ZAI LAB (09688) Q2 2026 product revenue increased by 11% quarter-on-quarter, with core products like zoci and ZL-1503 rapidly advancing in the global pipeline, catalyzing imminent activities.

ZAI LAB (09688) has announced its financial performance for the second quarter of 2026, along with recent product highlights and company progress. The financial report indicates that the companys total revenue for the second quarter of 2026 amounted to $106.3 million, with net product revenue of $105.8 million, representing an 11% quarter-on-quarter increase, driven by the stable performance of Zevilax and the sustained growth in sales of Efgartigimod. As the commercialization fundamentals remain robust, the company has also experienced significant regulatory progress in its oncology pipeline. Notably, the DLL3-targeted ADC drug Zocilurtatug Pelitecan (Zoci) has shown particularly impressive performance. In July 2026, ZAI LAB received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for Zoci for the treatment of neuroendocrine cancers (NECs). In June, ZAI LAB received orphan drug designation from the European Medicines Agency (EMA) for Zoci for the treatment of patients with pulmonary neuroendocrine tumors. In May, ZAI LAB received fast track designation (FTD) from the FDA for Zoci for the treatment of patients with extrathoracic neuroendocrine cancers (epNECs). This marks the second fast track designation granted to Zoci by the FDA, and the company is actively communicating with regulatory agencies to advance the registration plan for treating epNECs. In April, ZAI LABs partner Amgen initiated enrollment for a global Phase 1b study (DeLLphi-313) to evaluate Zoci in combination with Talazoparib (with or without anti-PD-L1) for the treatment of small cell lung cancer (SCLC) patients. In addition, in June 2026, the National Medical Products Administration (NMPA) of China approved a Biologics License Application (BLA) for Tezolizumab for the treatment of recurrent or metastatic cervical cancer in adult patients with disease progression during or after chemotherapy. Tezolizumab is the first ADC approved in China for this indication. In the fields of immunology and neuroscience, the companys various products have also made significant progress: ZL-1503 (IL-13/IL-31R): The single ascending dose (SAD) portion of the Phase 1/1b study of ZL-1503 conducted in healthy volunteers has completed enrollment, and preliminary pharmacokinetic (PK), pharmacodynamic (PD), safety, and immunogenicity data are expected to be released in the second half of 2026. Enrollment for the multiple ascending dose (MAD) portion of the study for patients with atopic dermatitis is currently ongoing. Efgartigimod (FcRn): In May 2026, the FDA approved the supplemental biologics license applications (sBLA) submitted by ZAI LABs partner Argenx for VYVGART (intravenous formulation of Efgartigimod) and VYVGART Hytrulo (subcutaneous formulation of Efgartigimod), expanding its indication to encompass all serotypes of adult patients with generalized myasthenia gravis (gMG) including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple serotype negative patients. This approval was based on data from the Phase 3 study ADAPT SERON. ZAI LAB participated in the ADAPT SERON study in Greater China. The company is preparing to advocate for the inclusion of Efgartigimod in Chinas National Reimbursement Drug List in 2027. Rosenolam (M1/M4 agonist): In June 2026, ZAI LAB commercialized Rosenolam capsules (Kaijiele) in mainland China for the treatment of adult schizophrenia. Rosenolam is the first approved schizophrenia therapy with a new mechanism of action in over 70 years, providing a novel approach to treating schizophrenia through selective activation of M1 and M4 muscarinic receptors. ZAI LAB is preparing to seek opportunities for Rosenolam to be included in Chinas National Reimbursement Drug List in 2027. Povetacicept (Pove, APRIL/BAFF): In June 2026, ZAI LABs partner Vertex announced that the FDA has accepted the biologics license application for Pove for adult patients with IgA nephropathy (IgAN) and included it in the accelerated approval program, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2026. ZAI LAB participated in the global Phase 3 study RAINIER in Greater China. Dr. Ying Du, Founder, Chairman, and CEO of ZAI LAB, stated, ZAI LAB is entering an exciting new chapter. Over the past few years, we have grown from bringing innovative medicines to Chinese patients to becoming a global biopharmaceutical company that develops differentiated medicines for patients worldwide. Today, our innovative pipeline is rapidly maturing. In less than two years, we have advanced our potential best-in-class DLL3 antibody-drug conjugate (ADC) Zocilurtatug Pelitecan (Zoci) from an Investigational New Drug (IND) application to a global Phase 3 clinical trial, and our continually expanding internal development portfolio, including ZL-1503, assures us that innovation will increasingly become the core driver of ZAI LABs growth in the next phase. Meanwhile, we continue to strengthen our commercialization efforts. In this quarter, we further focused on commercialization priorities, achieving quarter-on-quarter revenue growth and maintaining commercial profitability, laying a solid foundation for significant growth restoration in 2027. All these achievements contribute to creating long-term value for ZAI LABs patients and shareholders.