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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 positive results from the Phase 3 NORA study presented at ESMO 2020, demonstrating that niraparib maintenance treatment led to a 68% reduction in the risk of disease progression or death compared to placebo. The median progression-free survival (PFS) for niraparib was significantly longer at 18.3 months, versus 5.4 months for placebo. An individualized dosing regimen reduced adverse events significantly. The study evaluated 265 patients, marking a key step in addressing treatment options for recurrent ovarian cancer in China.
Zai Lab has announced a Hong Kong public offering of 10,564,050 new ordinary shares, with 771,700 shares available in the public offering and 9,792,350 shares for international investors. The maximum offer price is set at HK$648.00 per share. The shares will be listed on the Hong Kong Stock Exchange under stock code 9688 and will be fully fungible with American depositary shares listed on Nasdaq. Proceeds will support R&D, clinical trials, and general corporate purposes. The application process will be entirely electronic, in line with the company's commitment to sustainability.
Zai Lab Limited (NASDAQ: ZLAB) announced that the China National Medical Products Administration (NMPA) has approved ZEJULA® (niraparib) for maintenance treatment in adults with advanced ovarian cancer following platinum-based chemotherapy. This approval marks ZEJULA as the first PARP inhibitor approved globally for all-comer patients in this context. The company emphasized ZEJULA’s potential to change treatment standards in China, highlighting its efficacy and safety. Zai Lab is actively pursuing several studies related to ZEJULA, which may further enhance its market position in oncology therapeutics.
Zai Lab Limited (NASDAQ: ZLAB) announced that CEO Dr. Samantha Du will present at two upcoming virtual conferences. The presentations are scheduled for September 10, 2020, at Citi’s 15th Annual Biopharma Virtual Conference, and September 29, 2020, at JP Morgan’s Women’s Leadership Conference. These conferences are significant as they provide Zai Lab with opportunities to showcase its innovative biopharmaceutical developments, particularly in cancer, infectious, and autoimmune diseases. Archived replays of the presentations will be accessible on Zai Lab’s investor relations website.
Zai Lab Limited (NASDAQ: ZLAB) reported significant advancements in its clinical pipeline and financial results for the six months ending June 30, 2020. The company achieved net product revenues of $19.2 million, driven by ZEJULA and Optune sales. With two successful launches, NMPA approval for Optune, and three NDAs accepted for priority review, Zai Lab is positioned for growth. Despite a net loss of $128.6 million, the company has $464.1 million in cash, supporting ongoing R&D and commercialization efforts. A conference call is scheduled for today at 8:00 a.m. EDT.
On August 4, 2020, Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has granted priority review for the New Drug Application of ripretinib, aimed at adult patients with advanced gastrointestinal stromal tumors (GIST) who have failed three or more kinase inhibitors. This status highlights the unmet need for over 30,000 new GIST cases annually in China. Ripretinib targets a broad range of KIT and PDGFRα mutations, showing potential to transform GIST treatment. The drug is already approved in the U.S., Canada, and Australia under the brand name QINLOCK™.
Zai Lab Limited (NASDAQ: ZLAB) announced it will report financial results for the six months ending June 30, 2020, and provide corporate updates on August 13, 2020, before the market opens. The company will host a live conference call and webcast at 8:00 a.m. ET on the same day, requiring prior registration. Zai Lab focuses on innovative biopharmaceutical solutions for cancer, infectious, and autoimmune diseases, targeting the Chinese pharmaceutical market with a robust pipeline through global partnerships.
Zai Lab Limited (NASDAQ: ZLAB) has announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ripretinib, aimed at treating adult patients with advanced gastrointestinal stromal tumor (GIST) after prior treatments with multiple kinase inhibitors. Following the recent U.S. FDA approval, ripretinib shows potential to address a significant unmet medical need in China, where over 30,000 new GIST cases are diagnosed annually. The INVICTUS trial results demonstrate ripretinib's efficacy, significantly improving progression-free and overall survival rates.
Zai Lab Limited (NASDAQ: ZLAB) announced positive topline results from the NORA study, a Phase 3 trial evaluating ZEJULA (niraparib) as maintenance therapy in Chinese patients with recurrent ovarian cancer. The study, the largest of its kind in China, randomized 265 patients and met its primary endpoint of statistically significant improvement in progression-free survival. Additionally, the individualized starting dose regimen improved safety, showing lower rates of anemia and thrombocytopenia. This study aligns with results from the global NOVA study, reinforcing ZEJULA's potential in clinical practice.
Zai Lab Limited (NASDAQ: ZLAB) announced its participation in three upcoming virtual conferences in June. Dr. Samantha Du, the CEO, will present at the Jefferies Global Healthcare Conference on June 2, the Goldman Sachs Annual Global Healthcare Conference on June 11, and participate in a panel at the JP Morgan China Investor Conference on June 24. Webcasts will be available live and archived on Zai Lab's website. The company focuses on developing medicines for cancer, infectious, and autoimmune diseases, aiming to establish a global pipeline of innovative drug candidates.
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