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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 its drug ZEJULA (niraparib) has been included in China's National Reimbursement Drug List by the NHSA. This designation allows ZEJULA to be more accessible as a maintenance therapy for adult patients with recurrent ovarian cancer responding to platinum-based chemotherapy. Dr. Samantha Du emphasized the importance of this inclusion in achieving patient access, while William Liang noted ZEJULA's unique clinical value in China. Ovarian cancer remains a significant health concern, with over 52,000 new cases reported annually.
Zai Lab Limited (NASDAQ: ZLAB) has entered an exclusive license agreement with Cullinan Oncology for CLN-081, an EGFR inhibitor targeting exon 20 insertion mutations, in Greater China. Cullinan will receive $20 million upfront and has the potential to earn up to $211 million in milestone payments and royalties based on sales. This collaboration aims to address high unmet medical needs in lung cancer treatment in China. CLN-081 is currently in a Phase 1/2a trial for NSCLC patients who have previously undergone treatment.
Zai Lab Limited (NASDAQ: ZLAB) announced that the FDA has approved MARGENZA (margetuximab-cmkb) for the treatment of adult patients with metastatic HER2-positive breast cancer, following two or more anti-HER2 regimens. In a Phase 3 trial, MARGENZA demonstrated a 24% reduction in disease progression risk compared to trastuzumab with chemotherapy. The product is set for U.S. launch in March 2021. MARGENZA is also being developed for advanced gastric cancer. Notably, it presents adverse reactions like fatigue (57%) and nausea (33%), with a BOXED WARNING for left ventricular dysfunction.
Zai Lab Limited (NASDAQ: ZLAB) has appointed Alan Sandler, M.D., as President and Head of Global Development for Oncology. Sandler, previously of Genentech, will lead the company's global oncology efforts and support its expanding R&D initiatives. His nearly 30 years of experience in oncology includes significant contributions to innovative therapies. CEO Dr. Samantha Du expressed confidence in Sandler's leadership to enhance Zai Lab's oncology pipeline. The company aims to become a prominent global biopharma player while addressing unmet medical needs in cancer and other diseases.
Zai Lab's Phase 2 FIGHT trial for bemarituzumab shows positive results in treating FGFR2b+ gastric cancer. Key endpoints achieved statistical significance: median progression-free survival rose from 7.4 to 9.5 months, overall survival improved significantly, and overall response rate increased by 13%. The trial included 155 patients and targeted a crucial biomarker in HER2- gastric cancers. Bemarituzumab, a first-in-class therapy, could expand treatment options for cancers with FGFR2b overexpression, currently affecting about 30% of gastric cancer cases globally.
Zai Lab Limited (NASDAQ: ZLAB) announced the initiation of patient dosing in China for the global POD1UM-101 study, assessing retifanlimab for previously treated, microsatellite instability-high endometrial cancer. This study aims to enroll around 100 patients and primarily evaluates the overall response rate. Endometrial cancer, prevalent in China, has a significant unmet medical need, particularly for patients with high microsatellite instability. Retifanlimab is an investigational anti-PD1 antibody also being assessed for other cancers, with Orphan Drug Designation granted for anal cancer.
On October 28, 2020, Zai Lab announced its participation in several virtual investor conferences in November. Key events include the Citi China Investor Conference on November 5, the BioCentury 7th China Healthcare Summit and Nomura Investment Forum on November 12, and the Goldman Sachs Asia Pacific Healthcare Forum on November 17, followed by the Jefferies Virtual London Healthcare Conference on November 18. A live webcast of the Jefferies conference will be available for 90 days post-event. Zai Lab aims to deliver transformative medicines for various diseases.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has fully exercised its over-allotment option, resulting in the issuance of 1,584,600 additional shares. This represents 15% of the total number of Offer Shares available under the recent Global Offering. The shares will be priced at HK$562 each, generating approximately HK$890.55 million in gross proceeds. The Hong Kong Stock Exchange has approved the listing of these shares, scheduled to commence on October 16, 2020. Zai Lab aims to utilize the proceeds for purposes outlined in its Prospectus.
Zai Lab announced the dosing of the first patient in Greater China for the global MAHOGANY study, evaluating margetuximab in combination with a checkpoint inhibitor for HER2-positive gastric cancer and gastroesophageal junction cancer. This Phase 2/3 trial aims to assess margetuximab’s efficacy with or without chemotherapy. Gastric cancer is prevalent, with significant unmet medical needs. Zai Lab collaborates with MacroGenics for this study, which is crucial for addressing advanced stage cancers in China, where the prognosis is often poor.
Zai Lab Limited (NASDAQ: ZLAB) has initiated dosing of the first patient in China for the global Phase 3 POD1UM-304 study, evaluating retifanlimab alongside platinum-based chemotherapy for first-line metastatic non-small-cell lung cancer (NSCLC). The trial aims to enroll approximately 530 patients and focuses on overall survival and progression-free survival as primary endpoints. The collaboration with Incyte aims to address the significant unmet medical need for NSCLC treatment in China, where lung cancer is the leading cause of cancer deaths.
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