…complement previously presented positive Phase III SANET-ep results in patients with non-pancreatic NET, including across multiple subgroups ― ― Results of both SANET-p and SANET-ep studies published in The…
…by 67%, extending PFS of non-pancreatic NET patients with an acceptable risk/benefit ratio – – The pivotal Phase III SANET-p trial demonstrated surufatinib reduced risk of progression or death by…
…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…
…$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…
…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…
…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…
…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,…
…(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…
…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…
…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…
…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…
…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…
…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…
…trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio – – ~400-strong oncology commercial…
…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…
…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…
…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…
…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…
…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…
…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…
…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…
…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…
…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…
…China Healthcare and Consumer Products Divisions – our Commercial Platform: sales of subsidiaries and JVs up 17%, net profit up 15%. Strong outlook for full year and beyond. London: Tuesday,…
…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]…
…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,…
…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…
…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…
…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…
…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,…
…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…
…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…
…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…
…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 ― ―…
…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…
…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…
…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…
…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…
…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…
…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…
…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,…
…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…
…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…
…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…
…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…
…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)…
…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…
…(high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section…
…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…
…(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)…
…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…
…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…
…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…
…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…