标新生物首个分子胶降解剂管线GT919新药临床研究申请获FDA批准

发布日期：2023-05-19 文章来源：标新生物

今日，标新生物（Gluetacs Therapeutics）的首个分子胶降解剂管线1类新药GT919胶囊获得美国食品药品监督管理局（FDA）批准进入临床试验，用于恶性血液肿瘤的治疗。

该管线此前已于2022年12月20日获得国家药品监督管理局（NMPA）批准开展临床试验，目前正在中国进行I期临床研究。

这是标新生物首个在中美同时获批临床试验的产品管线，是标新生物全球化进程的又一里程碑。

PRESS RELEASE

Shanghai, China – 19 May 2023

Gluetacs Therapeutics Announces Approval of IND Application from the FDA for GT919, an IKZF1/3 Targeted Immunomodulatory Drug Candidate

Gluetacs Therapeutics, a ShanghaiTech University-incubated company focusing on molecular glue and heterobifunctional degrader development, today announced that it has received the Investigational New Drug (IND) application approval from U.S. Food and Drug Administration (FDA) to initiate its first-in-human Phase 1 clinical trial of GT919 in patients with relapsed or refractory Multiple Myeloma. 

In China, the enrollment of GT919 study is ongoing continuously for patients with relapsed or refractory multiple myeloma. The Approval of the GT919 clinical trial application from FDA is another ground-breaking landmark in the progress of globalization of Gluetacs Therapeutics. We look forward to initiating Phase 1 study of GT919 soon in the US and the collaboration with any potential partners. “