…
…Results (IFRS11) Revenue up 100% to $91.8 million (2013: $46.0m). Net profit attributable to Chi-Med equity holders of $ 5.4 million (2013: $5.9m) as the Company continues to balance a…
…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…
…progressing well – evidence of the strength and adaptability of our Commercial Platform to enter new therapeutic areas in future, including oncology and immunology. New factories: Coming online at the…
…Raise and Offering do proceed, Chi‑Med intends to use the net proceeds of the potential Equity Raise, together with the cash generated by its operations, primarily to advance the clinical…
…and joint ventures (excluding non-consolidated joint ventures) of Chi-Med. OVERALL GROUP: Group revenue of $204.9 million (2018: $214.1m). Net loss attributable to Chi-Med of $106.0 million (2018: net loss of…
…treatment of non-pancreatic NET. Surufatinib being granted priority review is a positive step forward in potentially bringing this innovative drug to patients, who currently have very limited treatment options.” In…
…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…
…Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA Session: Proffered Paper – NETs Abstract Number: 1156O Date & Time: Sunday, September 20, 2020 2:25 PM…
…price. Chi-Med has applied to have its ADSs approved for listing on the Nasdaq Stock Market under the symbol “HCM.” In addition to the net proceeds which may be generated…
…Market under the symbol “HCM.” In addition to the net proceeds which may be generated by the Offering, Chi-Med plans to continue to utilize its various resources, including existing cash…
…This study follows several trials that are underway in China, including two Phase III studies in pancreatic and non-pancreatic NET that commenced after positive results from a Phase II study,…
…as detailed below: 2018 Previous Guidance 2018 Current Guidance Adjustment Group Level: · Consolidated revenue $155-175m $155-175m None · Admin., interest & tax $(16)-(18)m $(16)-(18)m None · Net loss[1]…
…in proof-of-concept clinical trials in the U.S. and several proof-of-concept and late-stage clinical trials in China. Pancreatic NET in China: In 2016, we initiated the SANET-p study, which is a…
…grade advanced NET whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. Patients are randomized at a 2:1 ratio to receive either…
…sulfatinib monotherapy in patients with advanced grade 1 or 2 advanced NET. 81 patients (41 pancreatic NET and 40 extra-pancreatic NET) were enrolled between November 2014 and January 2016, in…
…NET was accepted for review by the China National Medical Products Administration (NMPA) on November 11, 2019. About FDA Orphan Drug Designation The FDA Orphan Drug Designation Program provides…
…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…
…the potential approval and launch of surufatinib in China, an important development for NET patients with limited treatment options. In order to maximize patient access to surufatinib upon regulatory approval,…
…and Cancer Therapeutics in early November 2015 (www.chi-med.com/sulfatinib-ph1-eortc-2015/). The Phase I clinical data indicates that sulfatinib has a superior ORR in NET patients. An ORR of 44% was observed for…
…objective response rate among the 18 efficacy-evaluable NET patients was 44.4% and disease control rate was 100%. By comparison, sunitinib and everolimus, the two approved single agent therapies for neuroendocrine…
…September 29. Safety and tolerability data presented from an ongoing U.S. Phase Ib study of surufatinib in pancreatic NET patients who have progressed on Sutent® or Afinitor® treatment will also…
…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. A second NDA for…
…survival hazard ratio of 0.51 with median not reached ― ― Ongoing surufatinib study in U.S. progressive NET patients demonstrated promising efficacy irrespective of prior lines of therapy ― ―…
…be very suitable for possible combinations with other immunotherapies. A New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by…
…this year in non-pancreatic NET. Our first NDA for surufatinib was granted Priority Review following our submission in late 2019, and preparation for a second NDA in pancreatic NET is…
…tumours (NETs). Eight NET patients (5 in 300mg QD and 3 in 350mg QD cohort) had confirmed partial response (PR) with median duration of response (DoR) of 13.8 months. The…
…as it becomes available online. — Aruba Afghanistan Angola Anguilla Åland Islands Albania Andorra United Arab Emirates Argentina Armenia American Samoa Antarctica French Southern Territories Antigua and Barbuda Australia Austria…
…Hutchison China MediTech Limited 2019. All rights reserved. Your privacy is important to us. This notice explains our online information practices and the choices you can make about…
…statements reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the NDA approval and launch of surufatinib for the treatment of patients with pancreatic or non-pancreatic NET in…
…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…
…surufatinib and savolitinib.” Simon To, Chairman, Mar 3, 2020 Read More FY2019 Financial Summary Group US$ Revenue $204.9m Net income/(loss) ($106.0m) — Innovation Platform Revenue $16.0m Net income/(loss) ($133.2m) —…
…cohort, 1 liver neuroendocrine tumour (NET) and 1 NET with unknown primary site in 300mg cohort, and 1 lymph node NET in 350mg cohort. ORR is 30% among the 13…
…BofA MERRILL LYNCH Dr. Alec W. Stranahan+1 646 743 2109 alec.stranahan@bofa.com Dr. Geoff Meacham+1 646 855 1004 geoff.meacham@bofa.com BLOOMBERG Cinney Zhangczhang429@bloomberg.net Sam Fazelimfazeli@bloomberg.net CANACCORD GENUITY Dr. John Newman+1…
…SANET-p trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 pathologically low or intermediate grade pancreatic NET patients in China whose disease has…
…underway in China and the United States, including two Phase III studies and one Phase II study in NET patients (SANET-p, SANET-ep and SANET-1), one Phase II study in thyroid…
…for the Offering has not yet been determined. Chi-Med will receive all of the net proceeds from the sale of ADSs in the Offering, if completed, which it intends to…
…Although the final structure and size of the potential Offering is yet to be determined, Chi-Med expects that the net proceeds from any primary sale of Shares in the Offering,…
…discounts and commissions. The Offering is expected to close on January 27, 2020, subject to customary closing conditions. Chi-Med will receive all of the net proceeds from the sale of…
…October 30, 2017. The net proceeds from the Offering are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for…
…Funding: Hutchison MediPharma. Trial Registration: ClinicalTrials.gov Identifier: NCT02588170. Citations and Links Please follow the link below to access the publication: Lancet Oncol. 2020;S1470-2045(20)30496-4. [published online ahead of print, 2020…
…patient population. Funding: Hutchison MediPharma. Trial Registration: ClinicalTrials.gov Identifier: NCT02589821. Citations and Links Please follow the link below to access the publication: Lancet Oncol. 2020; S1470-2045(20)30493-9. [published online ahead…
…infant formula is sold in China through an online retailer and specialty retail outlets. Hutchison Healthcare Our wholly owned subsidiary and is primarily engaged in the manufacture, marketing and distribution…
…to see if the firm is authorized by FCA. Report the call to the FCA by calling the FCA Consumer Helpline on 0800 111 6768 or complete the online boiler…
… Citations Journal: Clinical Cancer Research June 15, 2019 (25) (12) 3486-3494 (Published Online First March 4, 2019) DOI: 10.1158/1078-0432.CCR-18-2994 PubMed: 30833272 Abstract Purpose: No anti-angiogenic treatment is yet…
…or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement…
…(iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to…
…managers to institutional and high net worth clients. CB&T is a U.S.-based investment management company that is a registered investment adviser and an affiliated federally chartered bank. Neither CGC nor…
…“Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or…
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…Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in…
…Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv)…
…of the Financial Services and Markets Act 2000 (Financial e49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) any other person to whom it…
…Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article…
…Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d)…
…19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, or the Order, (ii) high net worth entities, and other persons to whom it may lawfully be…
…The net proceeds from the Offering are expected to be used to fund the on-going research and development of the Chi-Med Innovation Platform drug pipeline and for working capital and…
…net book value of the old site and its buildings, as well as taxes and other costs. The re-zoning of the Site prompted SHPL to build a new factory with…
…net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being…
…who fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all…
…(d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv)…
…Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in…
…(high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together…
…(d) (high net worth companies, unincorporated associations etc) of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv)…
…achievement of clinical development and first sale milestones. The agreement also contains possible significant future commercial sale milestones and up to double-digit percentage royalties on net sales. This collaboration further…
…net sales. Additional terms of the agreement were not disclosed. Christian Hogg, Chief Executive Officer of Chi-Med said: “Our belief is that Fruquintinib has potential activity against multiple tumour types…
…CSF-1R = colony stimulating factor-1 receptor; Syk = spleen tyrosine kinase; PI3Kδ = Phosphatidylinositol-3-Kinase delta; NSCLC = non-small cell lung cancer; RCC = renal cell carcinoma; NET = neuroendocrine tumors;…
…“Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or…