Zelgen: Injectable ZG006 initiates key clinical trials and completes enrollment of the first subject

According to the Zhitong Finance APP, Zelgen Pharmaceuticals (688266.SH) announced that it recently received feedback from the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding the conditional approval for the marketing qualification of its investigational product, injectable ZG006. Based on the current safety and efficacy data of injectable ZG006 and the proposed target population, the CDE has agreed to conduct pivotal clinical trials for injectable ZG006. The company is actively advancing the pivotal clinical trial of injectable ZG006 for the proposed indication and has recently completed the enrollment of the first subject. ZG006 (INN name: alveltamig) is a trispecific antibody drug developed by the company through its dual/multi-specific antibody research and development platform. It has received clinical trial approval from the U.S. FDA and China's NMPA, and has been included by the CDE in the list of breakthrough therapies, while also being granted orphan drug designation by the U.S. FDA. ZG006 is a trispecific T-cell engager targeting two different DLL3 epitopes and CD3. According to inquiries, ZG006 is the world's first trispecific antibody targeting the DLL3 target (DLL3/DLL3/CD3) and is a first-in-class molecular form with the potential to become a best-in-class molecule. The anti-DLL3 end of ZG006 binds to different DLL3 epitopes on the surface of tumor cells, while the anti-CD3 end binds to T cells. ZG006 connects tumor cells and T cells, bringing T cells closer to tumor cells, thereby utilizing T cells to specifically kill tumor cells. Preclinical research results show that ZG006 has significant tumor suppression effects in mouse tumor models, leading to a significant proportion of mice with complete tumor regression, indicating that ZG006 has a strong tumor-killing effect. Injectable ZG006 has been included in the list of breakthrough therapies by the CDE, with the indication for the treatment of patients with advanced small cell lung cancer who have relapsed or progressed after at least one platinum-based chemotherapy and one other systemic treatment (third-line and above)