Tuberculosis, Multidrug-Resistant

TB Alliance's third licensed manufacturer makes pretomanid available through the Global Drug Facility, further improving affordability and access NEW YORK, April 24, 2025 /PRNewswire/ -- TB Alliance applauds a new milestone in the fight against drug-resistant tuberculosis (DR-TB): a 25% price reduction for pretomanid, a key component of the BPaL/M regimens. Pretomanid is now available through the Global Drug Facility (GDF) at just $169 per treatment course—less than $1 per day, a key pricing benchmark identified by the global TB advocacy community. This latest price drop—down from $364 upon pretomanid's initial approval in 2019, and down further from $224 in October 2024—reflects ongoing efforts by TB Alliance and its partners to broaden access and improve affordability through a multi-manufacturer approach to access. TB Alliance, a nonprofit organization that developed pretomanid, has pioneered an innovative access model by partnering with multiple quality-assured manufacturers. This strategy helped launch pretomanid at an initial low price and ensured rapid, sustainable, and affordable access across high-TB burden countries. Simultaneously, by enabling healthy competition and fostering multiple high-quality supply sources, TB Alliance's strategy expanded availability while driving down costs. "This progress demonstrates how thoughtful collaboration and planning can translate into real-world impact," said Dr. Mel Spigelman, President and CEO of TB Alliance. "By enabling multiple high-quality producers to supply this medicine, we're fostering a healthy and sustainable market to deliver on our mandate that the life-saving medicines we develop will be adopted, available, and affordable to all those in need. We're grateful to partners such as Lupin and GDF for their shared commitment to supplying the market with life-saving TB medicines and stand committed to working with all our manufacturing partners to ensure equitable and affordable access." The current GDF price reduction, led by Lupin Limited, represents a crucial step in delivering on this vision. Procurement through GDF will save an estimated $37 million annually according to The Stop TB Partnership, the organization responsible for managing GDF, allowing for the treatment of an additional 120,000 people with DR-TB. Together with recent price reductions for the other regimen components, the cost of a full BPaL/M treatment course has dropped to a new low of $310—less than $2 per day, and a 47% reduction from its December 2022 price. BPaL/M is a six-month treatment recommended by the World Health Organization to treat most forms of DR-TB. It consists of bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). In 2024 alone, approximately 110,000 courses of pretomanid were ordered across the world—enough to treat more than 60% of the global market for DR-TB treatment, perhaps the fastest ever scale up for a new TB medicine in modern times. "Lupin is proud to collaborate with TB Alliance and the Global Drug Facility to make pretomanid, an essential medicine in the fight against multidrug-resistant TB, more accessible and affordable for TB patients across the globe," said Ramesh Swaminathan, Global CFO, Executive Director, Head of API Plus SBU at Lupin. "The recent price reduction reflects our strong and deep-rooted commitment to delivering high-quality and affordable medicines to TB patients worldwide. Through this partnership, we reaffirm our dedication to patient-centric innovation and equitable access, ensuring that countries burdened by TB have the necessary treatment options they need to save lives and strengthen public health systems." "For years, advocates from the TB community have called for TB treatments that are not just effective, but also affordable for every person who needs them," said Olya Klymenko, Development Director of TBPeopleUkraine. "The full BPaL/M regimen now costing less than $2 per day is deeply meaningful. We express our gratitude to everyone who made this result possible. There really is no reason for governments and health systems around the world to not provide these treatments to every person who can benefit from them." TB Alliance remains committed to expanding its innovative access model to ensure new innovations in TB treatment reach all who need them as rapidly as possible. With additional planned future tenders, TB Alliance expects additional price reductions for pretomanid in the future. Beyond pricing strategies, TB Alliance continues to develop and execute innovative market access initiatives like LIFT-TB, SLASH-TB, and the PeerLINC Knowledge Hub to speed the global uptake, procurement, and implementation of shortened DR-TB treatments for all who need them around the world. About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that all traces of the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Previously, less than two-thirds of drug-resistant TB patients around the world had been successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Media Contact: Jess Wiggs at [email protected] SOURCE TB Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

January 15, 2025 Throughout 2024, one of TB Alliance’s foremost priorities has been ensuring that pretomanid and BPaL-based regimens reach all people with drug-resistant TB (DR-TB) around the world. To meet this challenge, TB Alliance has been working with and empowering a diverse set of stakeholders to help scale access to this treatment more quickly and widely than had been achieved for a TB therapy in the modern era. We are heartened to share an update on approval and programmatic implementation milestones in the five BRICS countries, four of which are among the world’s ten highest DR-TB burden countries. South Africa continues to make dramatic progress against DR-TB South Africa is a prime example of what a country can achieve when they truly commit to tackling DR-TB. Between 2015 and 2022, South Africa reduced its DR-TB burden by nearly 80%. Following first approval of pretomanid, South Africa rapidly implemented the BPaL Clinical Access Programme (BCAP), which helped inform local implementation. Working with the National TB Programme and a local partner, TB Alliance helped develop a national implementation plan. South Africa is firmly on the path toward full national implementation of BPaL-based regimens launched on September 1, 2023. By November 2024, more than 5,000 individuals had been enrolled on the treatments. At least 90% of all individuals who are eligible for these regimens are now receiving them. Brazil rolls out BPaL/M following visit to PeerLINC Knowledge Hub Brazil, a leader in implementing health innovations and making them rapidly available to all who need them in the country, began rolling out BPaL/M in December 2024. This follows a training and capacity building visit by a delegation of TB experts and policymakers from the Brazilian National TB Program to the PeerLINC Knowledge Hub in Manila. PeerLINC is a collaboration between TB Alliance and the Tropical Disease Foundation, Inc. (TDF) and works closely with the Department of Health, Philippines and provides practical training, technical support and peer-to-peer thought partnership to NTPs to develop implementation plans and help speed programmatic implementation of new TB technologies. India issues national guidelines; initiates BPaL rollout With the largest DR-TB burden of any country in the world, India was one of the first countries in the world to approve pretomanid and the BPaL regimen. However, the path from approval to national implementation requires many steps. Upon approval, a study on BPaL was conducted by Indian researchers under India’s National TB Elimination Programme to generate local evidence and confirm the global clinical trial results of the regimen. Having completed this study, India updated its national treatment guidelines in December 2024 to include BPaL/M. National and regional trainings have been rolled out rapidly by the Central TB Division which will enable roll-out of BPaL/M under programmatic settings. Russia approves pretomanid/BPaL One of only three countries in the world that reports 30,000 or more cases of DR-TB annually, Russia is a key high DR-TB burden country with a complex and independent approval process for new medicines. Regulatory approval for pretomanid and BPaL was granted in December 2024. Plans to make pretomanid available in the country have commenced. China approves pretomanid/BPaL With the world’s fourth-highest DR-TB burden, pretomanid and BPaL could prove to be a crucial tool to speed up China’s intention to eliminate DR-TB and build on the country’s efforts that have already led to a reduction in overall DR-TB burden by approximately 50% over the previous decade. In December 2024, pretomanid and BPaL received regulatory approval in China and TB Alliance is working closely with national stakeholders including the China Anti-Tuberculosis Association and the manufacturer in the country to ensure rapid roll-out of the regimen. PeerLINC Knowledge Hub Mylan Secures DCGI Approval in India for Pretomanid, a Treatment for Highly Drug-Resistant Forms of Tuberculosis

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 .