Zelgen(SH:688266) Shang Hai Zheng Quan Bao·2025-09-16 20:15Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received conditional approval from the National Medical Products Administration (NMPA) to conduct pivotal clinical trials for its investigational drug ZG006, with the first subject enrolled in the trial [1][2]. Drug Information - ZG006 (INN: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform, and it has received clinical trial approval from both the U.S. FDA and China's NMPA [1][2]. - ZG006 targets two different DLL3 epitopes and CD3, acting as a T-cell engager to connect T-cells with tumor cells, demonstrating significant tumor suppression in preclinical studies [2]. Clinical Trial Details - The pivotal clinical trial for ZG006 is actively being advanced, with the first subject enrolled recently. The company plans to continue progressing the trial and will apply for conditional marketing approval if the trial results meet expectations [1][2]. Impact on the Company - The initiation of the pivotal clinical trial and the enrollment of the first subject are not expected to have a significant impact on the company's recent performance. The drug must complete clinical trials and receive regulatory approval before it can be marketed [2][3].