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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 (NASDAQ: ZLAB) announced that China's NMPA has accepted the New Drug Application for KarXT to treat adult schizophrenia. The application is supported by successful Phase 1 and Phase 3 trials in China, alongside global EMERGENT clinical program data.
The China Phase 3 study achieved its primary endpoint, showing a significant 9.2-point improvement over placebo in PANSS total score reduction (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all key secondary efficacy endpoints. Common side effects included vomiting, tachycardia, nausea, hypertension, dizziness, and diarrhea.
With over 8 million schizophrenia patients in China facing treatment options, KarXT represents the first new treatment class in decades. The drug recently received FDA approval in September 2024 under the brand name COBENFY™, notably without atypical antipsychotic class warnings or boxed warnings.
Zai Lab (NASDAQ: ZLAB) announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 trial for TIVDAK in recurrent or metastatic cervical cancer patients. The study demonstrated a 45% reduction in death risk compared to chemotherapy in Chinese patients, with median overall survival not reached versus 10.7 months for chemotherapy.
The results were consistent with the global population data, showing improved overall survival (OS), progression-free survival (PFS), and confirmed objective response rate (ORR). The safety profile was manageable and aligned with global findings. More than half of the Chinese study population had received prior anti-PD(L)1 therapy.
Following FDA's full approval of TIVDAK in April 2024, Zai Lab plans to submit a New Drug Application to China's NMPA in Q1 2025. With approximately 150,000 new cervical cancer cases annually in China, TIVDAK could provide a important treatment option for patients with alternatives after initial treatment failure.
Vertex Pharmaceuticals (VRTX) and Zai Lab (ZLAB) have announced an exclusive collaboration and license agreement for the development and commercialization of povetacicept in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist being studied for Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.
Under the agreement, Vertex will receive an upfront payment, regulatory milestone payments, and tiered royalties on net sales. Zai Lab will leverage its R&D expertise to advance clinical trials and handle regulatory submissions in the licensed territory. Once approved, Zai Lab will be responsible for all commercialization activities in the region, utilizing its established commercial infrastructure.
Zai Lab (ZLAB) and Vertex Pharmaceuticals (VRTX) have announced an exclusive collaboration and license agreement for the development and commercialization of povetacicept in mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore.
Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of BAFF and APRIL with best-in-class potential, being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.
Under the agreement terms, Vertex will receive an upfront payment, regulatory milestone payments, and tiered royalties on net sales. Zai Lab will leverage its R&D expertise for clinical trials and regulatory submissions, while also managing all commercialization activities in the licensed territory upon approval.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced a strategic collaboration and worldwide license agreement with MediLink Therapeutics to develop ZL-6201, a novel LRRC15 antibody-drug conjugate (ADC). The partnership will utilize MediLink's TMALIN® ADC platform combined with an antibody discovered by Zai Lab.
The collaboration expands Zai Lab's global oncology pipeline with a potential first-in-class ADC targeting multiple solid tumors. ZL-6201 has shown promising preclinical data, with an Investigational New Drug (IND) filing expected in 2025. This partnership builds upon ongoing clinical trials for ZL-1310 and reinforces Zai Lab's commitment to developing ADC-based cancer therapies.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its upcoming participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's senior management team will deliver a presentation on Tuesday, January 14, 2025, at 1:30 p.m. PST in San Francisco. Investors can access a live webcast of the presentation through Zai Lab's Investor Relations website, with an archived replay available for 30 days after the event.
Zai Lab (ZLAB) and Novocure announced positive results from their Phase 3 PANOVA-3 trial, evaluating Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel for pancreatic cancer. The trial met its primary endpoint, showing a statistically significant improvement in median overall survival of 16.20 months compared to 14.16 months in the control group (hazard ratio=0.819; P=0.039). The treatment demonstrated increasing survival benefits over time, with a 13% improvement at 12 months and 33% at 24 months. Both companies plan to seek regulatory approvals in their respective markets.
Zai Lab announced significant updates to China's 2024 National Reimbursement Drug List (NRDL). AUGTYRO® (repotrectinib) has been included for treating ROS1-positive non-small cell lung cancer. The NRDL also renewed NUZYRA® (omadacycline) for bacterial infections and QINLOCK® (ripretinib) for advanced gastrointestinal stromal tumor. These inclusions will expand patient access and provide more affordable treatment options across China. The company plans to launch AUGTYRO by the end of 2024, marking its sixth product in the NRDL.
Zai Lab (NASDAQ: ZLAB) and Pfizer announced a strategic collaboration for XACDURO® (sulbactam-durlobactam) in mainland China through November 2028. Pfizer will exclusively handle commercialization activities for XACDURO®, leveraging its anti-infective infrastructure. XACDURO® is the only antimicrobial specifically developed for treating carbapenem-resistant Acinetobacter baumannii (CRAB) in hospital-acquired and ventilator-associated bacterial pneumonia. In China, where Acinetobacter baumannii resistance to carbapenem antibiotics has reached approximately 74%, this collaboration aims to accelerate patient access to this critical therapy.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced the closing of its public offering of 9,019,607 American Depositary Shares (ADSs) at $25.50 per ADS, including the full exercise of underwriters' option for additional 1,176,470 ADSs. The offering is expected to generate approximately $230 million in gross proceeds before deducting underwriting discounts and commissions. Goldman Sachs, Jefferies, and Leerink Partners served as joint book-running managers for the offering, which was made under an automatically effective S-3ASR registration statement.
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