Sedge Pharmaceuticals (688266.SH): Injection ZG006 conducted a crucial clinical trial and completed the enrollment of the first subject.

Zejing Pharmaceuticals (688266.SH) announced that the company has recently received feedback from the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding their application for communication and conditional approval for the market qualification of their investigational product, injectable ZG006. Based on the safety and efficacy data of injectable ZG006 at the current stage and the target population, the CDE has agreed to conduct crucial clinical trials for injectable ZG006. The company is actively progressing with the crucial clinical trials of injectable ZG006 for the designated indication and has recently completed the enrollment of the first participant. ZG006 (INN name: alveltamig) is a three-specific antibody drug developed by the company through its dual/multi-specific antibody development platform. It has obtained clinical trial permits from the FDA and NMPA in the US and China, and has been included in breakthrough therapeutic varieties by the Center for Drug Evaluation of the National Medical Products Administration, and granted Orphan-drug Designation by the FDA. ZG006 is a three-specific T cell engager targeting two different DLL3 epitopes and CD3. It is the world's first three-specific antibody (DLL3/DLL3/CD3) targeting DLL3, representing a First-in-Class molecule form globally with the potential to become the 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 bridges tumor cells and T cells, bringing T cells closer to tumor cells and utilizing T cell-specific killing of tumor cells. Preclinical results have shown significant tumor suppression effects of ZG006 in mouse tumor models, leading to a significant proportion of tumors in mice completely regressing, indicating potent tumor killing effects of ZG006. Injectable ZG006 has been included in the list of breakthrough therapeutic varieties by the CDE, with the indication for ZG006 monotherapy in the treatment of advanced small cell lung cancer patients who have had previous platinum-containing chemotherapy and at least one other systemic treatment (third-line and above) with recurrence or progression.