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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 announced that its shares are now included in the Shanghai-Hong Kong Stock Connect program, effective today. This inclusion provides mainland Chinese investors greater access to Zai Lab’s shares, complementing its prior inclusion in the Shenzhen-Hong Kong Stock Connect since June 2022. The dual-primary listing on Nasdaq and the Hong Kong Stock Exchange enhances Zai Lab’s market presence. CFO Billy Cho highlighted the potential for expanding the shareholder base and accelerating growth in developing transformative medicines.
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection, the first FcRn antagonist for treating generalized myasthenia gravis (gMG) in adults. This milestone is pivotal for the estimated 200,000 gMG patients in China facing limited treatment options. Efgartigimod has previously received FDA and Japanese MHLW approvals. The drug specifically targets disease-causing autoantibodies, aiming for an effective therapy with minimal side effects.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has successfully transitioned from a secondary to a primary listing on the Hong Kong Stock Exchange, marking a first for any company. This dual-primary listing enhances access for investors and broadens Zai Lab's shareholder base, thereby improving liquidity and visibility in global markets. The move is aligned with Zai Lab's strategy to attract investors and leverage the potential of the China-Hong Kong Stock Connect, which will facilitate trading for Chinese investors. This shift underscores the company's commitment to improving healthcare solutions worldwide.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that the Center for Drug Evaluation (CDE) in China granted two Breakthrough Therapy Designations for repotrectinib, a treatment for ROS1-positive metastatic non-small cell lung cancer (NSCLC). These designations are for patients who have previously received specific lines of treatment. The recognition underscores repotrectinib's potential as a leading therapy for ROS1-positive NSCLC. The company aims to expedite the drug's availability for patients in need.
On June 3, 2022, Zai Lab (NASDAQ: ZLAB) and Novocure announced promising results from the EF-31 Phase 2 pilot study for Tumor Treating Fields (TTFields) in treating gastric adenocarcinoma. The study achieved a 50% objective response rate and a one-year survival rate of 72%. Patients experienced a median progression-free survival of 7.8 months and a duration of response lasting 10.3 months. TTFields therapy demonstrated good tolerability with no significant increase in toxicity. This represents a significant step forward in managing a challenging cancer.
Novocure (NASDAQ: NVCR) and Zai Lab (NASDAQ: ZLAB) announced promising results from their EF-31 phase 2 study on Tumor Treating Fields (TTFields) combined with the XELOX chemotherapy regimen for gastric adenocarcinoma. The study achieved a confirmed objective response rate of 50%, with a median progression-free survival of 7.8 months and a duration of response of 10.3 months. The one-year survival rate stood at 72%. TTFields therapy demonstrated good tolerability, with no significant increase in systemic toxicity. These results pave the way for future clinical studies.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced new findings from a subgroup analysis of the Phase 3 PRIME study on niraparib maintenance therapy for advanced ovarian cancer patients in China. The study showed that niraparib significantly extends progression-free survival (PFS) for patients who responded to first-line platinum-based chemotherapy, with a median PFS of 29.4 months versus 8.3 months for placebo in those with complete response. Results were presented at the 2022 ASCO Annual Meeting, emphasizing the importance of niraparib in treating advanced ovarian cancer.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in two major investor conferences in June 2022, aimed at enhancing investor relations. Management will present at the Jefferies Global Healthcare Conference on June 9 at 9:00 a.m. ET, followed by a Fireside Chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 16 at 9:20 a.m. PT. These presentations will be accessible via webcast on the company’s website, with archived replays available for 90 days. Zai Lab focuses on innovative therapies for oncology, autoimmune disorders, and infectious diseases.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced a change in the format of its 2022 Annual General Meeting due to COVID-19 pandemic restrictions in Shanghai. The Annual Meeting will be held virtually on June 22, 2022, at 8:00 a.m. U.S. Eastern Time. Shareholders of record can attend by visiting the dedicated website and using their control number from proxy materials. Zai Lab remains focused on developing therapies for unmet medical needs across oncology, autoimmune disorders, infectious diseases, and neuroscience.
Zai Lab reported Q1 2022 revenues of $46.7 million, up from $20.1 million in Q1 2021, driven by substantial growth in its marketed products. ZEJULA's product revenue was $29.6 million, and Optune reached $12.8 million.
R&D expenses decreased to $53.9 million due to the absence of upfront licensing fees. However, SG&A expenses rose to $57.0 million, reflecting investment in commercial operations. Zai Lab's net loss was $82.4 million, significantly lower than the $232.9 million loss in the same quarter last year. Cash reserves totaled $1.31 billion.
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