TIDMHCM
Hutchmed (China) Limited
01 March 2022
Press Release
HUTCHMED Receives Approval to Commercialize ELUNATE(R) in
Macau
- First homegrown innovative medicine approved in Macau based on
China clinical data -
Hong Kong, Shanghai & Florham Park, NJ -- Tuesday, March 1,
2022: HUTCHMED (China) Limited (" HUTCHMED ") (Nasdaq/AIM: HCM;
HKEX: 13) today announces that it has received approval to market
fruquintinib (ELUNATE(R) in China), a selective and potent oral
inhibitor of vascular endothelial growth factor receptors ("VEGFR")
1, 2 and 3, in the Macau Special Administrative Region.
The approval follows the latest update to the provisions on new
drug importation which allows drugs that have been approved in one
or more specified jurisdictions to be authorized for use in Macau.
Prior to the update, regulations required approval from at least
two other jurisdictions. Fruquintinib was approved in Mainland
China by the National Medical Products Administration ("NMPA") in
September 2018 for the treatment of metastatic colorectal cancer
("CRC"). ELUNATE(R) will become the first homegrown innovative
oncology drug to be marketed in Macau based on its approval by the
NMPA.
D r. Karen Atkin, Chief Operating Officer of HUTCHMED, said,
"With the rapid pace of innovation in China's biotech sector in
recent years, more homegrown innovative drugs are being developed
and launched in China. We are encouraged by the Macau government's
policy for registration of novel therapies, such as ELUNATE(R) ,
based on China clinical trial data. We now look forward to patients
in Macau having full access to ELUNATE(R) in the coming
months."
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR-1, -2 and -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 favorable tolerability in patients treated to date, along
with fruquintinib's low potential for drug-drug interactions based
on preclinical assessment, suggests that it may also be highly
suitable for combinations with other anti-cancer therapies.
About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing
by the China NMPA in September 2018 and commercially launched in
China in late November 2018 under the brand name ELUNATE(R) . It
was included in the China National Reimbursement Drug List (NRDL)
in January 2020. ELUNATE(R) is indicated for the treatment of
patients with metastatic CRC who 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[1], a Phase III
pivotal registration trial of fruquintinib in 416 patients with
metastatic CRC in China, were published in The Journal of the
American Medical Association , JAMA, in June 2018
(clinicaltrials.gov identifier: NCT02314819).
About Fruquintinib Development
The safety and efficacy of fruquintinib for the following
investigational uses have not been established and there is no
guarantee that it will receive health authority approval or become
commercially available in any country for the uses being
investigated:
Metastatic CRC in the U.S., Europe, and Japan: The U.S. Food and
Drug Administration ("FDA") granted Fast Track Designation for the
development of fruquintinib for the treatment of patients with
metastatic CRC in June 2020. A Phase III registration study of
fruquintinib for the treatment of patients with metastatic CRC,
FRESCO-2, is currently underway in the U.S., Europe, Japan and
Australia. Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT04322539. The U.S. FDA has
acknowledged that the totality of the fruquintinib clinical data,
including the FRESCO-2 study (if positive), the prior positive
Phase III FRESCO study demonstrating improvement in overall
survival that led to fruquintinib approval for metastatic CRC in
China in 2018, and additional completed and ongoing supporting
studies in metastatic CRC, could potentially support a New Drug
Application (NDA) for the treatment of patients with advanced
metastatic CRC (third-line and above). The FRESCO-2 study design
was also reviewed and endorsed by The European Medicines Agency
(EMA) and Japanese Pharmaceuticals and Medical Devices Agency
(PMDA).
Gastric Cancer ("GC") in China : In October 2017, HUTCHMED
initiated the FRUTIGA study, a randomized, double-blind, Phase III
trial evaluating the efficacy and safety of fru quintinib combined
with paclitaxel for second-line treatment of advanced g astric or
esophagogastric junction ("GEJ") a denocarcinoma. The trial is
designed to enroll patients who did not respond to first-line
standard chemotherapy. Subjects receive either fruquintinib
combined with paclitaxel or placebo combined with paclitaxel.
Patients are randomized at a 1:1 ratio and stratified according to
factors such as stomach vs. GEJ tumor type and performance status.
The primary efficacy endpoint is overall survival (OS). Secondary
efficacy endpoints include progression-free survival (as defined by
RECIST 1.1), objective response rate, disease control rate,
duration of response, and quality-of-life score (EORTC QLQ-C30,
version 3.0). Biomarkers related to the antitumor activity of
fruquintinib will also be explored (clinicaltrials.gov identifier:
NCT03223376). In June 2020, HUTCHMED completed a planned interim
data review. Based on the preset criteria, the Independent Data
Monitoring Committee (IDMC) recommended that the trial
continue.
Immunotherapy combinations: HUTCHMED has entered into
collaboration agreements to evaluate the safety, tolerability and
efficacy of fruquintinib in combination with PD-1 monoclonal
antibodies, including with tislelizumab (BGB-A317, developed by
BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent
Biologics, Inc. and marketed as TYVYT(R) in China).
-- Metastatic breast and endometrial cancers in the U.S.:
HUTCHMED initiated this open-label, multi-center, non-randomized,
Phase Ib/II study in the U.S. to assess the safety and efficacy of
fruquintinib in combination with tislelizumab in patients with
advanced, refractory triple negative breast cancer ("TNBC") and
endometrial cancer ("EMC"). This study is being conducted to
investigate if the addition of fruquintinib can potentially induce
activity to immune checkpoint inhibitor therapy in TNBC and EMC.
Additional details of the study may be found at clinicaltrials.gov,
using identifier NCT04577963. Safety and preliminary efficacy of
fruquintinib were demonstrated in advanced solid tumors, including
TNBC, in a Phase I study conducted in China (NCT01645215) and a
Phase I/Ib study is ongoing in the United States (NCT03251378).
-- Gastric, colorectal and non-small cell lung cancers in China
& Korea: BeiGene, Ltd. initiated this open-label, multi-center,
Phase II study to assess the safety and efficacy of fruquintinib in
combination with tislelizumab in patients with advanced or
metastatic, unresectable GC, CRC or non-small cell lung cancer
("NSCLC"). Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT04716634.
-- Solid tumors in China: HUTCHMED initiated this open-label,
multi-center, non-randomized, Phase II study to assess the safety
and efficacy of fruquintinib in combination with sintilimab in
patients with advanced EMC, cervical cancer, CRC, GC,
hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma
(RCC). Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT03903705. Preliminary
results of certain cohorts were presented at the 2021 American
Society of Clinical Oncology Annual Meeting (ASCO) and the Chinese
Society of Clinical Oncology Annual Meeting (CSCO).
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is an innovative,
commercial-stage, biopharma-ceutical company. It is committed to
the discovery and global develop-ment and commercial-ization of
targeted therapies and immuno-therapies for the treatment of cancer
and immuno-logical diseases. It has more than 4,600 personnel
across all its companies, at the center of which is a team of over
1,500 in oncology/ immunology. Since inception it has advanced 12
cancer drug cand-idates from in-house discovery into clinical
studies around the world, with its first three oncology drugs now
approved and marketed in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
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 HUTCHMED's current expectations regarding future
events, including its expectations regarding the therapeutic
potential of fruquintinib for the treatment of patients with
advanced CRC and the further clinical development of fruquintinib
in this and other indications. Forward-looking statements involve
risks and uncertainties. Such risks and uncertainties include,
among other things, assumptions regarding the sufficiency of
clinical data to support New Drug Application approval of
fruquintinib for the treatment of patients with advanced CRC in the
U.S., Europe, Japan, Australia or other jurisdictions, its
potential to gain expeditious approvals from regulatory
authorities, the safety profile of fruquintinib, HUTCHMED's ability
to fund, implement and complete its further clinical development
and commercialization plans for fruquintinib, the timing of these
events, and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. In addition, as
certain studies rely on the use of other drug products such as
paclitaxel, tislelizumab and sintilimab as combination therapeutics
with fruquintinib, such risks and uncertainties include
assumptions regarding the safety, efficacy, supply and continued
regulatory approval of these therapeutics. 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 HUTCHMED's
filings with the U.S. Securities and Exchange Commission, on AIM
and on The Stock Exchange of Hong Kong Limited. HUTCHMED 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.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo
on Overall Survival in Patients With Previously Treated Metastatic
Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA .
2018;319(24):2486-2496. doi: 10.1001/jama.2018.7855.
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