International Department

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 »

December 04，2024，the New Drug Application (NDA) for the combination of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have ...Read more »

GC203 is a novel non-viral vector gene-modified TIL therapy developed leveraging Juncell Therapeutics’ proprietary DeepTIL® cell expansion platform and NovaGMP® gene modification platform. DeepTIL® enables TILs to be potent enough that no IL-2 combination will be required after infusion, an...Read more »

Glioblastoma Multiforme (GBM) is one of the most deadly cancers, and nearly all patients experience recurrence upon the current standard of care for newly diagnosed GBM. The recurrent GBM (rGBM) exhibits a median survival of less than 8 months with limited therapeutic options. TX103 is a CAR-T ce...Read more »

RD13-02 is a universal CAR-T cell product targeting CD7 derived from healthy donors, and intended for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma(T-ALL/LBL). It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-...Read more »