Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting.
Additionally, the Chinese pharmaceutical company announced NMPA clearance to initiate Phase Ib/II clinical trials for HRS-8080, an estrogen receptor (ER) degrading agent, SHR-A1811, an antibody drug conjugate (ADC) targeting HER2, and SHR-A2009, another ADC targeting HER3, in ER positive unresectable or metastatic breast cancer in combination with other therapies. Adebrelimab was also approved for a clinical study in HER2 abnormal advanced solid tumors in combination with SHR-A1811 with/out SHR-8068.
Adebrelimab, a programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), received approval in China in March for the first-line treatment of extensive stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. SHR-A1811 is under multiple Phase I, II, and III clinical studies for advanced solid tumors and advanced breast cancer with HER2 expression or mutation. Overseas, similar products include Roche’s Kadcyla (trastuzumab emtansine) and AZ/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan). HRS-8080, under development for ER positive and ER mutated breast cancer, has no similar product approved for marketing globally, as is the case for SHR-A200. Lastly, SHR-8068 is an in-licensed CTLA-4 monoclonal antibody (mAb), similar to Yervoy (ipilimumab) and Imjudo (tremelimumab).- Flcube.com
