Tiangang Immunotherapeutics' Bispecific Antibody TGI-6 Receives NMPA Approval to Initiate Phase I Clinical Trial in China

HefeiOctober 27, 2023PR Newswire -- On October 27, 2023, a bispecific antibody (project code TGI-6) independently developed by Hefei TG ImmunoPharma Co., Ltd. (TGI) received approval from the National Medical Products Administration (NMPA) of China and will soon commence Phase I clinical research in China. The product had already obtained FDA clearance for clinical trials in the United States on June 16, 2023. TGI's TGI-6 is the second product globally to enter the clinical stage targeting the same indication.

TGI-6 is a novel and highly potent bispecific antibody independently developed by TGI. TGI-6 specifically binds to tumor-associated antigens on the surface of tumor cells and CD3 molecules on the surface of T cells, activating T cells and effectively identifying and killing tumor cells. The antibody exhibits high-affinity binding to tumor targets and low-affinity binding to CD3, effectively increasing the local effective concentration in tumors and enhancing drug safety.

As a bispecific antibody targeting an entirely new drug target, TGI-6 demonstrates favorable drug-like properties, high anti-tumor activity, and potential safety. It is primarily used for treating colorectal cancer and other solid tumors that are positive for tumor-associated antigens. Preclinical studies have shown that this antibody can completely eliminate tumors in animal models of various cancer types, exhibiting potent anti-tumor activity. Compared with the only international competitor (currently in Phase I clinical trials), TGI-6 shows superior anti-tumor activity and safety, with best-in-class potential. The product received IND filing and submission services from TGI's strategic partner Clinipace, as well as preclinical CMC services provided by GenScript ProBio.

Tian Zhigang, academician of the Chinese Academy of Engineering and the European Academy of Sciences, and founder of TGI, stated, "We are very pleased to see that the Phase I clinical trial of TGI-6 has been approved in China. As the only product in China and the second globally approved for the same target, we look forward to bringing this innovative treatment to patients in China as soon as possible. Currently, TGI has established a unique 'global new' R&D pipeline, covering various drug types such as monoclonal antibodies, bispecific antibodies, and multifunctional antibodies. Multiple products are ready to enter Phase I clinical trials, with the hope of providing safer, more effective, and precise innovative therapies to cancer patients in China and around the world in the near future."