Zai Lab Limited reports developments for a commercial-stage biopharmaceutical company with American depositary shares traded under ZLAB and ordinary shares listed in Hong Kong. The company discovers, develops, licenses and commercializes therapies for oncology, immunology, neuroscience and infectious disease, with operations based in China and the United States.
Recurring company updates include financial results, regulatory designations, clinical and preclinical data, collaborations and product updates across programs such as zocilurtatug pelitecan, ZL-1503, ZL-6201 and ZL-1222. Updates also address regional commercial products and pipeline assets including ZEJULA, VYVGART, KarXT and TIVDAK.
Zai Lab presented promising Phase 1a/1b study results for ZL-1310, a next-generation antibody-drug conjugate (ADC), in treating extensive-stage Small Cell Lung Cancer. The study showed a 74% objective response rate across all dose levels in previously treated patients. Key findings include positive responses in patients with brain metastases and favorable safety profile with mainly Grade 1 or 2 adverse events. Of 25 patients treated, only 20% experienced Grade ≥3 treatment-related adverse events, with neutropenia being most common. The drug demonstrated efficacy across various DLL3 expression levels, with 13 of 14 responders still on treatment.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its participation in three upcoming investor conferences. The company's senior management team will attend the Goldman Sachs APAC Healthcare Corporate Day 2024 in Hong Kong from November 5-8, 2024. They will also participate in the Jefferies London Healthcare Conference, featuring a fireside chat on Tuesday, November 19, 2024, at 1:30 p.m. GT in Aldwych, London. Lastly, Zai Lab will be present at Citi's 2024 Global Healthcare Conference in Miami, Florida, from December 3-5, 2024.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced an upcoming investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, their investigational DLL3-targeted antibody-drug conjugate (ADC) for patients with advanced stage small cell lung cancer (SCLC). The live conference call and webcast is scheduled for October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT), following a plenary oral presentation at the EORTC-NCI-AACR Symposium (ENA) 2024.
Interested parties can access the live webcast through Zai Lab's website at http://ir.zailaboratory.com. Participants must register in advance using the provided link: https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40. Upon registration, dial-in details will be sent via confirmation email. A replay of the webcast will be available on the company's website shortly after the call.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced that it will release its third quarter 2024 financial results and provide recent corporate updates before the U.S. equity markets open on Tuesday, November 12, 2024. The company will host a live conference call and webcast on the same day at 8:00 a.m. ET (9:00 p.m. HKT).
Interested parties can access the live webcast through Zai Lab's website at http://ir.zailaboratory.com. To participate in the conference call, attendees must register in advance using the provided link. Upon registration, participants will receive dial-in details via email. A replay of the call will be available on the company's website shortly after the event concludes.
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.