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news.The China’s National Medical Products Administration (NMPA) has granted marketing authorisation to Sichuan Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (sac-TMT), a domestically developed trophoblast cell surface antigen 2 (TROP-2)-directed antibody-drug conjugate (ADC) for the treatment of the adult population with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The approval of sac-TMT is based on the outcomes of the Phase III OptiTROP-Breast01 study. Credit: National Cancer Institute on Unsplash.
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This authorisation marks a first TROP2 ADC and the first fully approved domestically developed ADC for marketing in China.
The approval of sac-TMT is based on the outcomes of the Phase III OptiTROP-Breast01 study, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) for patients with TNBC, compared to chemotherapy.
The study included adult subjects with unresectable locally advanced or metastatic TNBC who had received at least two previous systemic therapies, with a minimum of one for advanced or metastatic disease.
Sac-TMT is a core product of the company with intellectual property rights, targeting advanced solid tumours such as non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, and gynaecological tumours.
The mechanism of sac-TMT involves the detection of TROP2 on the surface of tumour cells by recombinant anti-TROP2 humanised monoclonal antibodies.
In addition to the recent approval, the NMPA has accepted two supplemental new drug applications (sNDAs) for sac-TMT as a monotherapy for patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) who have progressed following EGFR-TKI therapy only or both EGFR-TKI and previous platinum-based chemotherapy, respectively.
In May 2022, Sichuan Kelun-Biotech licensed the exclusive rights to MSD for developing, manufacturing, and commercialising the therapy in all territories outside of Greater China.
Kelun-Biotech CEO Dr Micheal Ge said: “It is a great pleasure to share with you the important milestone moment of the successful approval and launch of sacituzumab tirumotecan in China, which is a significant achievement of Kelun-Biotech’s years of deep-rooted source innovation.
“As the company’s first proprietary TROP2 ADC innovative drug, the successful launch of sacituzumab tirumotecan officially opens up a new pattern for the treatment of patients with 2L+ advanced TNBC. We expect that its excellent clinical efficacy and safety results will significantly enhance the clinical benefits and improve the quality of life of patients with advanced TNBC.
“In the future, we will continue to explore the clinical value of sacituzumab tirumotecan in other indications, maximise the market potential of sacituzumab tirumotecan, and satisfy the clinical needs of patients nationwide.”
