Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the
Center for Drug Evaluation (CDE) of the National Medical Products
Administration (NMPA) granted Breakthrough Therapy Designation for
efgartigimod alfa injection (subcutaneous injection) (efgartigimod
SC) for the treatment of patients with chronic inflammatory
demyelinating polyneuropathy (CIDP). The Breakthrough Therapy
Designation for efgartigimod SC was supported by data from both
global and Chinese patients enrolled in the ADHERE study.
“In granting Breakthrough Therapy Designation, we are pleased to
see that the CDE recognizes the promise of efgartigimod SC as an
innovative treatment option for CIDP patients,” said Dr. Harald
Reinhart, President and Head of Global Development, Neuroscience,
Autoimmune & Infectious Diseases, Zai Lab. “We have seen how
efgartigimod SC can meaningfully improve and stabilize disease
symptoms in these patients. Existing treatment options are quite
limited, and problematic given the general reliance on long-term
steroid or chronic immunoglobulin therapy. In the ADHERE study,
significant efficacy was demonstrated with a favorable safety
profile. We are excited about the therapeutic potential of
efgartigimod SC in CIDP, and we look forward to working with
regulatory authorities in China to bring this important medicine to
patients in need as soon as possible.”
The Breakthrough Therapy Designation review
policy is designed to facilitate the development and expeditious
review of novel medicines that are intended for the prevention or
treatment of serious, life-threatening diseases or diseases that
severely impact the quality of life for which there is no existing
treatment, or where sufficient evidence indicates advantages of the
novel drug over currently available treatment options. Drugs
granted Breakthrough Therapy Designation receive priority
communications and guidance from the CDE to promote and expedite
the drug review process.
In July 2023, Zai Lab and argenx reported positive topline
results from the ADHERE study evaluating efgartigimod SC in adults
with CIDP.
- Primary endpoint met (p=0.000039); efgartigimod SC demonstrated
61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse
versus placebo.
- 67% of global study participants in open-label Stage A
demonstrated evidence of clinical improvement (ECI) indicating that
IgG autoantibodies play a significant role in the underlying
biology of CIDP.
- Safety and tolerability profile consistent with confirmed
safety profile of VYVGART.
In the subgroup analysis for ADHERE trial participants in China,
the results were consistent with global outcomes.
- The subgroup analysis of the mainland Chinese participants
demonstrated an impressive reduction in relapse risk by 69% with
efgartigimod SC compared to placebo.
- The mainland Chinese participants showed a similar level of
response compared to the global population, with 78% of the
mainland Chinese participants treated with open-label efgartigimod
SC demonstrating confirmed ECI.
- In the mainland Chinese subgroup, efgartigimod SC demonstrated
a safety profile consistent with that observed in the global
population.
About ADHERE Trial Design
The ADHERE trial, sponsored by argenx, was a multicenter,
randomized, double-blind, placebo-controlled trial evaluating
efgartigimod SC for the treatment of CIDP. ADHERE enrolled 322
adult patients with CIDP who were treatment naïve (not on active
treatment for ≥6 months) or being treated with immunoglobulin
therapy or corticosteroids. Zai Lab enrolled patients in the ADHERE
trial in Greater China (mainland China, Hong Kong, Taiwan and
Macau). The trial consisted of an open-label Stage A followed by a
randomized, placebo-controlled Stage B. In order to enter Stage A
and receive efgartigimod SC the diagnosis of CIDP was confirmed by
an independent panel of experts. Patients entered a run-in stage,
where any ongoing CIDP treatment was stopped and they had to
demonstrate active disease, with clinically meaningful worsening on
at least one CIDP clinical assessment tool, including INCAT,
I-RODS, or mean grip strength. Treatment naïve patients were able
to skip the run-in period with proof of recent worsening. To
advance to Stage B, patients needed to demonstrate ECI to
efgartigimod SC. ECI was achieved through improvement of INCAT
score, or improvement on I-RODS or mean grip strength if those
scales had demonstrated worsening during the run-in period. In
Stage B, patients were randomized to either efgartigimod SC or
placebo for up to 48 weeks. The primary endpoint was based on the
hazard ratio for the time to first adjusted INCAT deterioration
(i.e. relapse). After Stage B, all patients had the option to
roll-over to an open-label extension study to receive efgartigimod
SC.
About CIDP in China
The prevalence of CIDP in China is estimated at
50,000 patients.1 Current treatment options are primarily
corticosteroids and intravenous immunoglobulin (IVIg), with plasma
exchange (PLEX) generally reserved for refractory patients. There
is limited access to PLEX or IVIg in many parts of the world,
including China. As most patients require treatment for an extended
period of time there remains a significant unmet need for alternate
treatment options that are effective, well-tolerated, and
convenient for patients with CIDP in China.
1 Chronic inflammatory demyelinating
polyneuropathy and diabetes, 2020.
About Efgartigimod SC
Efgartigimod SC is a subcutaneous combination of efgartigimod
alfa injection, a human IgG1 antibody fragment marketed for
intravenous use as VYVGART®, and recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to
facilitate subcutaneous injection delivery of biologics. In binding
to the neonatal Fc receptor (FcRn), egartigimod SC results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection.
Efgartigimod alfa injection (subcutaneous injection) is the
proposed China International Nonproprietary Name for subcutaneous
efgartigimod alfa injection and recombinant human hyaluronidase
PH20. It is marketed in the United States as VYVGART Hytrulo and
may be marketed under different names following approval in other
regions.
Zai Lab has an exclusive license agreement with argenx to
develop and commercialize efgartigimod in mainland China, Hong
Kong, Macau, and Taiwan (Greater China).
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 disease, 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 regarding the prospects of and plans
for development and commercialization of efgartigimod in Greater
China, the safety and efficacy of efgartigimod, and the potential
treatment of patients with chronic inflammatory demyelinating
polyneuropathy. 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 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 (SEC).
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 the SEC’s website at www.sec.gov.
For more information, please contact:
Investor Relations:Christine Chiou / Lina
Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media:Jennifer Chang / Xiaoyu Chen+1 (917)
446-3140 / +86 185 0015 5011jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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