Hengrui Gains NMPA Approval for Phase III Study of SHR-8068 in PD-L1 Negative NSCLC

Hengrui Gains NMPA Approval for Phase III Study of SHR-8068 in PD-L1 Negative NSCLC

China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study of its SHR-8068 combined with adebrelimab (SHR-1316) and platinum for the first-line treatment of PD-L1 negative advanced or metastatic non-small cell lung cancer (NSCLC).

SHR-8068 and Adebrelimab: Mechanism and Combination
SHR-8068 is a CTLA-4 monoclonal antibody (mAb) licensed by Hengrui. The global market already includes similar products such as Yervoy (ipilimumab) and Imjudo (tremelimumab). Adebrelimab, a PD-L1 monoclonal antibody, received approval in China in March 2023 for the treatment of first-line extensive-stage small cell lung cancer when combined with carboplatin and etoposide.

Clinical Trial and Strategic Implications
The Phase III study will evaluate the efficacy and safety of SHR-8068 in combination with adebrelimab and platinum. This trial represents a strategic move by Hengrui to expand its presence in the oncology space, leveraging its portfolio of immunotherapies to address unmet medical needs in NSCLC.-Fineline Info & Tech