Zai Lab Limited Stock Price, News & Analysis

Zai Lab (NASDAQ: ZLAB) announced NMPA approval of AUGTYRO (repotrectinib) for adult patients with NTRK‑positive solid tumors who have locally advanced or metastatic disease, or for whom surgery would cause morbidity, and who have progressed after prior therapies or lack satisfactory alternatives. This is AUGTYRO’s second indication in China, and the approval covers both TKI‑naïve and TKI‑pretreated patients. The decision cites data from the pivotal Phase 1/2 TRIDENT‑1 study showing robust, durable efficacy and a manageable safety profile. Zai Lab contributed to TRIDENT‑1 and dosed the first Greater China patient in May 2021. AUGTYRO was earlier approved in China for ROS1‑positive NSCLC in May 2024.

Zai Lab (NASDAQ: ZLAB) announced senior management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 at 3:00 p.m. PST / 6:00 p.m. EST. A live webcast will be available on the company's Investor Relations site and an archived replay will be accessible for up to 30 days after the event.

Investors can watch the presentation via webcast at ir.zailaboratory.com/webcasts-presentations.

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).

Zai Lab (NASDAQ: ZLAB) announced dosing of the first participant on December 8, 2025 in a global Phase 1/1b study of ZL-1503, an IL-13/IL-31R bispecific antibody for moderate-to-severe atopic dermatitis (AD).

The randomized, double-blind, placebo-controlled single- and multiple-ascending dose trial will evaluate safety, tolerability, pharmacokinetics, and efficacy in healthy volunteers and participants with moderate-to-severe AD. ZL-1503 was discovered internally and showed preclinical suppression of inflammatory and pruritogenic pathways; findings were presented at EAACI 2025.

Zai Lab (NASDAQ: ZLAB) announced that three medicines were renewed on China’s 2025 National Reimbursement Drug List (NRDL) released by the National Healthcare Security Administration on December 7, 2025.

Renewed entries: VYVGART (efgartigimod) for adult generalized myasthenia gravis with AChR antibody positivity; NUZYRA oral (omadacycline) for adult CABP and ABSSSI; ZEJULA (niraparib) for maintenance treatment of platinum-sensitive first-line and recurrent ovarian cancer. Zai Lab noted this brings its total to six products on the NRDL, which the company says will broaden patient access and reduce disease burden in China.

Zai Lab (NASDAQ: ZLAB) reported Q3 2025 total revenue $116.1M (14% y/y) and revised full‑year 2025 revenue guidance to at least $460M. Operating loss improved to $48.8M (adjusted loss $28.0M). Cash and short‑term investments totaled $817.2M as of Sept 30, 2025.

Pipeline progress: zoci (DLL3 ADC) entered a global registrational study in Oct 2025 after Phase 1 data showing a 68% ORR at 1.6 mg/kg and intracranial activity; ZL-1503 global Phase 1 started Nov 2025; povetacicept received FDA Breakthrough Therapy Designation and rolling BLA review.

Zai Lab (NASDAQ: ZLAB) said members of its senior management will participate in investor conferences in November and December 2025.

Key events: a Fireside Chat on November 19, 2025 at 8:30 AM GMT at the Jefferies Global Healthcare Conference in London, and a Fireside Chat on December 2, 2025 at 1:00 PM ET at Citi's Global Healthcare Conference in Miami.

Both events will be live webcast and archived on the company's investor relations site at ir.zailaboratory.com/webcasts-presentations for up to 90 days after each event.

Zai Lab (NASDAQ: ZLAB) reported updated Phase 1 data for zocilurtatug pelitecan (zoci) in extensive-stage small cell lung cancer (ES-SCLC) as of Sept 15, 2025. In 102 evaluable patients, zoci showed high activity across doses, including a 68% ORR in the 1.6 mg/kg second-line cohort (n=19) and an 80% ORR in patients with brain metastases who had not received prior brain radiotherapy (n subset). Median duration of response was 6.1 months and median PFS was 5.4 months. Safety at 1.6 mg/kg showed 13% Grade ≥3 TRAEs and no discontinuations for toxicity in that cohort. A global Phase 3 registrational study (≈665 patients, NCT07218146) has opened for enrollment.

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.