Hengrui Pharmaceuticals Receives NMPA Clearance for Phase II Trial of SHR-4849, SHR-8068, and Adebrelimab in Advanced Solid Tumors

Hengrui Pharmaceuticals Receives NMPA Clearance for Phase II Trial of SHR-4849, SHR-8068, and Adebrelimab in Advanced Solid Tumors

China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received regulatory clearance from the National Medical Products Administration (NMPA) to initiate a multi-center, open-label Phase II trial. The trial will evaluate the combination of SHR-4849, SHR-8068, and adebrelimab (SHR-1316) in the treatment of advanced solid tumors.

Drug Candidates Overview

  • SHR-4849: An in-house developed DLL3-targeting Topo-I-payload antibody drug conjugate (ADC), currently under development for advanced malignant solid tumors. Hengrui entered into a USD 1 billion licensing agreement with IDEAYA Biosciences Inc. (NASDAQ: IDYA), granting the US firm exclusive global rights (excluding Greater China) to the drug.
  • SHR-8068: An in-licensed CTLA-4 monoclonal antibody (mAb). There are two similar products on the global market: Yervoy (ipilimumab) and Imjudo (tremelimumab).
  • Adebrelimab (SHR-1316): A programmed-death ligand 1 (PD-L1) mAb approved in China in March 2023. It is indicated for the treatment of first-line extensive-stage small cell lung cancer when combined with carboplatin plus etoposide.-Fineline Info & Tech