Zai Lab Limited Stock Price, News & Analysis

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has scheduled the release of its fourth quarter and full year 2024 financial results for February 27, 2025, before U.S. market opening. The company will host a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT) on the same day to discuss the results and provide corporate updates.

Interested participants must register in advance through the provided registration link. Upon registration, they will receive dial-in details via confirmation email. A replay of the call will be available on the company's investor relations website.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has received Orphan Drug Designation (ODD) from the U.S. FDA for ZL-1310, their first-in-class DLL3 antibody-drug conjugate (ADC) designed to treat small cell lung cancer (SCLC). The designation comes after promising results from an ongoing Phase 1a/1b study in patients with previously treated extensive-stage SCLC.

The ODD grants several benefits, including waiver of Prescription Drug User Fee Act registration application fee, tax credits for certain clinical trials, and potential seven-year U.S. market exclusivity upon approval. The drug has shown promising objective response rates and favorable safety profile in Phase 1 trials for patients with recurrent SCLC.

Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has accepted the New Drug Application for KarXT to treat adult schizophrenia. The application is supported by successful Phase 1 and Phase 3 trials in China, alongside global EMERGENT clinical program data.

The China Phase 3 study achieved its primary endpoint, showing a significant 9.2-point improvement over placebo in PANSS total score reduction (-16.9 KarXT vs. -7.7 placebo, p=0.0014). The study also met all key secondary efficacy endpoints. Common side effects included vomiting, tachycardia, nausea, hypertension, dizziness, and diarrhea.

With over 8 million schizophrenia patients in China facing treatment options, KarXT represents the first new treatment class in decades. The drug recently received FDA approval in September 2024 under the brand name COBENFY™, notably without atypical antipsychotic class warnings or boxed warnings.

Zai Lab (NASDAQ: ZLAB) announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 trial for TIVDAK in recurrent or metastatic cervical cancer patients. The study demonstrated a 45% reduction in death risk compared to chemotherapy in Chinese patients, with median overall survival not reached versus 10.7 months for chemotherapy.

The results were consistent with the global population data, showing improved overall survival (OS), progression-free survival (PFS), and confirmed objective response rate (ORR). The safety profile was manageable and aligned with global findings. More than half of the Chinese study population had received prior anti-PD(L)1 therapy.

Following FDA's full approval of TIVDAK in April 2024, Zai Lab plans to submit a New Drug Application to China's NMPA in Q1 2025. With approximately 150,000 new cervical cancer cases annually in China, TIVDAK could provide a important treatment option for patients with alternatives after initial treatment failure.

Vertex Pharmaceuticals (VRTX) and Zai Lab (ZLAB) have announced an exclusive collaboration and license agreement for the development and commercialization of povetacicept in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist being studied for Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.

Under the agreement, Vertex will receive an upfront payment, regulatory milestone payments, and tiered royalties on net sales. Zai Lab will leverage its R&D expertise to advance clinical trials and handle regulatory submissions in the licensed territory. Once approved, Zai Lab will be responsible for all commercialization activities in the region, utilizing its established commercial infrastructure.

Zai Lab (ZLAB) and Vertex Pharmaceuticals (VRTX) have announced an exclusive collaboration and license agreement for the development and commercialization of povetacicept in mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore.

Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of BAFF and APRIL with best-in-class potential, being studied for the treatment of Immunoglobulin A nephropathy (IgAN) and other B cell-mediated diseases.

Under the agreement terms, Vertex will receive an upfront payment, regulatory milestone payments, and tiered royalties on net sales. Zai Lab will leverage its R&D expertise for clinical trials and regulatory submissions, while also managing all commercialization activities in the licensed territory upon approval.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced a strategic collaboration and worldwide license agreement with MediLink Therapeutics to develop ZL-6201, a novel LRRC15 antibody-drug conjugate (ADC). The partnership will utilize MediLink's TMALIN® ADC platform combined with an antibody discovered by Zai Lab.

The collaboration expands Zai Lab's global oncology pipeline with a potential first-in-class ADC targeting multiple solid tumors. ZL-6201 has shown promising preclinical data, with an Investigational New Drug (IND) filing expected in 2025. This partnership builds upon ongoing clinical trials for ZL-1310 and reinforces Zai Lab's commitment to developing ADC-based cancer therapies.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has announced its upcoming participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's senior management team will deliver a presentation on Tuesday, January 14, 2025, at 1:30 p.m. PST in San Francisco. Investors can access a live webcast of the presentation through Zai Lab's Investor Relations website, with an archived replay available for 30 days after the event.

Zai Lab (ZLAB) and Novocure announced positive results from their Phase 3 PANOVA-3 trial, evaluating Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel for pancreatic cancer. The trial met its primary endpoint, showing a statistically significant improvement in median overall survival of 16.20 months compared to 14.16 months in the control group (hazard ratio=0.819; P=0.039). The treatment demonstrated increasing survival benefits over time, with a 13% improvement at 12 months and 33% at 24 months. Both companies plan to seek regulatory approvals in their respective markets.