Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company's potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs). The designation follows a positive opinion from the EMA's Committee for Orphan Medicinal Pro.

Business Wire • Jun 16, 2026

Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, wh.

Business Wire • Jun 9, 2026

Zai Lab Announces Changes to Senior Leadership Team

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced changes to its senior leadership team aimed at strengthening operational performance and efficiency. As part of these changes, the Board has made the decision that Josh Smiley, President and COO, will no longer be with the Company, effective Friday, May 22. "I want to thank Josh for his contributions to Zai Lab over the past three and a half years and wish him well in his future endeavors,".

Business Wire • May 21, 2026

Zai Lab: A Speculative Bet On Global Oncology, With A Greater China Bag Attached

Zai Lab faces stalling growth in Greater China due to price controls and declining Zejula revenues, shifting focus to global pipeline assets. I assign zero intrinsic value to ZLAB's China business, given minimal "bottom line" contributions from blockbuster launches like Vyvgart and anticipated similar outcomes for KarXT. Zoci, a wholly owned Phase 3 oncology asset, is the key value driver for the company, with a modeled global rNPV near $1 billion and potential for multi-billion upside if expanded to 1L SCLC.

Seeking Alpha • May 13, 2026

Zai Lab Receives U.S. FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci), a DLL3-Targeting ADC, for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs)

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company's potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of extrapulmonary neuroendocrine carcinomas (epNECs) following progression after standard first-line therapy. epNECs are an aggressive mal.

Business Wire • May 11, 2026

Zai Lab Q1 Earnings Call Highlights

Zai Lab NASDAQ: ZLAB reported a year-over-year decline in first-quarter 2026 product revenue as pressure on ZEJULA weighed on results, while management emphasized progress across its global oncology and immunology pipeline and pointed to multiple upcoming regulatory and clinical milestones.

MarketBeat • May 9, 2026

Zai Lab Limited (ZLAB) Q1 2026 Earnings Call Transcript

Zai Lab Limited (ZLAB) Q1 2026 Earnings Call Transcript

Seeking Alpha • May 8, 2026

Zai Lab Announces First Quarter 2026 Financial Results and Recent Corporate Updates

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2026, along with recent product highlights and corporate updates. “We continue to accelerate the development of our global pipeline, with numerous clinical trials underway across oncology and immunology,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “During the quarter, we made strong progress advancing zoci, wi.

Business Wire • May 7, 2026

Zai Lab Limited (ZLAB) Reports Q1 Earnings: What Key Metrics Have to Say

Although the revenue and EPS for Zai Lab Limited (ZLAB) give a sense of how its business performed in the quarter ended March 2026, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Zacks Investment Research • May 7, 2026

Zai Lab to Announce First Quarter 2026 Financial Results and Recent Corporate Updates on May 7, 2026

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its first quarter 2026 financial results and provide recent corporate updates on May 7, 2026, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed by visiting the Company's website at http://ir.zailaboratory.com.

Business Wire • Apr 22, 2026