Sichuan Kelun-Biotech's Core Product Sacituzumab Tirumotecan and Tagitanlimab Combination Receives Breakthrough Therapy Designation for First-Line Treatment of Metastatic Non-Squamous NSCLC by China's NMPA
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that its core product, the TROP2-directed antibody-drug conjugate $(ADC)$ sacituzumab tirumotecan (sac-TMT), in combination with the PD-L1 monoclonal antibody (mAb) tagitanlimab, has been granted Breakthrough Therapy Designation by the National Medical Products Administration in China. This designation is specifically for the first-line treatment of locally advanced, metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. This development marks a significant milestone for the company as it continues to advance its clinical research program, which includes multiple ongoing studies in collaboration with global partners.
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