Zai Lab Limited American Depositary Shares - ZLAB STOCK NEWS

Zai Lab has initiated patient enrollment in a pivotal global Phase 2 trial of odronextamab monotherapy for B-cell non-Hodgkin lymphoma (B-NHL) in China. This study, conducted in collaboration with Regeneron, aims to assess treatment efficacy across various B-NHL subtypes, including follicular and diffuse large B-cell lymphoma. The trial's primary goal is to evaluate the anti-tumor activity based on objective response rates. With an annual incidence of 92,834 NHL cases in China, this study represents a significant opportunity to address unmet medical needs in a heavily affected patient population.

Zai Lab has announced positive results from a Phase 1b proof-of-concept study of ZL-1102, an anti-IL-17A Humabody® for chronic plaque psoriasis. This study is the first to show clinical improvement through psoriatic skin penetration and involved 53 patients, reporting improvements in PASI scores, erythema, and scaling. The safety profile was similar to placebo. The successful trial triggers a milestone payment to Crescendo Biologics, which licenses ZL-1102 to Zai Lab, marking a significant advancement in their collaboration for developing targeted therapies.

Zai Lab Limited (NASDAQ: ZLAB) announced positive topline results from a Phase 1b proof-of-concept study of ZL-1102, a topical treatment for mild-to-moderate chronic plaque psoriasis. The study showed a 45% relative improvement in the local Psoriasis Area Severity Index (PASI) score after four weeks, with sustained clinical benefits up to six weeks post-treatment. The drug demonstrated a favorable safety profile compared to placebo, with minimal adverse events. Zai Lab plans to advance ZL-1102 into full development, including registrational studies, aiming to address the significant need for effective topical treatments for psoriasis.

Zai Lab Limited (NASDAQ: ZLAB) and Entasis Therapeutics announced positive topline results from the ATTACK trial, a Phase 3 study evaluating SUL-DUR in patients with carbapenem-resistant Acinetobacter infections. SUL-DUR demonstrated statistically non-inferior 28-day all-cause mortality compared to colistin and showed a significant clinical cure rate of 61.9%. The treatment also exhibited a favorable safety profile, reducing nephrotoxicity by 13.2% versus 37.6% with colistin. The trial enrolled 207 patients across 17 countries, indicating potential for SUL-DUR as an effective option against severe bacterial infections.

Zai Lab Limited (NASDAQ: ZLAB) announced the appointment of Scott Morrison to its Board of Directors and as a member of the Audit Committee. Morrison brings over 40 years of experience in the life sciences sector, previously serving as a partner at Ernst & Young. He has held significant roles in various public and private companies, enhancing his expertise in financial oversight and M&A transactions. CEO Dr. Samantha Du expressed enthusiasm for Morrison's role, citing numerous growth opportunities ahead for Zai Lab.

Zai Lab, a biopharmaceutical company, will present at two upcoming virtual investor conferences in October 2021. They will participate in the J.P. Morgan Global Healthcare Conference on October 13 at 9:30 a.m. HKT and the Jefferies China Biotech Virtual Summit on October 26 at 8:30 a.m. EDT. A live webcast for the Jefferies summit will be available on Zai Lab’s website, with a replay accessible for 90 days. Zai Lab focuses on developing therapies for unmet medical needs in oncology, autoimmune disorders, and infectious diseases.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced successful results from its bridging study of margetuximab plus chemotherapy for advanced HER2+ breast cancer. The study met its primary endpoint with a hazard ratio of 0.69 for median progression-free survival, aligning with results from the global SOPHIA study. The safety profile was consistent and acceptable. Zai Lab plans to file a Biologics License Application (BLA) in China for this indication by the end of 2021, enhancing its portfolio in oncology.

Zai Lab Limited (NASDAQ: ZLAB) and Turning Point Therapeutics, Inc. (NASDAQ: TPTX) announced that the FDA granted a Breakthrough Therapy designation to their lead drug candidate, repotrectinib. This status is for treating advanced solid tumors with an NTRK gene fusion, particularly after prior treatments have failed. The designation aims to expedite the drug's development, indicating potential significant improvement over existing therapies. A Type B meeting with the FDA is planned to discuss next steps for registration, anticipated in the first half of 2022.

Zai Lab Limited (NASDAQ: ZLAB) and Novocure (NASDAQ: NVCR) announced the completion of patient enrollment in a phase 2 pilot trial focusing on the use of Tumor Treating Fields (TTFields) combined with chemotherapy for treating unresectable gastric adenocarcinoma. Conducted in Greater China, this trial aims to assess safety and efficacy, with final data collection expected in the first half of 2022. Gastric cancer poses a significant healthcare challenge in China, with a high incidence and low survival rates, underscoring the importance of this trial in addressing unmet medical needs.