International Department

On January 20th,The National Medical Products Administration (NMPA) approves the innovative humanized monoclonal antibody tagitanlimab (formerly KL-A167) Combination therapy of cisplatin and gemcitabine for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients. ...Read more »

On January 16, 2025, China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). About Limertinib Limertinib ...Read more »

On January 8th, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI343, a potentially best-in-class TOPO1i anti-CLDN18.2 ADC, as monotherapy for the treatment of CLDN18.2-positive advanced pancr...Read more »

On January 8, 2025, 9MW2821 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.9MW2821 is given in combination with toripalimab, an anti-PD-1 monoclonal antibody, for treatment-naïve, unresecta...Read more »

December 3, 2024，the innovative drug Zepzelca (lurbinectedin for injection) has been approved for marketing by China’s National Medical Products Administration (NMPA) through the priority review program. The drug is indicated for the treatment of adult patients with metastatic small cell lung ca...Read more »

On December 31st,China’s National Medical Products Administration (NMPA) has approved VYLOYTM (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growt...Read more »

December 31, 2024，Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlim...Read more »

C-CAR031 is an autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, being studied for the treatment of HCC. It is based on a novel GPC3-targeting CAR-T designed by AstraZeneca using their dominant negative transforming growth factor-beta receptor II dominant negati...Read more »

December 20，2024 ，China’s National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) of DOVBLERON ® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS...Read more »

C-CAR031 is an autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, being studied for the treatment of HCC. The research progress of C-CAR031 in hepatocellular carcinoma (HCC) was presented orally at the American Society of Clinical Oncology (ASCO) annual meeting h...Read more »

GT101 is an autologous cell therapy made of expanded and rejuvenated TIL from the patient’s own tumor. The therapy is administered by harvesting tumor tissue from patients and extracting TIL. The extracted TIL will then be scaled up using Grit Bio’s proprietary manufacturing platform StemTe...Read more »

TAEST16001 cells are genetically engineered autologous T cells expressing high-affinity NY-ESO-1-specific T-cell receptor (TCR) targeting NY-ESO-1 (expressed in a wide range of tumors) positive soft tissue sarcoma (STS) in the context of HLA-A*02:01. A phase I study of in patients with advanced S...Read more »