Zai Lab Limited Stock Price, News & Analysis

Zai Lab Limited (NASDAQ: ZLAB) announced the treatment of the first patient in Greater China in the PANOVA-3 trial. This pivotal Phase 3 trial investigates Tumor Treating Fields for pancreatic cancer, a highly aggressive cancer with a low five-year survival rate of about 7% in China. The trial will enroll approximately 556 patients, focusing on overall survival and various secondary endpoints. Given the urgent need for effective treatments, the promising results of Tumor Treating Fields previously approved for other cancers highlight the potential impact on patient outcomes.

Zai Lab Limited (NASDAQ: ZLAB) announced the acceptance of its New Drug Application (NDA) in China for margetuximab, a monoclonal antibody targeting HER2, aimed at treating adult patients with metastatic HER2-positive breast cancer who have undergone prior anti-HER2 therapies. This marks Zai Lab's sixth NDA acceptance by the China National Medical Products Administration (NMPA). The NDA is supported by positive results from the SOPHIA trial, showing improved progression-free survival compared to trastuzumab. Margetuximab has been previously approved by the FDA in the U.S. in 2020.

Zai Lab Limited (NASDAQ: ZLAB) announced its participation in two virtual investor conferences in January 2022. The first is the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 9:00 a.m. ET, followed by the BofA 2022 New York Asia Day on January 18, 2022, at 9:00 a.m. ET. A webcast link for the J.P. Morgan conference will be available on Zai Lab's website, with a replay accessible for 30 days. Zai Lab focuses on developing therapies for unmet medical needs in various fields, including oncology and autoimmune disorders.

Zai Lab Limited (NASDAQ: ZLAB) has announced the promotion of Dr. Harald Reinhart to President and Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases. Having served as Chief Medical Officer since 2017, Dr. Reinhart's promotion recognizes his significant contributions to the company's pipeline in these therapeutic areas. Dr. Reinhart has extensive experience in clinical development, previously holding senior roles at Shionogi and Novartis. This leadership change aims to enhance Zai Lab's clinical capabilities and drive innovation in drug development.

Zai Lab announced FDA approval of VYVGART™ (efgartigimod alfa-fcab) for treating generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive, representing about 85% of gMG patients. Results from the Phase 3 ADAPT trial showed a significant response rate of 68% in patients treated with VYVGART compared to 30% with placebo (p<0.0001). Zai Lab has exclusive rights to develop VYVGART in Greater China and plans to file a New Drug Application by mid-2022 to expedite patient access.

Zai Lab Limited (NASDAQ: ZLAB) announced the approval of NUZYRA (omadacycline) by the China National Medical Products Administration (NMPA) for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). This marks the fourth product approval for Zai Lab in two years. NUZYRA is manufactured locally in China, providing flexible treatment options with both oral and intravenous formulations. Its efficacy against multi-drug-resistant bacteria positions it as a promising solution in the face of rising antibiotic resistance.

Zai Lab Limited (NASDAQ: ZLAB) announced that ZEJULA (niraparib) has been added to China's National Reimbursement Drug List (NRDL) for first-line maintenance treatment of advanced ovarian cancer. This inclusion is expected to enhance accessibility for patients across China. ZEJULA is notably the only PARP inhibitor approved for this indication regardless of biomarker status. The company has previously demonstrated ZEJULA's clinical benefits in the Phase 3 PRIME study, which showed significant progression-free survival. This move aligns with Zai Lab's mission to provide transformative medicines for patients in need.

Zai Lab Limited (NASDAQ: ZLAB) announced that its Phase 3 PRIME study of ZEJULA (niraparib) successfully met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) for advanced ovarian cancer patients in China. This trial included 384 patients and highlighted a tolerable safety profile consistent with prior studies. ZEJULA, already approved for maintenance in recurrent cases, is now positioned as a leading option for first-line treatment. Zai Lab plans to present the PRIME study results at an upcoming medical conference.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in two upcoming virtual investor conferences in December 2021. The events include a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference on December 1 at 8:25 a.m. ET, and another at the SVB Leerink CybeRx Series on December 8 at 9:00 a.m. ET. Interested investors can access the webcast links through the 'Events & Presentations' section on Zai Lab's website. The company focuses on innovative therapies in oncology, autoimmune disorders, infectious diseases, and neuroscience.