Zai Lab Limited American Depositary Shares - ZLAB STOCK NEWS

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced that data from a Phase 1 study of ZL-1310, its investigational antibody-drug conjugate (ADC), will be presented at the EORTC-NCI-AACR Symposium (ENA) 2024 in Barcelona. The presentation will focus on ZL-1310's potential as a novel treatment for small cell lung cancer (SCLC). ZL-1310 targets Delta-like ligand 3 (DLL3), which is overexpressed in many neuroendocrine tumors and associated with poor clinical outcomes.

The compound features a novel linker-payload platform called TMALIN®, designed to overcome challenges of first-generation ADC therapies. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, emphasized the need for new therapies with reduced off-target toxicity and increased anti-tumor effectiveness for SCLC and other neuroendocrine tumors. The presentation, titled 'Preliminary Results from a Phase 1a/1b, Open-Label, Multicenter Study of ZL-1310,' will be given by Dr. Alex Spira on October 24, 2024.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) will present preclinical data on ZL-1503, an IL-13/IL-31 bispecific antibody for treating atopic dermatitis, at the EADV Congress 2024. This internally developed drug targets both inflammatory and pruritogenic pathways, potentially offering improved treatment for moderate-to-severe atopic dermatitis and related conditions. Current IL-4/IL-13 inhibitors have limitations in addressing IL-31-mediated symptoms, resulting in slow and modest clinical responses. ZL-1503 aims to inhibit both IL-13 and IL-31 signaling pathways, potentially expanding treatment options. The late-breaking oral presentation, scheduled for September 25, 2024, will discuss ZL-1503's potential as a novel treatment for atopic dermatitis and other IL-13/IL-31 related diseases.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) will present preliminary data from a Phase 1 trial of ZL-1218, an investigational anti-CCR8 antibody for advanced solid tumors, at the ESMO Congress 2024. The study (NCT05859464) aims to demonstrate ZL-1218's potential to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment. ZL-1218 is a humanized monoclonal antibody targeting CCR8, a receptor on tumor-associated regulatory T cells, potentially enhancing antitumor immune response.

The ongoing global Phase 1 study evaluates ZL-1218 as a single agent and in combination with pembrolizumab. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, highlighted the importance of overcoming tumor microenvironment complexities in cancer immunotherapy. The poster presentation at ESMO 2024 will focus on preliminary clinical PK and PD analysis of ZL-1218 in patients with advanced solid tumors.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its participation in two major investor conferences in September 2024. The company's senior management team will attend the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Additionally, they will participate in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference on Thursday, September 19, 2024, at 8:00 a.m. ET in Track 2, also held in New York.

These conferences provide Zai Lab with opportunities to engage with investors and showcase their company's progress and future plans in the healthcare sector.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) reported strong Q2 2024 financial results, with net product revenue of $100.1 million, up 45% year-over-year. VYVGART sales reached $23.2 million, prompting a raised full-year guidance to exceed $80 million. The company expanded its oncology pipeline with a new ROR1 ADC program. Three product approvals were obtained in China, including XACDURO for HABP/VABP, efgartigimod SC for gMG, and AUGTYRO for ROS1+ NSCLC. Zai Lab maintains a strong cash position of $730 million as of June 30, 2024. The company expects at least four regulatory submissions to the NMPA within the next 12 months, including KarXT for schizophrenia.

Zai Lab (NASDAQ: ZLAB) and argenx announced the approval of efgartigimod alfa injection (subcutaneous injection) by China's NMPA for treating adult generalized myasthenia gravis (gMG) patients who are anti-AChR antibody positive. This marks the first and only NMPA-approved subcutaneous injectable for gMG in China, offering additional flexibility for patients.

The approval is based on the Phase 3 ADAPT-SC study, which demonstrated consistent clinical benefit and safety compared to the IV formulation. Efgartigimod SC showed a 66.4% mean total IgG reduction from baseline at day 29, compared to 62.2% with IV administration. The most common adverse event was mild to moderate injection site reactions.

This approval enhances treatment options for the estimated 170,000 gMG patients in China, allowing for a more individualized approach. Zai Lab reported 2,700 new patients starting VYVGART IV treatment in Q1 2024, highlighting the significant unmet need in the market.

Zai Lab (NASDAQ: ZLAB) announced groundbreaking research published in Cell, offering new insights into HRD-positive ovarian cancer treatment. The study, supported by Zai Lab, revealed that niraparib, a PARP inhibitor, achieves high response rates and reshapes the tumor microenvironment (TME) in HRD-positive ovarian cancer patients. Key findings include:

1. Niraparib monotherapy achieved 62.5% and 73.6% response rates per RECIST v.1.1 and GCIG CA125, respectively.
2. The study identified eTregs as key responders to HRD and neoadjuvant therapies.
3. Combining niraparib with Zai Lab's investigational CCR8 antibody, ZL-1218, showed enhanced tumor suppression in pre-clinical models.

This research opens new avenues for immunotherapy and combination treatments in HRD-positive ovarian cancer and other HRD-related cancers.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is set to announce its second quarter 2024 financial results and recent corporate updates on August 6, 2024, after the U.S. markets close. The company will host a conference call and webcast on August 7, 2024, at 8:00 a.m. ET (8:00 p.m. HKT) to discuss these results. Interested participants must pre-register for the call via a provided registration link. Dial-in details will be shared upon registration, and a replay of the call will be available on the company's website shortly after the event.

Zai Lab announced that Harald Reinhart, M.D., President and Head of Global Development for Neuroscience, Autoimmune, and Infectious Diseases (NSAiID), will retire at the end of June. He will continue as a senior advisor for the company. Rafael Amado, M.D., currently President and Head of Global Oncology R&D, will take over all Global R&D responsibilities following Dr. Reinhart's retirement.

Dr. Reinhart has nearly 50 years of experience, joining Zai Lab 10 years ago and significantly expanding its NSAiID capabilities. Dr. Amado will now oversee Zai Lab’s entire R&D pipeline across therapeutic areas. He has held senior roles in various pharmaceutical and biotech companies, contributing to the discovery and development of numerous innovative therapies.