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UCB Media Room: Cimzia China Approval

INFORMATION REGLEMENTEE


[22/07/2019 | 07:00]
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** UCB announces approval of Cimzia=C2=A0in China
------------------------------------------------------------

=C2=B7 After receiving priority review in 2018, CIMZIA=C2=AE (certolizumab =
pegol) is now approved in China for the treatment of Moderate-to-Severe Rhe=
umatoid Arthritis=C2=A0
=C2=B7 CIMZIA approval in China reinforces UCB=E2=80=99s ongoing commitment=
to supporting patient value across China and to offering Chinese patients =
innovative medicines to help manage their disease

Brussels (Belgium), July 22, 2019 =E2=80=93 07:00 (CET): Belgium-based glob=
al bio-pharmaceutical company UCB today announced it has received an Import=
Drug License (IDL) from the National Medical Product Administration (NMPA)=
, enabling people living with moderate-to-severe rheumatoid arthritis to ac=
cess CIMZIA^=C2=AE (certolizumab pegol) in China. This approval provides th=
e first biologic therapy in UCB=E2=80=99s portfolio in China, allowing the =
company to transition its agile biopharmaceutical model into this important=
patient population.=C2=A0

The NMPA granted priority review for the approval of CIMZIA to treat modera=
te-to-severe RA in 2018, based on the therapeutic advantage seen with the t=
herapy. The submission was based on Phase 3 clinical trial results, RAPID-C=
and RAPID-C open-label extension (OLE), which demonstrated efficacy and sa=
fety for the approved indication in China. In the 24-week RAPID C study, Ci=
mzia in combination with methotrexate showed a rapid onset of response, sus=
tained effects in reducing the signs and symptoms of rheumatoid arthritis a=
nd improving physical function compared with methotrexate alone with an acc=
eptable safety profile in Chinese patients with rheumatoid arthritis and an=
inadequate response to methotrexate.^1=C2=A0 =C2=A0UCB also included in th=
e submission specific pregnancy and lactation information, based on finding=
s from two first-of-their-kind studies in women of childbearing age, CRIB a=
nd CRADLE, together with pregnancy outcomes data.

The results of the RAPID-C and RAPID-C OLE trials demonstrate the potential=
value of CIMZIA for Chinese patients.^2=C2=A0In addition, due to its uniqu=
e Fc-free molecular structure, CIMZIA is the only anti-TNF that has evidenc=
e from clinical studies from conception to late pregnancy and lactation.^3=
=C2=A0

Rheumatoid arthritis is three times more common in women than men. For wome=
n patients who have family plans, treatment planning is a key concern. The =
approval of Cimzia provides an exciting new choice for those affected by rh=
eumatoid arthritis in China, and especially for women of childbearing age,=
=E2=80=9D said Professor Li Zhanguo from Peking University People=E2=80=99s=
Hospital, Former President of Asia Pacific league of Associations for Rheu=
matology, Former Chair of Chinese Rheumatology Association.=C2=A0

=E2=80=9CUCB has a long heritage in rheumatology, with many years of clinic=
al experience with CIMZIA in moderate-to-severe rheumatoid arthritis, and w=
e are delighted to be bringing a new treatment option to Chinese patients l=
iving with this challenging chronic rheumatic condition. This approval is a=
lso important for Chinese women who need treatment options to manage their =
RA without compromising their plans for pregnancy and breastfeeding,=E2=80=
=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Patient Va=
lue Unit, UCB. "As a company, UCB is fully dedicated to delivering innovati=
ve medicines by connecting our science and research to the needs of patient=
s suffering from severe immunological conditions.=E2=80=9D=C2=A0

There are an estimated 5 million patients living with rheumatoid arthritis =
in China, with an age-adjusted prevalence of 0.28% (95% CI 0.19%, 0.41%), i=
ndicating a need for effective treatment options.^4=C2=A0 =C2=A0=C2=A0

UCB will ensure accelerated patient access to Cimzia=C2=AE through a pionee=
ring partnership with Cinkate, a well-established Chinese pharmaceutical co=
mpany in rheumatology. The leading digital solutions from Cinkate will help=
the alliance to gain patient insights and maximize Physician-Patient inter=
action for better disease management.

UCB has been present in China since 1996 and has a strong commitment to mak=
ing our novel medicines available to support patients living with severe di=
seases in the country. UCB=E2=80=99s innovative neurology drugs Neupro and =
Vimpat were approved in China in 2018. Additionally, in 2014, UCB inaugurat=
ed a new state of the art 13,000 m=C2=B2 manufacturing site in Zhuhai, whic=
h strengthened the company=E2=80=99s footprint in the country.=C2=A0

About CIMZIA^=C2=AE in the EU/EEA
In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate=
d for the treatment of moderate to severe active RA in adult patients inade=
quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu=
ding MTX.=C2=A0

CIMZIA can be given as monotherapy in case of intolerance to MTX or when co=
ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX=
is also indicated for the treatment of severe, active and progressive RA i=
n adults not previously treated with MTX or other DMARDs.

CIMZIA has been shown to reduce the rate of progression of joint damage as =
measured by X-ray and to improve physical function, when given in combinati=
on with MTX.

CIMZIA, in combination with MTX, is also indicated for the treatment of act=
ive psoriatic arthritis in adults when the response to previous DMARD thera=
py has been inadequate. CIMZIA can be given as monotherapy in case of intol=
erance to MTX or when continued treatment with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult patients with=
severe active axial spondyloarthritis (axSpA), comprising:=C2=A0

=C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w=
ho have had an inadequate response to, or are intolerant to non-steroidal a=
nti-inflammatory drugs (NSAIDs).=C2=A0
=C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS =
=E2=80=93 adults with severe active axSpA without radiographic evidence of =
AS but with objective signs of inflammation by elevated C-reactive protein =
(CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re=
sponse to, or are intolerant to NSAIDs.

CIMZIA is also indicated for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.=C2=A0

About CIMZIA^=C2=AE in Fertility, Pregnancy and Lactation in the EU/EEA
=C2=A0
Women of childbearing potential
The use of adequate contraception should be considered for women of childbe=
aring potential. For women planning pregnancy, continued contraception may =
be considered for 5 months after the last CIMZIA dose due to its eliminatio=
n rate, but the need for treatment of the woman should also be taken into a=
ccount (see below).
=C2=A0
Pregnancy
Data from more than 500 prospectively collected pregnancies exposed to CIMZ=
IA with known pregnancy outcomes, including more than 400 pregnancies expos=
ed during the first trimester, does not indicate a malformative effect of C=
IMZIA. However, the available clinical experience is too limited to, with a=
reasonable certainty, conclude that there is no increased risk associated =
with CIMZIA administration during pregnancy.
=C2=A0
Animal studies using a rodent anti-rat TNF=CE=B1 did not reveal evidence of=
impaired fertility or harm to the foetus. However, these are insufficient =
with respect to human reproductive toxicity. Due to its inhibition of TNF=
=CE=B1, CIMZIA administered during pregnancy could affect normal immune res=
ponse in the newborn.
=C2=A0
CIMZIA should only be used during pregnancy if clinically needed. Non-clini=
cal studies suggest low or negligible level of placental transfer of a homo=
logue Fab-fragment of certolizumab pegol (no Fc region).
=C2=A0
In a clinical study 16 women were treated with certolizumab pegol (200 mg e=
very 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol =
plasma concentrations measured in 14 infants at birth were Below the Limit =
of Quantification (BLQ) in 13 samples; one was 0.042 =C2=B5g/ml with an inf=
ant/mother plasma ratio at birth of 0.09%. At Week 4 and Week 8, all infant=
concentrations were BLQ. The clinical significance of low levels certolizu=
mab pegol for infants is unknown. It is recommended to wait a minimum of 5 =
months following the mother's last CIMZIA administration during pregnancy b=
efore administration of live or live-attenuated vaccines (e.g. BCG vaccine)=
, unless the benefit of the vaccination clearly outweighs the theoretical r=
isk of administration of live or live-attenuated vaccines to the infants.
=C2=A0
Breastfeeding
In a clinical study in 17 lactating women treated with CIMZIA, minimal tran=
sfer of certolizumab pegol from plasma to breast milk was observed. The per=
centage of the maternal certolizumab pegol dose reaching an infant during a=
24 hour period was estimated to 0.04% to 0.30%. In addition, since certoli=
zumab pegol is a protein that is degraded in the gastrointestinal tract aft=
er oral administration, the absolute bioavailability is expected to be very=
low in a breastfed infant. Consequently, CIMZIA can be used during breastf=
eeding.

Important Safety Information about CIMZIA^=C2=AE in the EU/EEA=C2=A0
Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. The commonly repor=
ted adverse reactions (1-10%) in clinical trials with Cimzia=C2=AE =C2=A0an=
d post-marketing were viral infections (includes herpeszoster, papillomavir=
us, influenza), bacterial infections (including abscess), rash, headache (i=
ncluding migraine), asthaenia, leukopaenia (including lymphopaenia, neutrop=
aenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormali=
ties, hypertension, pruritus (any sites), hepatitis (including hepatic enzy=
me increase), injection site reactions, and nausea. Serious adverse reactio=
ns include sepsis, opportunistic infections, tuberculosis (including miliar=
y, disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, so=
lid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart f=
ailure), ischemic coronary artery disorders, pancytopaenia, hypercoagulatio=
n (including thrombophlebitis, pulmonary embolism), cerebrovascular acciden=
t, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impair=
ment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.=
4% of patients discontinued taking Cimzia^=C2=AE due to adverse events vs. =
2.7% for placebo.

Cimzia^=C2=AE is contraindicated in patients with hypersensitivity to the a=
ctive substance or any of the excipients, active tuberculosis or other seve=
re infections such as sepsis or opportunistic infections and moderate to se=
vere heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati=
ents receiving Cimzia^=C2=AE. Some of these events have been fatal. Monitor=
patients closely for signs and symptoms of infections including tuberculos=
is before, during and after treatment with Cimzia^=C2=AE. Treatment with Ci=
mzia must not be initiated in patients with a clinically important active i=
nfection. If an infection develops, monitor carefully and stop Cimzia^=C2=
=AE until the infection is controlled. Before initiation of therapy with Ci=
mzia=C2=AE, all patients must be evaluated for both active and inactive (la=
tent) tuberculosis infection. If active tuberculosis is diagnosed prior to =
or during treatment, Cimzia^=C2=AE therapy must not be initiated and must b=
e discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuber=
culosis therapy must be started before initiating treatment with Cimzia=C2=
=AE. Patients should be instructed to seek medical advice if signs/symptoms=
(e.g. persistent cough, wasting/weight loss, low grade fever, listlessness=
) suggestive of tuberculosis occur during or after therapy with Cimzia=C2=
=AE.=C2=A0

Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including Cimzia^=C2=AE who are chronic carriers of the virus (i.e. su=
rface antigen positive). Some cases have had a fatal outcome. Patients shou=
ld be tested for HBV infection before initiating treatment with Cimzia^=C2=
=AE. Carriers of HBV who require treatment with Cimzia^=C2=AE should be clo=
sely monitored and in the case of HBV reactivation Cimzia^=C2=AE should be =
stopped and effective anti-viral therapy with appropriate supportive treatm=
ent should be initiated.=C2=A0

TNF antagonists including Cimzia^=C2=AE may increase the risk of new onset =
or exacerbation of clinical symptoms and/or radiographic evidence of demyel=
inating disease, including multiple sclerosis; of formation of autoantibodi=
es and uncommonly of the development of a lupus-like syndrome; of severe hy=
persensitivity reactions. If a patient develops any of these adverse reacti=
ons, Cimzia^=C2=AE should be discontinued and appropriate therapy institute=
d.=C2=A0

With the current knowledge, a possible risk for the development of lymphoma=
s, leukaemia or other malignancies in patients treated with a TNF antagonis=
t cannot be excluded. Rare cases of neurological disorders, including seizu=
re disorder, neuritis and peripheral neuropathy, have been reported in pati=
ents treated with Cimzia^=C2=AE.=C2=A0

Adverse reactions of the haematologic system, including medically significa=
nt cytopaenia, have been reported with Cimzia^=C2=AE. Advise all patients t=
o seek immediate medical attention if they develop signs and symptoms sugge=
stive of blood dyscrasias or infection (e.g., persistent fever, bruising, b=
leeding, pallor) while on Cimzia^=C2=AE. Consider discontinuation of Cimzia=
=C2=AE therapy in patients with confirmed significant haematological abnorm=
alities.=C2=A0

The use of Cimzia^=C2=AE in combination with anakinra or abatacept is not r=
ecommended due to a potential increased risk of serious infections. As no d=
ata are available, Cimzia^=C2=AE should not be administered concurrently wi=
th live vaccines. The 14-day half-life of Cimzia^=C2=AE should be taken int=
o consideration if a surgical procedure is planned. A patient who requires =
surgery while on Cimzia=C2=AE should be closely monitored for infections.=
=C2=A0

Cimzia=C2=AE was studied in 325 patients with active axial spondyloarthriti=
s (axSpA) and in 409 patients with psoriatic arthritis (PsA) for up to 4 ye=
ars. The safety profile for axSpA and PsA patients treated with Cimzia^=C2=
=AE was consistent with the safety profile in RA and previous experience wi=
th Cimzia=C2=AE .=C2=A0

Cimzia^=C2=AE was studied in 1112 patients with psoriasis in controlled and=
open-label studies for up to 18 months. The safety profile of Cimzia=C2=AE=
400 mg every 2 weeks and Cimzia=C2=AE 200 mg every 2 weeks were generally =
similar.=C2=A0

Please consult the full prescribing information in relation to other side e=
ffects, full safety and prescribing information. European SmPC date of revi=
sion March 2019. https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO=
-2F12d8lSllQB1bgRcJUw8Y6HnHitlehmUp9p23N1ICSEkr9hUTj0vim7zTMmQo26bK8O-2BjuX=
88sB9OJdL3Ci054qpQT9GBqra6-2FDw0ibG27mjCbSf4S7UMr0tZzAfDuNLnfIXchRi4BuA-3D-=
3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTx=
d9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsAALNCzTgTqdBs7Z9NGnROoCyO7AK7gYff6RhVk=
FhN5EzqoDjvU2l7P8HWBKZw9C7xmcvMRxZMcSX2d7Ugb6g8eON16BnjT0OCAzIPgfsi-2BcIVA8=
wMcjNIkiiT2WnWW1iDkDdSUAVU9m42TlXFdkjMrGn792arGbDP-2FMM450MuXlhjNAZani2u7F4=
ZvvAv0qoS-2BLjq1sXpckMtPh5tfGClWfcScZObsaIR0H7-2BWqc2Abg7RdhGZEssSIIXK-2BBB=
PIApA-3D

CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.

For further information, UCB:

Corporate Communications
France Nivelle =C2=A0
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications

Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.levin@ucb.com=C2=A0

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases in immunol=
ogy and neurology. With approximately 7 500 people operating in 40 countrie=
s, the company generated revenue of =E2=82=AC 4.6 billion in 2018. UCB is l=
isted on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements=C2=A0
This press release contains forward-looking statements based on current pla=
ns, estimates and beliefs of management. All statements, other than stateme=
nts of historical fact, are statements that could be deemed forward-looking=
statements, including estimates of revenues, operating margins, capital ex=
penditures, cash, other financial information, expected legal, political, r=
egulatory or clinical results and other such estimates and results. By thei=
r nature, such forward-looking statements are not guarantees of future perf=
ormance and are subject to risks, uncertainties and assumptions which could=
cause actual results to differ materially from those that may be implied b=
y such forward-looking statements contained in this press release. Importan=
t factors that could result in such differences include: changes in general=
economic, business and competitive conditions, the inability to obtain nec=
essary regulatory approvals or to obtain them on acceptable terms, costs as=
sociated with research and development, changes in the prospects for produc=
ts in the pipeline or under development by UCB, effects of future judicial =
decisions or governmental investigations, product liability claims, challen=
ges to patent protection for products or product candidates, changes in law=
s or regulations, exchange rate fluctuations, changes or uncertainties in t=
ax laws or the administration of such laws and hiring and retention of its =
employees.=C2=A0

Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction. UCB is providing this information as of the date of this document an=
d expressly disclaims any duty to update any information contained in this =
press release, either to confirm the actual results or to report a change i=
n its expectations.

There is no guarantee that new product candidates in the pipeline will prog=
ress to product approval or that new indications for existing products will=
be developed and approved. Products or potential products which are the su=
bject of partnerships, joint ventures or licensing collaborations may be su=
bject to differences between the partners. Also, UCB or others could discov=
er safety, side effects or manufacturing problems with its products after t=
hey are marketed.

Moreover, sales may be impacted by international and domestic trends toward=
managed care and health care cost containment and the reimbursement polici=
es imposed by third-party payers as well as legislation affecting biopharma=
ceutical pricing and reimbursement.

References:

1.=C2=A0 L. Bi, Y. Li, L. He, H. Xu, Z. Jiang, Y. Wang, X. Li, W. Wei, J. G=
u, G. Wang, Z. Zhang, B. Zhou, Y. Liu, Z. Wu, H. Liu, D. He, Z. Lv, Z. Li, =
X. Zuo, L. Dong, H. Wu, H. Zhang, H. Chen, C. Bao, Z. Zhang, M. Zhang, H. S=
ong, Y. Zheng, L. Jiang, X. Liu, M. Boehnlein, J. Dunkel, J. Shao, K. Harri=
s, Z. Li. Clin Exp Rheumatol. 2019; 37(2):227-234. Epub 2018 Aug 29.

2=C2=A0 Bi L, Li Y, He L, Xu H, Gu J, Wang G, Zhang Z, Liu Y, Boehnlein M, =
Dunkel J, Shao J, Harris K, Li Z. Rapid Onset of Response Observed with Cer=
tolizumab Pegol in Rheumatoid Arthritis Patients with Inadequate Response t=
o Methotrexate: Efficacy and Safety Results of a Randomized, Double-Blind, =
Placebo-Controlled Phase 3 Study [abstract]. Arthritis Rheumatol. 2017; 69 =
(suppl 10)

2.=C2=A0 RAPID-C OLE. Clinical Study Report. Data on File. UCB. 2018.

3.=C2=A0 Mariette X, Forger F, Abraham B, et al. Ann Rheum Dis Published On=
line First: 13 October 2017. doi:10.1136/annrheumdis-2017-212196

3.=C2=A0 Clowse ME, F=C3=B6rger F, Hawng C, et al. Minimal to no transfer o=
f certolizumab pegol into breast milk: results from CRADLE, a prospective, =
postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;0:1=
=E2=80=937.

4.=C2=A0 Ru Li, Jian Sun, Li-Min Ren, Hong-Yu Wang, Wen-Hong Liu, Xue-Wu Zh=
ang, Shi Chen, Rong Mu, Jing He, Yi Zhao, Li Long, Yan-Ying Liu, Xia Liu, X=
iao-Lan Lu, Yu-Hui Li, Shi-Yao Wang, Si-Si Pan, Chun Li, Hong-Yuan Wang and=
Zhan-Guo Li. Epidemiology of eight common rheumatic diseases in China: a l=
arge-scale cross-sectional survey in Beijing. Rheumatology 2012;51:721 729.

GenericFile
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