标新生物第二个分子胶管线GT929新药临床研究申请获FDA批准

发布日期：2023-05-16 文章来源：标新生物

今日，标新生物（Gluetacs Therapeutics）第二个分子胶降解剂管线1类新药GT929胶囊获得美国食品药品监督管理局（FDA）批准进入临床试验，用于治疗恶性血液肿瘤。
该管线此前已于2023年7月24日获得国家药品监督管理局（NMPA）批准开展临床试验，预计将在2023年底入组中国I期临床研究首例病人。
这是标新生物继GT919后第二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。

GT919和GT929用于临床一期研究的试验药物

PRESS RELEASE

Shanghai, China – 27 Oct 2023

Gluetacs Therapeutics Announces IND Approval of Its Second Molecular Glue Degrader Pipeline GT929 from FDA

Today, the second molecular glue degrader pipeline of Gluetacs Therapeutics, Class 1 new drug GT929 capsule, was approved by the U.S. Food and Drug Administration (FDA) to initiate clinical trial for the treatment of patients with Hematological Malignancies.

GT929 was previously approved by the National Medical Products Administration (NMPA) for clinical trial on July 24, 2023, and is expected to enroll the first patient in China’s Phase I clinical study by the end of 2023.

This is the second pipeline approved for clinical trials in both China and the U.S. besides GT919, marking another milestone in the globalization process of Gluetacs Therapeutics.