Antengene-B (06996.HK) :ATG-201 IND for Autoimmune Diseases Approved by China's NMPA

Newtimespace (newtimespace.com) reports that Antengene (6996.HK) announced the NMPA has approved the IND application for ATG-201, a CD19/CD3 bispecific T-cell engager antibody for B-cell-mediated autoimmune diseases, allowing Phase I studies to proceed; the company plans to rapidly initiate the China Phase I trial while preparing for Australian clinical development, with ATG-201 based on the proprietary AnTenGager® second-generation TCE platform, though the Group does not guarantee its ultimate successful development or commercialization.

Newtimespace (newtimespace.com) reports that Antengene Corporation Limited (6996.HK) announced the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ATG-201, a CD19/CD3 bispecific T-cell engager antibody for the treatment of B-cell-mediated autoimmune diseases, to proceed with Phase I studies. Antengene plans to rapidly initiate and advance the Phase I study in China, while simultaneously preparing for the clinical development of ATG-201 in Australia. ATG-201 is developed based on the Company's proprietary AnTenGager® second-generation TCE platform featuring a "2+1" bivalent binding structure capable of targeting low-expression targets, integrated with steric hindrance masking technology and a proprietary CD3 sequence with rapid binding/dissociation kinetics to reduce cytokine release syndrome (CRS) risk and enhance efficacy. The Group does not guarantee that ATG-201 will ultimately be successfully developed or launched.

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