StockTitan

@stocktitan.net

1 month ago

Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates Zai Lab (NASDAQ: ZLAB) reported Q4 2025 revenue $127.6M (+17% YoY) and FY2025 revenue $460.2M (+15% YoY). Product revenue growth was led by ZEJULA, XACDURO and NUZYRA. Net loss narrowed to $175.5M for FY2025 from $257.1M in FY2024. Cash and equivalents totaled $789.6M at year-end.The company accelerated global oncology and immunology programs, highlighting zoci with three registration-enabling studies planned by end-2026, China approval and early 2026 launch plans for KarXT, and pivotal readouts for povetacicept and elegrobart in 2026.

#ZLAB Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

2 months ago

China clears new AUGTYRO use for adults with NTRK‑positive cancers China’s NMPA okays an sNDA for AUGTYRO in NTRK fusion‑positive solid tumors, its second indication after ROS1‑positive NSCLC, backed by TRIDENT‑1 data.

#ZLAB Zai Lab Announces National Medical Products Administration (NMPA) Approval of AUGTYRO™ (repotrectinib) for Patients with NTRK-Positive Solid Tumors

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

3 months ago

Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia Zai Lab (NASDAQ: ZLAB) announced that China’s National Medical Products Administration approved COBENFY (xanomeline and trospium chloride) for treatment of schizophrenia in adults on December 23, 2025. COBENFY is described as the first schizophrenia therapy with a novel mechanism in over 70 years, selectively activating M1 and M4 receptors. Approval is supported by a China Phase 1 PK study, the Phase 3 China study ZL-2701-001, and three global EMERGENT studies. COBENFY was also included in China’s national schizophrenia guidelines (2025 edition).

#ZLAB Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

3 months ago

#ZLAB Zai Lab Announces Dosing of First Participant in Global Phase 1/1b study of ZL-1503, an IL-13/IL-31R Bispecific Antibody for the Treatment of Atopic Dermatitis

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

3 months ago

Zai Lab Announces Updates to China’s National Reimbursement Drug List We thank the NHSA for their ongoing support for the innovation in China and its efforts to include more new and effective drugs in the NRDL. Zai Lab will continue to enhance the accessibility and affordability of our medicines so that patients in need can benefit from innovative therapies as early as possible,” said Andrew Zhu, Chief Commercial Officer of Zai Lab...

#ZLAB Zai Lab Announces Updates to China’s National Reimbursement Drug List

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

5 months ago

Zai Lab to Announce Third Quarter 2025 Financial Results and Recent Corporate Updates on November 6, 2025 Zai Lab (NASDAQ: ZLAB) will report third quarter 2025 financial results and provide corporate updates on November 6, 2025, before U.S. markets open. A conference call and live webcast will follow at 8:00 a.m. ET (9:00 p.m. HKT). Participants must register in advance using the provided webcast or dial-in registration links. Dial-in details will be sent in the confirmation email after registration. A replay will be posted on the company website shortly after the call. The live webcast is accessible via the company's investor site and the listed media-server registration pages.

#ZLAB Zai Lab to Announce Third Quarter 2025 Financial Results and Recent Corporate Updates on November 6, 2025

www.stocktitan.net/news/ZLAB/zai-lab-to-ann...

StockTitan

@stocktitan.net

7 months ago

First ADC Therapy for Cervical Cancer: Zai Lab's TIVDAK Gets Hong Kong Regulatory Green Light TIVDAK approved in Hong Kong for recurrent/metastatic cervical cancer patients post-chemotherapy. First ADC therapy for cervical cancer, pending NMPA review in China since March 2025.

#ZLAB Zai Lab Announces Approval of TIVDAK® for Patients with Recurrent or Metastatic Cervical Cancer in Hong Kong

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

7 months ago

134,000 Annual Cases: Zai Lab's Innovative Cancer Device TTFields Fast-Tracked in China for Pancreatic Cancer China NMPA grants innovation status to Zai Lab's TTFields for pancreatic cancer following positive Phase 3 results. Device targets 134K annual Chinese patients. Regulatory submission planned H2 2025.

#ZLAB Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

7 months ago

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates Zai Lab (NASDAQ: ZLAB) reported Q2 2025 financial results with total revenues growing 9% year-over-year to $110.0 million. The company reaffirmed its full-year 2025 revenue guidance of $560-590 million. Operating loss improved by 28% year-over-year to $54.9 million, with the company on track to achieve profitability in Q4 2025.Key highlights include VYVGART's record patient utilization and ZL-1310's promising clinical data showing 67% overall response rate in second-line SCLC. The successful Phase 3 FORTITUDE-101 study of bemarituzumab in gastric cancer met its primary endpoint, with China regulatory submission expected in H2 2025.The company maintains a strong financial position with $832.3 million in cash and equivalents as of June 30, 2025, supporting its commercial expansion and pipeline development.

#ZLAB Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

8 months ago

Zai Lab Sets Q2 Earnings Date: Global Biotech Reports Financial Results August 7 Join Zai Lab's Q2 earnings call on August 7 at 8 AM ET. Dual-listed biotech to share latest financial performance and corporate updates. Register now.

#ZLAB Zai Lab to Announce Second Quarter 2025 Financial Results and Recent Corporate Updates on August 7, 2025

www.stocktitan.net/news/ZLAB/zai-lab-to-ann...

StockTitan

@stocktitan.net

9 months ago

Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer Zai Lab (NASDAQ: ZLAB) announced positive Phase 3 results for bemarituzumab in treating FGFR2b-positive first-line gastric cancer. The FORTITUDE-101 clinical trial demonstrated that bemarituzumab plus chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer.The study focused on patients with FGFR2b overexpression (defined as 2+/3+ staining in ≥10% of tumor cells) who are non-HER2 positive. Bemarituzumab is the first FGFR2b inhibitor to show significant overall survival benefit in a Phase 3 trial for first-line treatment of FGFR2b-positive gastric cancer.The most common adverse events included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Ocular events occurred with greater frequency and severity in the bemarituzumab arm. The company plans to pursue regulatory submission in China, where the drug has already received Breakthrough Therapy designation.

#ZLAB Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

9 months ago

Zai Lab Presents New Preclinical Data for ZL-1503, an IL-13/IL-31R Bispecific Antibody for the Treatment of Atopic Dermatitis, at EAACI Congress 2025 Zai Lab (NASDAQ: ZLAB) presented promising preclinical data for ZL-1503, their IL-13/IL-31R bispecific antibody for treating moderate-to-severe atopic dermatitis, at EAACI Congress 2025. The study demonstrated ZL-1503's ability to simultaneously suppress both inflammatory and itch-causing pathways. Key findings showed that a single 10 mg/kg dose completely inhibited target pathways for at least 76 days, with some subjects showing effects beyond 118 days. The drug exhibited slow clearance, strong pharmacokinetic/pharmacodynamic relationships, and was well-tolerated at doses up to 150 mg/kg. Zai Lab plans to file an IND by the end of 2025, positioning ZL-1503 as a potential advancement over current treatments that only partially alleviate symptoms through IL-4/IL-13 inhibition alone.

#ZLAB Zai Lab Presents New Preclinical Data for ZL-1503, an IL-13/IL-31R Bispecific Antibody for the Treatment of Atopic Dermatitis, at EAACI Congress 2025

www.stocktitan.net/news/ZLAB/zai-lab-presen...

@spontonic.bsky.social

10 months ago

Expansion of multiple CD4+ T cell lineages in lymphocytic variant hypereosinophilic syndrome - PubMed These data provide further evidence for direct involvement of the aberrant T cell populations in disease pathogenesis in LHES and a rationale for further exploration of T cell-directed therapies.

#CHRS #ZLAB many others..... a non-oncology indication for anti- #CCR8? pubmed.ncbi.nlm.nih.gov/40350095/

StockTitan

@stocktitan.net

10 months ago

FDA Fast-Tracks Revolutionary DLL3 Cancer Drug: Zai Lab's Novel Therapy Targets Aggressive Lung Cancer First-in-class DLL3-targeted therapy advances toward pivotal trial. See upcoming ASCO data presentation and potential 2027 accelerated approval timeline. Learn More

#ZLAB Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer

www.stocktitan.net/news/ZLAB/zai-lab-receiv...

StockTitan

@stocktitan.net

10 months ago

Zai Lab Announces First Quarter 2025 Financial Results and Recent Corporate Updates Zai Lab reported strong Q1 2025 financial results with total revenues growing 22% year-over-year to $106.5 million. The company reaffirmed its full-year 2025 revenue guidance of $560-590 million. Operating loss improved significantly, declining 20% to $56.3 million. The company maintains a strong cash position of $857.3 million. Key product performances include VYVGART at $18.1 million (up from $13.2M), ZEJULA at $49.5 million (up from $45.5M), and NUZYRA at $15.1 million (up from $9.9M). The company's pipeline is advancing with promising developments in oncology therapies, including ZL-1310 (DLL3 ADC) with upcoming ASCO 2025 data presentation. Zai Lab expects to achieve profitability in Q4 2025 and is progressing toward becoming a leading global biopharmaceutical company with multiple upcoming catalysts and pipeline developments.

#ZLAB Zai Lab Announces First Quarter 2025 Financial Results and Recent Corporate Updates

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

11 months ago

Zai Lab Presents Data Highlighting Potential of Internally Developed, Next-Generation Oncology Therapies at AACR 2025 Zai Lab (NASDAQ: ZLAB) will present data on two internally developed oncology therapies at AACR 2025. The first, ZL-6201, is a potential first-in-class antibody-drug conjugate (ADC) targeting LRRC15-positive solid tumors, with plans to begin IND-enabling studies in 2025. Preclinical studies show ZL-6201 effectively suppresses tumor growth and demonstrates efficient internalization within tumor cells.The second therapy, ZL-1222, is a novel anti-PD-1/interleukin-12 immunocytokine designed to improve upon current IL-12 treatments by reducing systemic toxicity while maintaining anti-tumor activity. Preclinical data indicates potent anti-tumor activity in both anti-PD-1 sensitive and resistant tumor models with improved safety profiles.Both therapies showcase Zai Lab's commitment to developing innovative oncology treatments that address limitations of first-generation therapies, particularly in delivering higher concentrations of cytotoxic agents while limiting off-target toxicity.

#ZLAB Zai Lab Presents Data Highlighting Potential of Internally Developed, Next-Generation Oncology Therapies at AACR 2025

www.stocktitan.net/news/ZLAB/zai-lab-presen...

StockTitan

@stocktitan.net

11 months ago

Zai Lab Q1 2025 Earnings Preview: Key Financial Results Coming May 8 Zai Lab schedules Q1 2025 earnings call for May 8, featuring financial results and corporate updates. Join the 8:00 AM ET webcast for latest insights.

#ZLAB Zai Lab to Announce First Quarter 2025 Financial Results and Recent Corporate Updates on May 8, 2025

www.stocktitan.net/news/ZLAB/zai-lab-to-ann...

StockTitan

@stocktitan.net

1 year ago

China Accepts TIVDAK Application: 45% Lower Death Risk in Cervical Cancer Trial Breakthrough cervical cancer drug TIVDAK shows superior survival vs chemotherapy in Phase 3 trial, targeting 150,000 annual China cases. NMPA review now underway.

#ZLAB Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer

www.stocktitan.net/news/ZLAB/zai-lab-announ...

@spontonic.bsky.social

1 year ago

Selective depletion of CCR8+Treg cells enhances anti-tumor immunity of cytotoxic T cells in lung cancer via dendritic cells Accumulation of regulatory T (Treg) cells, an immunosuppressive population, limits the efficacy of immunotherapy in non-small cell lung cancer (NSCLC)…

#CHRS #BMY #ZLAB #CCR8 LM-108? >>depletion of CCR8+Treg cells combined with PD1 inhibitor extremely increased interleukin-12 secretion by the JAK-STAT pathway activation on CCL5+ DCs, thereby promoting cytotoxic activity of CD8+ T cells<< www.sciencedirect.com/science/arti....

StockTitan

@stocktitan.net

1 year ago

Zai Lab's Revenue Surges 66% as Biotech Firm Charts Clear Path to Profitability Q4 revenue reached $109.1M with 45% reduced operating losses. Company projects $560-590M for 2025 and targets $2B by 2028, with profitability expected next year.

#ZLAB Zai Lab Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

1 year ago

Zai Lab Earnings Alert: Key Date Set for Critical 2024 Performance Review Zai Lab announces Q4 and FY2024 financial results release scheduled for February 27, with management hosting conference call to discuss performance and strategic updates.

#ZLAB Zai Lab to Announce Fourth Quarter and Full Year 2024 Financial Results and Provide Recent Corporate Updates on February 27, 2025

www.stocktitan.net/news/ZLAB/zai-lab-to-ann...

StockTitan

@stocktitan.net

1 year ago

Zai Lab's Cancer Drug ZL-1310 Wins FDA Orphan Drug Status for Lung Cancer Treatment Zai Lab's DLL3 antibody-drug ZL-1310 receives FDA Orphan Drug Designation for small cell lung cancer, offering potential 7-year market exclusivity and promising Phase 1 results.

#ZLAB Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)

www.stocktitan.net/news/ZLAB/zai-lab-receiv...

StockTitan

@stocktitan.net

1 year ago

Zai Lab's Breakthrough Schizophrenia Drug KarXT Accepted for Review in China After Strong Trial Results China's NMPA accepts KarXT application following impressive 9.2-point efficacy improvement in Phase 3 trials. Drug targets 8M+ patients with first new treatment class in decades.

#ZLAB Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia

www.stocktitan.net/news/ZLAB/zai-lab-announ...

StockTitan

@stocktitan.net

1 year ago

Vertex Partners with Zai Lab to Expand Povetacicept Reach Across Asian Markets Vertex Pharmaceuticals licenses povetacicept, its promising IgA nephropathy treatment, to Zai Lab for development and commercialization across key Asian territories.

#VRTX #ZLAB Vertex and Zai Lab Announce Strategic Agreement to Develop and Commercialize Povetacicept in Mainland China, Hong Kong SAR, Macau SAR, Taiwan Region and Singapore

www.stocktitan.net/news/VRTX/vertex-and-zai...

StockTitan

@stocktitan.net

1 year ago

Zai Lab Partners with Vertex to Develop Breakthrough IgAN Treatment in Asia Markets Zai Lab secures exclusive rights to develop and commercialize povetacicept, a promising dual BAFF/APRIL antagonist for IgA nephropathy, across major Asian markets.

#ZLAB #VRTX Zai Lab and Vertex Announce Strategic Agreement to Develop and Commercialize Povetacicept in Mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore

www.stocktitan.net/news/ZLAB/zai-lab-and-ve...

StockTitan

@stocktitan.net

1 year ago

Zai Lab Partners with MediLink for Novel Cancer-Fighting ADC Development Program Zai Lab secures worldwide rights to develop ZL-6201, a potential first-in-class LRRC15 antibody-drug conjugate for solid tumors, leveraging MediLink's TMALIN® platform.

#ZLAB Zai Lab Announces Strategic Partnership with MediLink Therapeutics to Develop a Novel LRRC15 Antibody-Drug Conjugate

www.stocktitan.net/news/ZLAB/zai-lab-announ...

@spontonic.bsky.social

1 year ago

#CCR8 companies presenting at #JPM2025.... #BMY #ZLAB #CHRS #BGNE #AMGN #BAYN.DE #ABBV #RHHBY #GILD