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REG - Hutchmed China Ltd - HUTCHMED Receives CRL from the US FDA

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RNS Number : 9827J  Hutchmed (China) Limited  03 May 2022

This announcement was first released at 11:00 BST on Monday, 2 May 2022 via
Globe Newswire (https://www.globenewswire.com/en/news-release/2022/05/02/2433243/0/en/HUTCHMED-Receives-Complete-Response-Letter-from-the-U-S-FDA-for-Surufatinib-for-the-Treatment-of-Advanced-Neuroendocrine-Tumors.html)
 and also submitted to the Hong Kong stock exchange. It has been uploaded to RNS following the reopening of the service after the early May Bank Holiday which took place on Monday, 2 May 2022 in the UK



HUTCHMED Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors


Recording of conference call held on 2 May 2022 available on HUTCHMED's


Hong Kong, Shanghai & Florham Park, NJ - Monday, May 2, 2022: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) " or the "Company")
(Nasdaq/AIM:HCM; HKEX:13) announced that the U.S. Food and Drug Administration
("FDA" or the "Agency") has issued a Complete Response Letter ("CRL")
regarding the New Drug Application ("NDA") for surufatinib for the treatment
of pancreatic ("pNETs") and extra-pancreatic (non-pancreatic, "epNETs")
neuroendocrine tumors ("NETs"). FDA determined that the current data package,
based on two positive Phase III trials in China and one bridging study in the
United States (U.S.), does not support an approval in the U.S. at this time.
The CRL indicated that a multi-regional clinical trial ("MRCT") is required
for U.S. approval.


The safety and efficacy of surufatinib, an oral inhibitor of angiogenesis and
immune modulation, was demonstrated in the SANET-p and SANET-ep studies, two
randomized double-blind Phase III trials in patients with advanced pNETs and
epNETs conducted in China. Results of a HUTCHMED sponsored bridging study
conducted in the U.S. suggest similar safety and efficacy to the SANET study
population in China. Surufatinib was approved in China for the treatment of
pNETs and epNETs in June 2021 and December 2020, respectively.


Surufatinib received U.S. FDA Fast Track Designations in April 2020 for the
treatment of pNETs and epNETs. Orphan Drug Designation for pNETs was granted
in November 2019. In a May 2020 pre-NDA meeting, HUTCHMED reached an agreement
with the FDA that the two positive Phase III studies of surufatinib in
patients with pNETs and epNETs in China, along with the bridging trial in the
U.S. could form the basis to support a U.S. NDA submission. The FDA accepted
the filing of the NDA on June 30, 2021.


The FDA evaluated the applicability of the SANET studies data generated in one
country to U.S. patients and U.S. medical practice. The CRL stated that the
FDA will require a MRCT that includes subjects more representative of the US
patient population and aligned to current U.S. medical practice. In addition,
pandemic-related issues concerning inspection scheduling and access
contributed to the FDA action. This action by the FDA is not related to any
safety issues with surufatinib. HUTCHMED is working with the FDA to evaluate
next steps.


Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, commented: "Although this decision from the FDA is disappointing, we
remain confident about the clinical value of surufatinib for NET patients and
committed to making surufatinib available to patients globally. We look
forward to working with the Agency to evaluate its feedback. Throughout the
duration of the U.S. review process, we have been transparent and
collaborative with the FDA. There are very few treatments approved and used in
these rare diseases, and patients and physicians would benefit from more
options to address the unmet medical need. We look forward to continued
engagement with the FDA on developing a plan to bring surufatinib to patients
in the U.S."


HUTCHMED International, headquartered in Florham Park, New Jersey, drives
clinical and regulatory development in the US, Europe and Japan. Dr Marek
Kania, Executive Vice President, Managing Director and Chief Medical Officer
of HUTCHMED International, commented: "Our global development strategy remains
unchanged. Outside of the U.S. and China, we remain committed to engaging with
regulators in Europe, where our Marketing Authorization Application ("MAA")
submission for surufatinib is under review, and in Japan where we have an
ongoing Japanese bridging study. Furthermore, our foundational approach is to
conduct multi-regional registration trials, such as our 14-country,
691-patient FRESCO-2 Phase III trial for fruquintinib for patients with
metastatic colorectal cancer which is expected to read-out in the second half
of this year."


Conference call

HUTCHMED hosted a conference call at 8:00 am EDT / 1:00 pm BST / 8:00 pm HKT
on Monday, May 2, 2022. A recording of this is available via HUTCHMED's
website at www.hutch-med.com/event/ (https://www.hutch-med.com/event/) .


About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with vascular endothelial
growth factor receptors (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 Surufatinib Development

epNETs in China: On December 29, 2020, surufatinib was granted drug
registration approval
in China for the treatment of epNET. Surufatinib is marketed in China under
the brand name SULANDA(®). The approval was based on results from the
SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170
(https://clinicaltrials.gov/ct2/show/NCT02588170) ) in patients with advanced
epNETs conducted in China. The study met the pre-defined primary endpoint of
PFS at a preplanned interim analysis, and was published
in The Lancet Oncology 1 . 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%).


pNETs in China: On June 16, 2021, surufatinib was granted drug registration
(https://www.hutch-med.com/nmpa-approval-of-surufatinib-for-advanced-pnet/) in
China for the treatment of pNET. The approval was based on results from the
SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821
(https://clinicaltrials.gov/ct2/show/NCT02589821) ) in patients with advanced
pNET in China. The pre-defined primary endpoint of PFS was met
at a preplanned interim analysis and was published
in The Lancet Oncology 2 , demonstrating that surufatinib reduces the risk of
disease progression or death by 51% in patients, with a 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.


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) and TUOYI®
(toripalimab), which are approved as monotherapies in China.


NETs in Europe: An MAA submission to the EMA was validated in July 2021, which
includes data from a U.S. Phase I/II study, as well as the completed Phase III
SANET-ep and SANET-p studies used to support marketing authorization in China.


NETs in Japan: A Japan registration-enabling bridging study was initiated in
September 2021. Based on dialogue with the Japanese Pharmaceuticals and
Medical Devices Agency (PMDA), it was agreed that a Japanese NDA include
results from a pivotal study to be conducted in Japan.


The surufatinib Expanded Access Protocol (EAP) in the U.S. will no longer
allow new patients to enroll in the study.



HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) 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. It has more than 4,600
personnel across all its companies, at the center of which is a team of over
1,600 in oncology/immunology. Since inception it has advanced 12 cancer drug
candidates 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 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
therapeutic potential of surufatinib for the treatment of patients with NETs
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 NETs in the U.S.,E.U., China, Japan and other
jurisdictions , its potential to gain approvals from regulatory authorities on
an expediated basis or at all, the safety profile of surufatinib, 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 regulators' ability to access and inspect
clinical sites in China, and on general economic, regulatory and political
conditions. In addition, as certain studies rely on the use of tislelizumab,
and TUOYI(®) 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, on AIM and on The Stock Exchange of Hong Kong Limited.
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 (as it forms part of retained EU law as defined in
the European Union (Withdrawal) Act 2018).


 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)

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

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

Panmure Gordon (UK) Limited



 1    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. Lancet Oncol. 2020;21(11):1500-1512. doi:
10.1016/S1470-2045(20)30496-4 (https://doi.org/10.1016/S1470-2045(20)30496-4)

 2    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. Lancet Oncol. 2020; 21(11):1489-1499. doi:
10.1016/S1470-2045(20)30493-9 (https://doi.org/10.1016/S1470-2045(20)30493-9)

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