Zai Lab and Innoviva Specialty Therapeutics Announce NMPA Approval for XACDURO® (Sulbactam-Durlobactam or SUL-DUR) for Hospital-Acquired and Ventilator-Associated Pneumonia Caused by Acinetobacter Baumannii-Calcoaceticus Complex in China
Drug-resistant Acinetobacter baumannii is agrowing global health threat and high priority pathogen needing newantibiotics, according to World Health Organization
China NMPA approval based on comprehensiveclinical data demonstrating robust activity of SUL-DURagainst carbapenem-resistant bacterial strains
In China, it is estimated there areapproximately 300,000 cases of Acinetobacter infections andapproximately 74% of them are carbapenem-resistant
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and InnovivaSpecialty Therapeutics today announced that China’s NationalMedical Products Administration (NMPA) has approved Zai Lab’s NewDrug Application (NDA) for XACDURO®(sulbactam-durlobactam) for the treatment of hospital-acquiredbacterial pneumonia and ventilator-associated bacterial pneumonia(HABP/VABP) caused by susceptible isolates of Acinetobacterbaumannii-calcoaceticus complex in patients 18 years of age andolder. The World Health Organization considers Acinetobactera top-priority pathogen worldwide that needs novelantibiotics1.
This press release features multimedia. Viewthe full release here:https://www.businesswire.com/news/home/20240519020622/en/
“The NMPA approval of XACDURO demonstrates Zai Lab’s commitmentto developing and delivering innovative therapies that address highunmet 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. “Thepublic threat of dangerous pan-resistant Acinetobacterinfections requires urgent action, as treatment options are limitedand mortality rates remain high. We believe XACDURO represents amajor step forward in an area of significant patient need.”
The NMPA approval of XACDURO in China is based on positiveresults from the ATTACK trial (NCT03894046), a global, Phase 3registrational trial evaluating the safety and efficacy of XACDUROversus colistin in patients with infections caused by A.baumannii. In the pivotal study, XACDURO demonstratedstatistical non-inferiority versus colistin for the primaryendpoint of 28-day all-cause mortality in patients withcarbapenem-resistant Acinetobacter infections and astatistically significant improvement in clinical cure rates.XACDURO was well tolerated and exhibited a favorable safety profileacross the clinical program. Zai Lab participated in the globalATTACK study by enrolling patients in China. The Chinese patientcohort data confirm the findings of the global study regardingmortality and clinical response improvement.
In May 2023, Innoviva Specialty Therapeutics announced that theU.S. Food and Drug Administration (FDA) approved XACDURO for thetreatment of hospital-acquired bacterial pneumonia andventilator-associated pneumonia caused by susceptible isolates ofAcinetobacter baumannii-calcoaceticus complex – the firstsuch FDA-approved pathogen-targeted therapy.
“Six years ago, our two companies shared the vision of creatingan innovative antibiotic therapy that could effectively address theglobal rise of drug-resistant Acinetobacter-relatedinfections,” said Matt Ronsheim, PhD, President of InnovivaSpecialty Therapeutics. “This approval is a testament to our strongand successful partnership with Zai Lab. Their invaluablecollaboration during the Phase 3 trials provided the crucial dataneeded 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 intravenousdrug developed by Entasis Therapeutics Inc., an affiliate ofInnoviva Specialty Therapeutics, which is a combination ofsulbactam, a β-lactam antibiotic, and durlobactam, a β-lactamaseinhibitor, or BLI. XACDURO has been approved in the United Statesand mainland China for the treatment of adult patients withhospital-acquired bacterial pneumonia and ventilator-associatedbacterial pneumonia (HABP/VABP), caused by susceptible isolates ofAcinetobacter baumannii-calcoaceticus complex. Zai Lab hasan exclusive license to develop and commercialize XACDURO inGreater China (mainland China, Hong Kong, Taiwan and Macau,collectively), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia,Indonesia, the Philippines, Singapore, Australia, New Zealand andJapan.
About Acinetobacter Baumannii
Members of the Acinetobacter baumannii-calcoaceticuscomplex (Acinetobacter) are Gram-negative, opportunistichuman pathogens that predominantly infect critically ill patientsand often result in severe pneumonia and bloodstreaminfections.1 They can also infect other body sites, suchas the urinary tract and the skin. Acinetobacter isconsidered a global threat in the healthcare setting due in part toits ability to acquire multidrug resistance. Acinetobacteris resistant to penicillins and has also acquired resistance genesfor almost all antibiotics used to treat Gram-negative bacteria,including fluoroquinolones, aminoglycosides, cephalosporins, andcarbapenems.
The Centers for Disease Control and Prevention (CDC) hasidentified carbapenem-resistant micro-organisms as an urgentthreat.2 Globally, Acinetobacter baumannii wasamong the top six leading pathogens for deaths associated withresistance in 2019.3 Carbapenem-resistantAcinetobacter is considered a Priority 1 pathogen by theWorld Health Organization (WHO)4.
In the U.S., there are an estimated 40,000 to 80,000 cases ofAcinetobacter each year, and about 40 percent of those arecarbapenem-resistant Acinetobacter.5,6 Globally,there are about a million cases each year of Acinetobacter,and about two-thirds of those are carbapenem-resistantAcinetobacter baumannii5. More than 300,000global deaths annually are associated with carbapenem-resistantAcinetobacter7.
About Acinetobacter Baumannii Infections in China andEastern Asia
Based on the 2022 Annual Report of CARSS (China AntimicrobialResistance Surveillance System), approximately 300,000Acinetobacter infections were reported in mainland China.According to the most recent CHINET report, resistance ofAcinetobacter baumannii to the carbapenem class ofantibiotics has risen to approximately 74% in China.Acinetobacter is also the most common pathogen that leads tohospital-acquired pneumonia and ventilator-associated pneumonia inChina8. With commercially available therapy, themortality rate is estimated to be 38% in China and 43% in EasternAsia9.
XACDURO® INDICATION & USAGEFROM U.S. PRESCRIBING INFORMATION
Indication
XACDURO (sulbactam for injection; durlobactam for injection),co-packaged for intravenous use is indicated in adults for thetreatment of hospital-acquired bacterial pneumonia andventilator-associated bacterial pneumonia (HABP/VABP) caused bysusceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
Limitations of Use
XACDURO is not indicated for the treatment of HABP/VABP causedby pathogens other than susceptible isolates of Acinetobacterbaumannii-calcoaceticus complex.
Usage
To reduce the development of drug-resistant bacteria andmaintain the effectiveness of XACDURO and other antibacterialdrugs, XACDURO should be used only to treat or prevent infectionsthat are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION FROM U.S. PRESCRIBINGINFORMATION
Contraindications: XACDURO is contraindicated in patients with ahistory of known severe hypersensitivity to the components ofXACDURO or other beta-lactam antibacterial drugs.
Warnings and Precautions:
- Hypersensitivity was observed in patients treated with XACDUROin clinical trials. Serious and occasionally fatal hypersensitivity(anaphylactic) reactions and serious skin reactions have beenreported in patients receiving beta-lactam antibacterial drugs.Before initiating therapy with XACDURO, careful inquiry should bemade concerning previous hypersensitivity reactions to carbapenems,penicillins, cephalosporins, other beta lactams, and otherallergens. If an allergic reaction occurs, discontinueXACDURO.
- Clostridioides difficile-associated diarrhea (CDAD) has beenreported with use of nearly all antibacterial agents and may rangein severity from mild diarrhea to fatal colitis. Evaluate ifdiarrhea occurs. If CDAD is suspected or confirmed, therisk/benefit of continuing treatment with XACDURO should beassessed.
- Prescribing XACDURO in the absence of a proven or stronglysuspected bacterial infection or a prophylactic indication isunlikely to provide benefit to the patient and increases the riskof the development of drug-resistant bacteria.
Adverse Reactions: The most common adverse reactions reported in>10% of patients treated with XACDURO were liver testabnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia(12%).
For U.S. patients: please see the Full Prescribing Informationfor XACDURO.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,research-based, commercial-stage biopharmaceutical company based inChina and the United States. We are focused on discovering,developing and commercializing innovative products that addressmedical conditions with significant unmet needs in the areas ofoncology, autoimmune disorders, infectious disease andneuroscience. Our goal is to leverage our competencies andresources to positively impact human health in China andworldwide.
For additional information about Zai Lab, please visitwww.zailaboratory.com or follow us atwww.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relatingto 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 causedby Acinetobacter baumannii, including carbapenem-resistantstrains; clinical trial data; and risks and uncertaintiesassociated with drug development and commercialization. Allstatements, other than statements of historical fact, included inthis press release are forward-looking statements, and can beidentified by words such as “aim,” “anticipate,” “believe,”“could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,”“plan,” “possible,” “potential,” “will,” “would,” and other similarexpressions. Such statements constitute forward-looking statementswithin the meaning of the Private Securities Litigation Reform Actof 1995. Forward-looking statements are not guarantees orassurances of future performance. Forward-looking statements arebased on our expectations and assumptions as of the date of thispress release and are subject to inherent uncertainties, risks, andchanges in circ*mstances that may differ materially from thosecontemplated by the forward-looking statements. We may not actuallyachieve the plans, carry out the intentions, or meet theexpectations or projections disclosed in our forward-lookingstatements, and you should not place undue reliance on theseforward-looking statements. Actual results may differ materiallyfrom those indicated by forward-looking statements as a result ofvarious important factors, including but not limited to (1) ourability to successfully commercialize and generate revenue from ourapproved products, (2) our ability to obtain funding for ouroperations and business initiatives, (3) the results of ourclinical and pre-clinical development of our product candidates,(4) the content and timing of decisions made by the relevantregulatory authorities regarding regulatory approvals of ourproduct candidates, (5) risks related to doing business in China,and (6) other factors identified in our most recent annual andquarterly reports and in other reports we have filed with the U.S.Securities and Exchange Commission (SEC). We anticipate thatsubsequent events and developments will cause our expectations andassumptions to change, and we undertake no obligation to update orrevise any forward-looking statements, whether as a result of newinformation, future events, or otherwise, except as may be requiredby law. These forward-looking statements should not be relied uponas representing our views as of any date subsequent to the date ofthis press release.
Our SEC filings can be found on our website atwww.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 andinfectious disease. Innoviva Specialty Therapeutics’ products,through its affiliate, La Jolla Pharmaceutical Company, includeGIAPREZA® (angiotensin II), approved to increase bloodpressure in adults with septic or other distributive shock, andXERAVA® (eravacycline) for the treatment of complicatedintra-abdominal infections in adults. Innoviva SpecialtyTherapeutics’ products, through its affiliate, Entasis TherapeuticsInc., include XACDURO® (sulbactam for injection;durlobactam for injection), co-packaged for intravenous useapproved for the treatment of adults with hospital-acquiredbacterial pneumonia and ventilator-associated bacterial pneumoniacaused by susceptible strains of Acinetobacterbaumannii-calcoaceticus complex (Acinetobacter). Formore information about Innoviva Specialty Therapeutics, pleasevisit here.
Innoviva Forward-Looking Statements
This press release contains certain “forward-looking” statementsas that term is defined in the Private Securities Litigation ReformAct of 1995 regarding, among other things, statements relating togoals, plans, objectives, and future events. Innoviva intends suchforward-looking statements to be covered by the safe harborprovisions for forward-looking statements contained in Section 21Eof the Securities Exchange Act of 1934 and the Private SecuritiesLitigation Reform Act of 1995. The words “anticipate”, “expect”,“goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”,“target” and similar expressions are intended to identify suchforward-looking statements. Such forward-looking statements involvesubstantial risks, uncertainties, and assumptions. These statementsare based on the current estimates and assumptions of themanagement of Innoviva as of the date of this press release and aresubject to known and unknown risks, uncertainties, changes incirc*mstances, assumptions and other factors that may cause theactual results of Innoviva to be materially different from thosereflected in the forward-looking statements. Important factors thatcould cause actual results to differ materially from thoseindicated by such forward-looking statements include, among others,risks related to: expected cost savings; the commercialization ofXACDURO® in the jurisdictions in which these productshave been approved; the strategies, plans and objectives ofInnoviva (including Innoviva’s growth strategy and corporatedevelopment initiatives); the timing, manner, and amount ofpotential capital returns to shareholders; the status and timing ofclinical studies, data analysis and communication of results; thepotential benefits and mechanisms of action of product candidates;expectations for product candidates through development andcommercialization; the timing of regulatory approval of productcandidates; and projections of revenue, expenses and otherfinancial items; the impact of the novel coronavirus (COVID-19);the timing, manner and amount of capital deployment, includingpotential capital returns to stockholders; and risks related to theCompany’s growth strategy. Other risks affecting Innoviva aredescribed under the headings “Risk Factors” and “Management’sDiscussion and Analysis of Financial Condition and Results ofOperations” contained in Innoviva’s Annual Report on Form 10-K forthe year ended December 31, 2023, and Quarterly Reports on Form10-Q, which are on file with the Securities and Exchange Commission(SEC) and available on the SEC’s website at www.sec.gov. Pastperformance is not necessarily indicative of future results. Noforward-looking statements can be guaranteed, and actual resultsmay differ materially from such statements. Given theseuncertainties, you should not place undue reliance on theseforward-looking statements. The information in this press releaseis provided only as of the date hereof, and Innoviva assumes noobligation to update its forward-looking statements on account ofnew information, future events or otherwise, except as required bylaw.
Notes:
(1) Tala, B., Jad, A., Claude, A., Jihad, I., Chantal, L.,Rakan, N.,& Eid, A. (2017). Risk Factors, ClinicalPresentation, and Outcome of Acinetobacter baumannii Bacteremia.Front. Cell. Infect. Microbiol., 04 May 2017, Sec. MolecularBacterial 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 urgentpublic 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 ofbacterial 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 bacteriafor 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-pathogenantibacterial 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. AntibioticResistance & Patient Safety Portal. “Carbapenem-resistantAcinetobacter,” May 2023:https://arpsp.cdc.gov/profile/antibiotic-resistance/carbapenem-resistant-acinetobacter
(7) Antimicrobial Resistance Collaborators. Global burden ofbacterial 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 forhospital-acquired pneumonia and ventilator-associated pneumonia,2018;
(9) Mohd 2021Sazlly Lim S, et al. The global prevalence ofmultidrug-resistance among Acinetobacter baumannii causinghospital-acquired and ventilator-associated pneumonia and itsassociated mortality: A systematic review and meta-analysis. JInfect. 2019 Dec;79(6):593-600.
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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 CorporateCommunications
David Patti
+1 908.421.5971
David.Patti@inva.com
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Ty Edmondson, as well as Jonathan Wang, today...","one_line_short_text":"\nThe Executive Officers of Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), Samantha Du, Josh Smiley, Rafael Amado, Harald Reinhart, Yajing Chen, F. Ty...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93636893\/zai-lab-statement-on-executive-management-team-s","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1712835000,"date":"Thu Apr 11, 2024 ","time":"7:30 AM (1 month ago)","full_date":"April 11, 2024 7:30 AM","post_time":"April 11 2024","article_id":93636893,"source_id":"bw","media_url":null,"press_release":true}],"All News": [{"headline":"Zai Lab and Innoviva Specialty Therapeutics Announce NMPA Approval for XACDURO\u00ae (Sulbactam-Durlobactam or SUL-DUR) for Hospital-Acquired and Ventilator-Associated Pneumonia Caused by Acinetobacter Baumannii-Calcoaceticus Complex in China","short_text":"\nDrug-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...","one_line_short_text":"\nDrug-resistant Acinetobacter baumannii is a growing global health threat and high priority pathogen needing new antibiotics, according to World...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93885597\/zai-lab-and-innoviva-specialty-therapeutics-announ","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1716178860,"date":"Mon May 20, 2024 ","time":"12:21 AM (19 hours ago)","full_date":"May 20, 2024 12:21 AM","post_time":"19 hours ago","article_id":93885597,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Form 4 - Statement of changes in beneficial ownership of securities","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93873191\/form-4-statement-of-changes-in-beneficial-owners","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715892740,"date":"Thu May 16, 2024 ","time":"4:52 PM (4 days ago)","full_date":"May 16, 2024 4:52 PM","post_time":"May 16 2024","article_id":93873191,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Zai Lab Announces Participation in May and June Investor Conferences","short_text":"\nZai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company\u2019s senior management team will participate in the following investor conferences in May and June 2024: J.P...","one_line_short_text":"\nZai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company\u2019s senior management team will participate in the following...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93867261\/zai-lab-announces-participation-in-may-and-june-in","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1715859000,"date":"Thu May 16, 2024 ","time":"7:30 AM (4 days ago)","full_date":"May 16, 2024 7:30 AM","post_time":"May 16 2024","article_id":93867261,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Form 4 - Statement of changes in beneficial ownership of securities","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93860107\/form-4-statement-of-changes-in-beneficial-owners","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715803392,"date":"Wed May 15, 2024 ","time":"4:03 PM (5 days ago)","full_date":"May 15, 2024 4:03 PM","post_time":"May 15 2024","article_id":93860107,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Form 144 - Report of proposed sale of securities","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93848062\/form-144-report-of-proposed-sale-of-securities","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715707342,"date":"Tue May 14, 2024 ","time":"1:22 PM (6 days ago)","full_date":"May 14, 2024 1:22 PM","post_time":"May 14 2024","article_id":93848062,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China","short_text":"\nsBLA submission based on positive results from the ADHERE trial, the first positive global neonatal FC receptor (FcRn) pivotal study for CIDP There are currently no approved therapies available...","one_line_short_text":"\nsBLA submission based on positive results from the ADHERE trial, the first positive global neonatal FC receptor (FcRn) pivotal study for CIDP...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93844490\/zai-lab-announces-acceptance-of-supplemental-biolo","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1715686200,"date":"Tue May 14, 2024 ","time":"7:30 AM (6 days ago)","full_date":"May 14, 2024 7:30 AM","post_time":"May 14 2024","article_id":93844490,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Zai Lab Announces Approval of AUGTYRO\u2122 (repotrectinib) for Patients with ROS1-positive NSCLC by China\u2019s NMPA","short_text":"\nThe approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust intracranial responses Zai Lab Limited (NASDAQ: ZLAB;...","one_line_short_text":"\nThe approval is based on the pivotal TRIDENT-1 trial, in which AUGTYRO achieved a high response rate and durable responses, including robust...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93829770\/zai-lab-announces-approval-of-augtyro-repotrectin","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1715559600,"date":"Sun May 12, 2024 ","time":"8:20 PM (1 week ago)","full_date":"May 12, 2024 8:20 PM","post_time":"May 12 2024","article_id":93829770,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Form 10-Q - Quarterly report [Sections 13 or 15(d)]","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93806751\/form-10-q-quarterly-report-sections-13-or-15d","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715199291,"date":"Wed May 08, 2024 ","time":"4:14 PM (2 weeks ago)","full_date":"May 8, 2024 4:14 PM","post_time":"May 08 2024","article_id":93806751,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Form 8-K - Current report","short_text":"","one_line_short_text":"","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93806506\/form-8-k-current-report","source":"Edgar (US Regulatory)","source_logo":"\/common\/images\/news-sources\/edgar2.png","tags":["REGULATORY"],"timestamp":1715198979,"date":"Wed May 08, 2024 ","time":"4:09 PM (2 weeks ago)","full_date":"May 8, 2024 4:09 PM","post_time":"May 08 2024","article_id":93806506,"source_id":"edgar2","media_url":null,"press_release":true},{"headline":"Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates","short_text":"\n\nNet product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) VYVGART\u00ae (efgartigimod alfa injection) sales...","one_line_short_text":"\n\nNet product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93806216\/zai-lab-announces-first-quarter-2024-financial-res","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1715198700,"date":"Wed May 08, 2024 ","time":"4:05 PM (2 weeks ago)","full_date":"May 8, 2024 4:05 PM","post_time":"May 08 2024","article_id":93806216,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Zai Lab to Announce First Quarter 2024 Financial Results and Recent Corporate Updates on May 8, 2024","short_text":"\n- Company to Host Conference Call and Webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for...","one_line_short_text":"\n- Company to Host Conference Call and Webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93656754\/zai-lab-to-announce-first-quarter-2024-financial-r","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1713180600,"date":"Mon Apr 15, 2024 ","time":"7:30 AM (1 month ago)","full_date":"April 15, 2024 7:30 AM","post_time":"April 15 2024","article_id":93656754,"source_id":"bw","media_url":null,"press_release":true},{"headline":"Zai Lab Statement on Executive Management Team\u2019s Agreement on Share Activities","short_text":"\nThe Executive Officers of Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), Samantha Du, Josh Smiley, Rafael Amado, Harald Reinhart, Yajing Chen, F. Ty Edmondson, as well as Jonathan Wang, today...","one_line_short_text":"\nThe Executive Officers of Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), Samantha Du, Josh Smiley, Rafael Amado, Harald Reinhart, Yajing Chen, F. Ty...","link":"https:\/\/ih.advfn.com\/stock-market\/NASDAQ\/zai-lab-ZLAB\/stock-news\/93636893\/zai-lab-statement-on-executive-management-team-s","source":"Business Wire","source_logo":"\/common\/images\/news-sources\/bw.png","tags":[],"timestamp":1712835000,"date":"Thu Apr 11, 2024 ","time":"7:30 AM (1 month ago)","full_date":"April 11, 2024 7:30 AM","post_time":"April 11 2024","article_id":93636893,"source_id":"bw","media_url":null,"press_release":true}],"Preferred Contributors": ""}},created: function () {this.loaded = true;Vue.nextTick(function(){});}});});
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