[Translation] A phase 1, randomized, double-blind study comparing the effects of oral omadacycline tosylate tablets and oral moxifloxacin hydrochloride tablets on the intestinal flora in healthy adult subjects

本研究的主要目的是评估口服甲苯磺酸奥马环素对肠道菌群耐药性的影响。

[Translation]

The primary objective of this study was to evaluate the effect of oral omadacycline tosylate on drug resistance in the intestinal flora.

Start Date23 Apr 2024

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+1]

NCT06462326

/ CompletedPhase 1

A Phase 1, Randomized, Double-Blind Study to Compare the Effect of Omadacycline PO Versus Moxifloxacin PO on the Gut Microbiota in Healthy Adult Volunteers

This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Start Date16 Apr 2024

Sponsor / Collaborator

Zai Lab (Hong Kong) Ltd.

CTR20232385

/ RecruitingPhase 3

一项3b期、随机、双盲、多中心临床研究：比较奥马环素IV/PO与莫西沙星IV/PO治疗成人社区获得性细菌性肺炎（CABP）受试者的安全性与有效性

[Translation] A phase 3b, randomized, double-blind, multicenter clinical study to compare the safety and efficacy of omadacycline IV/PO versus moxifloxacin IV/PO in the treatment of adult subjects with community-acquired bacterial pneumonia (CABP)

主要目的：本研究的主要目的是显示在中国成人CABP患者中，奥马环素（iv/po）和莫西沙星（iv/po）的临床有效性相似。本研究设计为桥接研究，旨在在中国患者中证实奥马环素治疗成人社区获得性细菌性肺炎的疗效（CABP）与全球临床研究结果一致。次要目的：评估早期临床应答（ECR，研究药物首次给药后72-120小时）和治疗后评估（PTE）访视时的临床应答率（根据治疗结束[EOT]和PTE访视的研究者评估）；在安全性人群中评估奥马环素治疗中国成人CABP受试者的安全性；根据确认的基线致病病原体评估临床应答。

[Translation]

Primary objective: The primary objective of this study is to show that the clinical efficacy of omadacycline (iv/po) and moxifloxacin (iv/po) is similar in Chinese adult CABP patients. This study is designed as a bridging study to confirm the efficacy of omadacycline in treating adult community-acquired bacterial pneumonia (CABP) in Chinese patients consistent with global clinical research results. Secondary objectives: To evaluate the early clinical response (ECR, 72-120 hours after the first dose of study drug) and clinical response rate at the post-treatment evaluation (PTE) visit (based on investigator assessment at the end of treatment [EOT] and PTE visits); to evaluate the safety of omadacycline in treating Chinese adult CABP subjects in the safety population; to evaluate clinical response according to confirmed baseline pathogens.

Start Date28 Nov 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+1]

100 Clinical Results associated with Omadacycline Tosylate

100 Translational Medicine associated with Omadacycline Tosylate

100 Patents (Medical) associated with Omadacycline Tosylate

391

Literatures (Medical) associated with Omadacycline Tosylate

01 Mar 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

In vitro activity of omadacycline against geographically diverse rapidly growing nontuberculous mycobacteria (NTM) clinical isolates

Article

Author: Serio, Alisa W ; Terschlüsen, Eva ; van Ingen, Jakko ; Anastasiou, Diane M ; Aono, Akio ; Mitarai, Satoshi

Nontuberculous mycobacteria (NTM) are emerging opportunistic pathogens with limited treatment options due to resistance to multiple antibiotic classes. This study aimed to evaluate the in vitro activity of omadacycline and comparator antibiotics against rapidly growing mycobacteria (RGM) clinical isolates. Minimum inhibitory concentration (MIC) evaluation of RGM clinical isolates was performed by two independent laboratories (EU and Japan). A total of 383 isolates (211 EU, 172 Japan) were evaluated. Omadacycline was active against all RGM species tested. For Mycobacterium abscessus subsp. abscessus, MIC₅₀ and MIC₉₀ values (read at 100 % inhibition) were 1 and 4 µg/mL (EU) and 0.5 and 1 µg/mL (Japan), respectively. Mycobacterium fortuitum and Mycobacterium chelonae both had MIC₉₀ values of 0.5 µg/mL (Japan). Omadacycline has consistent, potent in vitro activity against RGM clinical isolates from 15 geographically diverse countries, and thus warrants additional studies and continued development of omadacycline as a potential treatment option for NTM-related disease.

01 Dec 2024·CLINICAL PHARMACOKINETICS

Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis

Article

Author: Sanders, Madeline ; Hong, Eunjin ; Rao, Adupa P. ; Rao, Adupa P ; Beringer, Paul ; Chung, Peter S ; Chung, Peter S.

BACKGROUND:

Omadacycline offers a potential advancement in the management of infections in people with cystic fibrosis (CF) because of its spectrum of activity, intrapulmonary penetration, and oral bioavailability. A prospective single-dose, single-arm study was conducted to characterize the pharmacokinetic (PK) profile of omadacycline in people with CF, considering the known alterations in PK observed in this population (NCT04460586, 2020-07-01).

METHODS:

Plasma samples were obtained from nine adults with CF who received a single dose of intravenous omadacycline 100 mg over 0.5 h followed by a 1-week washout and an oral dose of omadacycline 300 mg. The data were analyzed using noncompartmental PK.

RESULTS:

The maximum plasma concentration (C_max) and area under the curve extrapolated to infinity (AUC_0-∞) after intravenous administration of omadacycline were similar between healthy volunteers and people with CF. The absorption kinetics of oral omadacycline, encompassing both the rate (C_max and time to C_max [t_max]) and the extent (AUC_0-∞), also showed consistency between healthy volunteers and people with CF. The absolute bioavailability of the oral tablet formulation of omadacycline in people with CF (31.2%) was also consistent with that observed in healthy volunteers (34.5%). In comparing the two routes of administration, intravenous omadacycline 100 mg provided plasma exposures equivalent to those with oral omadacycline 300 mg in people with CF, as evidenced by geometric mean ratios for both AUC_0-∞ (0.9381; 90% confidence intervals [CI] 0.6783-1.2975) and C_max (0.7746; 90% CI 0.5478-1.0951).

CONCLUSIONS:

Overall, the similarity in plasma PK observed in this study when comparing healthy volunteers and infected patients indicates that no dosing alterations are necessary when using omadacycline in people with CF.

01 Dec 2024·Infectious Diseases and Therapy

Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety

Article

Author: Gao, Weiwen ; Zhang, Xiangwang ; Yang, Jian ; Tian, Lei ; Xu, Shuyun ; Xu, Dong ; Liu, Dong ; He, Yan

INTRODUCTION:

The efficacy and safety of omadacycline have been primarily documented through Phase III clinical trials; however, there are limited data from real-world clinical settings. This study aims to explore the real-world use of omadacycline in China and identify the factors associated with its efficacy.

METHODS:

We conducted a retrospective review of medical records for patients treated with omadacycline at a single center from March 2022 to March 2024. We analyzed demographic characteristics, laboratory results, antibiotic regimens, and clinical outcomes. Logistic regression was employed to identify risk factors associated with clinical treatment failure or failure of microbial clearance.

RESULTS:

A total of 183 patients were included in the final analysis. Clinical success was achieved in 71.0% (130/183) of patients, with a bacterial clearance rate of 61.9% (26/42). Renal impairment was observed in 20.8% (38/183) of patients, with 39.5% (15/38) of these patients receiving nephrotoxic antibiotic treatments. Noteworthy adverse drug reactions were rare during the course of the treatment. Multivariate logistic regression analysis identified several independent factors associated with treatment failure: moderate to severe liver damage (OR: 3.073, 95% CI 1.345-7.021, p = 0.008), admission to the respiratory department (OR: 2.573, 95% CI 1.135-5.834, p = 0.024), and a duration of omadacycline therapy of less than 7 days (OR: 3.762, 95% CI 1.626-8.706, p = 0.002).

CONCLUSIONS:

Our study demonstrates that omadacycline treatment can achieve favorable clinical success and bacterial clearance, with positive safety and tolerability outcomes. However, high-quality randomized controlled trials are needed to validate these initial findings.

News (Medical) associated with Omadacycline Tosylate

28 Nov 2024

·www.businesswire.com

Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List

SHANGHAI & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2024 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications: AUGTYRO ® (repotrectinib) is included in the NRDL for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC); NUZYRA ® (omadacycline) is renewed for its intravenous (IV) formulation for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI); and QINLOCK ® (ripretinib) is renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. “The NRDL inclusion of AUGTYRO significantly expands access to patients living with ROS1 + NSCLC in China to a new treatment option with promising durability. We look forward to launching AUGTYRO by the end of 2024,” said Andrew Zhu, Chief Commercial Officer of Zai Lab. “The addition of AUGTYRO, as well as the renewals of NUZYRA and QINLOCK, further support patient access to these important medications throughout China at more affordable treatment costs 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,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “We are pleased that we now have six products included in the NRDL, and we will continue our efforts to broaden patient access to our innovative treatments across China. We look forward to continuing to work with the NHSA to improve affordability and accessibility for differentiated innovative treatments in China, with the goal of improving patient lives.” About ROS1 + NSCLC in China Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 1,060,600 new cases and 733,300 cases of deaths from lung cancer in China in 2022. 1 NSCLC accounts for approximately 85% of lung cancer, and approximately 70% of NSCLC is locally advanced or metastatic at initial diagnosis. In China, ROS1 rearrangements occur in approximately 2% of patients with advanced NSCLC. 2 1 Bingfeng Han, et al. Cancer incidence and mortality in China, 2022. 2 Zhang, et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer, Thoracic Cancer January 2019. About AUGTYRO AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI) that targets ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 or NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. AUGTYRO is the first next-generation TKI that targets ROS1 oncogenic fusions in NSCLC and provides improved durability of benefit, including in metastases to the brain. In November 2023, AUGTYRO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic ROS1 -positive NSCLC. In May 2024, AUGTYRO was approved by China’s National Medical Products Administration (NMPA) for the same indications. Additionally, in August 2023, the NMPA granted AUGTYRO Breakthrough Therapy Designation for the treatment of patients with advanced solid tumors harboring a NTRK gene fusion. Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively). Zai Lab expects to commercially launch AUGTYRO in mainland China by the end of 2024. 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 patients 3 , and in 2015, the estimated incidence of ABSSSI was 2.8 million patients 4 . There are significant unmet needs for broad-spectrum antibiotics addressing multi-drug resistance infections with a favorable safety profile. 3 Incidence of community-acquired pneumonia in urban China: A national population-based study, 2020. 4 2015 estimates, Zai Lab analysis. About NUZYRA NUZYRA (omadacycline), a novel tetracycline-class antibacterial with both oral and IV formulations, is active 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, and Zai Lab launched NUZYRA in mainland China for these indications in December 2021. It was included in the NRDL for the treatment of adult patients with CABP and ABSSSI in January 2023 for its IV formulation and in January 2024 for its oral formulation. Zai Lab has an exclusive license from Paratek Pharmaceuticals, Inc. (acquired by Novo Holdings A/S) to develop, manufacture, and commercialize NUZYRA in Greater China. About GIST in China It is estimated that approximately 30,000 GIST patients are newly diagnosed each year in China. Treatment of GIST remains an important unmet medical need in China as many GIST patients, who initially respond to traditional TKIs, ultimately develop tumor progression due to secondary mutations. About QINLOCK QINLOCK (ripretinib) is an orally administered switch-control TKI that inhibits KIT and PDGFRA kinases, including wild-type and forms with multiple primary and secondary mutations, by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. The NMPA approved QINLOCK in March 2021 for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib, and Zai Lab launched QINLOCK in mainland China for this indication in 2021. It was included in the NRDL in January 2023 for the treatment for GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. Zai Lab has an exclusive license agreement with Deciphera Pharmaceuticals, Inc. (a member of ONO Pharmaceutical) for the development and commercialization of QINLOCK in Greater China. About Zai Lab Zai Lab Limited (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, immunology, neuroscience, and infectious disease. 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 and potential of AUGTYRO (repotrectinib), NUZYRA (omadacycline), and QINLOCK (ripretinib) and the treatment of ROS1 + NSCLC, CAPB, ABSSSI and GIST in Greater China. 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 .

Drug ApprovalLicense out/inBreakthrough TherapyPriority ReviewNDA

14 Nov 2024

·www.globenewswire.com

Paratek Pharmaceuticals Announces Completion of U.S. Onshoring Program, Making NUZYRA® (omadacycline) the Only Novel Antibiotic with Domestic Supply and Manufacturing Capabilities

-- Onshoring of NUZYRA is a Key Deliverable in Company’s Partnership with U.S. Biomedical Advanced Research and Development Authority (BARDA) to Enhance National SecurityBOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that its U.S. supply and manufacturing capabilities for its novel antibiotic NUZYRA® (omadacycline) are now complete. NUZYRA is the company's broad-spectrum, novel antibiotic available in both intravenous and oral formulations approved by the U.S. Food and Drug Administration (FDA) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). “Establishing a U.S. manufacturing and supply chain is the culmination of one of the most important elements of our public-private partnership with BARDA, an agreement intended to strengthen our national security,” said Evan Loh, M.D., Paratek chief executive officer. “This onshoring milestone is significant because it ensures that NUZYRA has a secure domestic supply chain that reduces dependency on foreign production and decreases the national security risk for the manufacturing and supply of antibiotics.” Major onshoring milestones that established the U.S. capabilities included the successful technology transfer by Paratek and its manufacturing partners and related FDA approval/implementation for 1) U.S. manufacturing of NUZYRA tablets in 2022; 2) U.S. manufacturing of the active pharmaceutical ingredient (API) as of August 2024; and 3) U.S. manufacturing of NUZYRA’s IV formulation (vials) in October 2024. “Paratek continues to deliver on the milestones of this important agreement with BARDA, in many cases exceeding agreed-upon timelines, thanks to ongoing, highly productive collaboration and communication between BARDA and Paratek,” said Randy Brenner, Paratek's chief development and regulatory officer. “We are grateful to BARDA for their partnership and look forward to completing our studies to support our sNDA filing for NUZYRA for treatment and prophylaxis of pulmonary anthrax in the near term.” This project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00001. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. Paratek is conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA®NUZYRA® (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium 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. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. MEDIA CONTACT: Christine Fanelle Scient PR Christine@ScientPR.com215-595-5211

Drug ApprovalLicense out/inPhase 2Clinical Result

12 Nov 2024

·ir.zailaboratory.com

Zai Lab Announces Third Quarter 2024 Financial Results and Recent Corporate Updates

Strong growth in net product revenue of 47% y-o-y to reach $101.8 million for the third quarter of 2024 Positive China bridging study of KarXT in schizophrenia; expected regulatory submission in early 2025 Global Phase 1 data of ZL-1310 (DLL3 ADC) suggests best-in-class potential in extensive-stage SCLC Three product launches in mainland China expected by the end of 2024, and up to four potential regulatory submissions to the NMPA in the next six months Strong balance sheet with a cash position1 of $716.1 million as of September 30, 2024 , compared to $730.0 million as of June 30, 2024 Conference call and webcast today, November 12 , at 8:00 a.m. ET ( 9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Nov. 12, 2024-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the third quarter of 2024, along with recent product highlights and corporate updates. “In the third quarter, we delivered strong commercial results, maintained financial discipline, and continued to advance our global pipeline of innovative medicines,” said Dr. Samantha Du , Founder, Chairperson, and Chief Executive Officer of Zai Lab . “The launch of VYVGART® has been a great success, and we are well-positioned to support the ongoing needs of many patients living with generalized myasthenia gravis (gMG). Our late-stage pipeline is progressing well. The China bridging study of KarXT for schizophrenia had positive results for all study endpoints, and we expect a China submission in early 2025. The FORTITUDE-102 study, which evaluates bemarituzumab in gastric cancer, has completed enrollment. Additionally, promising data from our global Phase 1 study of ZL-1310 – a potential best-in-class DLL3-targeted ADC being developed globally for small cell lung cancer (SCLC) – has shown preliminary breakthrough antitumor activity. We believe we are on track to drive substantial value for our business over the next few years.” “Our net product revenues in the third quarter grew 47% y-o-y, driven by the continued strong uptake of VYVGART,” said Josh Smiley , President and Chief Operating Officer of Zai Lab . “VYVGART in gMG, is on track to be a blockbuster launch in its first year on China’s National Reimbursement Drug List (NRDL). The VYVGART franchise has tremendous potential. In addition to evaluating a variety of additional indications, we expect to launch the subcutaneous formulation of VYVGART (VYVGART Hytrulo) for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP) in the fourth quarter. Our late-stage programs including bemarituzumab for gastric cancer and KarXT for schizophrenia present high potential opportunities that will further drive growth. Meanwhile, we had significant improvement in net loss, driven by our continued efforts to improve efficiency and exercise financial discipline. We are well positioned for future growth and profitability, supported by our current commercial portfolio and advancing global and late-stage pipeline.” 1 Cash position includes cash and cash equivalents, current restricted cash, and short-term investments. Third-Quarter 2024 Financial Results Product revenue, net was $101.8 million in the third quarter of 2024, compared to $69.2 million for the same period in 2023, representing 47% y-o-y growth, 46% y-o-y growth at constant exchange rate (CER). This increase was primarily driven by increased sales for VYVGART and was also supported by increased sales for ZEJULA® and NUZYRA®. VYVGART was $27.3 million in the third quarter of 2024, compared to $4.9 million for the same period in 2023, driven by increased sales since its launch in September 2023 and listing on NRDL for the treatment of gMG effective January 1, 2024 . ZEJULA was $48.2 million in the third quarter of 2024, an increase of 16% y-o-y from $41.6 million for the same period in 2023. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China . NUZYRA was $10.0 million in the third quarter of 2024, an increase of 82% y-o-y compared to $5.5 million for the same period in 2023, driven by the NRDL listings for the IV formulation of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024. Research and Development (R&D) expenses were $66.0 million in the third quarter of 2024, compared to $58.8 million for the same period in 2023. This increase was primarily due to increased upfront and milestone fees for our license and collaboration agreements, partially offset by decreased clinical trial expenses and personnel costs as a result of ongoing resource prioritization and efficiency efforts. Selling, General and Administrative expenses were $67.2 million in the third quarter of 2024, compared to $68.6 million for the same period in 2023. This decrease was primarily driven by decreased personnel costs as a result of ongoing resource prioritization and efficiency efforts, partially offset by increased general selling expenses primarily for VYVGART. Loss from operations was $67.9 million in the third quarter of 2024, $48.2 million when adjusted to exclude non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release. Net loss was $41.7 million in the third quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.04 (or loss per American Deposit Share (ADS) of $0.42 ), compared to a net loss of $69.2 million for the same period in 2023, or a loss per ordinary share of $0.07 (or loss per ADS of $0.71 ). Cash and cash equivalents, short-term investments, and current restricted cash totaled $716.1 million as of September 30, 2024 , compared to $730.0 million as of June 30, 2024 . VYVGART was $27.3 million in the third quarter of 2024, compared to $4.9 million for the same period in 2023, driven by increased sales since its launch in September 2023 and listing on NRDL for the treatment of gMG effective January 1, 2024 . ZEJULA was $48.2 million in the third quarter of 2024, an increase of 16% y-o-y from $41.6 million for the same period in 2023. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China . NUZYRA was $10.0 million in the third quarter of 2024, an increase of 82% y-o-y compared to $5.5 million for the same period in 2023, driven by the NRDL listings for the IV formulation of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024. Corporate Updates Below are key corporate updates since our last earnings release: Organizational Update: In September 2024 , the Company appointed Prista Charuworn , M.D., as Vice President, Immunology, Global R&D. Dr. Charuworn is an accomplished gastroenterologist with extensive experience and leadership in clinical development in hepatology and immunology. She reports to Rafael Amado , M.D., President of Global Research and Development, and is responsible for leading and advancing the R&D strategy and execution of our immunology therapeutic area as well as our neuroscience and infectious disease assets. She previously held key leadership roles in clinical development at Amgen, AstraZeneca and Gilead. Recent Pipeline Highlights Below are key product updates since our last earnings release: Oncology Pipeline Global Pipeline – ZL-1310 (DLL3 ADC): In October 2024 , Zai Lab presented data from a Phase 1 study of ZL-1310 in extensive-stage SCLC (ES-SCLC) after platinum-based therapy. The data, from the ongoing Part 1a monotherapy dose-escalation portion of the study, included results from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0 mg/kg, 2.4 mg/kg). Findings from this study suggest that ZL-1310 delivers anti-tumor activity across multiple dose levels with an overall response rate of 74%. It was well tolerated across all dose levels with the majority of treatment emergent adverse events being Grade 1 or 2. Bemarituzumab (FGFR2b): In October 2024 , Zai Lab and partner Amgen completed patient enrollment for the global Phase 3 FORTITUDE-102 study of bemarituzumab in combination with chemotherapy and a checkpoint inhibitor in first-line gastric cancer. Immunology, Neuroscience, and Infectious Disease Pipeline Efgartigimod (FcRn): In November 2024 , China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for the subcutaneous formulation of efgartigimod, under the brand name VYVGART Hytrulo, for the treatment of adult patients with CIDP. It is the first and only NMPA-approved treatment for patients with CIDP in China . The product is to be administered as a single subcutaneous injection per week (1,000 mg fixed dose) delivered over 30 to 90 seconds. Xanomeline and Trospium Chloride (KarXT) (M1/M4-agonist): In October 2024 , Zai Lab announced positive topline results from the Phase 3 bridging study evaluating the safety and efficacy of KarXT in schizophrenia in China . The study met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all secondary efficacy endpoints. Zai Lab expects to submit a New Drug Application to the NMPA for KarXT for the treatment of schizophrenia in early 2025. In October 2024 , Zai Lab partner Bristol Myers Squibb (BMS) announced new topline results from the Phase 3 EMERGENT-4 and EMERGENT-5 open-label trials evaluating the long-term efficacy, safety and tolerability of KarXT in adults with schizophrenia over 52 weeks of treatment. In the analysis, KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures. KarXT continued to see a lack of weight gain, and it was not associated with movement disorders or metabolic changes. In September 2024 , BMS announced that the U.S. FDA approved KarXT, under the brand name COBENFYTM, for the treatment of adult patients with schizophrenia. Global Pipeline – ZL-1503 (IL-13/IL-31): In September 2024 , Zai Lab presented pre-clinical data of ZL-1503, an IL-13/IL-31 bi-specific antibody, at the European Academy of Dermatology and Venerology Congress (EADV) 2024. The presentation discussed the potential of ZL-1503 as a novel treatment for moderate-to-severe atopic dermatitis, as well as other diseases involving the IL-13 and IL-31 pathways. In October 2024 , Zai Lab announced positive topline results from the Phase 3 bridging study evaluating the safety and efficacy of KarXT in schizophrenia in China . The study met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all secondary efficacy endpoints. Zai Lab expects to submit a New Drug Application to the NMPA for KarXT for the treatment of schizophrenia in early 2025. In October 2024 , Zai Lab partner Bristol Myers Squibb (BMS) announced new topline results from the Phase 3 EMERGENT-4 and EMERGENT-5 open-label trials evaluating the long-term efficacy, safety and tolerability of KarXT in adults with schizophrenia over 52 weeks of treatment. In the analysis, KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures. KarXT continued to see a lack of weight gain, and it was not associated with movement disorders or metabolic changes. In September 2024 , BMS announced that the U.S. FDA approved KarXT, under the brand name COBENFYTM, for the treatment of adult patients with schizophrenia. Anticipated Major Milestones in 2024 and 2025 Expected Commercial Launches in China by the End of 2024 XACDURO (SUL-DUR) 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. VYVGART Hytrulo (efgartigimod alfa injection (subcutaneous injection)) as an add on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody positive and for the treatment of adult patients with CIDP. AUGTYRO (repotrectinib, ROS1/TRK) for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Upcoming Potential NMPA Submissions Xanomeline and Trospium Chloride (KarXT) (M1/M4-agonist): NDA submission in schizophrenia in early 2025. TTFields (Tumor Treating Fields): Marketing Authorization Application (MAA) submission in second-line+ NSCLC following progression on or after platinum-based chemotherapy. Zai Lab partner Novocure announced that TTFields was approved by the FDA under the brand name Optune Lua® for the treatment of metastatic NSCLC in October 2024 . Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy. Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors. Expected Clinical Development and Data Readouts in 2024 and 2025 Efgartigimod (FcRn) Zai Lab partner argenx to provide topline data from the Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy, anti-synthetase syndrome, and dermatomyositis) by the end of 2024. Zai Lab to join the Phase 3 portion of this study in the fourth quarter of 2024. Zai Lab to continue to work with argenx to explore the potential of efgartigimod to treat other IgG-mediated autoimmune indications by joining several studies in Greater China , including: The global registrational studies of efgartigimod alfa injection given by prefilled syringe in Thyroid Eye Disease (TED) in the fourth quarter of 2024. The global registrational Phase 3 studies in seronegative gMG and ocular MG in early 2025 aiming to expand the label into broader MG populations. The global registrational Phase 3 study in Sjogren’s disease in the second half of 2025. The global registrational studies of efgartigimod alfa injection given by prefilled syringe in Thyroid Eye Disease (TED) in the fourth quarter of 2024. The global registrational Phase 3 studies in seronegative gMG and ocular MG in early 2025 aiming to expand the label into broader MG populations. The global registrational Phase 3 study in Sjogren’s disease in the second half of 2025. Bemarituzumab (FGFR2b) Zai Lab partner Amgen to provide a data readout from the Phase 3 FORTITUDE-101 study of bemarituzumab combined with chemotherapy versus chemotherapy alone in first-line gastric cancer. We are participating in the study in Greater China . TTFields Zai Lab partner Novocure to provide a topline data readout from the Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the fourth quarter of 2024. We are participating in the study in Greater China . ZL-1310 (DLL3 ADC) Zai Lab to enroll patients into dose expansion in the ongoing global Phase 1 study for ZL-1310 monotherapy for second-line+ ES-SCLC in 2024, and initiate dose escalation for the first-line setting, in combination with atezolizumab and platinum-based chemotherapy in 2025. Zai Lab to initiate a global Phase 1 study to explore ZL-1310 in other neuroendocrine tumors in 2025. ZL-6301 (ROR1 ADC) Zai Lab to initiate a global Phase 1 study in solid tumors in 2025. ZL-1503 (IL-13/IL-31) Zai Lab to submit an Investigational New Drug Application to the FDA in 2025. Conference Call and Webcast Information Zai Lab will host a live conference call and webcast today, November 12, 2024 , at 8:00 a.m. ET ( 9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration Link: https://register.vevent.com/register/BIe3071c05888e4577aa901f5de0f00669 All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company’s website. About Zai Lab Zai Lab Limited (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, immunology, neuroscience, and infectious disease. 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. Non-GAAP Measures In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation. These adjusted growth rates and adjusted loss from operations are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on trends. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; and financial guidance, including with respect to our planned sources and uses of cash and our expected path to profitability. 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 on the SEC’s website at www.SEC.gov. Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets (in thousands of U.S. dollars ($), except for number of shares and per share data) September 30 , 2024 December 31 , 2023 Assets Current assets Cash and cash equivalents 616,086 790,151 Restricted cash, current 100,000 — Short-term investments — 16,300 Accounts receivable (net of allowance for credit losses of $14 and $17 as of September 30, 2024 and December 31, 2023 , respectively) 49,970 59,199 Notes receivable 19,278 6,134 Inventories, net 39,548 44,827 Prepayments and other current assets 35,667 22,995 Total current assets 860,549 939,606 Restricted cash, non-current 1,118 1,113 Long term investments 3,153 9,220 Prepayments for equipment 32 111 Property and equipment, net 50,765 53,734 Operating lease right-of-use assets 12,833 14,844 Land use rights, net 3,012 3,069 Intangible assets, net 51,669 13,389 Long-term deposits 975 1,209 Value added tax recoverable 1,240 — Total assets 985,346 1,036,295 Liabilities and shareholders’ equity Current liabilities Accounts payable 120,652 112,991 Current operating lease liabilities 6,585 7,104 Short-term debt 112,994 — Other current liabilities 46,084 82,972 Total current liabilities 286,315 203,067 Deferred income 24,924 28,738 Non-current operating lease liabilities 6,113 8,047 Other non-current liabilities 325 325 Total liabilities 317,677 240,177 Commitments and contingencies Shareholders’ equity Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 989,268,370 and 977,151,270 shares issued as of September 30, 2024 and December 31, 2023 , respectively; 984,356,170 and 972,239,070 shares outstanding as of September 30, 2024 and December 31, 2023 , respectively) 6 6 Additional paid-in capital 3,031,628 2,975,302 Accumulated deficit (2,371,399) (2,195,980) Accumulated other comprehensive income 28,270 37,626 Treasury Stock (at cost, 4,912,200 shares as of both September 30, 2024 and December 31, 2023 ) (20,836) (20,836) Total shareholders’ equity 667,669 796,118 Total liabilities and shareholders’ equity 985,346 1,036,295 Zai Lab Limited Unaudited Condensed Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) Three Months Ended September 30 , Nine Months Ended September 30 , 2024 2023 2024 2023 Revenues Product revenue, net 101,847 69,228 289,102 200,889 Collaboration revenue 418 — 816 — Total revenues 102,265 69,228 289,918 200,889 Expenses Cost of product revenue (36,569) (25,479) (105,336) (70,579) Cost of collaboration revenue (348) — (433) — Research and development (65,982) (58,767) (182,252) (183,920) Selling, general, and administrative (67,219) (68,552) (216,123) (198,982) Gain on sale of intellectual property — — — 10,000 Loss from operations (67,853) (83,570) (214,226) (242,592) Interest income 9,029 9,172 28,017 29,493 Interest expense (745) — (1,350) — Foreign currency gains (losses) 14,457 4,852 8,281 (26,315) Other income, net 3,441 394 3,859 223 Loss before income tax (41,671) (69,152) (175,419) (239,191) Income tax expense — — — — Net loss (41,671) (69,152) (175,419) (239,191) Loss per share - basic and diluted (0.04) (0.07) (0.18) (0.25) Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 981,687,390 968,767,730 976,941,030 965,060,570 Zai Lab Limited Unaudited Condensed Consolidated Statements of Comprehensive Loss (in thousands of $) Three Months Ended September 30 , Nine Months Ended September 30 , 2024 2023 2024 2023 Net loss (41,671) (69,152) (175,419) (239,191) Other comprehensive income, net of tax of nil: Foreign currency translation adjustments (14,503) (4,228) (9,356) 22,267 Comprehensive loss (56,174) (73,380) (184,775) (216,924) Zai Lab Limited Non-GAAP Measures ($ in thousands) Growth on a Constant Exchange Rate (CER) Basis Three Months Ended September 30 , Year over Year % Growth Nine Months Ended September 30 , Year over Year % Growth 2024 2023 As reported At CER* 2024 2023 As reported At CER* Product revenue, net 101,847 69,228 47% 46% 289,102 200,889 44% 45% Loss from operations (67,853) (83,570) (19)% (20)% (214,226) (242,592) (12)% (11)% * The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods. Reconciliation of Loss from Operations (GAAP) to Adjusted Loss from Operations (Non-GAAP) Three Months Ended September 30 , Nine Months Ended September 30 , 2024 2023 2024 2023 GAAP loss from operations (67,853) (83,570) (214,226) (242,592) Plus: Depreciation and amortization expenses 2,871 1,918 8,824 6,570 Plus: Share-based compensation 16,795 21,992 53,413 59,164 Adjusted loss from operations (48,187) (59,660) (151,989) (176,858) View source version on businesswire.com: https://www.businesswire.com/news/home/20241112084615/en/ 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 Source: Zai Lab Limited

Phase 3Phase 1Clinical ResultDrug ApprovalFinancial Statement

100 Deals associated with Omadacycline Tosylate

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KEGG	Wiki	ATC	Drug Bank
-	Omadacycline Tosylate	J01AA15	DB12455

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Community-acquired bacterial pneumonia	US	Paratek Pharmaceuticals, Inc.	02 Oct 2018
Skin and skin structure infections	US	Paratek Pharmaceuticals, Inc.	02 Oct 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cellulitis	Phase 3	CN	Hangzhou Ausia Biological Technology Co. Ltd.	01 Mar 2019
Cellulitis	Phase 3	CN	Zai Lab (Shanghai) Co., Ltd.	01 Mar 2019
Erysipelas	Phase 3	CN	Zai Lab (Shanghai) Co., Ltd.	01 Mar 2019
Erysipelas	Phase 3	CN	Hangzhou Ausia Biological Technology Co. Ltd.	01 Mar 2019
Skin structures and soft tissue infections	Phase 3	-	Paratek Pharmaceuticals, Inc.	01 Jul 2009
Complicated skin and skin structure infection	Phase 3	US	Paratek Pharmaceuticals, Inc.	04 Apr 2009
Complicated skin and skin structure infection	Phase 3	US	Novartis Pharmaceuticals Corp.	04 Apr 2009
Skin Diseases, Infectious	Phase 3	US	Paratek Pharmaceuticals, Inc.	04 Apr 2009
Skin Diseases, Infectious	Phase 3	US	Novartis Pharmaceuticals Corp.	04 Apr 2009
Arthropathy associated with infection	Phase 2	US	Paratek Pharmaceuticals, Inc.	09 May 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04460586 (Pubmed \| Clin Pharmacokinet)	Phase 4	Cystic Fibrosis	9	Omadacycline 100 mg IV	jqeioumpdu(krdoarbwce) = ayfutvbmbm cphixxoorb (fpwxjyjpur )	Positive	01 Dec 2024
				Omadacycline 300 mg oral	jqeioumpdu(krdoarbwce) = idwpkcytbh cphixxoorb (fpwxjyjpur )
NCT04922554 (GlobeNewswire) Manual	Phase 2	Mycobacterium Infections, Nontuberculous	66	omadacycline	sungmqgqsi(bxmtqomzsf) = xvnszliexk itklmrqsxj (idxrdonwzv ) View more	Positive	08 Nov 2024
				Placebo	sungmqgqsi(bxmtqomzsf) = mopepaasjx itklmrqsxj (idxrdonwzv ) View more
NCT02378480 \| NCT02877927 (OASIS-1, Pubmed \| Infect Dis Ther) Manual	Phase 3	Skin Diseases, Bacterial	-	Intravenous Omadacyclinelinezolid	pgdulhxdpf(ggdmovcska) = tvtbumsrhc xhnogwaijq (mqfhjhwxht ) View more	Positive	26 Oct 2024
				Oral Omadacyclinelinezolid	pgdulhxdpf(ggdmovcska) = byzjrncfcc xhnogwaijq (mqfhjhwxht ) View more
GlobeNewswire Manual	Approved	Community-acquired bacterial pneumonia	670	NUZYRA® (omadacycline)	foburqfmxq(nqsxqennsy) = ufpssgfilo cvmroucmwl (scpiaugesz ) Met View more	Positive	18 Jul 2024
				Moxifloxacin	foburqfmxq(nqsxqennsy) = futbdqaxsl cvmroucmwl (scpiaugesz ) Met View more
75A50120C00001 (GlobeNewswire) Manual	Not Applicable	Inhalation Anthrax	-	NUZYRA	wfjzqrcntq(zdtaprpbzz) = qmzvznztxv pnnfrgmawa (dtgmrhuuqv ) View more	Positive	05 Mar 2024
NCT04922554 (Phase 2, Pubmed \| JAC Antimicrob Resist)	Phase 2	Infectious Diseases	-	Omadacycline	nshngddnve(zbgqyyoits) = hbysvcmhgh hazyypkukt (uhxohcusap )	Positive	01 Oct 2023
NCT02531438 (OPTIC, Pubmed)	Phase 3	Community-acquired bacterial pneumonia	774	Omadacycline	mszqcotjol(akkorekvxx) = margwzkavx qzaztkcwco (vwkkstbwtf )	Positive	01 Jan 2023
				Moxifloxacin	mszqcotjol(akkorekvxx) = sghbhgnyop qzaztkcwco (vwkkstbwtf )
NCT02531438 \| NCT02378480 \| NCT02877927 (Pubmed \| J Fam Pract)	Phase 3	Pneumonia \| Skin Diseases, Infectious	-	Omadacycline	eqcqtsujxq(jlgbopcdbf) = gxsxwznthc fxjtpceqjb (nmjrmzgggd ) View more	Positive	01 Jun 2022
				Linezolid	eqcqtsujxq(jlgbopcdbf) = jzdocqdtof fxjtpceqjb (nmjrmzgggd ) View more
ATS2022	Not Applicable	Mycobacterium Abscessus Infection	26	Omadacycline	bwcasyiwji(zkbdmqpsjs) = weight loss, intractable nausea, eosinophilia, and abnormal hepatic function testing icyggiyzym (cnamjlxiaq ) View more	Positive	15 May 2022
NCT04160260 (CTgov)	Phase 1	Community-acquired bacterial pneumonia	18	Omadacycline	gajdskxtwe(mjhxhqymzn) = wtzlvnuznj yrstfywbrl (zcrtzxrcbp, oekitmjxzv - scendjvnpe) View more	-	03 Nov 2021

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