标新生物第二款分子胶降解剂管线GT929新药临床研究申请获CDE受理

发布日期：2023-05-16 文章来源：标新生物

    今日，继GT919于2022月12月20日获得NMPA临床批件后，标新生物（Gluetacs Therapeutics）的第二款分子胶降解剂管线1类新药GT929新药临床研究申请 (IND) 获得国家药品监督管理局药品审评中心（CDE）受理，用于恶性血液肿瘤的治疗。这是标新生物进入临床阶段的第二条产品管线。

      标新生物创始人、董事长兼首席执行官杨小宝表示：“标新生物一直致力于打造分子胶降解剂和双机制降解剂相互融合的药物研发技术平台，除了GT919和GT929之外，其它数个GLUETAC降解剂也已显示良好的开发前景。在此由衷感谢公司全体员工的不懈努力，推动公司在短时间内取得又一个里程碑。我们将持续耕耘，加速推动科研成果的成功转化”。

PRESS RELEASE

Shanghai, China – 16 May 2023

Gluetacs Therapeutics AnnouncesSubmission of IND Application to the CDE for GT929, an IKZF1/3 Targeted Immunomodulatory Drug Candidate

Gluetacs Therapeutics, a ShanghaiTech University-spinout focusing on molecular glue and heterobifunctional degrader development, today announced that it has submitted an Investigational New Drug (IND) application to the Center For Drug Evaluation (CDE) requesting approval to initiate its first-in-human Phase 1 clinical trial of GT919 in patients with relapsed or refractory Non-Hodgkin Lymphoma.

“Submission of the GT929 clinical trial application to CDE based on the GLUETACS® platform is another momentous company milestone that represents years of research from academic pioneers and the tremendous focus and commitments of the team,” said Dr Xiaobao Yang, Founder, Chairman and CEO of Gluetacs Therapeutics. “Besides GT919 and GT929, we have also seen great prospect of more candidates in our pipeline focusing on innovative targeted protein degradation therapies in areas with high unmet medical needs. We look forward to initiating Phase 1 study of GT929 and the collaboration with any potential partners. “