Kelun-Biotech's Sac-TMT and Tagitanlimab Receives Breakthrough Therapy Designation
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced that its TROP2-targeting antibody-drug conjugate, sacituzumab tirumotecan, combined with the PD-L1 monoclonal antibody tagitanlimab, has been granted Breakthrough Therapy Designation by the Centre for Drug Evaluation under the National Medical Products Administration of China.
This designation applies to the initial treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in patients who do not have targetable genomic mutations.
Breakthrough Therapy Designation is given to therapies that show clear advantages over existing treatments and aim to speed up the development and approval of urgently needed medicines.
Sac-TMT is Kelun-Biotech’s core ADC product and is designed to treat multiple advanced solid tumours, including NSCLC, breast cancer, gastric cancer, and gynaecological cancers. It uses a novel linker to attach a belotecan-derived topoisomerase I inhibitor payload with a drug-to-antibody ratio (DAR) of 7.4.
The anti-TROP2 antibody directs the ADC to tumour cells, which internalise the drug and release the active compound KL610023. This agent induces DNA damage, resulting in cell-cycle arrest and tumour cell death.
KL610023 is also released into the tumour microenvironment, creating a bystander effect that can target nearby cancer cells
Sac-TMT is the first domestically developed antibody-drug conjugate (ADC) in China with global intellectual property rights to receive full regulatory approval, and it is also the first TROP2-targeting ADC in the world to be approved for treating lung cancer.
Two additional marketing applications have been submitted in China for sac-TMT in EGFR-mutant NSCLC and HR-positive/HER2-negative breast cancer and are under priority review.
Tagitanlimab is the first PD-L1 monoclonal antibody to receive global approval for the initial treatment of nasopharyngeal carcinoma (NPC). In China, it is authorized for use alongside cisplatin and gemcitabine as a first-line therapy for recurrent or metastatic NPC, and as a standalone treatment for patients who have previously undergone at least two chemotherapy regimens without success.
The Breakthrough Therapy Designation for sac-TMT combined with tagitanlimab underlines Kelun-Biotech’s continued progress in developing new treatment options for cancers with high unmet medical need.
