Colistimethate Sodium

Inhalation of colistimethate sodium via the I-neb® Adaptive Aerosol Delivery System (CMS I-neb) significantly reduced pulmonary exacerbations and improved quality of life in non-cystic fibrosis bronchiectasis (NCFB) patients colonized with P. aeruginosa Both trials showed that CMS I-neb was generally well tolerated, with no major safety concerns, and bronchospasm occurred in fewer than 5% of patients Zambon is continuing to work with regulatory authorities with the goal of making colistimethate sodium delivered via a customized inhalation device available to patients with bronchiectasis and P. aeruginosa chronic infection MILAN and MORRISTOWN, N.J., Sept. 12, 2024 /PRNewswire/ -- Zambon, a multinational pharmaceutical company focused on innovating cure and care to improve people's health and the quality of patients' lives, today announced the online publication of its Phase 3 PROMIS-I and PROMIS-II studies in The Lancet Respiratory Medicine journal. The PROMIS studies assessed the efficacy and safety of inhaled colistimethate sodium administered via the I-neb® Adaptive Aerosol Delivery System ("CMS I-neb") as a treatment to reduce the frequency of pulmonary exacerbations in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) chronically colonized with P. aeruginosa over 12 months, compared to placebo. "The publication of these pivotal data in The Lancet Respiratory Medicine represents an important milestone in our commitment to developing innovative therapies for patients with severe respiratory diseases," said Paola Castellani, Chief Medical Officer and R&D Head at Zambon. "For patients with NCFB, a condition with no approved treatment options, the results from the PROMIS program highlight the potential of CMS I-neb to improve outcomes and quality of life. We look forward to working with regulatory authorities on a path to making this important treatment available to patients as quickly as possible." Chronic infection with P. aeruginosa is associated with more severe disease, accelerated lung function decline, increased exacerbations, hospitalizations and a higher mortality rate.i The PROMIS trials represent the first large-scale, double-blind, placebo-controlled studies of inhaled colistimethate sodium, a widely used antibiotic in Europe for NCFB. The published study results are based upon the two global Phase 3, multicenter, randomized, double-blind, placebo-controlled PROMIS-I and PROMIS-II trials in adult patients with bronchiectasis chronically colonized with P. aeruginosa with a history of at least two exacerbations requiring oral antibiotics or one requiring intravenous antibiotics in the previous year. Patients were randomized (377 in PROMIS-I and 287 in PROMIS-II) to receive inhaled colistimethate sodium or placebo via the I-neb device twice daily for up to 12 months. The primary efficacy endpoint was the annual pulmonary exacerbation rate. Key secondary efficacy endpoints were time to first exacerbation, quality of life, change in P. aeruginosa density, severe exacerbation rate, and time to first severe exacerbation. Key Findings from PROMIS-I and PROMIS-II: In the PROMIS-I trial, the primary endpoint of a significant reduction in annual pulmonary exacerbation rate was achieved, with a 39% reduction in exacerbations (rate ratio 0.61; 95% CI 0.46–0.82; p=0.0010) compared with placebo. Severe exacerbations were reduced by 59%, and patients treated with CMS I-neb experienced a clinically importantii improvement in quality of life, as measured by the St. George's Respiratory Questionnaire, and a reduction of P. aeruginosa density. The PROMIS-II study had to be stopped prematurely due to the COVID-19 pandemic and the results were not satisfactory. However, when a sub analysis of the PROMIS-II pre-pandemic period was done, the results were consistent with those obtained in the PROMIS-I trial. Both trials reported good tolerability, with no major safety issues identified. Bronchospasm was rare, occurring in less than 5% of patients. "The results of the PROMIS program represent an important breakthrough for patients with NCFB, a population that has long suffered from chronic respiratory infections without any approved treatments. For the first time, we have robust evidence showing that CMS I-neb can significantly reduce exacerbations and improve quality of life in patients with NCFB and chronic P. aeruginosa infection, offering hope where there were previously limited options," said Dr. Charles Haworth, Respiratory Physician at the Cambridge Centre for Lung Infection at Royal Papworth Hospital, and PROMIS trials Chief Investigator. "These findings underscore the importance of inhaled antibiotics, such as CMS I-neb, in reducing exacerbations and improving outcomes in patients with NCFB chronically infected with P. aeruginosa. Chronic bronchial infection plays a key role in driving inflammation and airway damage in bronchiectasis, and reducing exacerbations has been linked to better prognosis, quality of life and lung function," said Professor James Chalmers, Professor of Respiratory Research at the University of Dundee and PROMIS Investigator. The PROMIS clinical program has received FDA Qualified Infectious Disease Product (QIDP), Fast Track and Breakthrough designations for the reduction in the incidence of pulmonary exacerbations in adult NCFB patients colonized with P. aeruginosa. About the PROMIS Development Program The PROMIS-I and PROMIS-II are multicenter, randomized, double-blind, placebo-controlled trials investigating the efficacy and safety of inhaled colistimethate sodium administered via the I neb® Adaptive Aerosol Delivery System (CMS I-neb®) in adults with non-cystic fibrosis bronchiectasis chronically infected with P. aeruginosa. The primary objective of both trials was to investigate the annual rate of pulmonary exacerbations in patients receiving CMS I-neb® administered twice daily versus placebo. Secondary endpoints included the time to first pulmonary exacerbation, the annual rate of severe pulmonary exacerbations, the time to first severe pulmonary exacerbation, quality of life measured by the St. George's Respiratory Questionnaire and the Quality of Life Questionnaire-Bronchiectasis (QOL-B), the number of exacerbation-free days, P. aeruginosa density and susceptibility, any developing resistance, and overall safety and tolerability. The PROMIS-I trial enrolled 377 patients in 12 countries, including Australia, Belgium, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Portugal, Spain, Switzerland, and the United Kingdom. The PROMIS-II trial enrolled 287 patients in 12 countries, including Argentina, Australia, Canada, Germany, Greece, Israel, Italy, New Zealand, Poland, Portugal, France, and the United States. About NCFB Non-cystic fibrosis bronchiectasis (NCFB) is a chronic lung disease characterized by recurrent infection, inflammation, persistent cough, and production of sputum, and its prevalence is increasing worldwide. NCFB has a progressive course primarily determined by the rate of exacerbations, many of which are related to Pseudomonas aeruginosa. Consequently, research efforts directed to treat infection by P. aeruginosa and its associated acute exacerbations remain a clinical priority.iii The objectives of treatment in bronchiectasis are to prevent exacerbations, reduce symptoms, improve quality of life, and stop disease progression. Cough and sputum production, along with breathlessness, are the most frequent symptoms, but rhinosinusitis, fatigue, hemoptysis, and thoracic pain are also common. Over the last decade, the prevalence of NCFB has increased by 40% and is now estimated to be up to 566 per 100,000 people, making it the third most common chronic airways disease.iv The incidence of NCFB appears to be rising too, particularly in women and older individuals. About Colistimethate sodium (CMS) Colistimethate sodium (CMS) is a pro-drug (the form used for inhalation therapy) of the antibiotic colistin. Colistin is a polymyxin antibiotic derived from Bacillus polymyxa var. colistinus. Polymyxin antibiotics are surface active agents that act by binding to and changing the permeability of the bacterial cell membrane, causing bacterial cell death. Colistin is an active agent against aerobic Gram-negative pathogens that can cause life-threatening infections, such as P. aeruginosa. Colistin remains one of the few active antimicrobial agents against multi-drug-resistant Gram-negative bacteria. It is currently considered one of the last therapeutic options for infections such as carbapenem-resistant P. aeruginosa. About Zambon SpA Zambon SpA is a multinational pharmaceutical company established in 1906 in Vicenza, whose history is founded on the values of an Italian family committed to innovating cure & care to improve patients' lives. It employs more than 2,500 people worldwide, is present in 23 countries in Europe, America and Asia, and has production facilities in Italy, Switzerland, China and Brazil. Thanks to its innovative, quality products commercialized in 87 countries, Zambon Spa reported a revenue of 843 million euros in 2023. Alongside the three historical therapeutic areas - diseases of the respiratory system, urinary tract infections and pain treatment – Zambon is focused on developing treatments for neurodegenerative diseases such as Parkinson's or rare diseases such as cystic fibrosis, BOS, to which is linked the major 2019 acquisition of Breath Therapeutics, and NCFB. For further information on Zambon please visit . For more information, please contact: [email protected] Elixir Health Public Relations Lindsay Rocco +1 862-596-1304 [email protected] i Finch S, McDonnell MJ, Abo-Leyah H, Aliberti S, Chalmers JD. A Comprehensive Analysis of the Impact of Pseudomonas aeruginosa Colonization on Prognosis in Adult Bronchiectasis. Ann Am Thorac Soc Vol 12, No 11, pp 1602–1611, Nov 2015 ii McLeese RH, Spinou A, Alfahl Z, et al. Psychometrics of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis. Eur Respir J 2021; 58: 2100025. iii Severiche-Bueno D, Gamboa E, Reyes LF, Chotirmall SH. Hot topics and current controversies in non-cystic fibrosis bronchiectasis. Breathe 2019; 15: 286–295 iv Thornton, Christina S., Somayaji, Ranjani, Lim, Rachel K. Assessment of factors and interventions towards therapeutic adherence among persons with non-cystic fibrosis bronchiectasis. ERJ Open Research. 2022; 2022-10-01, 00340-2022. 10.1183/23120541.00340-2022. SOURCE Zambon S.p.A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 SHANGHAI & CAMBRIDGE, Mass. & WALTHAM, Mass.--(BUSINESS WIRE)-- 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. This press release features multimedia. View the full release here: “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 pro 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 or follow us at . 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 and the SEC’s website at . 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 the Securities and Exchange Commission (SEC) and available on the SEC’s website at . 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: (2) Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: (3) Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext (4) World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: (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: (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. (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. View source version on businesswire.com: Contacts 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 Source: Zai Lab Limited View this news release online at: