RCS - Hutchmed China Ltd - Approval to Commercialize ELUNATE® in Macau

HUTCHMED (China)Announcement

01/03/2022 08:30

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RNS Number : 1715D  Hutchmed (China) Limited  01 March 2022

Press Release

 

HUTCHMED Receives Approval to Commercialize ELUNATE(®) 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 (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has received approval to market fruquintinib
(ELUNATE(®) 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(®) will become the first homegrown
innovative oncology drug to be marketed in Macau based on its approval by the
NMPA.

 

Dr. 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(®), based on China clinical trial data.  We now
look forward to patients in Macau having full access to ELUNATE(®) 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(®). It was included in the China National
Reimbursement Drug List (NRDL) in January 2020. ELUNATE(®) 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
(https://jamanetwork.com/journals/jama/fullarticle/2685988)  in The Journal
of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov
identifier: NCT02314819 (https://clinicaltrials.gov/ct2/show/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
(https://www.hutch-med.com/fruquintinib-granted-us-fda-fast-track-designation-for-mcrc/)
. 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
(https://clinicaltrials.gov/ct2/show/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 fruquintinib combined with paclitaxel for second-line
treatment of advanced gastric or esophagogastric junction ("GEJ")
adenocarcinoma. 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
(https://clinicaltrials.gov/ct2/show/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(®) 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
(https://clinicaltrials.gov/ct2/show/NCT04577963) . Safety and preliminary
efficacy of fruquintinib were demonstrated in advanced solid tumors, including
TNBC, in a Phase I study conducted in China (NCT01645215
(https://clinicaltrials.gov/ct2/show/NCT01645215) ) and a Phase I/Ib study is
ongoing in the United States (NCT03251378
(https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/NCT03903705) . Preliminary results of
certain cohorts were presented
(https://www.hutch-med.com/csco-2021-highlights/) 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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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 (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)

HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick

                                    HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

 

 

 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. (https://doi.org/10.1001/jama.2018.7855)

 

 

 

 

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