Company News

Kelun-Biotech will present the results from six clinical studies at the 2025 ASCO Annual Meeting including for innovative TROP2 ADC, anti-PD-L1 antibody, and novel RET fusion inhibitor.

Kelun-Biotech recently receives IND clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for its innovative ADC drug SKB518.

Kelun-Biotech’s Radionuclide-Drug Conjugate (RDC) SKB107 receives IND approval from NMPA for clinical trials investigating the treatment of bone metastases in solid tumors.

Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) is approved for marketing in its second indication of EGFRm NSCLC by the NMPA.

Study Results Abstracts for Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) will be presented at 2025 ASCO Genitourinary Cancers Symposium held in San Francisco from February 13-15, 2025.

Kelun-Biotech’s biosimilar product Cetuximab N01 Injection (达泰莱®, formerly A140) was approved for marketing by NMPA of China.

Kelun-Biotech’s tagitanlimab approved for marketing for second indication in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC.

Kelun-Biotech's innovative ADC SKB445 receives IND approval from NMPA in China.

The second NDA for Kelun-Biotech's innovative HER2 ADC (trastuzumab botidotin) was formally accepted by the NMPA in China.

Kelun-Biotech's Anti-PD-L1 (Tagitanlimab, 科泰莱®) approved for marketing by NMPA of China for 3L+ nasopharyngeal carcinoma.

Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT, 佳泰莱®) approved for marketing by NMPA of China for 2L+ advanced or metastatic TNBC.

Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA Accepted by NMPA for locally advanced or metastatic EGFR-mutant NSCLC.