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Hutchison China Meditech Limited
29 December 2020
Press Release
Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for
Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
- Company plans to complete rolling submission in the first half
of 2021 -
- The pivotal Phase III SANET-ep trial demonstrated surufatinib
reduced risk of progression or death 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 51%, extending PFS of
pancreatic NET patients with an acceptable risk/benefit ratio -
- First NDA submission by Chi-Med in the United States -
Hong Kong, Shanghai, & Florham Park, NJ: Monday, December
28, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that it has initiated the filing of a New Drug
Application ("NDA") to the U.S. Food and Drug Administration
("FDA") - the first portion of a rolling submission for surufatinib
for the treatment of pancreatic and non-pancreatic neuroendocrine
tumors ("NET"). Chi-Med plans to complete the NDA submission in the
first half of 2021, which would be the company's first NDA in the
U.S.
The Fast Track Designation granted earlier this year by the FDA
permits the company to submit sections of the NDA on a rolling
basis. The NDA is supported by data from the two positive Phase III
studies of surufatinib in NET in China, along with data from
surufatinib studies in U.S. non-pancreatic and pancreatic NET
patients. The company previously announced that it had reached an
agreement with the FDA during a pre-NDA meeting, whereby these
studies may serve as the basis to support an NDA submission. Filing
acceptance of the NDA is subject to FDA review of the complete
application. The data package will also be used to file a Marketing
Authorization Application ("MAA") to the European Medicines Agency
("EMA") in 2021, based on scientific advice from the EMA's
Committee for Medicinal Products for Human Use (CHMP).
Marek Kania, M.D., Managing Director and Chief Medical Officer
of Hutchison MediPharma International, said, "With the initiation
of our first regulatory filing in the U.S., we are executing our
strategy of building a global pharmaceutical company that brings
innovative cancer therapies to patients worldwide. There is a great
need for additional therapies to treat neuroendocrine tumors, and
surufatinib has demonstrated significant clinical benefit in
patients with advanced tumors. The NDA filing to the U.S. FDA
represents a significant step toward our goal of commercializing
surufatinib and other novel therapies globally."
The company plans to initiate an Expanded Access Protocol to
ensure patients with limited therapeutic options have access to
this important treatment. Enrollment into this early access program
is anticipated to begin in the first quarter of 2021, once
regulatory clearance of the protocol has been granted by the
FDA.
The FDA granted two Fast Track Designations to surufatinib for
development in pancreatic and non-pancreatic (extra-pancreatic) NET
in April 2020 and Orphan Drug Designation for pancreatic NET in
November 2019.
About NET
NET 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. NET are typically classified as pancreatic NET or
non-pancreatic NET. Approved targeted therapies include Sutent(R)
and Afinitor(R) for pancreatic NET, or well-differentiated,
non-functional gastrointestinal or lung NET.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2018. Importantly, NET are
associated with a relatively long duration of survival compared to
other tumors. As a result, there were approximately 141,000
estimated patients living with NET in the U.S. in 2018.[1]
About Surufatinib
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.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NET in the U.S., Europe and Japan: 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. A U.S. FDA NDA
submission was initiated in December 2020, to be followed by a MAA
submission to the EMA in Europe. The basis to support these filings
includes the completed SANET-ep and SANET-p[2] studies, along with
existing data from surufatinib in U.S. non-pancreatic and
pancreatic NET patients (clinicaltrials.gov identifier:
NCT02549937).
Non-pancreatic NET in China: In November 2019, a NDA for
surufatinib for the treatment of patients with advanced
non-pancreatic NET was accepted for review by the National Medical
Products Administration of China ("NMPA") and granted Priority
Review status in December 2019. The NDA is supported by data from
the successful SANET-ep[3] study, a Phase III trial
(clinicaltrials.gov identifier: NCT02588170 ) in patients with
advanced non -pancreatic NETs conducted in China. The study had met
the pre-defined primary endpoint of progression-free survival ("
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.[4] SANET-ep demonstrated that surufatinib reduces risk of
progression or death by 67%, with median PFS 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
risk/benefit ratio.
Pancreatic NET 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. It was
terminated early as the pre-defined primary endpoint of PFS was met
(clinicaltrials.gov identifier: NCT02589821) at a preplanned
interim analysis, leading to a second NDA accepted by the China
NMPA in September 2020. The positive results of this study were
presented at the 2020 ESMO Virtual Congress and published
simultaneously in The Lancet Oncology [5] , demonstrating that
surufatinib reduces the risk of disease progression or death by 51%
in patients, with median PFS of 10.9 months compared to 3.7 months
on placebo (HR 0.491; 95% CI: 0.391-0.755; p =0.0011). The safety
profile of surufatinib was manageable and consistent with
observations in prior studies.
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: We have 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 Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
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 nine 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.
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 Chi-Med's current expectations regarding future
events, including its expectations regarding the submission of an
NDA for surufatinib for the treatment of NET with the FDA and the
timing of such submission, the therapeutic potential of surufatinib
for the treatment of patients with NET and the further clinical
development of surufatinib 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 NDA approval
of surufatinib for the treatment of patients with NET in the U.S.,
China and other jurisdictions such as the E.U., its potential to
gain expeditious approvals from regulatory authorities, the safety
profile of surufatinib, Chi-Med'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 Chi-Med's filings 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.
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)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] According to Frost & Sullivan, in 2018, there were
19,000 newly diagnosed cases of NETs in the U.S. and an estimated
141,000 patients living with NETs. 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.
[2] Surufatinib in advanced neuroendocrine tumors -
pancreatic.
[3] Surufatinib in advanced neuroendocrine tumors -
extra-pancreatic.
[4] 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 .
[5] 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 .
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