Drug-resistant Acinetobacter baumannii is a
growing global health threat and high priority pathogen needing new
antibiotics, according to World Health Organization
China NMPA approval based on comprehensive
clinical data demonstrating robust activity of SUL-DUR against
carbapenem-resistant bacterial strains
In China, it is estimated there are
approximately 300,000 cases of Acinetobacter infections and
approximately 74% of them are carbapenem-resistant
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Innoviva
Specialty Therapeutics today announced that China’s National
Medical Products Administration (NMPA) has approved Zai Lab’s New
Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex in patients 18 years of age and older. The World Health
Organization considers Acinetobacter a top-priority pathogen
worldwide that needs novel antibiotics1.
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“The NMPA approval of XACDURO demonstrates Zai Lab’s commitment
to developing and delivering innovative therapies that address high
unmet medical needs for patients in China and around the world,”
said Dr. Harald Reinhart, President and Head of Global Development,
Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “The
public threat of dangerous pan-resistant Acinetobacter infections
requires urgent action, as treatment options are limited and
mortality rates remain high. We believe XACDURO represents a major
step forward in an area of significant patient need.”
The NMPA approval of XACDURO in China is based on positive
results from the ATTACK trial (NCT03894046), a global, Phase 3
registrational trial evaluating the safety and efficacy of XACDURO
versus colistin in patients with infections caused by A. baumannii.
In the pivotal study, XACDURO demonstrated statistical
non-inferiority versus colistin for the primary endpoint of 28-day
all-cause mortality in patients with carbapenem-resistant
Acinetobacter infections and a statistically significant
improvement in clinical cure rates. XACDURO was well tolerated and
exhibited a favorable safety profile across the clinical program.
Zai Lab participated in the global ATTACK study by enrolling
patients in China. The Chinese patient cohort data confirm the
findings of the global study regarding mortality and clinical
response improvement.
In May 2023, Innoviva Specialty Therapeutics announced that the
U.S. Food and Drug Administration (FDA) approved XACDURO for the
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated pneumonia caused by susceptible isolates of
Acinetobacter baumannii-calcoaceticus complex – the first such
FDA-approved pathogen-targeted therapy.
“Six years ago, our two companies shared the vision of creating
an innovative antibiotic therapy that could effectively address the
global rise of drug-resistant Acinetobacter-related infections,”
said Matt Ronsheim, PhD, President of Innoviva Specialty
Therapeutics. “This approval is a testament to our strong and
successful partnership with Zai Lab. Their invaluable collaboration
during the Phase 3 trials provided the crucial data needed to move
XACDURO through the regulatory process in China, just one year
after it was approved in the U.S.”
About XACDURO® (sulbactam-durlobactam)
XACDURO® (sulbactam-durlobactam) is an intravenous drug
developed by Entasis Therapeutics Inc., an affiliate of Innoviva
Specialty Therapeutics, which is a combination of sulbactam, a
β-lactam antibiotic, and durlobactam, a β-lactamase inhibitor, or
BLI. XACDURO has been approved in the United States and mainland
China for the treatment of adult patients with hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia
(HABP/VABP), caused by susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex. Zai Lab has an exclusive license
to develop and commercialize XACDURO in Greater China (mainland
China, Hong Kong, Taiwan and Macau, collectively), Korea, Vietnam,
Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines,
Singapore, Australia, New Zealand and Japan.
About Acinetobacter Baumannii
Members of the Acinetobacter baumannii-calcoaceticus complex
(Acinetobacter) are Gram-negative, opportunistic human pathogens
that predominantly infect critically ill patients and often result
in severe pneumonia and bloodstream infections.1 They can also
infect other body sites, such as the urinary tract and the skin.
Acinetobacter is considered a global threat in the healthcare
setting due in part to its ability to acquire multidrug resistance.
Acinetobacter is resistant to penicillins and has also acquired
resistance genes for almost all antibiotics used to treat
Gram-negative bacteria, including fluoroquinolones,
aminoglycosides, cephalosporins, and carbapenems.
The Centers for Disease Control and Prevention (CDC) has
identified carbapenem-resistant micro-organisms as an urgent
threat.2 Globally, Acinetobacter baumannii was among the top six
leading pathogens for deaths associated with resistance in 2019.3
Carbapenem-resistant Acinetobacter is considered a Priority 1
pathogen by the World Health Organization (WHO)4.
In the U.S., there are an estimated 40,000 to 80,000 cases of
Acinetobacter each year, and about 40 percent of those are
carbapenem-resistant Acinetobacter.5,6 Globally, there are about a
million cases each year of Acinetobacter, and about two-thirds of
those are carbapenem-resistant Acinetobacter baumannii5. More than
300,000 global deaths annually are associated with
carbapenem-resistant Acinetobacter7.
About Acinetobacter Baumannii Infections in China and Eastern
Asia
Based on the 2022 Annual Report of CARSS (China Antimicrobial
Resistance Surveillance System), approximately 300,000
Acinetobacter infections were reported in mainland China. According
to the most recent CHINET report, resistance of Acinetobacter
baumannii to the carbapenem class of antibiotics has risen to
approximately 74% in China. Acinetobacter is also the most common
pathogen that leads to hospital-acquired pneumonia and
ventilator-associated pneumonia in China8. With commercially
available therapy, the mortality rate is estimated to be 38% in
China and 43% in Eastern Asia9.
XACDURO® INDICATION & USAGE FROM U.S.
PRESCRIBING INFORMATION
Indication
XACDURO (sulbactam for injection; durlobactam for injection),
co-packaged for intravenous use is indicated in adults for the
treatment of hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii- calcoaceticus
complex.
Limitations of Use
XACDURO is not indicated for the treatment of HABP/VABP caused
by pathogens other than susceptible isolates of Acinetobacter
baumannii-calcoaceticus complex.
Usage
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XACDURO and other antibacterial
drugs, XACDURO should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION FROM U.S. PRESCRIBING
INFORMATION
Contraindications: XACDURO is contraindicated in patients with a
history of known severe hypersensitivity to the components of
XACDURO or other beta-lactam antibacterial drugs.
Warnings and Precautions:
- Hypersensitivity was observed in patients treated with XACDURO
in clinical trials. Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions and serious skin reactions have been
reported in patients receiving beta-lactam antibacterial drugs.
Before initiating therapy with XACDURO, careful inquiry should be
made concerning previous hypersensitivity reactions to carbapenems,
penicillins, cephalosporins, other beta lactams, and other
allergens. If an allergic reaction occurs, discontinue
XACDURO.
- Clostridioides difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs. If CDAD is suspected or confirmed, the
risk/benefit of continuing treatment with XACDURO should be
assessed.
- Prescribing XACDURO in the absence of a proven or strongly
suspected bacterial infection or a prophylactic indication is
unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
Adverse Reactions: The most common adverse reactions reported in
>10% of patients treated with XACDURO were liver test
abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia
(12%).
For U.S. patients: please see the Full Prescribing Information
for XACDURO.
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 relating
to our future expectations, plans, and prospects, including,
without limitation, statements relating to the possible benefits,
safety, and efficacy of SUL-DUR; the treatment of infections caused
by Acinetobacter baumannii, including carbapenem-resistant strains;
clinical trial data; and risks and uncertainties associated with
drug development and commercialization. All statements, other than
statements of historical fact, included in this press release are
forward-looking statements, and can be identified by 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 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. We may not actually achieve the
plans, carry out the intentions, or meet the expectations or
projections disclosed in our forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results may differ materially from those
indicated by 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 (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.
About Innoviva Specialty Therapeutics
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc.,
is focused on delivering innovative therapies in critical care and
infectious disease. Innoviva Specialty Therapeutics’ products,
through its affiliate, La Jolla Pharmaceutical Company, include
GIAPREZA® (angiotensin II), approved to increase blood pressure in
adults with septic or other distributive shock, and XERAVA®
(eravacycline) for the treatment of complicated intra-abdominal
infections in adults. Innoviva Specialty Therapeutics’ products,
through its affiliate, Entasis Therapeutics Inc., include XACDURO®
(sulbactam for injection; durlobactam for injection), co-packaged
for intravenous use approved for the treatment of adults with
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter). For more
information about Innoviva Specialty Therapeutics, please visit
here.
Innoviva Forward-Looking Statements
This press release contains certain “forward-looking” statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives, and future events. Innoviva intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. The words “anticipate”, “expect”,
“goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”,
“target” and similar expressions are intended to identify such
forward-looking statements. Such forward-looking statements involve
substantial risks, uncertainties, and assumptions. These statements
are based on the current estimates and assumptions of the
management of Innoviva as of the date of this press release and are
subject to known and unknown risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Innoviva to be materially different from those
reflected in the forward-looking statements. Important factors that
could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others,
risks related to: expected cost savings; the commercialization of
XACDURO® in the jurisdictions in which these products have been
approved; the strategies, plans and objectives of Innoviva
(including Innoviva’s growth strategy and corporate development
initiatives); the timing, manner, and amount of potential capital
returns to shareholders; the status and timing of clinical studies,
data analysis and communication of results; the potential benefits
and mechanisms of action of product candidates; expectations for
product candidates through development and commercialization; the
timing of regulatory approval of product candidates; and
projections of revenue, expenses and other financial items; the
impact of the novel coronavirus (COVID-19); the timing, manner and
amount of capital deployment, including potential capital returns
to stockholders; and risks related to the Company’s growth
strategy. Other risks affecting Innoviva are described under the
headings “Risk Factors” and “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” contained in
Innoviva’s Annual Report on Form 10-K for the year ended December
31, 2023, and Quarterly Reports on Form 10-Q, which are on file
with the Securities and Exchange Commission (SEC) and available on
the SEC’s website at www.sec.gov. Past performance is not
necessarily indicative of future results. No forward-looking
statements can be guaranteed, and actual results may differ
materially from such statements. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. The information in this press release is provided only
as of the date hereof, and Innoviva assumes no obligation to update
its forward-looking statements on account of new information,
future events or otherwise, except as required by law.
Notes:
(1) Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L.,
Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical
Presentation, and Outcome of Acinetobacter baumannii Bacteremia.
Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular
Bacterial Pathogenesis Volume 7 – 2017:
https://doi.org/10.3389/fcimb.2017.00156
(2) Centers for Disease Control and Prevention,
“Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent
public health threat in United States healthcare facilities,”
August 2021:
https://arpsp.cdc.gov/story/cra-urgent-public-health-threat
(3) Antimicrobial Resistance Collaborators. Global burden of
bacterial antimicrobial resistance in 2019: a systematic analysis.
Lancet. 2022; 399(10325):629-655.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
(4) World Health Organization, “WHO publishes list of bacteria
for which new antibiotics are urgently needed,” February 27, 2017:
https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed
(5) Spellberg B, Rex JH. The value of single-pathogen
antibacterial agents. Nat Rev Drug Discov. 2013 Dec;12(12):963.
doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15.
(6) Centers for Disease Control and Prevention. Antibiotic
Resistance & Patient Safety Portal. “Carbapenem-resistant
Acinetobacter,” May 2023:
https://arpsp.cdc.gov/profile/antibiotic-resistance/carbapenem-resistant-acinetobacter
(7) Antimicrobial Resistance Collaborators. Global burden of
bacterial antimicrobial resistance in 2019: a systematic analysis.
Lancet. 2022; 399(10325):629-655. Supplementary Material.
Supplementary appendix.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
(8) China Diagnosis and Treatment Guideline for
hospital-acquired pneumonia and ventilator-associated pneumonia,
2018;
(9) Mohd 2021Sazlly Lim S, et al. The global prevalence of
multidrug-resistance among Acinetobacter baumannii causing
hospital-acquired and ventilator-associated pneumonia and its
associated mortality: A systematic review and meta-analysis. J
Infect. 2019 Dec;79(6):593-600.
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version on businesswire.com: https://www.businesswire.com/news/home/20240519020622/en/
For more information:
Zai Lab Investor Relations: Christine Chiou / Lina
Zhang +1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Innoviva, Inc. Investor Relations Argot Partners +1
212.600.1902 Innoviva@argotpartners.com
Zai Lab Corporate Communications: Shaun Maccoun / Xiaoyu
Chen +1 (857) 270-8854 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Innoviva Specialty Therapeutics Corporate Communications
David Patti +1 908.421.5971 David.Patti@inva.com
Zai Lab (NASDAQ:ZLAB)
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