Press Release
— First NDA filing of savolitinib globally —
— Chi-Med seeking first-in-class Chinese marketing authorization for a selective MET inhibitor —
London: Friday, May 29, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announced that the New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations has been accepted for review by the China National Medical Products Administration (NMPA).
The NDA is supported by data from an open-label, Phase II registration study. Interim data were presented on the first 50 treated patients at the Chinese Society of Clinical Oncology Annual Meeting in September 2019. An updated analysis with 70 patients in the study will be presented by Professor Shun Lu as part of the American Society of Clinical Oncology (“ASCO”) 2020 Virtual Scientific Meeting, available on May 29, 2020 at 8:00 a.m. Eastern Time (“Phase II Study of Savolitinib in Patients with Pulmonary Sarcomatoid Carcinoma and Other Types of Non-Small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutations”, abstract #9519).
“With today’s NDA acceptance, savolitinib is one step closer to benefitting a specific group of NSCLC patients who have limited treatment options today and we are very proud of that. After many years of collaboration with AstraZeneca, we hope that this NDA is the first of many globally for savolitinib.” Mr Christian Hogg, Chief Executive Officer of Chi-Med, commented.
It is estimated that 2-3% of NSCLC patients have MET Exon 14 skipping mutations, which predicts poor prognosis.[i] Annual incidence of lung cancer in China accounted for 37.0% of the world’s annual incidence of lung cancer in 2018.[ii]
In 2011, Chi-Med entered into a global licensing and joint development and commercialization agreement with AstraZeneca (LSE, STO, NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes NSCLC and kidney cancer, and additional MET-driven tumors are being explored.
Savolitinib is a small molecule inhibitor of MET, a receptor tyrosine kinase enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.
Phase II in MET Exon 14 deletion NSCLC (NCT02897479) – NDA accepted and data to be presented at ASCO 2020.
SAVANNAH Phase II study of savolitinib in combination with Tagrisso® in patients who have progressed following Tagrisso® due to MET amplification (NCT03778229) – The SAVANNAH study is a single-arm, open-label study in epidermal growth factor receptor (EGFR) mutation positive NSCLC patients following first- or second-line Tagrisso® therapy.
CALYPSO Phase II of savolitinib in combination with Imfinzi® PD-L1 inhibitor in renal cell carcinoma (“RCC”) (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with Imfinzi®, an anti-PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib/Imfinzi® combination in patients with papillary RCC (“PRCC”) and clear cell RCC.
SAVOIR Phase III in MET-positive PRCC (NCT03091192) – In December 2018, enrollment was terminated in SAVOIR, a global Phase III registration study of savolitinib monotherapy compared with sunitinib monotherapy in MET-positive PRCC. The early termination was driven by factors external to the SAVOIR study. Data from the approximately 60 patients randomized in SAVOIR prior to termination matured during 2019 and will be presented by Professor Toni K. Choueiri at ASCO 2020 Virtual Scientific meeting in an oral abstract session, available on May 29, 2020 at 8:00 a.m. Eastern Time (“SAVOIR: A Phase III Study of Savolitinib Versus Sunitinib in Patients with MET-driven Papillary Renal Cell Carcinoma”, abstract #5002). Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to restart clinical work in PRCC for monotherapy savolitinib.
Investigator-initiated studies of savolitinib have been undertaken in gastric cancer, prostate cancer and colorectal cancer.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the therapeutic potential of savolitinib for the treatment of patients with NSCLC, the further clinical development of savolitinib in this and other indications, its expectations as to whether clinical studies of savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support NDA approval of savolitinib for the treatment of patients with NSCLC in China, its potential to gain expeditious approvals for savolitinib in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of savolitinib, the potential for savolitinib to become a new standard of care for NSCLC patients, its ability to implement and complete its further clinical development plans for savolitinib, its potential commercial launch of savolitinib in China and other jurisdictions, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
[i]Awad M et al. “MET Exon 14 Mutations in Non–Small-Cell Lung Cancer Are Associated With Advanced Age and Stage-Dependent MET Genomic Amplification and c-Met Overexpression.” Journal of Clinical Oncology 2016 34:7, 721-730.
[ii] Global Cancer Observatory.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+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
Press Release
― Savolitinib in MET exon 14 skipping NSCLC efficacy evaluable patients demonstrated 49.2% ORR, 93.4% DCR and 9.6 months DoR, including 36% patients with more aggressive disease subtype ―
― Savolitinib vs. sunitinib study in PRCC patients demonstrated 27% vs. 7% ORR, with no savolitinib responding patients with disease progression at data cut-off, and encouraging overall 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 ―
― Audio call and webcast on Monday, June 1 at 8 a.m. EDT to review select presentations ―
London: Friday, May 29, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today showcases new and updated analyses on the ongoing studies of savolitinib and surufatinib at the ASCO20 Virtual Scientific Program, May 29-31, 2020. Chi-Med will hold a conference call and audio webcast on Monday, June 1, 2020, at 1 p.m. GMT / 8 a.m. EDT / 8 p.m. HKT to review select clinical data and discuss development plan next steps.
A live audio webcast of the call will be broadcast via Chi-Med’s website at www.chi-med.com/event. Investors may participate in the call using one of the following dial-in numbers: 1‑866‑213‑0992 (U.S. toll-free) / 0800‑032‑2849 (U.K. toll-free) / +852-2112-1888 (Hong Kong). Additional dial-in numbers are also available at Chi-Med’s website. Please use participant access code “6929001#.”
Savolitinib, a potent, highly selective oral inhibitor of mesenchymal epithelial transition receptor (“MET”)
In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.
| Presentation Title: | Phase II study of savolitinib in patients with pulmonary sarcomatoid carcinoma (“PSC”) and other types of non-small cell lung cancer (“NSCLC”) harboring MET exon 14 skipping |
| Authors: | S Lu, J Fang, X Li, L Cao, J Zhou, Q Guo, Z Liang, Y Cheng, L Jiang, N Yang, Z Han, J Shi, Y Chen, H Xu, H Zhang, D Zhang, J Li, L Wang, Y Ren, W Su |
| Abstract Link: | 9519 |
This is an ongoing China Phase II study of savolitinib monotherapy in NSCLC patients with MET exon 14 skipping mutations who have failed prior systemic therapy or are unable to receive chemotherapy (clinicaltrials.gov number NCT02897479), in which savolitinib demonstrated promising anti-tumor activity and acceptable tolerability. Approximately 35% of patients in the study have an aggressive subtype of NSCLC, PSC).[i] Treatment naïve patients accounted for approximately 40% of the treated patients while the remainder received prior treatments.
As of March 31, 2020, confirmed responses were seen in 49.2% of efficacy evaluable patients and disease control were seen in 93.4% of efficacy evaluable patients.
Data were not mature for Duration of Response (“DoR”), Progression Free Survival (“PFS”) and Overall Survival (“OS”). Median DoR was 9.6 months (95% confidence interval [“CI”] 5.5–not reached [“NR”]) with maturity of 40%. Median PFS was 6.9 months (95% CI 4.2–19.3) with maturity of 50%. Median OS was 14.0 months (95% CI: 9.7–NR) with maturity of 46%. Efficacy observations were consistent across subgroups in this analysis.
Clinical data indicate an acceptable safety profile of savolitinib in patients with locally advanced or metastatic NSCLC who had MET exon 14 skipping mutations, with a low rate of adverse event (“AE”) related discontinuations of 14.3%.
On May 29, 2020, a new drug application (“NDA”) for savolitinib in this setting was accepted for review by the China National Medical Products Administration.
| Presentation Title: | SAVOIR: A phase III study of savolitinib versus sunitinib in patients with MET-driven papillary renal cell carcinoma (“PRCC”) |
| Authors: | TK Choueiri, DYC Heng, JL Lee, M Cancel, RB Verheijen, A Mellemgaard, L Ottesen, MM Frigault, A L’Hernault, Z Szijgyarto, S Signoretti, L Albiges |
| Abstract Link: | 5002 |
In this global study of savolitinib monotherapy compared with sunitinib in patients with MET-driven, locally advanced or metastatic PRCC, savolitinib demonstrated encouraging efficacy and an improved safety profile versus sunitinib (NCT03091192). This Phase III study was stopped in late 2018 due to confounding results from a separate, external, retrospective observational study. 60 randomized patients (33 savolitinib, 27 sunitinib) were followed through August 19, 2019. Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy versus sunitinib, with fewer grade ≥3 AEs and fewer dose modifications. Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to restart clinical work in PRCC for monotherapy savolitinib.
Savolitinib patients had not reached median OS at data cut-off, compared to 13.2 months for sunitinib patients (hazard ratio [“HR”] 0.51; 95% CI: 0.21–1.17; p=0.110). Median PFS was 7.0 months for savolitinib patients, compared to 5.6 for sunitinib patients (HR 0.71; 95% CI 0.37–1.36; p=0.313).
Responses were observed in 27% and 7% of savolitinib and sunitinib patients, respectively. This difference did not reach statistical significance due to the small sample size. None of the 9 responders on savolitinib treatment experienced disease progression as of data cut-off, compared to 1 of 2 responders on sunitinib treatment. Sunitinib response rate was in range with previous studies.[ii],[iii]
Grade ≥3 AEs were reported in 42% of savolitinib patients versus 81% of sunitinib patients, with AEs leading to dose modification in 30% and 74% of savolitinib and sunitinib patients, respectively.
Surufatinib, an oral selective inhibitor of vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), and colony stimulating factor-1 receptor (CSF-1R)
In clinical studies to date, involving over 900 patients, surufatinib has demonstrated robust efficacy and safety profile, including in two randomized, double-blind, placebo controlled, multi-center Phase III studies in pancreatic neuroendocrine tumor (“pNET”) and non-pancreatic (extra-pancreatic) neuroendocrine tumor patients (“epNET”). In the U.S. surufatinib was granted Fast Track Designations for development in pNET and epNET, and Orphan Drug Designation for pancreatic NET. In China a New Drug Application (“NDA”) is under review and a second is in preparation.
| Presentation Title: | Efficacy and safety of surufatinib in U.S. patients with neuroendocrine tumors (“NET”) |
| Authors: | A Dasari, D Li, MW Sung, C Tucci, JS Kauh, MK Kania, AS Paulson |
| Abstract Link: | 4610 |
Preliminary data from the two NET cohorts in the ongoing US Phase Ib trial for surufatinib demonstrated promising efficacy irrespective of prior lines of therapy, with a manageable safety profile comparable with the larger pool of surufatinib safety data (NCT02549937).
As of April 21, 2020, 16 patients with pNET were treated for a median of 7.1 months (range 2.0-17.5) and 16 patients with epNET were treated for a median of 4.9 months (range of 1.0-10.2). All 32 patients have pretreated progressive NETs (median prior lines of treatment: 3; range 1-8).
Confirmed response was observed in 18.8% of pNET patients; all remaining patients have stable disease (including 1 unconfirmed response), for disease control rate (“DCR”) of 100%. In the epNET cohort all patients had stable disease (including 1 unconfirmed response).
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations regarding the clinical development and therapeutic potential of its drug candidates, including savolitinib and surufatinib. Such risks and uncertainties include, among other things, the ability of Chi-Med to implement and complete further clinical development of its drug candidates, the sufficiency of clinical trial data to demonstrate the safety and efficacy of its drug candidates, actions of regulatory agencies which may affect the initiation, timing and progress of its clinical trials, its potential to gain expeditious approvals for and successfully commercialize its drug candidates, the sufficiency of funding to support the further clinical development and commercialization of its drug candidates and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+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
Press Release
– Collaboration to explore multiple solid tumor cancer indications –
– Initial development focused on multi-cohort trials in the U.S., Europe, China and Australia –
LONDON, UK; CAMBRIDGE, Mass. and BEIJING, China: May 26, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) and BeiGene, Ltd. (“BeiGene”) (Nasdaq: BGNE; HKEX: 06160) today announced that they have entered into a clinical collaboration agreement to evaluate the safety, tolerability and efficacy of combining two of Chi-Med’s drug candidates, surufatinib and fruquintinib, with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumor cancers, in the U.S., Europe, China and Australia.
Under the terms of the agreement, Chi-Med and BeiGene each plan to explore development of the combination of surufatinib with tislelizumab or fruquintinib with tislelizumab in different indications and regions. The companies have agreed to provide mutual drug supply and other support.
“We are very pleased to enter into this clinical collaboration with BeiGene, a company with which we share a vision to discover, develop and commercialize innovative targeted therapies and immunotherapies worldwide,” said Dr. Marek Kania, Senior Vice President and Chief Medical Officer, Hutchison MediPharma International.[1]
“By working together with a partner like Chi-Med, we hope to understand and develop innovative combination therapies that may bring meaningful treatments to cancer patients around the world. Through this collaboration we plan to further evaluate tislelizumab in combination with oral VEGFR inhibitors to target a variety of solid tumor cancers,” said Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development, at BeiGene.
Each of these three compounds are currently in late-stage global clinical development across many countries outside of China. Tislelizumab is a humanized IgG4 anti-programmed death-1 (“PD-1”) monoclonal antibody specifically designed to minimize binding to Fc receptor gamma (“FcγR”), which is believed to play an essential role in activating phagocytosis in macrophages, to minimize its negative impact on T effector cells. Fruquintinib is designed to improve kinase selectivity against vascular endothelial growth factor receptors (“VEGFR”) in order to minimize off-target toxicities, and thereby provide consistent coverage and better tolerability, which is very important in combinations. Surufatinib, a VEGFR inhibitor, inhibits colony stimulating factor-1 receptor (“CSF-1R”) additionally, thereby blocking the accumulation of tumor associated macrophages and promoting infiltration of T effector cells into tumors, leading to possible synergistic anti-tumor activity with PD-1 inhibitors.
Tislelizumab and fruquintinib have both been approved by the China National Medical Products Administration (“NMPA”), which is also currently reviewing the New Drug Application (“NDA”) for surufatinib that was submitted late last year.
Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
Tislelizumab is approved by the China NMPA as a treatment for patients with classical Hodgkin’s lymphoma (“cHL”) who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 11 Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China.
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company (“Lilly”) in late November 2018 under the brand name Elunate®. Elunate® is for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with colorectal cancer (“CRC”) in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
Global development of fruquintinib in CRC: We intend to initiate a Phase III registration study, known as the FRESCO-2 study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected to start enrolling patients in mid-2020. Based on our agreement with the U.S. Food and Drug Administration (FDA), the FRESCO and FRESCO-2 studies, if positive, could support our NDA application.
Gastric Cancer in China: In October 2017, we initiated the FRUTIGA study, a randomized, double-blind, Phase III study in China to evaluate the efficacy and safety of fruquintinib combined with paclitaxel (Taxol®) compared with paclitaxel monotherapy in the treatment of patients with advanced gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after first-line standard chemotherapy (clinicaltrials.gov identifier: NCT03223376). Over 540 patients are expected to be enrolled into the FRUTIGA study at a 1:1 ratio with the primary endpoint of this study being overall survival (OS). In April 2019, we conducted the first interim analysis of the FRUTIGA study for futility. Following the analysis of safety and efficacy of the first 100 patients, the Independent Data Monitoring Committee (“IDMC”) recommended to continue the study without changes. We expect to conduct a second interim analysis in mid-2020 and complete enrollment of the study in 2020.
Immunotherapy combinations: In November 2018, we entered into two collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with Tyvyt® (sintilimab) and geptanolimab (GB226, genolimzumab).
Fruquintinib is not approved for use outside of China.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and CSF-1R, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib worldwide.
Neuroendocrine tumors (“NET”) in the U.S., Europe and Japan: We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration, based on the robust data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019.
Non-pancreatic neuroendocrine tumors in China: In November 2019, a New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China NMPA and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the IDMC to determine that the study met the pre-defined primary endpoint of progression-free survival (“PFS”) and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).
Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended the registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (“OS”) (clinicaltrials.gov identifier NCT03873532).
Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with Tuoyi® (toripalimab) and Tyvyt®, which are approved in China.
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.
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA™ (zanubrutinib) in the United States, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the clinical development of surufatinib and fruquintinib in combination with tislelizumab, Chi-Med’s and BeiGene’s roles and responsibilities in the collaboration, the opportunity and potential benefits of their product candidates both as monotherapies and in combination, and other information that is not historical information. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the ability of Chi-Med and BeiGene to develop and receive regulatory approvals for the combination therapies in the collaboration; the risk that the potential benefits of the collaboration do not materialize or do not outweigh the costs; the ability of Chi-Med and BeiGene to demonstrate the efficacy and safety of their respective drug candidates as monotherapies or in combination; the clinical results for such drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Chi-Med’s and BeiGene’s ability to achieve commercial success for their marketed products and drug candidates, if approved; Chi-Med’s and BeiGene’s ability to obtain and maintain protection of intellectual property for their respective technology and drugs; BeiGene’s and Chi-Med’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene’s and Chi-Med’s ability to obtain additional funding for operations and to complete the development and commercialization of their drug candidates; and the impact of the COVID-19 pandemic on BeiGene’s and Chi-Med’s clinical development, commercial and other operations. 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 or BeiGene’s filings with the U.S. Securities and Exchange Commission and, in the case of Chi-Med, on AIM. All information in this press release is as of the date of this press release, and neither Chi-Med nor BeiGene undertakes a duty to update such information unless required by law.
[1] Hutchison MediPharma International – the international arm of Chi-Med’s innovative drug R&D operations.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+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
Craig West
+1 857-302-5189
ir@beigene.com
Liza Heapes
+1 857-302-5663
media@beigene.com
London: Thursday, May 14, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that new and updated analyses on the ongoing studies of savolitinib, surufatinib, and fruquintinib will be presented at the upcoming ASCO20 Virtual Scientific Program, taking place on May 29-31, 2020.
Chi-Med plans to hold a conference call on the following Monday, June 1, to discuss the results.
| Title: | Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping |
| Lead Author: | Shun Lu, MD, PhD., Shanghai Chest Hospital, Shanghai Jiao Tong University |
| Session: | Lung Cancer—Non-Small Cell Metastatic |
| Abstract Number: | 9519 |
| Title: | SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC) |
| Lead Author | Toni K. Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School |
| Session: | Genitourinary Cancer—Kidney and Bladder |
| Abstract Number: | 5002 |
| Title: | Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs) |
| Lead Author: | Arvind Dasari, MD, MS, MD Anderson Cancer Center |
| Session: | Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| Abstract Number: | 4610 |
| Title: | Health-related quality-of-life results from SANET-ep: A phase III study of surufatinib versus placebo for advanced extrapancreatic neuroendocrine tumors |
| Lead Author | Chunmei Bai, MD, Peking Union Medical College Hospital |
| Session: | Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
| Abstract Number: | 4613 |
| Title: | Early carcinoembryonic antigen (CEA) dynamics to predict fruquintinib efficacy in FRESCO, a 3+ line metastatic colorectal carcinoma (mCRC) phase III trial |
| Lead Author: | Yuxian Bai, Harbin Medical University Cancer Hospital |
| Abstract Number: | e16001 |
| Title: | Efficacy and safety of fruquintinib in the treatment of poor patients with metastatic gastrointestinal cancer |
| Lead Author: | Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University |
| Abstract Number: | e16028 |
Savolitinib is an inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
A New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission. We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.
Chi-Med currently retains all rights to surufatinib worldwide.
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company (“Lilly”) in late November 2018 under the brand name Elunate®, for the treatment of patients with metastatic colorectal cancer (“CRC”). We also intend to initiate a Phase III registration study for CRC in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of fruquintinib, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidates fruquintinib, surufatinib and savolitinib, including as a combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib, surufatinib and savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+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
| Date: June 10, 2020 (Wednesday ) |
| Time: 08:50 am EDT (01:50 pm GMT/08:50 pm HKT) |
| Date: June 4, 2020 (Thursday) |
| Time: 08:00 am EDT (01:00 pm GMT/08:00 pm HKT) |
| Time: 09:40 am EDT |
London: Monday, May 11, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that Mr Christian Hogg, Chief Executive Officer of Chi-Med, will participate in a virtual fireside chat at the Bank of America 2020 Health Care Conference on Thursday, May 14, 2020 9:40 a.m. Eastern Daylight Time (EDT).
The discussion will be webcast live and can be accessed at www.chi-med.com in the Shareholder Information section under “Events, Circulars & Forms.” Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.
Members of the senior management team will also attend virtual one-on-one meetings at the Bank of America Health Care Conference on May 14, as well as during the following other conferences:
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. 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 press release, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500