TIDMHCM
RNS Number : 4451C
Hutchmed (China) Limited
18 June 2021
HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda(R) in
China) for Advanced Pancreatic Neuroendocrine Tumors
- Second New Drug Application ("NDA") approved for Sulanda in
China -
- The pivotal Phase III SANET-p trial demonstrated surufatinib
reduced risk of progression or death by 51% in patients with
advanced pancreatic NET -
Hong Kong, Shanghai, & Florham Park, NJ: Friday, June 18,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today
announces that surufatinib has been granted approval for drug
registration by the National Medical Products Administration of
China ("NMPA") for the treatment of advanced pancreatic
neuroendocrine tumors ("pNETs"). This follows the approval of
surufatinib in China in December 2020 for the treatment of advanced
extra-pancreatic (non-pancreatic) neuroendocrine tumors
("epNETs").
The Company was made aware through the website of the NMPA that
surufatinib's approval for drug registration by the NMPA for the
treatment of pNETs was completed and is now pending
certification.
Christian Hogg, Chief Executive Officer of HUTCHMED, commented,
"Since its launch in January this year, patients with epNETs have
benefited from treatment with surufatinib through its unique mode
of action by both inhibiting angiogenesis and promoting the body's
immune response against tumor cells. With today's approval, we are
now able to provide this unique therapy to NET patients with
pancreatic tumor origin as well."
Surufatinib is marketed in China under the brand name Sulanda(R)
.
HUTCHMED's oncology commercial team today covers more than 2,500
hospitals across China. The team is led by a leadership team highly
experienced in oncology products commercialization in China with
deep knowhow in the field of NETs.
This NMPA approval was supported by the SANET-p study, a Phase
III pivotal study (clinicaltrials.gov identifier: NCT02589821) in
patients with advanced pancreatic NETs conducted in China. The
study met the pre-defined primary endpoint of progression-free
survival ("PFS") at a preplanned interim analysis and was stopped
early. The positive results of this trial were highlighted in an
oral presentation at the 2020 ESMO Congress and published in The
Lancet Oncology ([1]) in September 2020. Median PFS was 10.9 months
for patients treated with surufatinib, as compared to 3.7 months
for patients in the placebo group (hazard ratio ["HR"] 0.491; 95%
confidence interval ["CI"] 0.391-0.755; p =0.0011). Benefit was
observed across most major subgroups of pNET patients. The safety
profile of surufatinib was manageable and consistent with
observations in prior studies. Treatment was well tolerated for
most patients, with discontinuation rates as a result of treatment
emergent adverse events of 10.6% in the surufatinib group as
compared to 6.8% in the placebo group.
In China, there were an estimated 71,300 newly diagnosed NET
patients in 2020. Considering the current incidence to prevalence
ratio, there may be as many as 300,000 patients living with the
disease. [2]
About NETs
NETs form in cells that interact with the nervous system or in
glands that produce hormones. They can originate in various parts
of the body, most often in the gut or the lungs and can be benign
or malignant. NETs are typically classified as pNET or epNET.
Approved targeted therapies include Sutent(R) (for pNET only) and
Afinitor(R) for pNET and well-differentiated, non-functional
gastrointestinal or lung NET.
According to Frost and Sullivan, there were 19,700 newly
diagnosed cases of NETs in the U.S. in 2020. Importantly, NETs are
associated with a relatively long duration of survival compared to
other tumors.
About Surufatinib (Sulanda(R) in China)
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,
where there may be synergistic anti-tumor effects.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About Other Surufatinib Development
NETs in the U.S. and Europe: In the U.S., surufatinib was
granted Fast Track Designations for development in pNET and epNET
in April 2020, and Orphan Drug Designation for pNET in November
2019. A U.S. FDA NDA was submitted on April 30, 2021 , and a MAA
submission to the European Medicines Agency (EMA) is planned. The
basis to support these filings includes the completed SANET-ep and
SANET-p studies, along with existing data from surufatinib in U.S.
epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937
).
epNETs in China: On December 30, 2020, surufatinib was granted
drug registration approval by the NMPA for the treatment of epNET.
Surufatinib is marketed in China under the brand name Sulanda(R) .
The approval was based on results from the SANET-ep study, a Phase
III trial (clinicaltrials.gov identifier: NCT02588170 ) in patients
with advanced epNETs conducted in China. The study met the
pre-defined primary endpoint of PFS at a preplanned interim
analysis. The positive results of this trial were highlighted in an
oral presentation at the 2019 ESMO Congress and published in The
Lancet Oncology in September 2020. [3] Median PFS was significantly
longer for patients treated with surufatinib at 9.2 months,
compared to 3.8 months for patients in the placebo group (HR 0.334;
95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable
safety profile, with the most common treatment-related adverse
events of grade 3 or worse being hypertension (36% of surufatinib
patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and
anemia (5% vs. 3%).
Biliary tract cancer in China: In March 2019, HUTCHMED 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: HUTCHMED entered into collaboration
agreements to evaluate the safety, tolerability and efficacy of
surufatinib in combination with anti-PD-1 monoclonal antibodies,
including with tislelizumab (BGB-A317), Tuoyi (R) (toripalimab) and
Tyvyt (R) (sintilimab), which are approved as monotherapies in
China.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech)
is an innovative, commercial-stage, biopharmaceutical company. It
is committed to the discovery and global development and
commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. A dedicated
organization of over 1,300 personnel has advanced ten cancer drug
candidates from in-house discovery into clinical studies around the
world, with its first two oncology drugs now approved and launched.
For more information, please visit: www.hutch-med.com or follow us
on LinkedIn.
Forward-Looking Statements
This announcement 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 commercial launch
of surufatinib in China, the ability of its in-house oncology sales
team to distribute surufatinib quickly and broadly, the potential
market for surufatinib in NET patients in China, and the further
clinical development for surufatinib in these and other indications
in China, the United States and other jurisdictions.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding HUTCHMED's ability to commercialize surufatinib, the
benefits obtained from surufatinib during clinical trials being the
same for all patients who are prescribed surufatinib, no
unidentified side effects occurring which could result in the NMPA
pulling surufatinib from the market, HUTCHMED's ability to fund,
implement and complete its further clinical development and
commercialization plans for surufatinib, 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 capecitabine, tislelizumab,
Tuoyi(R), and Tyvyt(R) as combination therapeutics with
surufatinib, 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 and on AIM. HUTCHMED
undertakes no obligation to update or revise the information
contained in this announcement, whether as a result of new
information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
HUTCHMED@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
HUTCHMED@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Xu J, Shen L, Bai C, et al. Surufatinib in advanced
pancreatic neuroendocrine tumours (SANET-p): a randomised,
double-blind, placebo-controlled, phase 3 study [published online
ahead of print, 2020 Sep 20].
Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9 .
[2] According to Frost & Sullivan. The current incidence to
prevalence ratio in China is estimated at 4.4, lower than the 7.4
ratio in the U.S. due to lower access to treatment options.
[3] 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 of print, 2020 Sep 20]. Lancet Oncol. 2020;
S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4 .
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