Zai Lab Limited Stock Price, News & Analysis

On August 4, 2020, Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has granted priority review for the New Drug Application of ripretinib, aimed at adult patients with advanced gastrointestinal stromal tumors (GIST) who have failed three or more kinase inhibitors. This status highlights the unmet need for over 30,000 new GIST cases annually in China. Ripretinib targets a broad range of KIT and PDGFRα mutations, showing potential to transform GIST treatment. The drug is already approved in the U.S., Canada, and Australia under the brand name QINLOCK™.

Zai Lab Limited (NASDAQ: ZLAB) announced it will report financial results for the six months ending June 30, 2020, and provide corporate updates on August 13, 2020, before the market opens. The company will host a live conference call and webcast at 8:00 a.m. ET on the same day, requiring prior registration. Zai Lab focuses on innovative biopharmaceutical solutions for cancer, infectious, and autoimmune diseases, targeting the Chinese pharmaceutical market with a robust pipeline through global partnerships.

Zai Lab Limited (NASDAQ: ZLAB) has announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ripretinib, aimed at treating adult patients with advanced gastrointestinal stromal tumor (GIST) after prior treatments with multiple kinase inhibitors. Following the recent U.S. FDA approval, ripretinib shows potential to address a significant unmet medical need in China, where over 30,000 new GIST cases are diagnosed annually. The INVICTUS trial results demonstrate ripretinib's efficacy, significantly improving progression-free and overall survival rates.

Zai Lab Limited (NASDAQ: ZLAB) announced positive topline results from the NORA study, a Phase 3 trial evaluating ZEJULA (niraparib) as maintenance therapy in Chinese patients with recurrent ovarian cancer. The study, the largest of its kind in China, randomized 265 patients and met its primary endpoint of statistically significant improvement in progression-free survival. Additionally, the individualized starting dose regimen improved safety, showing lower rates of anemia and thrombocytopenia. This study aligns with results from the global NOVA study, reinforcing ZEJULA's potential in clinical practice.

Zai Lab Limited (NASDAQ: ZLAB) announced its participation in three upcoming virtual conferences in June. Dr. Samantha Du, the CEO, will present at the Jefferies Global Healthcare Conference on June 2, the Goldman Sachs Annual Global Healthcare Conference on June 11, and participate in a panel at the JP Morgan China Investor Conference on June 24. Webcasts will be available live and archived on Zai Lab's website. The company focuses on developing medicines for cancer, infectious, and autoimmune diseases, aiming to establish a global pipeline of innovative drug candidates.

Zai Lab Limited (NASDAQ: ZLAB) has commenced the Phase 3 ATTACK trial, evaluating the combination of sulbactam and durlobactam (SUL-DUR) against carbapenem-resistant Acinetobacter baumannii infections. This global trial includes around 300 patients and aims to address the rising incidence of these infections in China, where over 200,000 cases occur annually. The trial's data readout is anticipated in early 2021. The combination has shown positive in-vitro activity and safety in prior studies, marking a crucial step in combating multidrug-resistant infections.

Zai Lab has obtained marketing approval from the China National Medical Products Administration (NMPA) for Optune, a novel treatment for glioblastoma. This marks the first new treatment for glioblastoma in over 15 years in China. Clinical studies demonstrated that combining Optune with temozolomide more than doubled the five-year overall survival rate for newly diagnosed patients. The approval reinforces Zai Lab's position in the biopharmaceutical market, being its second product approval in six months.

Zai Lab (NASDAQ: ZLAB) announced that the Center for Drug Evaluation of China's NMPA has granted priority review status to its New Drug Application for omadacycline, targeting community-acquired bacterial pneumonia (CABP) and acute bacterial skin infections (ABSSSI). This designation aims to expedite the drug's approval process, addressing unmet medical needs in China related to bacterial resistance. Omadacycline, launched in the U.S. in February 2019, is designed to combat a broad range of bacterial infections, including multi-drug-resistant strains.