Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a subsidiary under Kelun Pharmaceutical, renowned for its dedication to the research, development, production, commercialization, and international partnership of novel biological and small molecule pharmaceuticals, has announced its receipt of marketing approval in China from the National Medical Products Administration (NMPA). This approval pertains to the first locally developed antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), known as sacituzumab tirumotecan (sac-TMT, previously SKB264/MK-2870). The ADC is approved for adult individuals with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), who have had at least two prior systemic treatments, including one for an advanced or metastatic condition. This historical achievement marks the first TROP2 ADC developed domestically that has received marketing approval in China, and it is the first ADC of such nature fully approved in the country.
The NMPA’s assent leverages favorable outcomes observed during the randomized, controlled phase 3 OptiTROP-Breast01 trial involving adult TNBC patients with inoperable locally advanced or metastatic conditions, who had undertaken at least two prior systemic therapies, including a treatment for advanced or metastatic disease. Sac-TMT exhibited statistically and clinically substantial improvements in progression-free survival (PFS) and overall survival (OS) when juxtaposed with chemotherapy. These findings were showcased at the special clinical science session on next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.
Earlier, the NMPA accepted two supplementary new drug applications (sNDA) aiming at the authorization of sac-TMT as a standalone treatment for patients presenting with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC), following treatment progression on EGFR-TKI therapy alone or both EGFR-TKI and platinum-based chemotherapy.
Dr. Michael Ge, the CEO of Kelun-Biotech, expressed his delight, “Breaking through with the successful endorsement and introduction of sacituzumab tirumotecan in the Chinese market is extraordinarily rewarding. It reflects Kelun-Biotech’s enduring and dedicated innovation efforts. As our first proprietary TROP2 ADC, the introduction of sacituzumab tirumotecan paves the way for new treatment paradigms in addressing advanced TNBC post-second-line therapies. We anticipate that its impressive clinical results will not only augment patient outcomes but will also enhance quality-of-life standards in advanced TNBC cases. Looking ahead, we are committed to further uncovering sacituzumab tirumotecan’s clinical value across different indications, optimizing its market potential, and adequately addressing the clinical demands of patients nationwide.”
Breast cancer is a significant threat to women’s health and lives worldwide. Among the various forms, triple-negative breast cancer is recognized for its distinctive biological traits and is oftentimes referred to as the “most aggressive” breast cancer. In the 2022 analysis of China’s cancer epidemiology, there were approximately 357,000 new breast cancer incidences and 75,000 fatalities among Chinese women annually. In the absence of effective therapeutic targets, traditional chemotherapy remains the primary systemic treatment option for triple-negative breast cancer, despite its limited efficacy and significant adverse effects. It varies from other breast cancer subtypes, necessitating active exploration of novel treatment strategies to advance clinical outcomes.
Sac-TMT is a core product of Kelun-Biotech, embodying a new-generation human TROP2 ADC accompanied by proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological cancers, among others. It integrates a novel linker connecting the payload—a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody ratio (DAR) of 7.4. The ADC specifically identifies TROP2 on tumor surfaces via humanized monoclonal anti-TROP2 antibodies, thereby internalized by tumor cells and subsequently releasing KL610023 within the cells. Functioning as a topoisomerase I inhibitor, KL610023 induces DNA damage, arresting the cell cycle and catalyzing apoptosis. Additionally, KL610023 is released within the tumor microenvironment, enabling a bystander effect, effectively eliminating adjacent tumor cells.
In May 2022, Kelun-Biotech transferred the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) for the global development, manufacture, and commercialization of sac-TMT outside Greater China (Mainland China, Hong Kong, Macao, and Taiwan).
Kelun-Biotech operates as a subsidiary under Kelun Pharmaceutical, focusing on the research, development, manufacturing, commercialization, and global collaborations surrounding innovative biological and small molecule drugs.