Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the 2023 National Reimbursement Drug List (NRDL) released by
China’s National Healthcare Security Administration (NHSA) has been
updated to include the following medicines and indications:
- VYVGART® (efgartigimod alfa injection) is included for
the first time in the NRDL for the treatment of adult patients with
generalized myasthenia gravis (gMG) who are anti-acetylcholine
receptor (AChR) antibody positive;
- NUZYRA® (omadacycline) is included for its oral
formulation for the treatment of adults with community-acquired
bacterial pneumonia (CABP) and acute bacterial skin and skin
structure infections (ABSSSI); and
- ZEJULA® (niraparib) is renewed for the maintenance
treatment of adult patients with platinum-sensitive, first-line and
recurrent ovarian cancer.
“The initial NRDL inclusion for VYVGART is an especially
important milestone for gMG patients and underscores the clinical
value Zai Lab is delivering to the medical community and to
patients in China,” said William Liang, Chief Commercial Officer of
Zai Lab. “The addition of both VYVGART and NUZYRA (oral
formulation) to the NRDL, as well as the renewal of previously
included indications for ZEJULA, further supports patient access to
these important medications throughout China at reduced prices,
which significantly lower the cost of treatment for patients and
their families.”
“A key part of Zai Lab’s mission is to bring innovative
medicines to patients with significant unmet medical needs in China
and around the world,” said Josh Smiley, President and Chief
Operating Officer of Zai Lab. “We are pleased that we now have four
products included in the NRDL, and we will continue our efforts to
expand patient access to our innovative treatments, including
through NRDL coverage of different indications and formulations for
our commercial products. We are grateful for this action by the
NHSA, and we look forward to continuing to work with the NHSA to
improve patient access and costs for high-quality treatments in
China.”
About Myasthenia Gravis in China
Myasthenia gravis (MG) is a chronic autoimmune disease,
characterized by debilitating and potentially life-threatening
muscle weakness. There are approximately 170,000 people in China
living with gMG1, and of those patients, 85% are estimated to have
confirmed AChR antibodies; in this generalized form of the disease,
skeletal muscles throughout the body may be affected, resulting in
weakness and early fatigue. Difficulties with double vision, facial
expression, speech, swallowing, and ambulation are frequent and
difficult to manage for patients and treating physicians. In more
life-threatening cases, gMG can affect the muscles responsible for
breathing, which can be fatal. Acetylcholinesterase (AChE)
inhibitors, steroids, immunosuppressants, and IVIg are the mainstay
of treatment in China. These drugs often achieve only partial
restoration of strength.
1 The growing burden of generalized myasthenia gravis: a
population-based retrospective cohort study in Taiwan, 2023.
About VYVGART
VYVGART is an antibody fragment designed to reduce
disease-causing immunoglobulin G (IgG) antibodies and block the IgG
recycling process. Efgartigimod binds to the neonatal Fc receptor
(FcRn), which is widely expressed throughout the body and plays a
central role in rescuing IgG antibodies from degradation.
The National Medical Products Administration (NMPA) approved
VYVGART as an add on to standard therapy for the treatment of adult
patients with gMG who are anti-AChR antibody positive in June 2023.
VYVGART is the first approved FcRn blocker in China. We
commercially launched VYVGART in China in September 2023.
Zai Lab has an exclusive license from argenx to develop and
commercialize efgartigimod in mainland China, Hong Kong, Macau, and
Taiwan (Greater China).
About CABP and ABSSSI in China
CABP is the most common type of pneumonia that is acquired
outside of the hospital. It is one of the most common infectious
diseases and is a significant cause of mortality and morbidity
worldwide. ABSSSI are bacterial infections of skin and associated
soft tissues, such as loose connective tissue and mucous membranes.
ABSSSI are common and encompass a variety of disease presentations
and degrees of severity. In 2020, the estimated incidence of CABP
in mainland China was approximately 10 million patients2, and in
2015, the estimated incidence of ABSSSI was 2.8 million patients3.
There are significant unmet needs for broad-spectrum antibiotics
addressing multi-drug resistance (MDR) infections with a favorable
safety profile.
2 Incidence of community-acquired pneumonia in urban China: A
national population-based study, 2020. 3 2015 estimates, Zai Lab
analysis.
About NUZYRA
NUZYRA, a novel tetracycline-class antibacterial with both
once-daily oral and IV formulations, is specifically designed to
overcome tetracycline resistance and to improve activity across a
broad spectrum of bacterial infections, such as those caused by
Gram-positive, Gram-negative, atypical, and many other
pathogens.
The NMPA approved NUZYRA as a Category 1 innovative drug for
both oral and IV formulations for the treatment of CABP and ABSSSI
in adult patients in December 2021. It was included in the NRDL for
the first time in January 2023 for the treatment of CABP and ABSSSI
for IV formulation, and it will be added to the NRDL in January
2024 for the treatment of CABP and ABSSSI for oral formulation.
Zai Lab has an exclusive license from Paratek Pharmaceuticals,
Inc. to develop, manufacture, and commercialize NUZYRA in Greater
China.
About Ovarian Cancer in China
Ovarian cancer is one of the most common gynecologic cancers in
China, with over 55,000 newly diagnosed cases and 37,000 deaths in
China annually4. While platinum-based chemotherapy is effective at
inducing an initial response in ovarian cancer, the disease will
recur in the majority of women. Effective treatment options for
patients with platinum-sensitive recurrent ovarian cancer remain
limited. New agents that prolong the duration of response following
first-line platinum-based treatment and delay the relapse of
ovarian cancer will benefit patients with ovarian cancer in
China.
4 Globocan 2020.
About ZEJULA
ZEJULA (niraparib) is an oral, once-daily small-molecule poly
(ADP-ribose) polymerase (PARP) 1/2 inhibitor. A PARP inhibitor
blocks the ability of cancer cells to repair themselves after they
have been damaged by radiation and certain chemotherapies. This
inhibition of DNA damage repair can result in the inability of
cancer cells to replicate themselves and in programmed cell death.
Tumors that are deficient in key DNA damage repair pathways, such
as BRCA1 mutant tumors, are particularly sensitive to ZEJULA. As
maintenance therapy, ZEJULA is for women who have had prior
chemotherapy treatment but are at high risk of cancer recurrence.
ZEJULA is intended to avoid or slow a recurrence of the cancer if
it is in remission after prior treatment. In the maintenance
setting, ZEJULA does not require the addition of radiation or
chemotherapies to kill tumor cells.
As a first-line monotherapy maintenance treatment of patients
with epithelial ovarian, fallopian tube, or primary peritoneal
cancer (collectively, ovarian cancer) following a response to
platinum-based chemotherapy, ZEJULA was approved by the NMPA in
September 2020 and included in the NRDL in December 2021.
As a maintenance treatment of patients with platinum sensitive
recurrent ovarian cancer, ZEJULA was approved by the NMPA in
December 2019 and included in the NRDL in December 2020.
Zai Lab has an exclusive license from GlaxoSmithKline to develop
and commercialize ZEJULA in mainland China, Hong Kong, and
Macau.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. We are focused on discovering,
developing, and commercializing innovative products that address
medical conditions with significant unmet needs in the areas of
oncology, autoimmune disorders, infectious diseases, and
neuroscience. Our goal is to leverage our competencies and
resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about
future expectations, plans, and prospects for Zai Lab, including,
without limitation, statements relating to the benefits of and
increased patient access to VYVGART (efgartigimod alfa injection),
NUZYRA (omadacycline), and ZEJULA (niraparib); the treatment of
gMG, CAPB, and ovarian cancer in Greater China; and regulatory
discussions, submissions, filings, and approvals and the timing
thereof. These forward-looking statements may contain words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” “would,” and other similar expressions. Such
statements constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are not statements of historical fact or
guarantees or assurances of future performance. Forward-looking
statements are based on our expectations and assumptions as of the
date of this press release and are subject to inherent
uncertainties, risks and changes in circumstances that may differ
materially from those contemplated by the forward-looking
statements. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including but not limited to (1) our ability to
successfully commercialize and generate revenue from our approved
products; (2) our ability to obtain funding for our operations and
business initiatives, (3) the results of our clinical and
pre-clinical development of our product candidates, (4) the content
and timing of decisions made by the relevant regulatory authorities
regarding regulatory approvals of our product candidates, (5) risks
related to doing business in China, and (6) other factors
identified in our most recent annual and quarterly reports and in
other reports we have filed with the U.S. Securities and Exchange
Commission. We anticipate that subsequent events and developments
will cause our expectations and assumptions to change, and we
undertake no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by law. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.sec.gov.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231212284668/en/
For more information, please contact:
Investor Relations: Christine Chiou / Lina Zhang
+1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen +1 (415) 317-7255 /
+86 185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Zai Lab (NASDAQ:ZLAB)
Historical Stock Chart
From Apr 2024 to May 2024
Zai Lab (NASDAQ:ZLAB)
Historical Stock Chart
From May 2023 to May 2024