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Zai Lab Limited (NASDAQ: ZLAB) is a pioneering biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines. Established in 2013 by industry veterans, Zai Lab addresses some of the world's most pressing unmet medical needs with a vision to transform patients’ lives globally.
The company employs a dual approach of in-licensing products and internal research and development to maintain a robust pipeline. This strategy has led to the development of promising drug candidates aimed at treating a range of severe health conditions, particularly in oncology, autoimmune, and infectious diseases.
Core Products and Pipeline:
- ZL-2306: An investigational treatment for multiple solid tumor types, including ovarian, breast, and lung cancers.
- ZL-2401: A novel antibiotic belonging to a new class of tetracycline derivatives, significant in the battle against resistant bacterial infections.
- ZL-2301: An oral small molecule targeting hepatocellular carcinoma (HCC), promising for liver cancer treatment.
Zai Lab's leadership team is acclaimed for their innovative regulatory approval pathways in China, which have expedited the introduction of new therapies. The company's partnerships with global pharmaceutical giants underscore its commitment to conducting world-class clinical development both in China and internationally.
Financially, Zai Lab has strong support from a cadre of leading healthcare investors, ensuring robust backing for its ambitious projects. This financial stability allows the company to explore cutting-edge research and expand its therapeutic offerings continually.
Recent Achievements and Current Projects:
- Successful initiation of multiple late-stage clinical trials across various therapeutic areas.
- Establishment of strategic partnerships with multinational pharmaceutical companies to enhance drug development and commercialization.
- Ongoing expansion of their research facilities to accommodate new projects and collaborations.
Zai Lab remains committed to leveraging its expertise, innovation, and strategic partnerships to bring life-changing therapies to market, ultimately improving patient outcomes worldwide.
Zai Lab Limited (NASDAQ: ZLAB) announced that China's Center for Drug Evaluation (CDE) has granted priority review status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR). This investigational drug targets infections by Acinetobacter baumannii, especially multidrug-resistant strains. The grant emphasizes the urgent need for new treatments in light of the high mortality rates associated with these infections in ICU settings. The FDA has also accepted the NDA for SUL-DUR for priority review, with an action date of May 29, 2023. Zai Lab holds exclusive commercialization rights for SUL-DUR in multiple Asia-Pacific regions.
Zai Lab Limited (NASDAQ: ZLAB) announced that its drugs QINLOCK® (ripretinib) and NUZYRA® (omadacycline) have been added to China's National Reimbursement Drug List (NRDL). This inclusion is significant for patients with advanced gastrointestinal stromal tumors and community-acquired bacterial pneumonia. William Liang, Zai Lab's Chief Commercial Officer, emphasized that NHSA reimbursement will expand patient access to these treatments. Both drugs previously received regulatory approval in China, with NUZYRA launched in 2019. GIST affects approximately 30,000 new patients annually in China, highlighting a critical need for effective treatments.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced the appointment of Michel Vounatsos to its Board of Directors, effective January 7, 2023. Vounatsos has over 25 years of experience in the biopharmaceutical sector, including leadership roles at Biogen and Merck. His extensive commercial background, particularly in neuroscience and operations in China, is expected to enhance Zai Lab's growth and product commercialization efforts. The company currently has four drugs on the market and plans to launch three more, aiming to improve patient care in China and globally.
The LUNAR study by Zai Lab and Novocure has achieved its primary endpoint, showing a statistically significant improvement in overall survival for stage 4 non-small cell lung cancer (NSCLC) patients.
The study demonstrated enhanced survival rates for patients receiving Tumor Treating Fields (TTFields) alongside standard treatments compared to those receiving standard treatments alone. Notably, results indicated a positive trend in survival with TTFields combined with docetaxel. Novocure plans to present the complete findings at an upcoming medical conference and file for FDA approval in late 2023.
Zai Lab Limited (NASDAQ: ZLAB) announced the appointment of Dr. Rafael G. Amado as President and Head of Global Oncology Research and Development, effective December 30, 2022. Dr. Amado, with extensive oncology expertise, previously held leadership roles at Allogene Therapeutics and Adaptimmune. His appointment aims to enhance Zai Lab's oncology R&D capabilities, supporting the company's goal of becoming a leading global biopharmaceutical entity. Dr. Amado's focus will be on accelerating existing and future oncology programs to address unmet medical needs in China and globally.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in key investor conferences in January 2023. The company will be present at the Morgan Stanley Virtual China Opportunity Conference from January 4-6, and will present at the J.P. Morgan 41st Annual Healthcare Conference on January 10 at 9:00 a.m. PST in San Francisco. The webcast for the J.P. Morgan conference will be accessible on Zai Lab’s Investor Relations site, with an archived replay available for 30 days. Zai Lab focuses on developing transformative medicines in oncology, autoimmune disorders, infectious diseases, and neurological disorders.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) presented new interim overall survival (OS) data for ZEJULA® (niraparib) in patients with platinum-sensitive recurrent ovarian cancer at the ESMO Virtual Plenary. The median overall survival was 46.3 months for ZEJULA compared to 43.4 months for placebo. Notably, the results suggest a favorable trend in OS regardless of gBRCA mutation status. No new safety concerns were identified in the study. The final OS analysis is anticipated in 2023, further establishing ZEJULA's role as a second-line maintenance therapy for ovarian cancer.
Zai Lab announced promising preliminary results for adagrasib combined with pembrolizumab in treating first-line advanced/metastatic NSCLC with KRASG12C mutation. Data from the KRYSTAL-7 Phase 2 trial and KRYSTAL-1 Phase 1b cohort show favorable tolerability and an overall response rate (ORR) of 49%, with a notable 56% in a select subset. The safety profile revealed manageable treatment-related adverse events. This data will be presented on December 7 at the ESMO Immuno-Oncology Congress, highlighting the potential of this combination therapy for treatment-naïve patients.
Zai Lab reported third-quarter 2022 revenues of $57.5 million, marking a 33% year-on-year and 19% quarter-on-quarter increase. This growth is driven by the success of ZEJULA and a new collaboration for TIVDAK. The company maintains a strong balance sheet with $1.12 billion in cash, supporting operations through 2025. R&D expenses rose to $99.5 million, influenced by increased clinical trial costs and a $30 million upfront payment to Seagen. Despite these expenses, Zai Lab expects net product revenue to surpass costs in 2023.
Zai Lab Limited (NASDAQ: ZLAB) will present new data on its immuno-oncology pipeline at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 8-12, 2022, in Boston, Mass. The focus will be on two key programs: ZL-1211 (anti-CLDN18.2 antibody) for gastric cancer and ZL-1218 (anti-CCR8 antibody) for solid tumors. Presentations will feature research on enhancing anti-tumor activities and targeting intratumoral Treg subpopulations, showcasing Zai Lab's commitment to advancing its global R&D pipeline.
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