Zai Lab Limited - American Depositary Shares (ZLAB)

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its fourth quarter and full year 2024 financial results and provide recent corporate updates on February 27, 2025, before the opening of the U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the licensed territory). Pove is a recombinant fusion protein therapeutic and dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) with best-in-class potential being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.

Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the licensed territory). Pove is a recombinant fusion protein therapeutic and dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) with best-in-class potential being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced a new strategic collaboration and worldwide license agreement with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”) to use MediLink’s TMALIN® antibody-drug conjugate (ADC) platform for the development of a novel LRRC15 ADC, ZL-6201, consisting of an antibody discovered by Zai Lab.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conference in January 2025:

Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQNVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2024 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:

Zai Lab (“Zai Lab”, NASDAQ: ZLAB; HKEX: 9688) and Pfizer (“Pfizer”, NYSE: PFE) announced today a strategic collaboration for the novel antibacterial drug XACDURO® (sulbactam-durlobactam) in mainland China. Pfizer’s affiliated companies will be exclusively authorized to undertake and perform certain commercialization activities for XACDURO® in mainland China. Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer’s affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China. The period of collaboration is for the imported product through November 2028, subject to early termination or extension.

Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced the anticipated closing of its previously announced underwritten public offering of 7,843,137 American depositary shares (“ADSs”), each representing ten ordinary shares of the Company, at a price of US$25.50 per ADS. In addition, Zai Lab today announced that the underwriters in the offering fully exercised their option to purchase an additional 1,176,470 ADSs at the public offering price, less underwriting discounts and commissions. The sale of additional ADSs pursuant to the exercise of the option to purchase additional ADSs is expected to close on November 19, 2024, subject to customary closing conditions.

Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced the pricing of its underwritten public offering of 7,843,137 American depositary shares (“ADSs”), each representing ten ordinary shares of the Company, at a price of US$25.50 per ADS.

Zai Lab Limited (“Zai Lab” or the “Company”) (NASDAQ: ZLAB; HKEX: 9688), an innovative, commercial-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of $200.0 million of American depositary shares (“ADSs”), each representing ten ordinary shares of the Company with a par value of $0.000006 per share. All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs sold in the public offering at the public offering price less underwriting discounts and commissions. Zai Lab intends to use the net proceeds from this offering for general corporate purposes.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the third quarter of 2024, along with recent product highlights and corporate updates.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [Efgartigimod Alfa Injection (Subcutaneous Injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the company’s Phase 3 multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) in China. Consistent with previous global studies, the registrational bridging trial met its primary endpoint, with KarXT demonstrating a statistically significant 9.2-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs. -7.7 placebo, p=0.0014).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral presentation during the plenary session. ZL-1310 is being tested in patients with previously treated extensive-stage Small Cell Lung Cancer (ES-SCLC) after at least one prior platinum-based chemotherapy regimen.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in November and December 2024:

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will hold an investor webcast to discuss data from a Phase 1 clinical trial of ZL-1310, the Company’s investigational DLL3-targeted antibody-drug conjugate (ADC), in patients with advanced stage small cell lung cancer (SCLC). The live conference call and webcast will take place on Thursday, October 24, 2024, at 8:30 a.m. ET (8:30 p.m. HKT).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report financial results for the third quarter of 2024 and recent corporate updates, before the opening of the U.S. equity markets on Tuesday, November 12, 2024. The Company will host a live conference call and webcast on the same date, at 8:00 a.m. ET (9:00 p.m. HKT).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a Phase 1 study of ZL-1310, the Company’s investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain. The preliminary results from the ongoing, open-label, multicenter clinical trial (NCT06179069) will address the potential of ZL-1310 as a novel treatment for small cell lung cancer (SCLC).

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a preclinical study of ZL-1503, the company’s internally discovered IL-13/IL-31 bispecific antibody for the treatment of atopic dermatitis (AD), will be presented in a late-breaking oral presentation at the European Academy of Dermatology and Venerology Congress (EADV) 2024 taking place September 25-28 in Amsterdam, Netherlands. The results will address the potential of ZL-1503 as a novel treatment for moderate-to-severe atopic dermatitis, as well as other diseases involving the IL-13 and IL-31 pathways.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that data from a Phase 1 study of ZL-1218, the company’s anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain. The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in September 2024: