Zai Lab Limited Stock Price, News & Analysis

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.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced the appointment of Dr. Richard Gaynor to its Board of Directors, where he will also chair the Research and Development Committee. Dr. Gaynor is the President and Chief of R&D at BioNTech US, bringing extensive experience from his previous roles at Neon Therapeutics and Lilly Oncology. His expertise is expected to enhance Zai Lab's innovative pipeline in oncology.

CEO Dr. Samantha Du expressed confidence in Dr. Gaynor's leadership, emphasizing the board's strengthened capabilities to advance their global strategy.

Zai Lab Limited (NASDAQ: ZLAB) announced the dosing of the first patient in the Greater China segment of the global ADHERE study for efgartigimod, targeting chronic inflammatory demyelinating polyneuropathy (CIDP). The trial, consisting of an open-label Stage A and a randomized Stage B, will assess the safety and efficacy of weekly subcutaneous efgartigimod over 48 weeks. CIDP affects around 50,000 patients in China, with limited treatment options available. The potential of efgartigimod is notable due to the need for effective alternatives to corticosteroids and IVIg therapy.

Zai Lab Limited (NASDAQ: ZLAB) announced that the first patient has been treated in China's Phase 3 ADDRESS study of efgartigimod for pemphigus vulgaris (PV) and pemphigus foliaceus (PF). This randomized, double-blind trial aims to evaluate the drug’s safety and efficacy in roughly 150 patients. Efgartigimod targets IgG antibodies, offering potential for better disease management in these severe autoimmune disorders. Pemphigus affects approximately 90,000 patients in China, highlighting a significant unmet need for effective treatments.