XPH(SZ:300147) Zheng Quan Ri Bao Zhi Sheng·2025-03-31 13:39Core Viewpoint - The clinical trial for TAEST16001, a groundbreaking TCR-T cell therapy for advanced soft tissue sarcoma, has received official recognition from China's CDE, marking a significant milestone in the field of immunotherapy in China [1][2]. Group 1: Clinical Trial Details - The expert seminar for the confirmatory clinical trial of TAEST16001 was held in Guangzhou, with participation from key stakeholders including principal investigators and investment partners [1]. - TAEST16001 has shown promising results in exploratory Phase II clinical trials, with an objective response rate (ORR) of 62.5% and a median progression-free survival (mPFS) of 5.9 months [3]. - The Phase I trial involved 12 patients with advanced soft tissue sarcoma, showing a good tolerance profile and an ORR of 41.7% [2]. Group 2: Product Significance - TAEST16001 is the first TCR-T cell therapy in China to be included in the breakthrough therapy list by the CDE, representing a significant advancement in the treatment of advanced solid tumors [2]. - The therapy utilizes engineered T cells to target tumor antigens, creating a "cell missile" effect for enhanced tumor destruction [2]. - The successful organization of the expert seminar is expected to facilitate the smooth progress of the confirmatory clinical trial and expedite the product's market launch [3].